ASLM’s Resource Center is designed to help you keep up with the latest tool kits, regulations, guides and other information published by ASLM, partners, and global health regulatory bodies. Use the filters above to locate the information you need based on the ASLM project, resource type, or topic of interest.
In December LabCoP conducted the inaugural session of the new LabCoP Extended series to introduce the Score-TB package, an integrated set of assessment tools for supporting the implementation of a QMS in laboratories performing tuberculosis tests. The Score-TB package was launched by Foundation for Innovative New Diagnostics (FIND), in collaboration with the Global Laboratory Initiative… Read More
ASLM and Foundation for Innovative New Diagnostics (FIND) have produced a guide on how to develop and validate in-house RT-PCR tests for SARS-CoV-2. This guidance is essential, particularly in settings with limited diagnostics, including low- and middle-income countries (LMIC) where diagnostics are not immediately available during a pandemic. During the current COVID-19 pandemic the much… Read More
On 12 November 2020, this COVID-19 ECHO session was convened to discuss the launch of the SARS-CoV-2 antigen rapid test training package developed by ASLM and Africa CDC, in partnership with CHAI, AFENET, AMREF, and Last Mile Health. The training package, available to all African Union Member States, aims to support the scale-up of SARS-CoV-2… Read More
ASLM in collaboration with the Africa Centres for Disease Control and Prevention, and in partnership with the Clinton Health Access Initiative, Amref and Last Mile Health present the Quality Assurance Framework for SARS-CoV-2 Antigen Rapid Testing for Diagnosis of COVID-19. This framework aims to provide general technical guidance to African Union Members States on the… Read More
On 18 September 2020, this COVID-19 ECHO session was convened to discuss antigen testing’s role in helping control the COVID-19 pandemic. Real time Polymerized Chain Reaction (rt-PCR) testing to detect SARS-CoV-2 has been the WHO recommended method to diagnose COVID-19. However, this method has not always been available at every tier of the laboratory network… Read More
On 10 September 2020 LabCoP hosted a special ECHO session about establishing diagnostic connectivity for laboratory network data flow across conventional and point-of-care systems. More than before, use of clinical laboratory data to inform decision making has become crucial in both direct patient care and in local, regional and international healthcare systems programming. The emergence… Read More
LabCoP’s August ECHO session covered external quality assurance (EQA) proficiency testing coverage, results and sustainability from the perspective of a service provider. EQA provides a measure of performance of testing laboratories and helps identify deficiencies and opportunities for improvement across the entire testing cascade. In this session, we discuss integrating economic principles into EQA, to… Read More
As part of the global response to the COVID-19 pandemic, laboratory diagnosis has remained as the cornerstone to this intervention. Molecular assays performed on nasopharyngeal swabs or other upper respiratory tract specimens are the most commonly used and reliable tests for the diagnosis of COVID-19. A variety of RNA gene targets are used by different… Read More
Decentralising laboratory testing for COVID-19 to on a national scale will be effective if COVID-19 nucleic acid testing is extended to subnational levels. However, this expansion process from national to sub-national levels has to be balanced carefully so as to meet the increasing demanding for the COVID-19 testing service while maintaining a high quality of… Read More
On 17 September 2020, this COVID-19 ECHO session was convened to discuss self-collection of nasal specimens as a means to lowering the barrier to SARS-CoV-2 testing and access to care. Diagnostic testing for SARS-CoV-2 remains a challenge today, even months since the outbreak of the pandemic and with the emergence of several innovations. In the… Read More
On 13 August 2020, this COVID-19 ECHO session was convened to discuss optimised diagnostic networks key role in responding to COVID-19. Optimised national diagnostic networks are key to increasing access to high-quality diagnostics. With the outbreak of the COVID-19 pandemic, some sub-Saharan African countries leveraged more than a decade of investments in strengthening and optimising… Read More
On 6 August 2020, this COVID-19 ECHO session was convened to discuss laboratory data management considerations for COVID-19 response. Long turnaround times (TAT) for laboratory test results and poor data quality are chronic problems for many testing services. Timely and accurate testing services for COVID-19 are essential for monitoring the spread of the pandemic and… Read More
These updated guidelines (in English, French and Portuguese) for the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA), published by WHO, provide a framework for countries in the Africa Region in their efforts to strengthen medical laboratory services through fulfillment of the requirements of the ISO 15189 standard. The SLIPTA Guideline describes key elements of… Read More
On 15 July 2020, this COVID-19 ECHO session was convened to discuss the public health lab networks and SARS-CoV-2 testing challenges, strategies, and lessons learned from the USA. During emergencies like COVID-19 when laboratory testing services surge, there are risks of a health care system being overwhelmed. Well-structured strategies must be formulated to cope with… Read More
