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. To find a specific resource, enter the resource name in the search bar. You may also use the search bar to enter key words related to the resources of your interest.
The study collected information from African countries about existing national guidance documents and the current process of decision making when selecting tier-specific in-vitro diagnostics (IVD). The lessons learnt represent useful insights on what works and what does not, that could be the basis for recommendations to supporting countries and stakeholders in developing and implementing a… Read More
In September 2021 the World Health Organization released updated guidance on maintaining essential health services during COVID-19, which provides direction on modifications and specific measures for safe delivery of HIV services, and considerations for transition towards restoration and recovery. Surveys of 101 countries have revealed substantial disruptions across all major health areas with up to… Read More
Low- and middle-income countries (LMIC) currently experience low testing coverage in the face of increasing demand to meet the needs of millions of people living with HIV, TB, HPV, hepatitis and other diseases. Therefore, innovative solutions are urgently needed to enable a robust, efficiently utilised testing capacity, and a healthy and secure market with competitive… Read More
These guidelines, published by the World Health Organization, provide new and updated recommendations and good practice statements in the following areas: starting antiretroviral therapy (ART), including initiating treatment outside the clinic and support for same-day ART start; frequency of clinical visits and ART refills; measuring adherence; tracing and re-engagement in care for all populations; psychosocial… Read More
This presentation by the Clinton Health Access Initiative outlines the steps of an integration implementation framework for tuberculosis (TB) and HIV diagnostics, and related diseases, top tips and caveats (what could go wrong and lessons learned) from pilot countries on each step and area of implementation. It provides a deeper understanding of activities required for… Read More
The GX Capacity Utilisation Analysis Tool is an Excel-based tool to assess the capacity utilisation of GeneXpert platforms for integrating tuberculosis (TB), HIV, HCV and HPV testing. It has been used to identify platforms running with full-capacity and with un-used capacity to inform integration decisions in Cameroon, Ethiopia, Indonesia, Malawi, Nigeria, Tanzania, Uganda, Zambia, and… Read More
The Integration Readiness Assessment Tool developed by Clinton Health Access Initiative and partners helps countries gather situation analysis information regarding an individual facility’s readiness to provide integrated testing for tuberculosis (TB), HIV and HPV. The assessment output of this MS Excel-based checklist allows for identification of sites where TB/HIV/HCV/HPV integration on the GeneXpert platform would… Read More
The catalytic investment in point-of-care (POC), early-infant-diagnosis (EID), and viral-load (VL) technologies by the Accelerating Access to Innovative Point of Care HIV Diagnostics Project, implemented in partnership between UNICEF, Clinton Health Access Initiative (CHAI), ASLM, Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) and Unitaid, has shown significant results over the years. It has contributed to filling… 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 23 October, 2020 ASLM’s LabCoP hosted the ninth session in a series about manufacturers of COVID-19 molecular diagnostic tools, featuring STANDARD Q COVID-19 antigen rapid diagnostic test (Ag RDT). A new global partnership by WHO, The Global Fund, UNITAID, Africa CDC, FIND and other partners ensures that low-priced, high-quality Ag RDTs are available internationally… Read More
On 21 October, 2020 ASLM’s LabCoP hosted the ninth session in a series about manufacturers of COVID-19 molecular diagnostic tools, featuring Abbott’s Panbio Ag RDT, an in-vitro diagnostic test for the qualitative detection of SAR-CoV-2 antigen. In this session, Dr Kuku Appiah, Director, Medical & Scientific Affairs, Africa, Abbott Rapid Diagnostics discuss the Abbott Panbio… Read More
On 11 June 2020, ASLM’s LabCoP 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… 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.
On 28 May, 2020 ASLM’s LabCoP 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… 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
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
On 8 May 2020, ASLM’s LabCoP 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… Read More
On 30 April 202, ASLM’s LabCoP 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,… Read More
On 29 April 2020, ASLM’s LabCoP 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… 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
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 assessment 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
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
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
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
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
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
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
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
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
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.
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
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 (WHO), African Society for Laboratory Medicine, Centers for… 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 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
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
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
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
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
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. Please follow the links below to watch the recorded session on ASLM’s… Read More
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
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
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
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