PKF South Africa https://cerbalancetafrica.com/ Cerba Lancet Africa Moving To New Headquarters To Deliver Ambitious Growth Plans For Africa

Johannesburg – March 2022 - Cerba Lancet Africa, the leading clinical pathology and medical diagnosis network in Africa, officially opened its new headquarter at 44 Stanley Studio, Milpark, Johannesburg. This is a major milestone for Cerba Lancet Africa, as the team is continuously growing and the move provides a much better workspace, as well as being more spacious and modern.

Johannesburg – March 2022 - Cerba Lancet Africa, the leading clinical pathology and medical diagnosis network in Africa, officially opened its new headquarter at 44 Stanley Studio, Milpark, Johannesburg. This is a major milestone for Cerba Lancet Africa, as the team is continuously growing and the move provides a much better workspace, as well as being more spacious and modern.

The new offices will also allow Cerba Lancet Africa to fulfil its ambitious growth plans for Africa and the commitment to delivering high-quality, cost-effective diagnosis services. To this end, the team will focus on developing a customer-centric culture, improved operational efficiencies and continually investing in employees, with the help of the new ERP system. “We are improving on our entire ecosystem to allow our teams to generate high-quality diagnostics and guide medical decision-making that will better serve our end customers” stated Matthieu Gogué, Corporate General Manager & COO, Cerba Lancet Africa.

Cerba Lancet Africa is gearing up to add value to its African business partners by building a dedicated team. Key supporting and back-office functions, such as HR, supply chain, IT, finance, and marketing are laying the groundwork to standardise and align processes and improve workflow and communications within the entire network.

Cerba Lancet Africa will also consolidate its service offerings by launching this year two strategic divisions; radiology which will reinforce its leading diagnostics service provider position, and a Corporate Health Services division, which will offer a full suite of medical services to businesses across a wide range of industries.

“The new structure should allow Cerba Lancet Africa to better serve our increasing number of customers across the African continent. They can count on the support and the engagement of its shareholders, Cerba Lancet Africa and Lancet Laboratories, to assist in the delivery of the long-term and sustainable strategy” commented Jérôme Thill, Deputy Chief Executive Officer of Cerba HealthCare.

Stephane Carré, VP International and CEO Cerba Lancet Africa, who frequently visited the team since the creation of the Joint Venture in 2019, commended them for “being part of such an incredible journey and having achieved so much in such a short time. Their enthusiasm combined with the potential of the new organization is a winning recipe for our growth across the African continent”.

About CERBA LANCET AFRICA

Cerba Lancet Africa is the leading network of clinical pathology and medical diagnosis in Africa, with the ambition to become the leading diagnostic services provider in Africa, bringing world-class standards of pathology services to patients and medical communities across the continent.

Cerba Lancet Africa is a joint venture created in 2019 with the French group Cerba HealthCare, a leading international player in medical diagnosis, and Lancet Laboratories, the foremost name in clinical pathology in sub-Saharan Africa.

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5/24/2022 12:00:00 PM https://cerbalancetafrica.com/news/press-releases/cerba-lancet-africa-moving-to-new-headquarters/
Cerba Lancet Africa Signs Strategic Partnership With International Clinical Laboratories in Ethiopia

Johannesburg (South Africa) and Addis-Ababa (Ethiopia), 29th September 2022 - Cerba Lancet Africa, a benchmark in the field of medical diagnosis in Africa, today announced it has signed a strategic partnership with International Clinical Laboratories (ICL) Ethiopia, the leading private clinical pathology laboratory in the country serving more than 3 million patients over the past 17 years.

  • The partnership* illustrates Cerba HealthCare’s strategy to support long term health response locally and increase patient access to a broader range of laboratory testing across the continent
  • International Clinical Laboratories (ICL) will leverage the world-class expertise range of Cerba HealthCare and its existing pan-African network Cerba Lancet Africa to sustainably meet the diagnostic tool expectations of patients, physicians and hospitals nationwide.

Johannesburg (South Africa) and Addis-Ababa (Ethiopia), 29th September 2022 - Cerba Lancet Africa, a benchmark in the field of medical diagnosis in Africa, today announced it has signed a strategic partnership with International Clinical Laboratories (ICL) Ethiopia, the leading private clinical pathology laboratory in the country serving more than 3 million patients over the past 17 years.

Cerba Lancet Africa is majority owned by the French group Cerba HealthCare, benefiting from a unique positioning on the whole value chain of medical diagnosis: alongside a worldwide presence through its expertise in clinical pathology for clinical trials, the Group has sound positions in Europe and Africa thanks to its historical activities in routine and specialty clinical pathology. Cerba HealthCare set foot on the African continent in 2019 where it operates today in 15 countries under the Cerba Lancet Africa umbrella, providing access to accurate diagnosis and high-quality care to more almost 3 million people yearly.

In Ethiopia, ICL stands as the reference player in clinical pathology with unparalleled experience and reputation. Its strong presence all over the country allowed the ICL’s team to play a critical role in handling the COVID-19 pandemic, which has exposed vulnerabilities of the numerous health systems across the globe and specifically the African one, together with the need for increased testing and diagnostic services.

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10/3/2022 12:00:00 PM https://cerbalancetafrica.com/news/press-releases/cerba-lancet-africa-signs-strategic-partnership-with-international-clinical-laboratories-in-ethiopia/
World-class medical diagnostics for Africa

Backed by over 50 years of expertise, Cerba Lancet Africa is pioneering a pan-African diagnostics network to better lives across the continent. We speak to CEO Stéphane Carré, to learn more

We acted promptly in 2020, despite the many pressures and bottlenecks induced by the COVID-19 pandemic on the supply chain worldwide. We mobilised a lot of capital to setup and deploy more than 10 PCR platforms by creating laboratories dedicated to combatting COVID-19.”

The words of Stéphane Carré, CEO of Cerba Lancet Africa and Vice President International for Cerba Healthcare lay bare both the international challenges of the past two years, as well as the company’s ability to adapt and operate all over Africa, in light of the COVID-19 pandemic.

Cerba Lancet Africa is a clinical pathology and medical imaging laboratory service provider serving over three million patients per year. The company has the largest amount of diagnostics equipment in Africa, as a private operator, with laboratory facilities ranging from basic level to the most advanced across the continent. On top of this, Cerba Lancet Africa provides medical logistics and regulatory services to ensure the provision of high-quality equipment and services supported to African communities in a multitude of different countries.

“Cerba Lancet Africa is the leading network of clinical pathology and medical diagnosis in Africa, with the ambition to become the leading diagnostic services provider offering world-class standards of pathology services to patients and medical communities across the continent,” S. Carré tells us.

Cerba Lancet Africa operates a network of 170 sites, across Botswana, Gabon, Ghana, Kenya, Mozambique, Nigeria, Rwanda, Eswatini, Tanzania, Uganda, Zambia and Zimbabwe, ensuring each facility is conveniently located for the communities. The company offers a portfolio of over 4,000 pathology testing services ranging from routine screening tests to highly specialised clinical testing for research, screening, industrial, and occupational health, under the direction of more than 20 pathologists. Cerba Lancet Africa’s pathologists assist doctors in making diagnoses and taking informed decisions, and this allows doctors to tailor appropriate treatments about their patients’ health or any medical conditions

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7/18/2022 12:00:00 PM https://cerbalancetafrica.com/news/in-the-news/world-class-medical-diagnostics-for-africa/
Detection of New SARS-COVID19 Variants on PCR Testing

Confirmation of detectability of the new mutated variants of SARS-CoV-2 using Seegene AllplexTM 2019-nCoV PCR Assay at Pathologists Lancet Kenya_PLK

Confirmation of detectability of the new mutated variants of SARS-CoV-2 using Seegene AllplexTM 2019-nCoV PCR Assay at Pathologists Lancet Kenya_PLK

We are pleased to confirm that the new mutated variants of SARS-COV-2, including the B.1.1.7 UK variant and the SA variant, can be detected with the AllplexTM 2019-nCoV PCR Assay that is used at Pathologists Lancet Kenya_PLK.

*Specialized in-silico analysis by Seegene has confirmed that the COVID-19 PCR test covers the new variants of SARS-CoV-2 virus specifically including the B.1.1.7 lineage that emerged in the United Kingdom (UK variant) and also the B.1.351 lineage that emerged in South Africa (SA variant).

The Seegene AllPlexTM Assay is able to detect these variants because the assays are designed to detect individual multiple gene targets of SARS-CoV-2 simultaneously.

It therefore means that we are rest assured of being able to diagnose those infected with COVID-19 using PCR test on swab samples collected and tested with the highly sensitive and specific PCR assay employed at Pathologists Lancet Kenya_PLK - as the assay is able to detect both the old and the SARS-CoV-2

Coronavirus

*The in-silico analysis showed that no mismatches were found in RdRP gene region, while few mismatches were found in the S gene region, but despite the few mismatches, the overall detectability of Seegene COVID-19 assays may not be affected by these mutations. Whereas the sensitivity variances can be affected by the mismatches, these are expected to be limited because of the complimentary multiple oligonucleotides(oligo) for each gene region in the assays. Further detailed information about the in-silico analysis can be availed from Seegene.

ABOUT THE SARS-COV-2 RT-PCR TEST AT PATHOLOGISTS LANCET KENYA

At Pathologists Lancet Kenya_PLK we've exclusively used the Seegene AllplexTM 2019-nCoV assay since April 2020 and conducted over 100,000 tests as at 25th of January 2021.

The Seegene AllplexTM assay is a reverse-transcriptase (rt) real-time (RT) polymerase chain reaction (PCR) that is a nucleic acid amplication test (NAAT) for detection of viral RNA for SARS-CoV-2 the virus that causes COVID-19.

The Seegene AllplexTM PCR assay has a unique feature that identies 3 different target genes (E, RdRP and N genes) in a single reaction tube which allows for highly accurate results and maximizes the throughput for high volume testing.