On 10 July 2020, ASLM hosted the eighth session in a series about manufacturers of COVID-19 molecular diagnostic tools, featuring Roche Diagnostics International. Presentations were made by Dr Wim van der Helm, Head of Healthcare Development, Roche Diagnostics, Europe, Middle-East, Africa and Latin America, and Dr Matthias Strobl, Senior Clinical Science Leader, Infectious Diseases, Roche… Read More
On 8 July 2020, ASLM hosted the seventh session in a series about manufacturers of COVID-19 molecular diagnostic tools, featuring EUROIMMUN AG, and Hologic. The session covers: overview of available SARS-CoV-2 laboratory test kit(s) e.g., what genes are targeted; performance, run time and other technical considerations of SARS-CoV-2 molecular diagnostics; requirements/consumables not supplied with the… Read More
The World Health Organization has updated their interim operational guide for maintaining essential health services during an outbreak, to support countries preparedness and response during the COVID-19 pandemic. It supplements existing and future WHO guidance on the wider implications of COVID-19 for health systems, and cross-government strategies for responding to the COVID-19 outbreak. The updated… Read More
In this study, Robert Fischer, et al, present their assessment findings on N95 respirator decontamination and re-use for SARS-CoV-2 (24 April 2020), using four different decontamination methods – UV radiation (260 – 285 nm), 70º C dry heat, 70% ethanol and vaporized hydrogen peroxide (VHP). The authors recommend that N95 respirators be decontaminated and re-used… Read More
In this paper, Kenneth Kintu, et al, investigated the virological suppression (achieving viral loads < 50 copies per mL) before giving birth with dolutegravir compared to efavirenz, when initiated during the third trimester. They found that dolutegravir was associated with higher rates of viral load reduction in pregnant women compared with efavirenz. Although both regimens… Read More
David Berlin, et al, present key clinical features of severe COVID-19 in the New England Journal of Medicine (21 May 2020). The authors start with a clinical description of a 50-year old COVID-19 patient. The authors recommendation is that the most important aspect of care is careful monitoring of respiratory status to determine whether endotracheal… Read More
The World Health Organization has published Version 2 (22 May 2020) of their guidance about HIV, viral hepatitis and STI programmes in relation to COVID-19. The guidance is intended to support national HIV and viral hepatitis programmes and their health workers, to provide guidance to people affected by HIV and viral hepatitis, and to maintain… Read More
The European Centre for Disease Prevention and Control (ECDC) has published this Rapid Risk Assessment Report on the association of paediatric inflammatory multisystem syndrome (PIMS) and SARS-CoV-2 infection in children (15 May 2020). ECDC concludes risk communication should emphasise that PIMS is a rare condition and that its potential link with COVID-19 is neither established… Read More
In Nature Communications, Chuyan Wang, et al (4 May, 2020) describe a human monoclonal antibody that neutralizes SARS-CoV-2 in cell culture. The authors highlight that the cross-neutralizing antibody targets a communal epitope on the virus and may offer potential for prevention and treatment of COVID-19.
LabCoP’s June ECHO session covered differentiated service delivery (DSD) for HIV care. DSD is a client-centered approach aimed at simplifying and adapting HIV services to different groups of people living with HIV, while reducing the burden on the health system. In recent months, the response to the COVID-19 pandemic has included adjustments to clinical care… Read More
On 18 June 2020, ASLM hosted the sixth session in a series about manufacturers of COVID-19 molecular diagnostic tools, featuring PerkinElmer and Pro-Med. Stephanie Wilbraham, Market Development Manager, PerkinElmer, and Neil Barker, Co-Founder, Pro-Med Diagnostics, South Africa presented about the overview of their available SARS-CoV-2 laboratory test kit(s), performance, run time & other technical considerations… Read More
On 11 June 2020, ASLM hosted the fifth session in a series about manufacturers of COVID-19 molecular diagnostic tools, featuring KH Medical and Inqaba Biotec. Dr Aron Abera, Technical Support Manager, Inqaba Biotec, South Africa; Dr Julius Muhumuza, Technical Advisor, KH Medical Co., Ltd.; Mr Adam Hong, CEO, KH Medical Co., Ltd.; and Dr Rugola… Read More
The World Health Organization has published interim guidance on the use of masks in the context of COVID-19 for health settings and home care. This interim guidance provides detailed pragmatic advice to decision makers on the use of masks for healthy people in community settings based on risk, vulnerability, settings and feasibility.
In a retrospective study of hospitalized patients with COVID-19, by Joshua Barbosa et al, published in the New England Journal of Medicine, it shows that Hydroxychloroquine does not seem to have meaningful benefits on clinical outcome measures of mortality, lymphopenia, or neutrophil-to lymphocyte ratio improvement. The authors demonstrate that patients receiving Hydroxychloroquine appeared to have… Read More
On 2 June 2020, this COVID-19 ECHO session was convened to discuss establishing an integrated specimen referral system (SRS) for SARS-CoV-2 testing recommended to enable access to testing services across the entire health pyramid. Many countries struggled to operationalise this guidance and failed to create sustainable and efficient sample transportation systems. Due to various challenges,… Read More
In July of 2019, the World Health Organization and the African Society for Laboratory Medicine organized a meeting with countries and key stakeholders in diagnostics to discuss and find concrete ways to improve and increase access to integrated multiplex technologies and determine how they can be translated into public health policy that impacts global impact.
In this MEDSCAPE commentary, Dr Paul Sax from Brigham and Women’s Hospital and Harvard Medical School summarises some of the most common questions regarding COVID-19 and HIV: Is COVID-19 a more severe disease in people with HIV? Do I need to come in for my regular blood tests and checkups? Do my antiretroviral medications protect… Read More
In this guideline, specifically prepared for COVID-19 pandemic, Africa CDC advises Member States to use the characteristics of the epidemic in their country to decide when and how to do contact tracing. Namely, in Epidemic Phase 1-2 where imported cases and cases in known transmission chains the guidance is to trace all contacts. In Epidemic… Read More
The Writing Group of the Johns Hopkins University and Johns Hopkins Hospital COVID-19 Treatment Guidance Working Group presents a compressive guidance for existing treatment for COVID-19. The guidance strongly recommends clinical trials for potential treatments before any use, how to use immune modulatory agents to treat COVID-19 such as IL-6R or IL-6 Monoclonal antibodies, intravenous… Read More
This study by Nathan Ford, et al. (20 March, 2020), published in the Journal of the International AIDS Society, presents the systematic review of clinical outcomes using antiretroviral drugs for the prevention and treatment of coronaviruses and planned clinical trials. Their review indicates that it is uncertain whether LPV/r and other antiretrovirals improve clinical outcomes… Read More
On 28 May, 2020 ASLM hosted the fourth session in a series about manufacturers of COVID-19 molecular diagnostic tools, featuring Abbott. Presentations were made by Dr Claudio Galli, Associate Director, Medical Scientific Affairs Global, Abbott Core Laboratory, and Dr Liane Bauer, Director, Professional Services EMEA, Abbott Core Laboratory. They covered topics including detection of COVID-19… Read More
During severe shortages of personal protective equipment (PPE) due to COVID-19, one solution to consider is decontamination and extended use of medical masks and N95/FFP2 respirators for health workers at the frontline. On 26 May, 2020 ASLM hosted a session that covered these considerations and additional recommendations on homemade masks that have protection equal to… Read More
On 20 May 2020, this COVID-19 ECHO session was convened to discuss procurement and the supply chain for COVID-19 diagnostics. Dr Lara Vojnov, Diagnostics Advisor at the World Health Organization, Geneva, and Dr Yenew Kebede, Head of Laboratory Services at Africa CDC presented about the need to coordinate and collaborate test availability and access; current… Read More
LabCoP’s May ECHO session covered the key considerations for expanding COVID-19 capacity to the sub-national level and featured the Ethiopian experience. During this session, participants learnt about the need to scale up diagnostic capacity; governance and coordination issues essential for expansion of COVID-19 testing; leveraging on existing capacity to cope with the needs; strategies for… Read More
The May 2020 Waste Management training session focused on SARS-CoV-2 laboratory biosafety guidance and featured the presentation of David Bressler, Health Scientist and Microbiologist at the International Laboratory Branch of the U.S. Centers for Disease Control and Prevention. Nearly all countries are scaling up COVID-19 testing as one of the main strategies to eliminate the… Read More
On 14 May 2020, this COVID-19 ECHO session was convened to assist the African laboratory community in designing and implementing an effective COVID-19 quality assured testing program. Mr Patrick Mateta, Vice President, Global Health Partnerships, at Clinical and Laboratory Standards Institute (CLSI) presented about how to plan and prepare for COVID-19 testing, the selection and… Read More
This article, published in STAT, lists the COVID-19 drugs and vaccines in development, to help inform efforts to treat or prevent COVID-19. Note: The article lists novel medicines, not repurposed medicines.
On 8 May 2020, ASLM hosted part 2 of an ECHO session about COVID-19 serology tests. Serological diagnostic testing has been proposed to be useful in combination with molecular testing, in confirming COVID-19 infection or exposure to the virus. Serology tests also have the potential to be delivered in rapid format and at the point… Read More
On 30 April 202, ASLM hosted the third session in a series about manufacturers of COVID-19 molecular diagnostic tools, featuring Abbott and Bio-Rad. Dr Danijela Lucic, Senior Scientific Affairs Manager, Global Infectious Disease, Abbott Molecular, and Dr Marcus Neusser, EMEA Product Manager, Gene Expression, Bio-Rad, Germany, and Mr Richie Petronis, Product Manager, Bio-Rad, USA, presented… Read More
On 29 April 2020, ASLM hosted this ECHO session on strategies to implement fast turn-around laboratory testing for control of COVID-19, presented by Dr Trevor Peter, Senior Director, Diagnostic Services, Clinton Health Access Initiative. Nucleic acid testing is the WHO-recommended method for detecting SARS-CoV-2. The global scale-up of COVID-19 diagnostics will depend on use of… Read More
On 24 April 2020, Professor Rosanna Peeling and colleagues from the International Diagnostics Centre at the London School of Hygiene and Tropical Medicine pulled together evidence for and against the original set of recommendations for use of serologic tests. Prof Peeling was joined by Dr Yenew Kebede from Africa CDC and Dr Amadou Sall from… Read More
This paper describes the steps taken by Brazil before the first COVID-19 cases were identified in that country. The steps included creation of ordinances and laws, setting up of emergency operating centers, and clearly articulating how isolation and quarantine will be done. The paper also examines the advantages of these measures. Based on the Brazilian… Read More
This paper highlights important research questions regarding SARS-CoV-2 which include origin, virus transmission, viral shedding, diagnosis, treatment, vaccine development and viral pathogenesis. The paper proposes that research on SARS-CoV-2 and COVID-19, if it seeks to answer these important questions, will solidify the scientific basis on which important policy and scientific decisions are made to contain… Read More
This presentation by Prof Yazdan Yazdanpanah, published by the Global Research and Innovation Forum, presents a global roadmap for the control of COVID-19. The roadmap defines research priorities regarding how to stop the transmission of COVID-19, and how to mitigate its impact, as well as a governance framework from an ethics point of view. The… Read More
This study, by Xi He et al, published in Nature Medicine (15 April, 2020), reports that 44% of secondary COVID-19 cases were transmitted by people who had not yet developed symptoms. The findings emphasize that control measures should be adjusted to account for probable substantial presymptomatic transmission. Sensitive and specific molecular and serological testing is… Read More
Laboratories need to conduct verification or validation studies to confirm that new tests for COVID-19 diagnosis perform as intended. In this document co-authored by ASLM, FIND and the London School for Hygiene and Tropical Medicine, further key requirements for quality assurance are defined, including quality control and external quality assurance that laboratories should follow to… Read More
LabCoP’s April ECHO session featured presentations about maintaining HIV and TB testing in the context of COVID-19 from Dr George Alemnji, Senior Technical Advisor for Laboratory Services at the State Department Office of Global AIDS Coordinator (SGAC) and Health Diplomacy, US CDC; Dr Lara Vojnov, Diagnostics Advisor, WHO; and Dr Dennis Falzon, Medical Officer, World… Read More
This study by Dr Bin Cao, et al, 2020, in the New England Journal of Medicine describes a trial of lopinavir–ritonavir in adults hospitalised with severe COVID-19 where no benefit was observed with this treatment beyond standard care.