The Seegene AllplexTM RT-PCR assay is FDA-approved and has been independently evaluated by FIND “Foundation for Innovative New Diagnostics” scoring it at 100% sensitivity and 100% specificity

SARS-Cov-2

Technical information on the SARS-COV-2 RT-PCR Test at Pathologists Lancet Kenya_PLK

  • The Seegene Allplex rtRT-PCR assay is an automated molecular test at PLK that utilizes three target genes protocol (rather than two or single gene assay protocol) in deciding the SARS-COV-2 status on a sample analyzed in a single reaction tube as multiplex PCR test per sample, thus serving as both screening and confirmatory test.
  • The interpretation of results is as per manufacturer's recommendation and in-line with WHO guideline that “In areas where COVID-19 virus is widely spread a simpler algorithm might be adopted in which, for example, screening by rtRTPCR of a single discriminatory target is considered sufcient (The viral genes targeted so far include the N, E, S and RdRP genes)”.
  • The Segeene Allplex assay is duly approved by Ministry of Health's regulatory bodies and validated against NIC laboratory and Lancet Laboratories South Africa
  • The PCR tests at PLK's Main Lab, which is registered and licensed as a National Class F Reference Laboratory by KMLTTB, are conducted by trained medical laboratory technologists who are also licensed by KMLTTB, with supervision from a PhD Molecular Scientist Doctor and several pathologists who work as a team to check and ensure accuracy of results.
  • Automated data interpretation and LIS interlocking with the proprietary Seegene Viewer software enables a seamless and rapid review of results with intelligent interpretation.
  • Accurate interpretation of the SARS-COV-2 PCR test results is enabled by the Seegene Viewer software which is designed to automate data analysis for multiplex real-time PCR assay allowing identication and differentiation for both Ct value of multiple targets in a single channel as well as melting curve analysis.
  • The results from automated interpretation on Seegene Viewer are further reviewed by a laboratory technologist and pathologist on the Seegene Viewer before results are interfaced to the LIMS and additionally reviewed for release of the report with applicable interpretative comments as relevant based on clinical and epidemiological information.
  • At PLK we interpret and report any viral target gene detected with a Ct lower or equal to the cut-off of 40 as positive. Ct > 40 is considered negative.
  • Single gene results with high Ct values (low viral RNA levels) are issued with comments to highlight the possible implication of the results which include a sample at concentrations near or below the limit of detection of the target gene not amplied or a mutation in the corresponding target gene not amplied.
  • From experience, the cases with single-gene only or low viral load are often seen in late-stage of infection but can also be seen early in the infection, thus it is important to correlate clinically and epidemiologically
  • Our PCR laboratory has been continuously undertaking internal quality control and also participated in local and international external quality assurance (EQA) since May 2020
  • We have consistently scored 100% in all the different EQA programs in over 10 consecutive cycles that include the LGC Thistle, NPHLS-MOH, KEMRI and RCPAQA prociency testing programs
  • In addition, PLK has undergone onsite inspection and audit by experts from Kenya Medical Practitioners and Dentists Council (KMPDC) and Kenya Medical Laboratory Technicians and Technologists Board (KLMTTB) whose reports confirmed the accuracy and validity of our test results
  • Our laboratory was the rst in Africa - in August 2020, and so far the only in the region, to receive ISO15189 accreditation specic for COVID-19 PCR test.

References

  • https://www.fda.gov/media/137178/download
  • https://apps.who.int/iris/handle/10665/330676
  • http://www.seegene.com/covid19_detection
  • http://www.seegene.com/assays/allplex_2019_ncov_assay
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COVID Press Statement

The government has issued an official confirmation that Pathologists Lancet Kenya  is among the laboratories accredited to conduct COVID-19 testing in the country as the Ministry of Health strives to expand testing of Kenyans to help curb the pandemic.

Government of Kenya officially confirms pathologists Lancet Kenya as an accredited lab for Covid-19 testing

The government has issued an official confirmation that Pathologists Lancet Kenya is among the laboratories accredited to conduct COVID-19 testing in the country as the Ministry of Health strives to expand testing of Kenyans to help curb the pandemic.

A communication by the Ministry's Director General Dr. Patrick Amoth dated 24th April, 2020 reads: “Pathologists Lancet Kenya like the other laboratories has validated its PCR assays for COVID-19 against the National Influenza Centre (NIC) which uses recommended primers and probes from the World Health Organization (WHO).”

“The Ministry of Health appreciates the contributions of all the various laboratories that have been validated to conduct COVID-19 testing in the country and whose results form part of the daily tally that the Ministry shares with the public.”

In response, Lancet’s Group MD and Consultant Pathologist Dr. Ahmed Kalebi said: “We are committed to supporting government's efforts in enhancing COVID-19 testing as that’s the key pathway of tackling this global pandemic effectively.”

He added: “Lancet obtained the government's approval on 4th April after which we launched testing locally on April 6th 2020. Since then, we’ve conducted more than 1700 PCR tests for COVID-19 despite the initial challenges of securing testing kits and reagents from our global suppliers. We currently have capacity to process between 180-270 samples a day with room to scale up to over 1000 samples a day as demand may dictate. The Turn-Around-Time for the tests is 24 hours.”

The lab employs various sample collection methods for COVID-19 testing including the drive-through system in which patients are attended to whilst in their cars; this is meant to cut potential risks of disease transmission to others. Lancet’s COVID-19 testing is offered only to patients referred by their doctors based on case definition or risk factors with priority given to hospitalized patients, those with underlying conditions, the elderly as well as healthcare workers.

Edwin Mosongo, Business Development & Marketing Manager 0724 702 040 / 0703 061 000 Edwin.mosongo@lancet.co.ke

ABOUT PATHOLOGISTS LANCET KENYA

Pathologists Lancet Kenya is an internationally-accredited laboratory that is ISO15189 certified since 2010. We’re duly registered and licensed as a Class F National Reference Laboratory by the Kenya Medical Laboratory Technicians and Technologists Board (KMLTTB) as well as the Kenya Medical Practitioners and Dentists Council (KMPDC). Pathologists Lancet Kenya is the first and only World Anti-Doping Agency (WADA)-approved lab in Sub-Saharan Africa since August 2018.Our branch network spreads across the country to ensure maximum coverage to our clients with other value-added services such as home collections and Courier services, aimed at personalized and convenient care.

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4/26/2020 12:00:00 PM https://cerbalancetafrica.com/news/in-the-news/covid-press-statement/
Letter from MOH for Covid-19 Testing

A letter from the Ministry of Health Director General For Health regarding Pathologists Lancet Kenya testing for COVID-19

All the laboratories undertaking PCR testing for COVID-19, both Government and private laboratories, have validated their PCR assays against the laboratory assay at the National Influenza Center (NIC) which uses recommended primers and probes from the World Health Organization.

Pathologists Lancet Kenya ('Lancet') liek the other laboratories has validated its assay against NIC and successfullly luanched its PCR test locally on 6th of April 2020.

Lancet's Main Laboratory in Nairboi is duly registered and licensed to practise by the Kenya Medical Laboratory Technicians and Technologists Board (KMLLTB) and the Kenya Medical Practicioners and Dentists Council (KMPDC). Lancet is also ISO15189 certified by SANAS.

The Ministry of Health appreciates the contribtions of all the various laboratories that have been validated to conduct COVID-19 testing in the country and whose results form part of the daily tally that the ministry shares with the public.

Download Letter from MOH for Covid-19 Testing

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4/24/2020 12:00:00 PM https://cerbalancetafrica.com/news/in-the-news/letter-from-moh-for-covid-19-testing/
News on Lancet at Goodlife Launch

Goodlife Pharmacy and the Lancet Group of Labs have inked a collaborative partnership deal that will, from this month, see Lancet establish and operate laboratory patient service centres within selected Goodlife Pharmacy stores to enable easier, better and more convenient access to quality lab test services to patients and health consumers.

Goodlife Pharmacy and the Lancet Group of Labs ink deal to offer quality lab tests

Goodlife Pharmacy and the Lancet Group of Labs have inked a collaborative partnership deal that will, from this month, see Lancet establish and operate laboratory patient service centres within selected Goodlife Pharmacy stores to enable easier, better and more convenient access to quality lab test services to patients and health consumers.

In his speech, Dr. Kalebi explained how the innovative partnership brings together Goodlife’s and Lancet’s mutual objective to provide a differentiated new level of quality services closer to the people who won’t need to necessarily go to medical facilities such hospitals or medical clinics to access lab tests. Through this partnership with Goodlife’s growing network, Lancet’s laboratory footprint will be doubled across Kenya, enabling patients and health consumers to access a wide range of quality laboratory services in a convenient and comfortable setting where they frequent during their regular routines.

In his speech, Mr. Amaan Khalfan, emphasized on how the two brands are associated with quality and excellence in services, which formed the natural attraction for the partnership. He expressed his excitement on how this partnership will ensure that Goodlife customers will be able to now access internationally accredited laboratory testing in the convenience of Goodlife Pharmacy stores unlike other pharmacies that run tests without having duly registered laboratories.

The first six (6) Lancet@Goodlife patient service centres have already been set-up at Greenspan Mall, Ridgeways mall Kiambu, Valley Arcade Mall Lavington, Langata Road Karen, Rupa’s Mall Eldoret and Westgate Mall in Westlands. These will be followed by more than 30 other centres expected to be launched this year in Kenya and in Uganda.

These lab service centres are being co-branded “Lancet at Goodlife” or “Lancet@Goodlife” labs, offering lab services to patients in easily accessible, secure, convenient and comfortable environments provided by Goodlife stores, whereby patients will be served in dedicated and customised phlebotomy rooms located within selected Goodlife stores across the country. Patients and health consumers will also be able to check-in at the pharmacy store and be reviewed at the lab patient service centre. All samples will be collected professionally, handled to the highest possible standards, and sent to an accredited Lancet laboratory facility where tests will be carried out, with results availed to the patient and designated doctor electronically.

With the convenient location of Goodlife stores, this partnership will enable patients coming from seeing their doctors with lab and pharmacy prescriptions, to access both services with one visit.

About Goodlife:

Goodlife Pharmacy is a fast-growing Pharmacy and health hub and only one of its kind in East Africa. Founded in 2013, the company provides trusted pharmaceuticals, personal care and beauty products to customers across the population from its convenient locations – with a total reach of over 1.2 million people.

Goodlife also offers a range health services including Blood Pressure, Blood Glucose, Body Mass Index, Malaria and Family Nutrition, Doctor Consultations, Laboratory Services in selected locations.

About Lancet:

Pathologists Lancet Kenya Limited is part of the Lancet Group of Laboratories, originally founded in South Africa and home-grown in Africa to become a leading pathology laboratory service in the continent.

They provide vital diagnostic, monitoring and screening testing from routine to specialised and esoteric tests through standalone laboratory facilities and in partnership with other institutions/organizations.

Committed to providing diagnostic excellence, Lancet adhere to international criteria set out according to ISO Standard 15189 in all our service points. Our main laboratory is ISO15189 certified and accredited by SANAS since 2010, while our other key branch laboratories are accredited by KENAS.

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2/21/2022 12:00:00 PM https://cerbalancetafrica.com/news/in-the-news/news-on-lancet-at-goodlife-launch/
MDS Lancet Laboratories Ltd won Customers’ Choice Medical Diagnostic Company Of The Year 2021

The 2021 National Customers’ Choice Awards recognizes the brand that consistently delivers quality products or services to its customers and honors companies and individuals who go that extra mile for their customers .

The 2021 National Customers’ Choice Awards recognizes the brand that consistently delivers quality products or services to its customers and honors companies and individuals who go that extra mile for their customers .

The awards event was organized by KN Unique Communications, one of the leading corporate events management companies in Ghana, with brand engagement across the world on the 15th of October, 2021.

A total of 30 companies and 4 individuals were honoured at the 2021 National Customers’ Choice Awards Ghana which seeks to recognize outstanding businesses through the lens of the customer.

Oheneba Kwabena Kena, the Event Director noted that “It is a true reflection of the marketplace as it represents the views of consumers and buyers across the nation. This award recognizes the brand that consistently delivers a high level of service to its customers. Each year, the KN Unique Communications will recognize the best companies for their earnest efforts in business excellence and keeping the customer’s best interests in mind.”