This systematic review of the efficacy and safety of antiretroviral drugs against SARS, MERS, or COVID-19 (initial assessment) was conducted by Dr Nathan Ford, et al, 2020. Their conclusion from the available evidence is that it is uncertain whether LPV/r and other antiretrovirals improve clinical outcomes or prevent infection among patients at high risk of… Read More
This report details the first full genome sequence of SARS-CoV-2 from Africa to be released, with genomic data generated and assembled, and phylogenetic analysis performed by ACEGID and NIMR scientists.
The Liverpool Drug Interactions Group (based at the University of Liverpool, UK), presents an exhaustive chart about common drug interactions with experimental COVID-19 therapies.
This March 2020 presentation of the WHO-China joint mission includes key findings on COVID-19. Epidemiologic and technical insights to contain the pandemic are also covered.
This modelling study by Marius Gilbert, et al, published in the Lancet, 2020, evaluates preparedness and vulnerability of African countries against importations of COVID-19. Their evaluation was based on WHO International Health Regulations (IHR) Monitoring and Evaluation Framework (MEF), and on an indicator of vulnerability to emerging epidemics.
This article published in the New England Journal of Medicine by W. Guan, et al, 2020, describes the clinical characteristics of affected patients with COVID-19 in China. The findings show more frequent absence of fever in COVID-19 than in SARS-CoV (1%) and MERS-CoV infection (2%). This can have an implication if surveillance case definition focuses… Read More
This paper published in the New England Journal of Medicine by Neeltje van Doremalen, et al, 2020, describes the stability of viable SARS-CoV-2 on surfaces and in aerosols in comparison with SARS CoV-1. The results indicate that aerosol and fomite transmission of SARS-CoV-2 is plausible, as the virus can remain viable in aerosols for multiple… Read More
This article by Mark S. Lesney and published by MDedge, 2020, highlights the news that researchers have identified the structure of a spike protein that could turn out to be a potential vaccine target for the 2019-nCoV that causes COVID-19. The research further suggests that future antibody isolation and therapeutic design efforts will benefit from… Read More
On 16 April 2020, ASLM hosted the second session in a series about manufacturers of COVID-19 molecular diagnostic tools. Dr Davide Manissero, Chief Medical Officer of Infection and Immune Diagnostics at QIAGEN, and Mr Riegardt Johnson, Field Application Scientist at Thermo Fisher Scientific presented about their available COVID-19 laboratory test kit(s), their status regarding regulatory… Read More
On 14 April 2020, ASLM hosted the first session in a series about manufacturers of COVID-19 molecular diagnostics tools, including BD and Cepheid. Dr Charles Cooper, Global Vice President, Medical Affairs, Integrated Diagnostic Solutions at BD, and Ms Rujeko Tsomondo, Regional Application Lead at Cepheid presented about their available COVID-19 laboratory test kit(s), their status… Read More
This report by WHO gives an overview on the use of licensed medicines for indications that have not been approved by regulatory authorities. It provides a scientific summary of key aspects to consider in off label use of medicines and the need to adhere to national regulations on the use of medicines. It also stipulates… Read More
This is an exhaustive PowerPoint presentation by Paolo Surico and Andrea Galeotti about the economics of a pandemic, using COVID-19 as a case study. The presentation sheds light on the science, health policies, economics and macroeconomic policies.
The European Centres for Disease Prevention and Control (ECDC) has published this technical report about safe handling of bodies of deceased persons with suspected or confirmed COVID-19 to be used by public health authorities in EU/EEA Member States and the United Kingdom. These considerations may help inform the approach in Africa.
This paper by Erin K. McCreary and Jason M. Pogue about COVID-19 treatment describes a review of early and emerging options. The authors summarize the current evidence as of 19 March 2020 to provide guidance on potential COVID-19 treatment options.
The Nigeria Centre for Disease Control published this self-isolation guidance for Nigerians on 18 March 2020 that providesdetailed description of what self-isolation means during COVID-19 pandemic and step-by-step instructions for adherence. This guidance may help inform the policies set forth my ministries of health of other African countries.
This paper by Chengzhi Yang & Zening Jin, 2020, indicated that individuals with underlying chronic cardiovascular diseases (CVDs) were both more susceptible to COVID-19 and more prone to critical conditions and death. Therefore, continued observations of the cardiovascular complications of the disease are needed.
On 8 April 2020, ASLM and LabCoP convened a special ECHO session on lessons the African continent can learn from the Korean experience in controlling COVID-19 Dr Seon Kui Lee, Director, Division of Risk Assessment & International Cooperation at the Korea Centers for Disease Control and Prevention (KCDC), shared an overview of the KCDC and… Read More
Mozambique provided this Excel-based tool, with its accompanying instructions, as a country example of a comprehensive diagnostic network optimization or mapping tool at the July 2019 Global Diagnostics Integration meeting in Geneva. The government sought a tool that could be: subnational, consider multiple potential technologies as well as both laboratory-based and point-of-care, incorporate testing across… Read More
Developed by the Clinton Health Access Initiative (CHAI) for its country teams and ministries of health, this tool can be used to assess the financial benefits of integrating tuberculosis (TB), HIV, and HCV testing on the GeneXpert machine. The tool only covers cross-cutting costs (i.e. not disease-specific) regarding the use of GeneXpert, such as equipment,… Read More
This paper by Shaobo Shi et al, 2020, explores the association of cardiac injury with mortality in hospitalized patients with COVID-19 in Wuhan, China.
Africa CDC has published this guidance and recommendations for community social distancing during the COVID-19 outbreak. Social distancing is an accepted strategy to delay and reduce the magnitude of outbreaks of pandemic influenza. It is necessary at the individual and community levels, because transmission occurs frequently from person-to-person.
This paper by David M. Morens and Anthony S. Fauci provides insight about the 1918 influenza pandemic and lessons learned, which could still apply in the 21st Century related to COVID-19, Ebola or other outbreaks.
This review about the epidemiology and pathogenesis of coronavirus disease (COVID-19) by Hussin A. Rothan et al, 2020, in the Journal of Autoimmunity highlights the symptoms, epidemiology, transmission, pathogenesis, phylogenetic analysis, and future directions to control the spread of this fatal disease.
This paper by Yixuan Wang et al, 2020 summarises the latest literature on genetic, epidemiological, and clinical features of COVID-19 compared to SARS and MERS, and emphasises special measures on diagnosis and potential interventions. This review can improve our understanding of the unique features of COVID-19 and enhance our control measures in the future.
WHO has published interim guidance for laboratory testing for coronavirus disease COVID-19 in suspected human cases. It also describes safety procedures for specimen collection and testing from suspected cases and contacts. Suspect cases should be screened for the virus with nucleic acid amplification tests (NAAT), such as RT-PCR. Download the guide and read more.
On 30 March 2020, ASLM and LabCoP convened a special ECHO session on the latest available technology to diagnose COVID-19, and recommendations for clinical care and surveillance. Dr Cassandra Kelly-Cirino, from the Foundation for Innovative New Diagnostics (FIND), and Prof Rosanna Peeling, from the London School of Hygiene & Tropical Medicine, gave an overview of… Read More
On 25 March 2020, ASLM and LabCoP convened an ECHO session on troubleshooting common challenges associated with establishing diagnostic testing for SARS-CoV-2 (the causative agent of COVID-19). Dr Jinal Bhiman, Director of the National Influenza Centre at the NICD, South Africa, presented practical solutions to address the most common challenges encountered by laboratory staff recently… Read More
The March 2020 waste management training session focused on Hologic’s Best Practices for Waste Handling. Todd Richmond of Hologic, shared his experiences, expertise and advice on the waste and contamination management of Hologic’s Panther. In collaboration with the African Society for Laboratory Medicine (ASLM) and the LabCoP community, the CDC International Laboratory Branch (ILB) offers… Read More
Pre-analytical challenges threaten the quality of viral load (VL) testing. This study determined the impact of delayed testing and warmer storage conditions on HIV RNA stability in diagnostic samples. Viral load in samples stored for up to a week reliably differentiated between patients with antiretroviral therapy (ART) suppression and ART failure in the majority of… Read More
Plasma preparation tubes (PPT) can simplify storage, transport, and preparation of plasma used for viral load (VL) testing. This systematic review evaluated the accuracy of PPTs for HIV VL testing. The results showed that following proper sample handling techniques helps provide accurate results. The authors thus recommended PPTs as a high-quality alternative specimen type for… Read More
This systematic review and meta-analysis summarizes evidence that shows that task shifting of testing using point-of-care technologies from laboratory professionals to non-laboratory staff was comparable to laboratory professionals operating the same technology in the laboratory. Task shifting of clinical tasks to lower cadres of health care workers and lay counselors has been successful in scaling… Read More
This paper by Jilian Sacks et al, 2019, presents a meta-analysis of studies comparing the Cepheid Xpert HIV-1 viral load (VL) plasma assay to traditional laboratory-based technologies. Cepheid Xpert HIV-1 VL plasma assay results were highly comparable to laboratory-based technologies with limited bias and high sensitivity and specificity to detect treatment failure. Alternative specimen types… Read More
This paper by Katherine Lamp et al, 2019, outlines an analysis of point-of-care (POC) CD4 invalid result rates across five countries. The authors found that the rate of invalid results was consistent across all types of health facilities, and the invalid rates were inversely correlated to operator usage, with high-volume operators. They concluded that POC… Read More
In this session, colleagues from Kenya shared findings from the assessment of waste handling practices in their viral load (VL) and Early infant diagnosis (EID) laboratories. They discussed contextual issues in regard to VL & EID laboratory testing capacity and networks, laboratory self-assessment using a VL & EID customized assessment checklist, findings/results, lessons learnt, challenges… Read More
WHO has published these recommendations for health workers and global health professionals who travel, to help them stay safe and minimise their chances of contracting the 2019-nCoV in the course of their work. Please download these documents below.