He stated that “The National Customers’ Choice Awards Ghana (NCCAG) is an event organized to solely recognize business excellence by conducting a comprehensive and objective accurate independent market research survey, to determine brand reputation, customer satisfaction and business excellence for the quality of their service, value, professionalism and integrity.”

MDS Lancet Laboratories Ltd won Customers’ Choice Medical Diagnostic Company Of The Year.

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10/19/2021 12:00:00 PM https://cerbalancetafrica.com/news/in-the-news/customers-choice-medical-diagnostic-company-of-the-year-2021/
Improving access to quality lab tests among private health care providers in Kenya

Gold Star Kenya and Pathologists Lancet Kenya have entered into a strategic partnership that will see over 100 private health facilities linked to Pathologists Lancet Kenya from all over the country.

Gold Star Kenya and Pathologists Lancet Kenya have entered into a strategic partnership that will see over 100 private health facilities linked to Pathologists Lancet Kenya from all over the country. The facilities under Gold Star Kenya Network franchise will benefit from quality assured and affordable lab tests provided by Pathologists Lancet Kenya.  

Speaking on behalf of Pathologists Lancet Kenya, Managing Director and CEO Mwende Musunga said, “One of our key objectives is to increase quality diagnostic care to patients through strategic partnerships, and being part of this healthcare network will ensure patients live healthy lives. We are delighted that with this partnership, we will be able to achieve our goal by increasing accessibility to quality diagnosis to a wider pool of patients."

In the past, Gold Star Kenya and Pathologists Lancet Kenya have worked together to improve HIV services through quality assured and subsidized HIV testing services including HIV treatment to reduce viral load to undetectable levels.

 “We are excited about this partnership and for us, at Gold Star Kenya, multi-sectoral and multi-disciplinary collaboration is the future solution to gaining ground in private health sector quality service delivery. Our widespread Gold Star private sector network of health facilities and medical practitioners and most importantly – the patients (our primary beneficiaries) will now be able to access high-quality and affordable lab tests from a globally reputable and accredited firm, Pathologists Lancet Kenya,” said Dr. Nyawira Gitahi, Executive Director, Gold Star Kenya.  

The private sector in the past has not had adequate support to address the challenges of quality, high cost of lab tests, infrastructure, and sample referral networking. Over the past year, there has been reduced funding in the supply chain which has resulted in many patients in both public and private facilities not being able to access viral tests as prescribed in policy guidelines. 

Dr. Charles Wahome, Chief Pathologist at Pathologists Lancet Kenya said, “In today’s world, we have innovative ways of testing for diseases such as HIV/AIDS. The availability of resources, and expertise have enabled us to advance our offering in different diagnosis and also venture into this partnership. We strongly believe in offering patients quality tests to improve their health. We hope that with this partnership, we will continue to do so with the added pool of patients to our portfolio.”

 This collaboration will improve access to ISO 15189 accredited laboratory services covering HIV related tests (Viral Load), Antenatal care profile, among many other tests. This will positively impact the quality of diagnosis and access to safe health care services in the private sector. 

Gold Star Kenya is a leading local Kenyan NGO implementing quality sustainable community health and development programs that cover reproductive, maternal, child, and adolescent health; HIV/TB, NCD, and nutrition. 

About Pathologists Lancet Kenya

Pathologists Lancet Kenya Ltd is a leading pathology and laboratory medicine service provider in Kenya with subsidiaries in Uganda, Tanzania and Rwanda. Pathologists Lancet Kenya provides vital diagnostic, monitoring, and screening testing from routine, to specialized and even esoteric tests across East Africa region.

Pathologists Lancet Kenya operates ethically, efficiently, and effectively, striving to continually improve its services by remaining at the cutting edge of technology while adhering to international criteria set out according to ISO Standard 15189. Regional referral and key hub laboratories in East Africa are all SANAS, KENAS or SADCAS accredited.

Pathologists Lancet Kenya is part of Cerba Lancet Africa, a leading network of clinical pathology and medical diagnosis in Africa, with the ambition to become the leading diagnostic services provider in Africa, bringing world-class standards of pathology services to patients and medical communities across the continent. Cerba Lancet Africa operated a network of 170+ laboratories across Kenya, Uganda, Tanzania, Uganda, Rwanda, Botswana, Gabon, Ghana, Mozambique, Nigeria, Swaziland, Zambia and Zimbabwe.

For further media queries kindly contact us via  communications@lancet.co.ke 

About Gold Star Kenya

Gold Star Kenya is a Non-Profit, local Non-Governmental Health Organization that focuses on empowering communities for better health and drawing its expertise from being involved in various projects in Kenya and collaborating with diverse public and private sector partners.

Gold Star Kenya aims at improving health outcomes of the communities as well as being positioned as an institution that stands for quality and results-driven interventions. It has achieved this primarily through its flagship social franchise health programs.

It was established and registered in Kenya in 2010 as a Non-Profit Health Organization and has its roots in the Gold Star Network (GSN), a social franchise initiative established in 2006 by Family Health International (FHI 360) to promote comprehensive HIV care and treatment through a Network of Private Healthcare Providers in Kenya. It leveraged on the capacities established through the implementation of the public sector HIV prevention, care, treatment, and support programs funded by the United States Agency for International Development (USAID), GSN sought to expand access to quality services through innovative public-private partnerships.

Gold Star Kenya has continued to implement programs with support from the United States Agency for International Development (USAID), Safaricom Foundation, Triggerise, and in collaboration with the Government of Kenya and diverse partners that include Family Health International (FHI 360), PS Kenya, Toto Health and the various service providers that form the membership of the Gold Star Network.

GS Kenya’s current health programs target strengthening the healthcare systems, high quality integrated HIV/TB prevention, care, treatment, and management of priority health conditions that include Comprehensive Reproductive Health, for mothers, children, adolescents, and young women, economic empowerment activities, nutrition services as well as malaria management and addressing the growing burden of Diabetes and other non-communicable diseases. 

 This is done through the delivery of comprehensive health service interventions to key populations, and strengthening public-private partnerships for improved community linkages to products and services.

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4/28/2022 12:00:00 PM https://cerbalancetafrica.com/news/in-the-news/improving-access-to-quality-lab-tests-among-private-health-care-providers-in-kenya/
MonkeyPox

Monkeypox virus is an enveloped double-strain DNA virus of the Poxviridae family. Orthopoxvirus genus. There are 2 distinct genetic clades, called the Central Africa and West African clades, depending on where they are originally described. The Central African clade causes more severe diseases. Various animal species are the natural hosts of this virus, mainly rodents, tree squirrels and some non-human primates.

Monkeypox virus is an enveloped double-strain DNA virus of the Poxviridae family. Orthopoxvirus genus. There are 2 distinct genetic clades, called the Central Africa and West African clades, depending on where they are originally described. The Central African clade causes more severe diseases. Various animal species are the natural hosts of this virus, mainly rodents, tree squirrels and some non-human primates.

The incubation period ranges from 5- 21 days. Initially the infection (lasting from 0-5 days) is characterized by fever and Lymphadenopathy. The rash or skin eruptions usually occurs 1-3 days after the onset of fever, affecting mainly the face, palms of the hands, soles of the feet, oral mucosa, genitalia and sometimes the conjunctivae.

The rash is initially maculopapular, then evolves into vesicles and thereafter into pustules which crust over with umbilication and finally desquamation and scarring. In contrast to chickenpox (VZV), the rash of Monkeypox is not painful or itchy and all lesions are in the same stage of evolution.

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7/18/2022 12:00:00 PM https://cerbalancetafrica.com/news/newsletters/monkeypox/
Drug Testing

This guide serves to inform you of the different types of Drug tests available, what type of test to choose, and under which circumstances. Drugs can be divided into legally prescribed drugs like: Benzodiazepines (E.g. Valium), Opiates and other Analgesics, and Illicit drugs like: Amphetamines, Vocaine and Marijuana. Prescription drugs are often abused and can also be obtained illicitly. Individuals who are abusing drugs display clinical signs that are associated with the drug of abuse.

This guide serves to inform you of the different types of Drug tests available, what type of test to choose, and under which circumstances. Drugs can be divided into legally prescribed drugs like: Benzodiazepines (E.g. Valium), Opiates and other Analgesics, and Illicit drugs like: Amphetamines, Vocaine and Marijuana. Prescription drugs are often abused and can also be obtained illicitly. Individuals who are abusing drugs display clinical signs that are associated with the drug of abuse.

LABORATORY TESTING

The laboratory is asked to test patient samples for drugs when drug abuse is suspected. There are 2 general test categories available: Screening tests and Confirmation tests.

  • The screening test is to separate patients that are negative from those that are not.
  • The samples that test not negative (i.e. positive) with the screening test, should be subjected to a confirmation test.
  • The confirmation test will identify the specific drug present, or if the confirmation test is negative classify the screening test result as a false-positive screening test.
  • Immunoassays are also available as a test performed by large automated analysers in the laboratory. The sample is placed in a tube/container and sent to the laboratory for testing.
  • These tests are done for specific drug classes;these have to be specifiedon the request form. If more than 1 drug class is needed, for example cannabis and opiates, it has to be specified.
  • This type of testing is quick; the tests pick up the drugs easily and are easy to perform. The result is reported as negative below a certain cut-off. This cut-off is often determined by the manufacturer, or a legal cut-off can be used.
  • These tests are also prone to cross-reactions, as seen with Codeine and morphine (both give positive opiate screening results).
  • Another example is Valiumand Dormicum, both are benzodiazepines, but they don't give the same screening result. Valium will give a higher result than a similar amount of Dormicum. Stocrin, an anti-retroviral agent, can give a false- positive cannabis result with certain test systems.
  • Above the cut-off the result is reported as a numerical value. In urine samples, although the concentration of the drug is obtained, the result gives no indication of the physical state of the urine sample donor at the time of collection.
  • As with near patient testing, laboratory testing is also inexpensive, however there are limitations to both types of screening tests. The limitations of all immunoassays, near patient and laboratory automated, include: only drug classes are tested for (e.g. opiates), NOT the specific drug (e.g. codeinevs. morphine – the one a common pain killer, the other a highly controlled drug used for specific reasons).

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7/13/2022 12:00:00 PM https://cerbalancetafrica.com/news/newsletters/drug-testing/
Interpretation of COVID-19 RT PCR Positive & Negative Results on Sequential Samples

RT-PCR for SARS-CoV-2 is a diagnostic test designed for detecting the virus in respiratory samples of symptomatic individuals.

  • It is therefore very specifc, so positive results are real sensitivity however is lower and false negative results may occur in up to 20% of swabs done, especially in mild or asymptomatically infected individuals.
  • Referring doctors and patients usually have difficulty in interpreting these results, particularly when performed sequentially on patients, resulting in negative/positive or positive/negative discordances.

RT-PCR for SARS-CoV-2 is a diagnostic test designed for detecting the virus in respiratory samples of symptomatic individuals.

  • It is therefore very specifc, so positive results are real sensitivity however is lower and false negative results may occur in up to 20% of swabs done, especially in mild or asymptomatically infected individuals.
  • Referring doctors and patients usually have difficulty in interpreting these results, particularly when performed sequentially on patients, resulting in negative/positive or positive/negative discordances.

Reasons for these discordances include:

A positive result followed by a negative one:

  • "NICD" recommends that patients who test positive are treated as such and isolated and their contacts traced.

A low positive result (ct value37-40) may be followed by a second negative swab if:

  • i. The patient is nearing the end of their infection and has stopped secreting virus
  • ii. The second swab wasn’t taken from infected epithelium resulting in a false negative result
  • iii. The patient is an intermittent secretor and was not secreting virus when the second swab was taken
  • iv. The second result was obtained using a less sensitive assay than the first one

The complex viral dynamics of this infection, complicated by the differing sensitivities of assays used by various laboratories, causes result discordances and variable RNA shedding at different times can cause results discordant between different laboratories.

Note: the HIV-1 DNA PCR only detects HIV-1. If infection with HIV-2 is suspected, an HIV-2 PCR can be done.

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7/13/2022 12:00:00 PM https://cerbalancetafrica.com/news/newsletters/interpretation-of-covid-19-rt-pcr-positive-negative-results-on-sequential-samples/
Cervical Cancer

'UNDERSTANDING CERVICAL CANCER?

The cervix is the lowermost part of the uterus (womb) that leads to the vagina. It connects the Vagina to the Womb.

Any of the following could be signs or symptoms of cervical cancer:

  • Blood spots or light bleeding between or following periods
  • Menstrual bleeding that is longer and heavier than usual
  • Bleeding after intercourse, douching, or a pelvic examination
  • Increased vaginal discharge
  • Pain during sexual intercourse

'UNDERSTANDING CERVICAL CANCER?

The cervix is the lowermost part of the uterus (womb) that leads to the vagina. It connects the Vagina to the Womb.

Any of the following could be signs or symptoms of cervical cancer:

  • Blood spots or light bleeding between or following periods
  • Menstrual bleeding that is longer and heavier than usual
  • Bleeding after intercourse, douching, or a pelvic examination
  • Increased vaginal discharge
  • Pain during sexual intercourse
  • Bleeding after menopause
  • Unexplained, persistent pelvic and/or back pain

IF YOU NOTICE ANY OR ALL OF THESE SYMPTOMS, PLEASE VISIT THE HOSPITAL SO THAT YOUR DOCTOR CAN CHECK FOR THE FOLLOWING TESTS USED TO DIAGNOSE CERVICAL CANCER:

  1. Bimanual pelvic examination and sterile speculum examination. In this examination, the doctor will check for any unusual changes in the patient's cervix, uterus, vagina, ovaries, and other nearby organs
  2. Pap test. During a Pap test, the doctor gently scrapes the outside and inside of the cervix, taking samples of cells for testing.
  3. HPV typing test. An HPV test is similar to a Pap test. The test is done on a sample of cells from the cervix. The doctor may test for HPV at the same time as a Pap test or after Pap test results show abnormal changes to the cervix. Certain types or strains of HPV, called highrisk HPV, such as HPV16 and HPV18, are seen more often in women with cervical cancer and may help confirm a diagnosis
  4. Colposcopy. Colposcopy can also be used to help guide a biopsy of the cervix. During a colposcopy, a special instrument called a colposcope is used. The colposcope magnifies the cells of the cervix and vagina, similar to a microscope. It gives the doctor alighted, magnified view of the tissues of the vagina and the cervix.
  5. Biopsy. A biopsy is the removal of a small amount of tissue for examination under a microscope. Other tests can suggest that cancer is present, but only a biopsy can make a definite diagnosis.

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Prostate Specific Antigen

Prostate Specific Antigen (PSA), is a protein secreted by the acinar cells of the Prostate, and is highly specific for the Prostate. Serum PSA levels are useful for determining the extent of Prostate Cancer, and assessing the response to therapy. However, it is NOT Prostate cancer specific and other conditions such as: Benign Prostatic hyperplasia (BPH) or Prostatitis can affect PSA levels.

  • PSA is commonly used as a tool to detect Prostate Cancer, but its role in screening programmes is widely debated and controversial.

Clinical utility:

PSA has a half-life of 2.2 days. Where levels are increased by different Benign conditions, the time to return to baseline levels is variable.

Prostate Specific Antigen (PSA), is a protein secreted by the acinar cells of the Prostate, and is highly specific for the Prostate. Serum PSA levels are useful for determining the extent of Prostate Cancer, and assessing the response to therapy. However, it is NOT Prostate cancer specific and other conditions such as: Benign Prostatic hyperplasia (BPH) or Prostatitis can affect PSA levels.

  • PSA is commonly used as a tool to detect Prostate Cancer, but its role in screening programmes is widely debated and controversial.

Clinical utility:

PSA has a half-life of 2.2 days. Where levels are increased by different Benign conditions, the time to return to baseline levels is variable.

The common causes of an elevated PSA are:

A) Perineal trauma:

Mechanical manipulation of the Prostate during biopsy or transurethral resection of the Prostate (TURP) can significantly affect PSA. In a study of 101 men who underwent one of these procedures, it was determined that PSA levels should not be measured for at least 6 weeks thereafter. In the same study, the median change in PSA level was of a lesser magnitude following Cystoscopy.

  • Digital Rectal Examination (DRE) has minimal effect on PSA levels. (Leading to transient elevations of 0.26 – 0.4 ng/ml).
  • Sexual activity can also elevate PSA levels by approximately 0.4 - 0.5 ng/ml.

B) Infection and inflammation:

  • Prostatitis, with or without active infection, is an important cause of an elevated PSA. Levels as high as 75 ng/ml have been reported. Many physicians will make a presumed diagnosis of infection, initially treating a patient with an isolated increase in PSA with antibiotics and repeating the PSA measurement afterwards.
  • A reduction in PSA levels can be expected if prostatitis with infection was solely responsible for the elevation. However, prostatitis can often exist without active infection, in which case the PSA will not normalise after treatment with antibiotics. Serum PSA should only be repeated about 2 - 4 weeks after completion of treatment for reassessment.

C) Benign Prostatic hyperplasia:

There is a high prevalence of this condition in men older than 50 years of age, and serum PSA levels in patients with BPH overlap considerably with those obtained from men who have Prostate cancer.

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7/13/2022 12:00:00 PM https://cerbalancetafrica.com/news/newsletters/prostate-specific-antigen/
Hepatitis B

Hepatitis B is inflammation of the Liver due to an infection with the Hepatitis B virus. The severity of the disease can range from a mild illness lasting only a few weeks (called acute infection), to a lifelong, serious (and potentially deadly) illness (called chronic infection.)

Understanding what Hepatitis B is?

Hepatitis B is inflammation of the Liver due to an infection with the Hepatitis B virus. The severity of the disease can range from a mild illness lasting only a few weeks (called acute infection), to a lifelong, serious (and potentially deadly) illness (called chronic infection.)

How common is Chronic Hepatitis B?

  • Chronic Hepatitis B is known to be a global problem.
  • More than 250 million people are chronically infected with Hepatitis B virus.
  • Chronic infection causes more than 650 000 deaths each year. Approximately 2.5 million people in South Africa have chronic Hepatitis B.

How likely is it that acute Hepatitis B will become chronic?

  • The likelihood depends on the age at which a person becomes infected.
  • The younger a person is when they are infected with Hepatitis B virus, the greater the chance that the infection will become chronic.
  • Approximately 90% of infants who are infected around the time of birth will develop chronic infection.
  • The risk decreases as you get older, dropping to around 5% if you are infected as an adult.

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7/29/2022 12:00:00 PM https://cerbalancetafrica.com/news/newsletters/hepatitis-b/
IgM and PCR Co-Testing for COVID-19 at PLK

To date, Pathologists Lancet Kenya has conducted over 100,000 tests for COVID-19 since commencing testing onsite in April 2020.

PCR Testing

To date, Pathologists Lancet Kenya has conducted over 100,000 tests for COVID-19 since commencing testing onsite in April 2020.

At PLK, we have been conducting SARS-COV-2 testing using the Seegene Allplex® reverse-transcriptase (rt) real-time (RT) polymerase chain reaction (PCR) in line with WHO recommendation that suspected cases should be screened for the virus with nucleic acid amplification tests (NAAT) such as rtRT-PCR.

The WHO recommends that routine conrmation of cases of COVID-19 is based on detection of unique sequences of virus RNA by NAAT such as rtRT-PCR. The viral genes targeted so far include the N, E, S and RdRP genes, whose detection in a sample confirms presence of SARS-CoV-2.

Seegene Allplex 2019-nCoV® RT-PCR Assay has a unique feature that identies 3 different target genes (E, RdRP and N genes) in a single reaction tube which allows for highly accurate results and maximizes the throughput for high volume testing.

The Seegene Allplex® RT-PCR assay is FDA-approved and has been independently evaluated by FIND “Foundation for Innovative New Diagnostics” scoring it at 100% sensitivity and 100% specificity.

SARS-Cov-2 Diagram

What are antibodies?

IgM Testing

The SARS-CoV-2 IgM antibody blood test is a chemiluminescent microparticle immunoassay (CMIA) similar to ELISA, designed to detect IgM antibodies to SARSCoV-2 spike protein in the blood from individuals who are suspected to have had COVID-19. Presence of the SARS-COV-2 IgM antibodies allows for identification of recent COVID-19 infection from 1 week to 4 weeks of onset of infection, after which it becomes negative - while IgG antibody test remains positive longer for months as an indicator of past infection.

Results from the SARS-CoV-2 IgM assay should not be used as the sole basis for diagnosis.

When combined with the SARS-COV-2 PCR test it provides >99% sensitivity for diagnosis of recent COVID-19.

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Antibiotic Guidelines in a Nutshell

Cloxacillin remains the drug of choice for all S. aureus infections where the isolate is deemed to be clinically significant.

Staphylococcus aureus

Cloxacillin remains the drug of choice for all S. aureus infections where the isolate is deemed to be clinically significant. The percentage of methicillin-resistant Staphylococcus aureus (MRSA) strains detected by Lancet Laboratories in Johannesburg during 2014 was less than 20% from all specimens and 27% from blood cultures. Cloxacillin resistance is now detected in both hospital- and community-acquired isolates of S. aureus. Strains of S. aureus that are cloxacillin resistant are insensitive to all currently available penicillins and cephalosporins. The highest burden of MRSAs is found in long-term care facilities, patients who require chronic care, trauma units and large ICUs. These MRSAs are usually multi-drug resistant and treatment is often limited to the glycopeptides and linezolid. All of our reported S. aureus cultures are vancomycin, teicoplanin and linezolid susceptible. However, there are reports of resistance to all three of these antibiotics in other parts of the world. Fortunately this is not yet a problem in South Africa.