These presentation slides are from the Women-Centered Diagnostics satellite session of the 2019 International Conference on AIDS and STIs in Africa (ICASA 2019) that was jointly organized by the African Society for Laboratory Medicine (ASLM), the Clinton Health Access Initiative (CHAI), the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF), UNICEF and Unitaid. Much has been done… Read More
To reach the third 90 of the UNAIDS 90–90–90 targets, country programmes must delve into their data and understand how they represent the quality of viral load (VL) testing services. This guide, published by WHO, presents key considerations and examples of tools (provided in the annexes) to assist countries in developing a national VL M&E… Read More
The SLIPTA Checklist, published by WHO, specifies requirements for quality and competency, aimed to develop and improve medical laboratory services to raise laboratory quality to established national and/or international standards. Laboratories will receive a 0-5 star level rating to certify that the audited laboratory is undergoing the quality improvement process to meet all the requirements… Read More
Use the Accredited Laboratories Distribution Map to see the distribution of Internationally Accredited laboratories and the detailed information of each specific country
The African Society for Laboratory Medicine (ASLM) has been designated by WHO-AFRO in October 2012 to coordinate and lead the implementation of the Stepwise Quality Laboratory Improvement Process towards Accreditation (SLIPTA) in Africa. ASLM has then developed a standardized SLIPTA auditor training curricula and trained the training at a country and regional levels. The training… Read More
Welcome to the point-of-care (POC) early infant diagnostic (EID) landscape in Africa. Through funding provided by Unitaid, partners including the Clinton Health Access Initiative (CHAI), UNICEF, and ASLM have successfully supported the introduction of POC EID and viral load (VL) technologies and pilot activities in sub-Saharan African countries. Strategic deployment of POC EID is key… Read More
WHO-AFRO has established the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) programme, a framework for improving the quality of public health laboratories in developing countries to achieve ISO 15189 standards. Through standardised processes, SLIPTA measures and evaluates the progress of laboratory systems towards international accreditation and awards a certificate of recognition (0-5 stars rating). This map shows the distribution and ratings of laboratories that have been audited.
The November 2019 Waste Management training session focused on the perspectives of Abbott Laboratories’ Best Practices for Waste Handling. Delfin Rubin, Global Product Manager of HIV Care for Infectious Disease Emerging Markets at Abbott Rapid Diagnostics, and Ami Soni, EHS Lead for Abbott Molecular describe the constituents of their HIV rapid point-of-care diagnostics, such as… Read More
The purpose of this tool is to assist in identifying gaps and creating awareness of best practices for waste management processes in viral load (VL) and early infant diagnosis (EID) molecular testing laboratories (and associated healthcare facilities), in order to provide a starting point for assistance in waste mitigation strategies. This tool is for completion… Read More
Diagnostic network optimization is an exercise that aims to redesign the diagnostic network set-up in order to increase access, maximize impact, and generate efficiencies. It aligns testing demand and capacity in the most cost-effective way by defining the optimal instruments mix, identifying the most appropriate locations where instruments should be placed, and designing the referral… Read More
WHO has produced a biosafety video series entitled, “Good Microbiological Practice and Procedures (GMPP)”, which is central to the WHO Laboratory Biosafety Manual (LBM4) being revised and finalised. These seven training videos will help enhance the safety of any health laboratory, including those in resource-limited settings.
With limited funding for global health, identifying practical, cost and time-saving solutions, while also ensuring quality of care is increasingly important. One approach to increasing access to point-of-care (POC) testing is integrated testing (a term often used interchangeably with “multi-disease testing”), which tests for different conditions or diseases using the same diagnostic platform. This brief… Read More
This fact sheet gives the situation as of July 2019 of the status of HIV self-testing (HIVST) in national policies, implementation of Treat All ART recommendations among adults and adolescents living with HIV, implementation of Treat All policy for pregnant and breastfeeding women living with HIV, national policy on routine viral load testing for monitoring… Read More
Increased access to antiretroviral therapy (ART) and treatment monitoring for pregnant and breastfeeding women living with HIV is a priority for promoting health during the pregnancy and post-partum periods, and to minimize the risk of vertical transmission of HIV to infants. Point-of-care viral load (POC VL), which allows testing to be conducted at or near… Read More
Currently, about half of patients on antiretroviral treatment have access to viral load testing; however, access remains focused within a small number of countries. To date, routine HIV VL monitoring, which is considered the best method for monitoring antiretroviral treatment, has been fully implemented in only 68% of low- and middle-income countries, and partially implemented… Read More
Scaling up viral load (VL) testing to reach the 3rd 90 of the UNAIDS 90-90-90 targets by 2020 requires a holistic approach, addressing each step of the VL testing continuum from the demand for test request for all eligible patients, to the utilization of test results. Improving VL scale-up at the facility level is important,… Read More
In this session we focused on the issues of policy, legal and regulatory frameworks for waste management, using an example from South Africa. This session underscored the fact one of the common noted challenges in many settings was that there were and still are limited or no existing national policies or guidelines on dealing with… Read More
This viral load (VL) cascade self-assessment scorecard and user guide is used by the LabCoP country teams to identify critical gaps in their laboratory systems and assess the status of the different thematic areas of the VL cascade and their testing services to help identify opportunities for improvement. It was designed by the LabCoP team… Read More
WHO has updated its Essential Diagnostics List, a catalogue of the tests needed to diagnose the most common conditions as well as a number of global priority diseases.