Coagulase Negative Staphylococci (CNS)

Most CNS isolates are skin contaminants. In recent years, however, these organisms have emerged as signicant causes of healthcare-associated infections. Staphylococcus epidermidis isolates are very often methicillin-resistant. Therefore, in patients with serious infections (e.g. infected prostheses or endocarditis) or with line sepsis, the empiric therapy for a clinically signicant CNS infection would be vancomycin, teicoplanin or linezolid. Resistance to these antibiotics are gradually increasing worldwide and treatment should be based on the antibiogram results. Please de-escalate as soon as possible when the antibiotic sensitivity of the isolate is known.

Streptococcus pneumoniae

Penicillin resistance in S. pneumoniae isolates occurs due to changes in the penicillin-binding proteins (PBPs) of the bacterial cell wall, resulting in decreased afnity for penicillins and consequently a stepwise resistance to members of this antibiotic class. At a low minimum inhibitory quotient (MIC), this resistance can be overcome by increasing the dose of the beta-lactam antibiotic. Closed infections such as meningitis require higher doses of antibiotic to achieve adequate levels in the infected area. Thus higher MIC breakpoints are used to determine susceptibility for CSF specimens than for lower respiratory tract specimens and bloodstream infections.

The recommended empiric treatment for suspected pneumococcal meningitis remains a 3rd generation cephalosporin. In the event of intermediate cephalosporin resistance from a CSF isolate, the maximum dose of ceftriaxone (adults 4 g daily, children 50 ? 75 mg/kg daily) or cefotaxime (adults 4 g daily, children 50 mg/kg/dose 6 hourly) should be used in combination with another agent e.g. vancomycin or rifampicin. In the event of a fully resistant isolate from the CSF (luckily none have been reported locally) vancomycin is the drug of choice.

In isolates from the upper and lower respiratory tract displaying intermediate resistance to penicillin and/or 3rd generation cephalosporins, resistance can be overcome by dosing maximally with the chosen beta-lactam agent. Erythromycin sensitivity in lower respiratory tract specimens has been below 50% during the past few years. Levooxacin and moxioxacin and telithromycin are all still 100% active against beta-lactam resistant strains.

Enterococcus faecalis / Enterococcus faecium

Prior to treatment of enterococcal infections, all intravenous lines, intra-arterial catheters, and urinary catheters should be removed if possible. Infections for which a single antibiotic directed against enterococci can be used include urinary tract infections (UTIs), most intra-abdominal infections, and uncomplicated wound infections. Combination therapy with a cell wallactive agent (e.g. betalactam) and a synergistic aminoglycoside should be considered for treating serious enterococcal infections in critically ill patients, and in those with evidence of sepsis, as well as in patients with endocarditis, meningitis, osteomyelitis, or joint infections.

Ampicillin is the drug of choice for monotherapy of susceptible E. faecalis infection. For rare strains that are resistant to ampicillin because of beta-lactamase production, amoxicillin-clavulanate may be used. Vancomycin should be used in patients with a penicillin allergy or infections with strains that have high-level penicillin resistance due to altered PBPs.

Nitrofurantoin is effective in the treatment of enterococcal UTIs, including many caused by vancomycin-resistant enterococci (VRE). Linezolid, daptomycin, and tigecycline, are the agents of choice for treating VRE infections

Extended-spectrum beta-lactamase (ESBL) Production

ESBLs are genes carried on plasmids and thus easily transferable from one member of the Enterobacteriaciae family to another. ESBLs were rst isolated in Klebsiella species, but have rapidly spread to all the Enterobacteriaciae. These bacteria are resistant to ampicillin, all cephalosporins (including the 4th generation cephalosporins) and pipericillin/tazobactam.

Infection control measures should be instituted for all patients with ESBL positive organisms.

The only antibiotic class currently proven to be effective in the treatment of severe infections caused by ESBL-producing organisms is the carbapenems (imipenem, meropenem, doripenem, and ertapenem). There are no clear differences in efcacy between imipenem and meropenem. The choice of one over the other is predominantly based on toxicity proles in specic hosts. Clinical data suggest that the efcacy of doripenem is equivalent to that of imipenem and meropenem. Ertapenem has the advantage of once-daily dosing and has good in vitro activity, but is reserved for treating susceptible ESBL-producing organisms that are not associated with severe sepsis.

ESBL-producing isolates typically show greater than average resistance to other agents, including aminoglycosides and uoroquinolones. Tigecycline, a tetracycline derivative, is a potential alternative for the treatment of ESBL-producing organisms, especially for patients with beta-lactam allergies.

Carbapenemase Producing Enterobacteriaciae (CPE) and Carbapenem-Resistant Enterobacteriaciae (CRE)

For years, carbapenems have been used successfully to treat infections due to resistant Enterobacteriaceae, such as Escherichia coli and Klebsiella pneumoniae, including those producing ESBLs. However, carbapenem-resistant Enterobacteriaceae have recently emerged. This is most commonly due to the production of a carbapenemase enzyme which confers broad resistance to most beta-lactam antibiotics, including the so-called “last-line” carbapenems. Carbapenem resistance can also be conferred when porin deciencies (which restrict the entry of the beta-lactam antibiotics into the cell) are combined with ESBLs. The prevalence of CRE infections has increased over the last decade, especially in healthcare settings. CREs are now recognized by the US Centers for Disease Control and Prevention as well as other international healthcare agencies as an urgent public health threat.

The optimal treatment of CRE infections is uncertain. Since carbapenem-resistant organisms are often resistant to other antimicrobial classes, including most beta-lactams, additional susceptibility tests are undertaken for antimicrobials such as colistin, tigecycline, aztreonam and rifampicin. The following antimicrobial therapies have been used with various levels of success in the treatment of CRE infections:

  • Colistin (polymyxin E) - colistin monotherapy is NOT recommended.
  • Carbapenems have been used, though counter-intuitively, in the treatment of infections with CRE, usually as the adjuvant component of a combination drug regimen. This strategy is potentially useful ONLY when the MICs of the infecting carbapenemresistant organisms are still relatively low (i.e. not more than 4 to 16 mg/L)
  • Tigecycline has been used in the treatment of infections with CRE, primarily as an adjuvant drug in combination with other antibiotics.

Recently the following treatment algorithm using combination therapy for the treatment of CRE infections was proposed, based on the site of infection and antibiogram results².

Empirical therapy

Empiric Treatment of Community-acquired Urinary Tract Infections

The empiric antibiotic of choice in the treatment of a community-acquired UTI remains amoxicillin-clavulanate or a 2nd generation cephalosporin. Please note that in 2014, 28% of E. coli isolates from the urinary tract were resistant to ciprooxacin in Johannesburg (26% in Pretoria and Cape Town, and 37% in Durban). This high rate of quinolone resistance should be kept in mind when empirically prescribing these agents to treat a community-acquired UTI.

Another option for the treatment of uncomplicated lower urinary tract infections (but ONLY where the organism retains susceptibility) is fosfomycin, which is a urinary antiseptic. Nitrofurantoin (also a urinary antiseptic) may also be considered, but is frequently out of stock in South Africa.

Pseudomonas aeruginosa

There are some strains of P. aeruginosa in the Gauteng region which are fully resistant. Colistin sensitivity is routinely tested, but there are practical problems with this antibiotic, and some strains are inherently resistant. In view of the rapidly increasing ESBL problem, the carbapenems have become the empiric choice in many ICU patients with suspected nosocomial Gramnegative infections. Please note that some Pseudomonas strains have isolated imipenem / meropenem resistance. In addition ertapenem has no activity against Pseudomonas aeruginosa, Acinetobacter baumanii, Burkholderia cepacia and Stenotrophomonas maltophilia.

AmpC producing bacteria

Certain organisms (e.g. Enterobacter, Serratia, Citrobacter, Morganella and Providencia species) have a chromosomal gene that encodes inducible resistance to the 1st, 2nd and 3rd generation cephalosporins as well as ampicillin. Therefore the abovementioned antibiotics cannot be used for treatment of infections with these bacteria. Empiric therapy for all AmpC producing bacteria includes quinolones, the 4th generation cephalosporins (e.g. cefepime) or the carbapenems (e.g. meropenem, imipenem and ertapenem).

References:

1. South African Society for Clinical Microbiology. SASCM Laboratory Surveillance Private Sector Data January to December 2014. Available at: http://www.dssa.co.za/images/SASCM_2014_Consolidated_Data.pdf

2. Petrosillo N, et al. Treatment of carbapenem-resistant Klebsiella pneumoniae: the state of the art. Expert Rev Anti Infect Ther 2013; 11(2): 159 - 177.

3. Morrill HJ, et al. Treatment options for carbapenem-resistant Enterobacteriaceae infections. Open Forum Infect Dis 2015; 2(2): 1 - 15.

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Why do you need blood testing

Lancet Laboratories is one of the leading pathology laboratories operating throughout South Africa and Africa. Lancet Laboratories operates in both the public and private healthcare environments and services business, insurance and
industry.

LAB

Lancet Laboratories

Lancet Laboratories is one of the leading pathology laboratories operating throughout South Africa and Africa. Lancet Laboratories operates in both the public and private healthcare environments and services business, insurance and industry. From our modest beginnings in the 1940s in the heart of central Johannesburg, we have grown rapidly and in 2013 Lancet Laboratories conducted 2.1 million blood tests each month across South Africa.

Q. Why do I need blood tests?

Our blood shows us a great deal about our health. Blood tests are used to diagnose illness and are also useful as they can draw attention to health problems in their early stages. For example, measuring Cholesterol levels helps to identify one of the risks of heart disease, long before the condition becomes more serious.

Medical technologists use either whole blood or they separate the blood cells from the fluid which is called plasma or serum, to analyse it. A nurse needs to take a blood sample from you to conduct these tests.

Q. What are the risks of having blood tests?

Lancet Laboratories nurses use a new needle for each new patient, to do away with the risk of being infected. The most common risk is slight bruising and discomfort where the needle went in, but should go away shortly.

Blood Draw

Q. How is the test carried out?

A nurse draws a small amount of blood from a vein in your arm using a thin needle. Some tests can also can be done using a finger prick. Drawing blood usually takes just a few minutes and should not be painful.

Q. What do the results show?

Blood tests are used for many reasons. They can show whether you have a particular illness, or a mineral deficiency (shortage) such as iron. They can also show whether the levels of various substances in your blood, such as anti-retroviral medication, fall within the correct range and are working properly, and can show if your organs, such as your heart, liver and kidneys are working properly.

Blood Testing

Q. How do I prepare for a blood test?

For some tests you will need to fast (go without food) for up to 12 hours before the test, and your doctor will tell you whether you need to do this.

Q. How long before I receive a result?

This can range from a few hours to a few weeks, depending on the tests you are having done. Our staff will be able to tell you how long your specific tests will take.

Q. How will I be billed for my blood tests?

Pathologists Lancet Laboratories Kenya will submit the account to your medical aid on your behalf. Should there be any shortfall, you are then responsible for settling the account. If you do not have a medical aid, you need to pay Pathologists Lancet Laboratories Kenya in cash.

Q. Will my medical aid pay for my blood tests?

This depends on what medical aid package you are on.You might be expected to share the cost of the tests, by making a co-payment.

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Panorama Prenatal Screen

Non-invasive prenatal testing (NIPT) uses a blood sample from the mother to analyse DNA from the baby that has crossed into the mother's bloodstream for certain chromosome conditions that could affect your baby's health.

WHAT IS NIPT?

Non-invasive prenatal testing (NIPT) uses a blood sample from the mother to analyse DNA from the baby that has crossed into the mother's bloodstream for certain chromosome conditions that could affect your baby's health.

NIPT:

  • Screens for genetic abnormalities such as Down syndrome
  • Can identify your baby's gender (optional)
  • Provides substantially fewer incorrect results than maternal serum screening or other prenatal blood tests
  • Can be done as early as nine weeks into your pregnancy
  • Poses no additional risk to your baby

WHAT DOES PANORAMA SCREEN FOR?

Singleton pregnancies

  • Trisomy 21 (Down syndrome)
  • Trisomy 18 (Edwards syndrome)
  • Trisomy 13 (Patau syndrome)
  • Triploidy
  • Monosomy X (Turner syndrome)
  • Microdeletions, including 22q11.2 deletion (optional)
  • Gender (optional)

Twin pregnancies

  • Identical or fraternal twins
  • Trisomy 21 (Down syndrome)
  • Trisomy 18 (Edward syndrome)
  • Trisomy 13 (Patau syndrome)
  • Gender of each twin (optional)

If our screening finds that your twins are identical, Panorama can additionally screen for:

  • Monosomy X (Turner syndrome)
  • 22q11.2 deletion syndrome (optional)

Egg donor or surrogate pregnancies

  • Trisomy 21 (Down syndrome)
  • Trisomy 18 (Edwards syndrome)
  • Trisomy 13 (Patau syndrome)

WHAT ARE MICRODELETIONS?

A small, missing piece of a chromosome is called a microdeletion. Unlike Down syndrome, which occurs more frequently in mothers who are 35 and older, microdeletions occur in pregnancies at the same rate for mothers of any age. Panorama screens for five microdeletion syndromes associated with serious health problems:

  • 22q11.2 deletion (DiGeorge) syndrome
  • 1p36 deletion syndrome
  • Angelman syndrome
  • Prader Willi syndrome
  • Cri-du-chat syndrome

IS PANORAMA RIGHT FOR ME?

If you would like to know whether your baby is at risk for certain genetic conditions, Panorama may be the right option for you. The rst step is to talk with your healthcare provider. Some women have a higher chance of their baby being affected with certain chromosome conditions, like Down syndrome, especially if they:

  • Are over the age of 35
  • Have certain family histories
  • Have abnormal ultrasound findings
  • Have abnormal blood test results

Panorama is designed for all pregnant women, regardless of age. We accept samples from:

  • Naturally-conceived singleton pregnancies
  • Twin pregnancies
  • Singleton pregnancies that are using an egg donor or surrogate

Unfortunately, we cannot accept samples from women in the following categories:

  • Bone marrow transplant recipients
  • Pregnancy with a vanishing twin
  • Pregnancy using an egg donor or surrogate in which there is more than one foetus

HOW IS PANORAMA DIFFERENT? Other NIPTs cannot tell the difference between mom and baby's DNA. Panorama™ can!

Because of its unique technology, Panorama is the only NIPT that can distinguish between the mom's DNA and the baby's DNA from the placenta. This enables Panorama to be a highly accurate screening test.

Diagram DNA

FEWER FALSE POSITIVES

Because Panorama analyses the baby's DNA separately, it has a lower false positive and 1,2,3 negative rate than other NIPTs.

HIGHEST FOETAL SEX ACCURACY

Panorama has the highest reported accuracy in determining the foetal sex, and reporting is 1,2,3 optional.

TRIPLOIDY

Panorama is the only NIPT that can detect triploidy, a severe chromosomal abnormality that can result in serious pregnancy 6,7complications if unmonitored.

ZYGOSITY

Panorama is the only NIPT that can determine zygosity (fraternal or identical twins).

WHAT DO PANORAMA RESULTS TELL ME?

Panorama gives you a personalised risk score and tells you if your baby is at high risk or low risk for the conditions it screens for. Like other screening tests, Panorama does not provide a definitive diagnosis of the condition.

WHAT RESULTS MIGHT I GET WITH PANORAMA?

Low Risk:
A Low Risk result indicates that it is unlikely that your baby is affected by one of the conditions on the Panorama panel. Note, however, that a low risk result does not guarantee a healthy pregnancy as Panorama is not a diagnostic test and only screens for certain conditions.

High Risk:
A High Risk result means that there is an increased risk that your baby has the condition, but it is not certain. Invasive testing during the pregnancy, such as amniocentesis (amnio) or chorionic villus sampling (CVS), or testing after the baby is born, can tell you for certain if the baby has the condition. Speak with your healthcare provider about your follow-up options. They may recommend that you speak with a genetic chancellor and/or a maternal-foetal medicine specialist.

No Result:
In a small percentage of cases, Panorama may not be able to obtain sufficient information from your blood sample to determine an accurate result. If this occurs, a second blood sample may be requested.

WHEN CAN I GET PANORAMA?

You can have this test as early as 9 weeks into the pregnancy. For women who weigh more than 90 kg, it is advised to wait until 12 weeks of pregnancy to improve the likelihood of obtaining a result.

WHEN WILL I GET MY PANORAMA RESULTS?

Most results will be returned to your treating doctor or specialist within 7 - 10 working days.

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Frequently Asked Questions on COVID-19 Vaccination in Kenya.

This section provides latest information and responses to questions from the public on COVID-19 vaccination in Kenya. The answers are aimed at providing the public with accurate, reliable and timely information on the ongoing COVID-19 Vaccination in Kenya. This document is regularly updated to reflect new developments and emerging issues.

This section provides latest information and responses to questions from the public on COVID-19 vaccination in Kenya. The answers are aimed at providing the public with accurate, reliable and timely information on the ongoing COVID-19 Vaccination in Kenya. This document is regularly updated to reflect new developments and emerging issues.

For more information, call the Ministry’s COVID-19 hotline number on 719.

What does COVID-19 stand for?

COVID-19 stands for Coronavirus disease of 2019.

It is the official name given by the World Health Organization (WHO) to the disease caused by the novel coronavirus SARS-CoV2.

The novel coronavirus SARS-CoV2 is a new coronavirus not previously seen in humans. This means it is different from the coronaviruses that cause the common cold and those that caused SARS in 2002 and MERS in 2012.

The first cases of the novel coronavirus SARS-CoV2 were reported in December 2019.

WHO officially named the disease COVID-19 in a press release issued on 11th February 2020.

Is COVID-19 the same as the common cold?

No. COVID-19 and common cold are not the same. COVID-19 is caused by the novel coronavirus SARS-CoV2 not previously seen in humans. Colds and flus are caused by different types of viruses common to humans. Unlike the flu, COVID-19 can sometimes cause a person to suddenly lose their sense of smell or taste.

The number of those who are likely to be severely ill or die as a result of contracting COVID-19 is up to 10 times higher for COVID-19 than for the common cold or flu.

Why is COVID-19 considered a pandemic?

On 11th March, 2020, the WHO officially classified COVID19 as a pandemic.

A pandemic is the worldwide outbreak of a disease that quickly spreads across different countries and continents. The WHO made the decision to classify COVID-19 as a pandemic based on the following factors:

  • Within a period of just two weeks, the number of cases of COVID-19 outside China had increased 13-fold.
  • The number of affected countries had tripled.
  • There were more than 118,000 cases in 114 countries.
  • 4,291 people had lost their lives.
  • Thousands more were admitted in hospitals.

COVID-19 is the first coronavirus to be classified as a pandemic. This is due to its high case fatality rate and rapid spread of the disease.

Download FAQ COVID-19 Vaccination

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Discrepancy in COVID-19 results explained

I tested positive for COVID-19, I did another swab test and it came out negative. How is that possible?

I tested positive for COVID-19, I did another swab test and it came out negative. How is that possible?

  • The PCR (polymerase chain reaction) test for SARS-CoV-2, which is the virus that causes COVID-19 infection, is robust and very specific.
  • False positives results rarely occur because the specificity of the test (ability to differentiate SARS-CoV-2 from other viruses) is quite high - this means a positive PCR result on a sample is a real positive result.
  • The sensitivity of the PCR test can vary and be lower - meaning that some negative results may be false negatives whereby some people who are truly infected may test negative yet they are positive.
  • False negative results are especially true for people with early infection, asymptomatically infected individuals who have lower quantities of the virus and those recovering from mild illness while having lower quantities of virus in their nose, nasopharyngeal, throat and the lining of the airwaves.
  • Additionally, intermittent viral shedding may occur in the respiratory tract lining of the nasal passage and throat thus the amount of viral material collected on swabs taken in quick succession and tested in the same laboratory or in different laboratories can actually yield different results. Sequential testing is not recommended for a negative result if there are clinical reasons to suspect infection.
  • Results between different laboratories can also vary due to the sensitivity and the specificity of the assay (type of PCR kit and machines used), with some assays having better performance at detecting very low levels of SARS-CoV-2 than others, therefore a low level of virus can be missed during analysis if the sensitivity is low. Likewise sample handling and quality assurance in the lab can affect a result.
  • Generally speaking, a positive SARS-CoV-2 result supersedes a negative result if the two are done within a short time-interval of each other, and any positive result should be used to guide isolation and contact tracing.
  • If a result is suspected to be false, it is best to communicate with the laboratory to have the result audited and conrmed as having no errors, then have the results correlated to the individual circumstances to inform follow-up testing under relevant conditions based on the clinical indications for re-testing.

About SARS-CoV-2 PCR Testing at Pathologists Lancet Kenya (PLK)

  • Pathologists Lancet Kenya currently has capacity to process between 270 - 450 samples a day with room to scale up to over 1,000 samples a day as demand may dictate. We have conducted over 10,000 tests to date. Our PCR lab is ISO 15189 accredited and has undertaken validation of the SARS-CoV-2 test kits with National Influenza Centre (NIC) and the Lancet Laboratories in South Africa which are also ISO 15189 accredited by SANAS.
  • PLK participates in LGC Thistle external quality assurance (EQA) scheme for proficiency testing to ensure the quality of the analysis and has scored excellent results in the recent EQA round.
  • The assay used at PLK is FDA-approved for highly accurate results. The Seegene Allplex assay has Consistently shown a very good sensitivity compared to most other assays, and from the experience on several occasions we have detected SARS-CoV-2 where other assays yielded negative results.

SARS-CoV-2 Molecular Evaluation by Foundation for Innovative New Diagnostics (FIND) - A Global Non-Prot Organization

  • Results just released from FIND conrm Seegene Allplex assay for SARS-CoV-2 has 100% sensitivity and 100% specicity performing better than most other assays including Altona and similar kits that use E-gene and ORF1/S-gene
  • FIND conducted independent evaluations at the Hôpitaux Universitaires de Genève, to verify the limit of detection (LOD) and the clinical performance (as reported by the manufacturers) of the following molecular test kits.
  • The LOD analysis was performed using cultured viral stocks from a clinical isolate from Switzerland, and quantied using an E gene standard.
  • The clinical performance analysis was conducted on extracted samples from individuals suspected to have COVID-19 that were tested using an in-house PCR protocol that was optimized based on the Tib Molbiol assay.