This Waste Management session covered updates to the checklist for assessments of viral load (VL) and early infant diagnosis (EID) testing laboratories and associated healthcare facilities. David Bressler, MS, CBSP (SM) NRM of the International Laboratory Branch, CDC, Division of Global HIV and TB presented to the audience about the checklist/tool and its ability to… Read More
Integrating testing using multiplex technologies at the appropriate level of care can lead to more efficient and cost-effective testing services and can help to simplify and streamline other systems, such as specimen referral, human resources, and quality assurance. Integration should be a priority for both those countries with currently operational multi-disease testing devices and those… Read More
This Rapid Testing Continuous Quality Improvement (RTCQI) training video and competency assessment tool is available on a free virtual education platform, PEPconnect to assist ministries of health, health-care providers, and stakeholders in planning, implementing and sustaining quality assurance for point-of-care testing. Critical for the first of UNAIDS’ 90-90-90 targets, this platform is developed by the… Read More
In 2013, the World Health Organization (WHO) recommended viral load (VL) monitoring as the gold standard for monitoring the effectiveness of antiviral therapy (ART). One of the key barriers to VL testing in resource-limited settings is the lack of efficient specimen transport systems, to allow plasma or whole blood samples to reach the testing laboratories… Read More
The Stronger Together public-private partnership between Siemens Healthineers and PEPFAR is institutionalising quality improvement via a free e-platform, PEPconnect, through this library of 48 videos (with a total viewing time of 14.5 hours) that capture the lectures from the 9-day classroom-based Quality Control and Method Validation course. The course is designed to enable the participants… Read More
Early infant diagnosis (EID) is critical for timely initiation of antiretroviral treatment (ART) in HIV-infected children who are at high risk of mortality. In recognition of the immense benefits of dried blood spot (DBS) as a means of increasing the access to EID, the World Health Organization, African Society for Laboratory Medicine, Centers for Disease… Read More
The Laboratory African Regional Collaborative (LARC) project supports clinicians, laboratorians and data record units to work together and improve the proportion of viral load test results put in patients’ files. LARC is a useful tool that can be used by countries to address inefficiencies at the laboratory-clinical interface at clinic level, and achieve the 3rd… Read More
This review article identifies the benefits, enabling factors, and associated challenges for public and private sectors to engage in public-private partnerships. These partnership contributions to laboratory systems strengthening are a model, and present opportunities that can be leveraged to strengthen systems to accelerate the scale up of Viral Load and Early Infant Diagnosis to achieve… Read More
This supplement, produced by Labs for Life, a public-private partnership between Becton Dickinson, Company and The President’s Emergency Plan for AIDS Relief (PEPFAR), was published in the Journal of Infectious Diseases. This supplement is designed to support Ministries of Health, Laboratory Experts, Clinical staff, and implementing partners to improve global laboratory systems. This is accomplished… Read More
This course provides key information on safe practices, infection control, personal protective equipment, pre- and post-exposure prophylaxis, and ways to manage and dispose of health care waste properly. The goal is to familiarize Clinical health care workers with proper safety practices and help them: Protect themselves and their coworkers Protect patients and clients Protect the… Read More
This insightful paper was published in Plos about the missed potential of CD4 and viral load testing to improve clinical outcomes for people living with HIV in lower-resource setting
In the May 2019 session, Dr Katrina Sleeman, Associate Service Fellow in the Viral Load/Early Infant Diagnosis Team at the CDC ILB introduced a draft of a viral load WM checklist tool that can be used as baseline audit of select country VL labs. The tool aims to assist in creating awareness of best practices… Read More
In collaboration with ASLM and the LabCoP community, the CDC International Laboratory Branch (ILB) presented an overview of the World Health Organization (WHO) Publication: ‘Safe Management of Wastes from Health-Care Activities’ during the second ECHO session dedicated to waste management. This document, developed by WHO in 2017, highlights the key aspects of safe healthcare waste… Read More
In collaboration with the African Society for Laboratory Medicine (ASLM) and the LabCoP community, the CDC International Laboratory Branch (ILB) presented the first session in a series of ECHO sessions dedicated to waste management. In this session we reviewed waste management practices at the country level using the responses to the November 2018 LabCoP Waste… Read More
This document, developed by the World Health Organization (WHO) in 2017, highlights the key aspects of safe healthcare waste management in order to guide policymakers, practitioners and facility managers to improve such services in healthcare facilities. It is based on the comprehensive WHO handbook ‘Safe Management of Wastes from Health-Care Activities’ (WHO, 2014), and also… Read More
This reference manual, published by PEPFAR and the U.S. Centers for Disease Control and Prevention, is a guide for Implementation Subject Matter Experts (ISME)s who offer either in country or remote technical assistance in viral load (VL) and early infant diagnosis (EID) scale-up. Collectively, it presents best practices and proposed solutions for the challenges that… Read More
The waste produced in the course of healthcare activities, from contaminated needles to radioactive isotopes, can cause infection and injury. Inadequate waste management is likely to have serious public health consequences and deleterious effects on the environment. The resources linked here and this downloadable handbook published by the World Health Organization (2014), provide comprehensive guidance… Read More
LabCoP members who attended the Kampala face-to-face meeting in October 2018 developed a Decision-Making Matrix that outlines strategic areas, strategic options, and priority action items for improvement in four focus areas within the viral load cascade, including demand creation, results utilization, waste management and biosafety, and network optimization. This matrix could be used as a… Read More
This presentation by Dr. Ritu Shrivastava from the International Laboratory Branch of the US Centers for Disease Control and Prevention covers free online, didactic and in-person resources available for global system strengthening through three public-private partnerships (PPP). These partnerships between the President’s Emergency Plan For AIDS Relief (PEPFAR) and three private entities (Becton Dickinson and… Read More
In 2017, UNAIDS estimated 3,300 children under the age of 15 years died from AIDS-related causes in Cameroon. A key challenge is diagnosing and treating infants early in life. Now, a new point-of-care device, which provides results within minutes of testing, has overcome some major obstacles to treatment, giving hope to thousands of mothers and… Read More
Several new laboratory technologies are available or are being developed to allow for testing of different conditions using disease-specific tests on the same platform. For example, a single device may be able to test for the presence of tuberculosis (TB) and HIV, and quantitatively measure HIV and hepatitis C viral load by using disease-specific reagents… Read More
This publication provides high-level guidance on implementing and scaling up HIV viral load (VL) testing programmes for health ministries and implementation partners, using a three-phased approach: (1) planning; (2) scale-up; and (3) sustainability. The guidelines for managing antiretroviral therapy (ART) issued by WHO have recognized the importance of viral load monitoring since 2003. Routine VL… Read More
Treatment initiation ART should be initiated in all children, adolescents, pregnant and breastfeeding women and adults living with HIV, regardless of WHO clinical stage and at any CD4 cell count. ART should be initiated in all children, adolescents, pregnant and breastfeeding women and adults living with HIV, regardless of WHO clinical stage and at any… Read More
The 2013 WHO consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection recommend viral load as the preferred monitoring approach to diagnose and confirm ART failure. As countries invest in the scale-up of routine viral load testing, it is critical to measure the impact and progress towards achieving the UNAIDS… Read More
Based on the recent encouraging evidence POC/ near-POC EID warrants consideration of rapid adoption and strategic scale up of this solution complementing the existing laboratory network. Ravikiran Bhairavabhotla from CDC briefly outlines the evidence and tools to support the strategic introduction of POC EID as part of a tiered national laboratory network.