For more details on the data for the first test evaluated see data on their website:
www.finddx.org/covid-19/sarscov2-eval-molecular/molecular-eval-results/

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Diagnosis of Helicobacter Pylori Infections

Helicobacter pylori is a spiral-shaped gram-negative rod. H. pylori is associated with antral gastritis, duodenal (peptic) ulcer disease, gastric ulcers and gastric carcinoma. Other Helicobacter species that infect the gastric mucosa exist but are rare.

Introduction

Helicobacter pylori is a spiral-shaped gram-negative rod. H. pylori is associated with antral gastritis, duodenal (peptic) ulcer disease, gastric ulcers and gastric carcinoma. Other Helicobacter species that infect the gastric mucosa exist but are rare.

Epidemiology

H. pylori is one of the commonest bacterial pathogens in humans. The prevalence of infection varies, but is falling in most developed countries. Seropositivity increases with age and low socioeconomic status.

Laboratory Diagnosis

Antigen Detection

Direct fecal antigen detection of H. pylori has been approved by the US Food and Drug Administration for diagnosis and follow-up testing.

H. pylori antigens from fresh human faecal specimens are detected by polyclonal antibodies. The sensitivity and specificity of faecal antigen detection is 89% and 94% - 95%, respectively, in multiple studies. Faecal antigen detection is a recommended noninvasive approach for confirmation of H. pylori infection in paediatric patients because serologic tests are less reliable (especially in children younger than 5 years) and are useful only for screening in this population.

Antibody Detection

Several assays have been developed to detect serum antibodies specific for H. pylori. The serum antibodies persist even if the H. pylori infection is eradicated and the role of antibody tests in diagnosing active infection or following therapy is therefore limited.

Urea Breath Tests

The breath tests are performed by asking the patient to swallow carbon- labelled urea which is metabolized by H. pylori produced urease to produce labelled carbon dioxide. This is absorbed into the blood stream and then exhaled in the breath of infected individuals.

An overnight fast is required. False negative breath test results can occur through suppression of urease activity if the breath tests are performed too soon after antibiotic or acid suppression therapy. Contact the local laboratory to confirm the availability of the urea breath test.

Culture

Culture remains a reference method, but its limited sensitivity and difficulty precludes its routine use. Patient factors which could affect culture results include high gastric activity, low bacterial load and alcohol.

Histology

Giemsa staining on oesophagogastroduodenoscopy specimens is also useful in the histological diagnosis of H. pylori related gastritis.

Management

Different treatment regimens have been summarised in the table below.²

Length of treatment (Days) Component Drugs
Regimens based on clarithromycin
14 Ranitidine bismuth citrate 400 mg twice daily Clarithromycin 500 mg twice daily  
7 - 10 Ranitidine bismuth citrate 400 mg twice daily Amoxicillin 1000 mg twice daily Clarithromycin 500 mg twice daily
7 - 10 Proton pump inhibitor twice daily Amoxicillin 1000 mg twice daily Clarithromycin 500 mg twice daily
Regimens based on metronidazole (or tinidazole)
14 bismuth compound 4 times/day Tetracyline 500 mg 4 times/day Metronidazole 400 - 500 mg 3 - 4 times/day
7 - 10 Proton pump inhibitor twice daily Amoxicillin 500 mg 2 - 3 times/day Metronidazole 400 - 500 mg 2 - 3 times/day
4 - 7 Proton pump inhibitor twice daily Colloidal bismuth subcitrate 4 times/day Tetracyline 500 mg 4 times/day Metronidazole 400 - 500 mg 3 - 4 times/day
Regimens based on clarithromycin plus metonidazole (or tinidazole)
7 Ranitidine bismuth citrate 400 mg twice daily Clarithromycin 500 mg twice daily Metronidazole 400 - 500 mg twice daily
7 Proton pump inhibitor twice daily Clarithromycin 500 mg twice daily Metronidazole 400 - 500 mg twice daily

References

  1. Atherton JC, Spiller RT. The urea breath test for Helicobacter pylori. Gut 1994, 35:723-725
  2. De Boer WA, Tytgat GNJ. Treatment of Helicobacter pylori infection. BMJ 2000, 320:31?4
  3. http://www.uptodate.com/contents/helicobacter-pylori-infection-and-treatment-beyond-thebasics, accessed December 2012.
  4. McNulty et al. Diagnosis of Helicobacter pylori Infection. Helicobacter 2011, 16 (Suppl. 1): 10-
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Cervical Cancer Screening

Cervical cancer is caused by chronic infection with one of 14 high-risk human papillomaviruses (HR-HPV). Most infected women will clear HR-HPV through natural immunity (usually between 1 - 2 years of acquisition), but a proportion (± 10%) will have infection that persists, resulting in cellular changes that may progress from premalignant dysplasia to high grade dysplasia (CIN2, CIN3), and eventually to invasive cervical carcinoma.

Cervical cancer is caused by chronic infection with one of 14 high-risk human papillomaviruses (HR-HPV). Most infected women will clear HR-HPV through natural immunity (usually between 1 - 2 years of acquisition), but a proportion (± 10%) will have infection that persists, resulting in cellular changes that may progress from premalignant dysplasia to high grade dysplasia (CIN2, CIN3), and eventually to invasive cervical carcinoma. The time line from exposure to the development of invasive carcinoma in the persistently infected, undetected woman is 10 - 15 years, though this may be shortened by concurrent HIV infection.

Why should I offer Cervical Cancer screening to my female patients?

Sexually transmitted infection with HPV is very common, with most women being exposed to HPV at some point. It is estimated that every year 4,802 Kenyan women are diagnosed with cervical cancer and 2,451 die from this preventable disease. It is the second most frequent cancer amongst women and the most frequent in women aged 15 - 44 years. HPV-16 and -18 are responsible for 63.9% of invasive cervical cancer cases. Approximately 3.2% of women are estimated to be infected with HPV-16 and -18 at any given time.

With appropriate screening, cervical cancer can be prevented, by detecting pre-cancerous lesions, or cured, by detecting cancer early and managing appropriately. Cervical cancer is one of the only cancers that can be prevented through appropriate screening with readily available tests and minimally invasive procedures.

What is the most appropriate strategy for cervical cancer screening?

The Ministry of Health's official position is captured in the National Cancer Screening Guidelines published by the Ministry of Health in November 2018 and launched by the CS for Health in February this year. The full document can be found on the link below.

https://www.health.go.ke/wp-content/uploads/2019/02/National-Cancer-Screening-Guidelines-2018.pdf

Who should be screened and when?

  • Any woman who has ever had sexual intercourse is eligible for cervical cancer screening
  • The target population for screening with HPV testing is women aged 25 to 49 years
  • Women aged 50-65 years are still at risk of cervical cancer and can therefore receive screening but with longer intervals between each test.
  • Screening interval is 5 years for any women who tests negative for HPV

Screening methods for cervical cancer

For the Kenyan screening program the National Cancer Screening Guideline recommends the following:

  1. HPV testing is recommended as the primary screening method for women above 30 years of age.
  2. Where HPV testing is not yet available, or loss-to-follow-up is a risk, then Visual Inspection with Acetic acid (VIA) or Visual Inspection with Acetic acid and Visual Inspection with Lugol's iodine (VIA/VILI) is recommended as the primary screening method.
  3. Pap smear is recommended as a primary screening method in the following situations:
    • For women not eligible for VIA or VIA/VILI because their squamo-columnar junction (SCJ) is not visible, and HPV screening not accessible
    • As a primary test in women under 30 years of age
    • As a co-test with HPV in HIV positive women where the resources are available

It is worthy to note that the guidelines are based on a sexual debut from 18-21 years. Women who had an earlier sexual debut should be screened with HPV earlier as HPV testing is recommended 5-years post-sexual debut.

Therefore HPV can be offered to women from 25 years of age who had sexual debut before the age of 20 years.

Lancet Laboratories offers the most affordable HPV testing available. Please contact your Lancet Marketer for more information.

Cancer Screening

Self collection sampling (Evalyn-brush)

Pathologist Lancet Kenya has introduced a self-collection kit that any woman can use to collect a sample by herself for HPV testing.

Evelyn Brush Image

  • The self-collection kit is Evalyn Brush ® that is specially patented for collecting material from the vagina
  • The Evalyn-brush has soft fine bristles, ensuring that enough fluid and cell material is collected for testing in the lab. The Evalynbrush ® was designed by women for women
  • Self-collected sample using the Evalyn-brush has been confirmed to be as accurate as cervical sample collected by a gynaecologist or a nurse

Evelyn Brush Figure

Components of the Evalyn-Brush

  • The Evalyn-brush is approx.20cm long and consists of a transparent casing with wings. Within the casing is a pink stick consisting of a plunger at one end and white bristles at the other end covered by a pink cap. The pink cap is removed before insertion.
  • The bristles are exposed by pushing the plunger when inserted into the vagina. The Evalyn-brush is inserted as far into the vagina up to the wings.

How to use the Evelyn Brush

References

  1. Andrae B, Kemetli L, Sparén P et al. Screening-preventable cervical cancer risks: evidence from a nationwide audit in Sweden. J Natl Cancer Inst 2008, 100; 9:622-629
  2. Castle PE, Stoler MH, Wright TC Jr, Sharma A, Wright TL, Behrens CM. Performance of carcinogenic human papillomavirus (HPV) testing and HPV16 or HPV18 genotyping for cervical cancer screening of women aged 25 years and older; a subanalysis of the ATHENA study [published online August 23, 2011] Lancet Oncol. doi;10.1016/S1470-2045(11)70188-7
  3. Cobas® HPV test [package insert]. Indianapolis, IN: Roche Diagnostic; 20145. Presented to FDA 12 March 2014: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/MicrobiologyDevicesPanel/ucm388531.htm
  4. http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/medicaldevices/me dicaldeviceadvisorycommitte/microbiologydevicespanel/ucm388565.pdf
  5. http://www.hpvcentre.net/statistics/reports/ZAF FS.pdf
  6. http:www.hpv16andhpv18.com
  7. http://seer.cancer.gov/archive/csr/1975 2010/#contents
  8. Leyde WA, Manos MM, Geiger AM, et al. Cervical cancer in women with comprehensive health care access: attributable factors in the screening process. J Natl Cancer Inst 2005, 97; 9:675-683
  9. Wright TC Jr, Stoler CM, Apple R, Derrion T, Wright TL. The ATHENA human papillomavirus study; design, methods and baseline results. AmJ Obstet Gynecol 2012, 206; 1:46.e1-46.e11
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Approach to the Adult Patient with Anaemia

Anaemia is defined as a reduction in one or more of the red blood cell indices of haemoglobin (Hb) concentration, hematocrit, and red blood cell (RBC) count. However, haemoglobin concentration is the most widely used parameter.