Sufficient evidence has been generated on the performance of these assays in the intended field settings to support rapid national regulatory approval and initiation of scale-up. Performance was consistent between laboratory and field settings, and across countries. Further technical evaluations of these technologies are unlikely to add value, but may instead delay implementation and timely… Read More
Because of the high risk of death before the age of 2 years among HIV-infected infants, and given the increasing availability of paediatric antiretroviral treatment in many resource-limited settings, WHO recommends that national programmes should establish the capacity to provide early virological testing of infants for HIV.
To reduce morbidity and mortality among HIV-infected children and close the treatment gap for HIV-infected children, there is an urgent need to evaluate existing programmatic and laboratory practices for early infant diagnosis and introduce strategies to improve identification of HIV-exposed infants and ensure access to systematic, early HIV testing, with early linkage to treatment for… Read More
In this Malawi study, ART initiation rates were significantly improved with the implementation of same-day POC EID testing compared with referred, longer-turnaround laboratory-based testing.
In this cluster-randomized controlled trial, Jani et al. evaluated the effect of point-of-care (POC) early infant HIV testing on rates of antiretroviral therapy (ART) initiation and retention in care among HIV-positive infants who presented for early infant diagnosis at health facilities in Mozambique. POC achieved more rapidly diagnosis and timely provision of treatment to HIV-infected… Read More
A real life story of how of POC EID devices strategically placed at the point where they are direly needed testing for HIV exposed infants in Malawi, are great impact for the infants and their families. Infants born to or breastfed by HIV positive mothers are in need of timely HIV because risk of mortality… Read More
Zibusiso Ndlovu, Epidemiologist and Laboratory Advisor with Médecins Sans Frontières, and colleagues demonstrated the feasibility of the GeneXpert multi-disease testing at the near point-of-care in district and sub-district health settings in Zimbabwe. Read the research article by clicking the link below.
In September 2018, Solange Baptiste and Helen Etya’ale from International Treatment Preparedness Coalition (ITPC) presented about HIV viral load testing (VLT) demand creation. These presentations contain helpful information that country teams can use to improve demand creation for their HIV VLT programs. This includes information about the significance of demand creation for VLT and the… Read More
This four-step overview of Laboratory African Regional Collaborative (LARC) was presented by Patricia Riley from the International Laboratory Branch of the US Centers for Disease Control and Prevention. LARC can be used by countries to address inefficiencies at the laboratory–clinical interface at clinic level, and achieve the 3rd ‘90’ of the UNAIDS 90-90-90 HIV targets.
On 15 May, 2018 UNICEF hosted a webinar to provide a broad overview of the Key Considerations Document and the HIV POC Diagnostics Toolkit and to promote coordinated dissemination of both resources amongst partners at the country level. Click the player to watch the webinar.
Kenya’s presentation during the May LabCoP ECHO session included their experiences implementing the ‘Plan, Do, Study, Act’ (PDSA) cycle to prioritise and rapidly test ‘change ideas’ needed to facilitate the rapid identification of unsuppressed viral load (VL), followed by swift appropriate clinical action.
An extension of Key Considerations for Introducing New HIV Point of Care Diagnostic Technologies in National Health Systems, this Toolkit contains various practical tools and guidance to support countries as they introduce point-of-care (POC) HIV technologies into existing national diagnostic networks and laboratory systems. It provides a roadmap for countries as they seek to expand… Read More
Point-of-Care Testing: Why is it important? Imagine yourself in a city at the centre of one of the world’s deadliest disease outbreaks. You watch as your friends and relatives are struck down by an aggressive illness that kills roughly 50-90% of those affected. One evening, you go to bed tired and achy, awakening the next… Read More
Broadens access to HIV viral load monitoring On July 20, 2017, Cepheid received World Health Organization (WHO) prequalification for its Xpert® HIV-1 Viral Load (VL) test. The Xpert® HIV-1 VL test measures Human Immunodeficiency Virus type 1 (HIV-1) RNA in human plasma from individuals infected with HIV-1 in less than 90 minutes. Measurement of blood… Read More
Representatives from the African Society for Laboratory Medicine (ASLM), UNICEF and the Clinton Health Access Initiative, Inc. (CHAI) came together 17-18 August 2017 in New York City, United States, to review progress to date on the implementation of a joint point-of-care project and to refine coordination mechanisms to achieve greater impact. “This project has… Read More
Gebremicael, et al. report results from a technical evaluation of the BD FACSPresto Point-of-Care CD4 platform in Ethiopia using capillary and venous blood samples. Researchers found acceptable agreement with conventional systems for measuring CD4 count, CD4% and Hgb concentration. This paper was published in April 2017 by PLOS ONE.
Vojnov, et al., present results from a systematic review and meta-analysis to assess the benefit of using short message service (SMS) and general packet radio service (GPRS) printers to increase the efficiency of early infant diagnosis (EID) test result delivery compared with traditional courier, paper-based result delivery methods. The authors found that SMS/GPRS result delivery… Read More