Anaemia is defined as a reduction in one or more of the red blood cell indices of haemoglobin (Hb) concentration, hematocrit, and red blood cell (RBC) count. However, haemoglobin concentration is the most widely used parameter.

Normal lower limits of Hb varies with age, sex and race.

As a clinician, one is often familiar with the Kinetic Approach to a patient with anaemia. This approach classifies anaemia by the mechanisms causing the anaemia. These mechanisms are decreased red blood cell production, increased red blood cell destruction and blood loss.

However, when one is faced with interpreting a patient's full blood count result, and anaemia is present, the Morphologic Approach can be used to work through the possible causes of the anaemia. The morphologic approach divides anaemia into Macrocytic Anaemia, Normocytic Anaemia and Microcytic Anaemia, based on the size of the red blood cells.

The parameter in the full blood count that indicates red cell size is the Mean Corpuscular Volume (MCV) measured in femtolitres (fL).

Anaemia Fig

The following tables outline the causes of Microcytic and Normocytic Anaemia. Macrocytic Anaemia will be discussed as a separate topic in a follow-up newsletter.

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Detection of New SARS-COVID19 Variants on PCR Testing

Confirmation of detectability of the new mutated variants of SARS-CoV-2 using Seegene AllplexTM 2019-nCoV PCR Assay at Pathologists Lancet Kenya_PLK

Confirmation of detectability of the new mutated variants of SARS-CoV-2 using Seegene AllplexTM 2019-nCoV PCR Assay at Pathologists Lancet Kenya_PLK

We are pleased to confirm that the new mutated variants of SARS-COV-2, including the B.1.1.7 UK variant and the SA variant, can be detected with the AllplexTM 2019-nCoV PCR Assay that is used at Pathologists Lancet Kenya_PLK.

*Specialized in-silico analysis by Seegene has confirmed that the COVID-19 PCR test covers the new variants of SARS-CoV-2 virus specifically including the B.1.1.7 lineage that emerged in the United Kingdom (UK variant) and also the B.1.351 lineage that emerged in South Africa (SA variant).

The Seegene AllPlexTM Assay is able to detect these variants because the assays are designed to detect individual multiple gene targets of SARS-CoV-2 simultaneously.

It therefore means that we are rest assured of being able to diagnose those infected with COVID-19 using PCR test on swab samples collected and tested with the highly sensitive and specific PCR assay employed at Pathologists Lancet Kenya_PLK - as the assay is able to detect both the old and the SARS-CoV-2

Coronavirus

*The in-silico analysis showed that no mismatches were found in RdRP gene region, while few mismatches were found in the S gene region, but despite the few mismatches, the overall detectability of Seegene COVID-19 assays may not be affected by these mutations. Whereas the sensitivity variances can be affected by the mismatches, these are expected to be limited because of the complimentary multiple oligonucleotides(oligo) for each gene region in the assays. Further detailed information about the in-silico analysis can be availed from Seegene.

ABOUT THE SARS-COV-2 RT-PCR TEST AT PATHOLOGISTS LANCET KENYA

At Pathologists Lancet Kenya_PLK we've exclusively used the Seegene AllplexTM 2019-nCoV assay since April 2020 and conducted over 100,000 tests as at 25th of January 2021.

The Seegene AllplexTM assay is a reverse-transcriptase (rt) real-time (RT) polymerase chain reaction (PCR) that is a nucleic acid amplication test (NAAT) for detection of viral RNA for SARS-CoV-2 the virus that causes COVID-19.

The Seegene AllplexTM PCR assay has a unique feature that identies 3 different target genes (E, RdRP and N genes) in a single reaction tube which allows for highly accurate results and maximizes the throughput for high volume testing.

The Seegene AllplexTM RT-PCR assay is FDA-approved and has been independently evaluated by FIND “Foundation for Innovative New Diagnostics” scoring it at 100% sensitivity and 100% specificity

SARS-Cov-2

Technical information on the SARS-COV-2 RT-PCR Test at Pathologists Lancet Kenya_PLK

  • The Seegene Allplex rtRT-PCR assay is an automated molecular test at PLK that utilizes three target genes protocol (rather than two or single gene assay protocol) in deciding the SARS-COV-2 status on a sample analyzed in a single reaction tube as multiplex PCR test per sample, thus serving as both screening and confirmatory test.
  • The interpretation of results is as per manufacturer's recommendation and in-line with WHO guideline that “In areas where COVID-19 virus is widely spread a simpler algorithm might be adopted in which, for example, screening by rtRTPCR of a single discriminatory target is considered sufcient (The viral genes targeted so far include the N, E, S and RdRP genes)”.
  • The Segeene Allplex assay is duly approved by Ministry of Health's regulatory bodies and validated against NIC laboratory and Lancet Laboratories South Africa
  • The PCR tests at PLK's Main Lab, which is registered and licensed as a National Class F Reference Laboratory by KMLTTB, are conducted by trained medical laboratory technologists who are also licensed by KMLTTB, with supervision from a PhD Molecular Scientist Doctor and several pathologists who work as a team to check and ensure accuracy of results.
  • Automated data interpretation and LIS interlocking with the proprietary Seegene Viewer software enables a seamless and rapid review of results with intelligent interpretation.
  • Accurate interpretation of the SARS-COV-2 PCR test results is enabled by the Seegene Viewer software which is designed to automate data analysis for multiplex real-time PCR assay allowing identication and differentiation for both Ct value of multiple targets in a single channel as well as melting curve analysis.
  • The results from automated interpretation on Seegene Viewer are further reviewed by a laboratory technologist and pathologist on the Seegene Viewer before results are interfaced to the LIMS and additionally reviewed for release of the report with applicable interpretative comments as relevant based on clinical and epidemiological information.
  • At PLK we interpret and report any viral target gene detected with a Ct lower or equal to the cut-off of 40 as positive. Ct > 40 is considered negative.
  • Single gene results with high Ct values (low viral RNA levels) are issued with comments to highlight the possible implication of the results which include a sample at concentrations near or below the limit of detection of the target gene not amplied or a mutation in the corresponding target gene not amplied.
  • From experience, the cases with single-gene only or low viral load are often seen in late-stage of infection but can also be seen early in the infection, thus it is important to correlate clinically and epidemiologically
  • Our PCR laboratory has been continuously undertaking internal quality control and also participated in local and international external quality assurance (EQA) since May 2020
  • We have consistently scored 100% in all the different EQA programs in over 10 consecutive cycles that include the LGC Thistle, NPHLS-MOH, KEMRI and RCPAQA prociency testing programs
  • In addition, PLK has undergone onsite inspection and audit by experts from Kenya Medical Practitioners and Dentists Council (KMPDC) and Kenya Medical Laboratory Technicians and Technologists Board (KLMTTB) whose reports confirmed the accuracy and validity of our test results
  • Our laboratory was the rst in Africa - in August 2020, and so far the only in the region, to receive ISO15189 accreditation specic for COVID-19 PCR test.

References

  • https://www.fda.gov/media/137178/download
  • https://apps.who.int/iris/handle/10665/330676
  • http://www.seegene.com/covid19_detection
  • http://www.seegene.com/assays/allplex_2019_ncov_assay
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Pollen allergy: causes and symptoms

Respiratory allergies affect many people, especially allergic rhinitis which alone affects about 25% of adults. The symptoms vary and are most often non-specific to the allergy.

Allergy in a few words

  • Respiratory allergies affect many people, especially allergic rhinitis which alone affects about 25% of adults. The symptoms vary and are most often non-specific to the allergy.
  • When seasonal, pollens are often involved. There are also cross-reactions with certain plant-based foods, such as fruits, legumes or nuts.
  • To complement the medical consultation, biological tests can first confirm the allergic origin of the symptoms, then in a second time will identify the allergens. Understanding the cause of the allergens will facilitate the making of preventive measures and possibly some level of desensitization in order to permanently suppress the symptoms.
  • Pollen and pollination periods vary from region to region or county to county. The symptoms encountered in respiratory allergy are varied and there may be cross-reactions with certain foods. Biological tests allow quality diagnosis and management.

What is an allergen?

Allergy is an inappropriate, harmful response of our body, which is called a hypersensitivity reaction. This reaction is triggered by exposure to a substance in our environment that should normally be tolerated, the allergen.

Allergy is related to the synthesis by our body of specific antibodies, immunoglobulins E or IgE. It is these antibodies that will interact with an allergen to trigger the allergic reaction.

The mechanism of allergy takes place in two stages. On the 1st contact, the body becomes aware of the allergen and produces IgE. It is from the 2nd contact that the symptoms appear, defining the allergy.

Note: the phenomena of intolerance are not to be confused with allergy. The mechanisms involved are different and the diagnostic tests are also distinct.

When are pollens found in the air?

Pollens are emitted by plants (trees, shrubs, herbaceous plants) at the time of their reproduction. Not all of them are allergenic. Only pollens that are disseminated via the wind may come into contact with the respiratory mucosa and thus cause allergy symptoms (unlike pollens that are disseminated by insects).

On the other hand, pollens are only present in the air for part of the year, which is specific to each variety. Their presence in the air varies depending on the region and climate. In dry weather, the amount of pollen in the air is greater. Indeed, the rain causes pollen to fall to the ground and reduces its amount in the air we breathe.

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Understand Allergies Better

Allergy is related to the development of an inappropriate reaction of the body to contact with an allergen. This reaction develops in a context that brings together a set of family and environmental factors. It results in the appearance of a wide variety of symptoms that evolve over the course of a lifetime and can affect several organs.

Background

Allergy is related to the development of an inappropriate reaction of the body to contact with an allergen. This reaction develops in a context that brings together a set of family and environmental factors. It results in the appearance of a wide variety of symptoms that evolve over the course of a lifetime and can affect several organs.

The medical consultation is essential to discuss the diagnosis, identify allergens and follow the evolution of the disease. In addition to the information collected during the consultation. (Symptoms, history of the disease, exposure to allergens.) The doctor has at his disposal quality biological tests.

There are indeed blood tests for allergies that can help confirm or exclude the diagnosis if the doctor is suspected. Other examinations, and identification tests, also make it possible to look for allergens responsible for symptoms or to personalize management.

What is Allergies?

Allergy is an inappropriate, harmful response of our body, which is called a hypersensitivity reaction. This reaction is triggered by exposure to a substance in our environment that should normally be tolerated, the allergen.

Allergy is related to the synthesis by our body of specific antibodies, immunoglobulins E or IgE.

It is these antibodies that will interact with an allergen to trigger the allergic reaction. The mechanism of an allergy takes place in two stages. On the 1'st contact, the body becomes aware of the allergen and produces IgE. It is from the 2'nd contact that the symptoms appear, defining the allergy.

Allergy is the consequence of an inappropriate and exaggerated reaction of the body following contact with a substance that should be tolerated. This phenomenon leads to the appearance of very diverse and sometimes severe symptoms.

Note: The phenomena of intolerance are not to be confused with allergy. The mechanisms involved are different and the diagnostic tests are also distinct.

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