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1
A total of 18 laboratories from 13 countries participated in the four rounds of EQA: 10 laboratories from eight African endemic countries, four of which participated in all four rounds and three in three rounds. The overall results showed that the median p
...
erformance of these laboratories improved over the four rounds. However, the proportion of laboratories reporting false–positive cases remains high and indicates a problem of specificity probably due to contamination. The proportion of laboratories reporting both false–positive and false–negative results raises the issue of the quality of the data reported by WHO in Africa as well as the results of the studies carried out in these different laboratories in various countries.
more
This report, published in conjunction with a summary overview of results of rounds 1–8, is the eighth and final report in a series of laboratory-based evaluations of rapid diagnostic tests (RDTs) for malaria. It provides a comparative measure of t
...
heir performance in a standardized way to distinguish between well and poorly performing tests.
These results constitute the laboratory evaluation component of the WHO prequalification process for malaria RDTs and inform the current WHO procurement recommendations. In round 8, 35 RDTs from 17 manufacturers were assessed. For the first time the evaluation included an assessment of product performance against a panel of P. falciparum parasites with pfhrp2/3 gene deletions and therefore not expressing HRP2.
more
On a need’s basis, the Immunization Analysis and Insights, Vaccine Preventable Diseases (VPD) Surveillance and Risk Assessment Team of the World Health Organization (WHO) posts expression of interest (EOI) calls, inviting manufacturers of specified technologies (in vitro diagnostics also known as
...
IVDs) to participate in a WHO product evaluation. The focus is on IVDs that are used by WHO’s laboratory networks undertaking surveillance for certain VPDs
more
Interim guidance, 6 October 2021
Direct detection of SARS-CoV-2 viral proteins (antigens) in nasal swabs and other respiratory secretions using lateral flow immunoassays (also known as rapid diagnostic tests, RDTs) offers a faster and less expensive method to test for SARS-CoV-2 than the reference
...
method, nucleic acid amplification tests (NAATs). This interim guidance offers recommendations on the priority uses of antigen-detecting rapid diagnostic tests (Ag-RDTs) in specific populations and settings, including (i) for primary case detection in symptomatic individuals suspected to be infected and asymptomatic individuals at high risk of COVID-19, (ii) for contact tracing, (iii) during outbreak investigations and (iv) to monitor trends of disease incidence in communities. Ag-RDTs meeting minimum performance requirements can be used outside of clinical and laboratory settings, including in communities, by trained operators in accordance with instructions. The guidance additionally provides recommendations on implementation, product selection and storage.
more
The survey, conducted between March 1–10, 2018, assessed the performance of 104 public and 33 private hospitals in Venezuela. According to the figures, most laboratory services and hospital nutrit
...
ion services are only available intermittently or are completely inoperative. Shortages of items such as basic medicines, catheters, surgical supplies, and infant formula are highlighted in the survey; 14% of intensive care units have been shut down because they are unable to operate and 79% of the facilities analysed have no water at all.
more
Quality Assurance Framework for SARS-CoV-2 Antigen Rapid Testing for Diagnosis of COVID-19
recommended
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 pr
...
ovide general technical guidance to African Union Members States on the rollout, establishment, implementation, monitoring, and evaluation of SARS-CoV-2 Ag RDT interventions so as to effectively and efficiently detect, control and minimise errors in the performance of COVID-19 laboratory testing processes. It describes the core components for quality assurance, resources mobilisation and advocacy for scale up, monitoring, evaluation, learning and accountability for SARS-CoV-2 implementation.
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 pr
...
ovide general technical guidance to African Union Members States on the rollout, establishment, implementation, monitoring, and evaluation of SARS-CoV-2 Ag RDT interventions so as to effectively and efficiently detect, control and minimise errors in the performance of COVID-19 laboratory testing processes. It describes the core components for quality assurance, resources mobilisation and advocacy for scale up, monitoring, evaluation, learning and accountability for SARS-CoV-2 implementation.
more
The WHO Cholera Rapid Diagnostic Test (RDT) Target Product Profile outlines the key requirements for developing improved cholera RDTs. It highlights the need for fast, accurate, and easy-to-use tests for early outbreak detection in resource-limited settings. The document sets desired and acceptable
...
performance criteria, including high sensitivity and specificity, rapid results (under 15 minutes), and usability by non-laboratory personnel. The tests should be affordable, stable in extreme conditions, and require minimal training. The goal is to enhance cholera surveillance and outbreak response, ensuring quick containment and improved public health outcomes.
more
Through the USAID-funded Organized Network of Services for Everyone’s Health (ONSE) Activity, MSH is assisting Malawi’s National Malaria Control Program to provide high-quality malaria services at the facility and community levels in 10 districts, covering nearly a third of the country.
Our
...
team in Malawi share recent results on strengthening malaria services through Outreach Training and Supportive Supervision (OTSS).
Designed to provide ongoing support to clinicians, data, and laboratory staff, OTSS combines a standardized checklist with targeted mentorship and supportive supervision to identify areas for improvement and strengthen clinical and diagnostic services in health facilities.
This webinar shares lessons learned on how the application of OTSS, as part of broader quality assurance systems, impacts staff performance and improves the provision and quality of malaria services.
more
Strict storage recommendations for insulin are difficult to follow in hot tropical regions and even more challenging in conflict and humanitarian emergency settings, adding an extra burden to the management of people with diabetes. According to pharmacopeia unopened insulin vials must be stored in a
...
refrigerator (2–8°C), while storage at ambient temperature (25–30°C) is usually permitted for the 4-week usage period during treatment. In the present work we address a critical question towards improving diabetes care in resource poor settings, namely whether insulin is stable and retains biological activity in tropical temperatures during a 4-week treatment period. To answer this question, temperature fluctuations were measured in Dagahaley refugee camp (Northern Kenya) using log tag recorders. Oscillating temperatures between 25 and 37°C were observed. Insulin heat stability was assessed under these specific temperatures which were precisely reproduced in the laboratory. Different commercialized formulations of insulin were quantified weekly by high performance liquid chromatography and the results showed perfect conformity to pharmacopeia guidelines, thus confirming stability over the assessment period (four weeks). Monitoring the 3D-structure of the tested insulin by circular dichroism confirmed that insulin monomer conformation did not undergo significant modifications. The measure of insulin efficiency on insulin receptor (IR) and Akt phosphorylation in hepatic cells indicated that insulin bioactivity of the samples stored at oscillating temperature during the usage period is identical to that of the samples maintained at 2–8°C. Taken together, these results indicate that insulin can be stored at such oscillating ambient temperatures for the usual four–week period of use. This enables the barrier of cold storage during use to be removed, thereby opening up the perspective for easier management of diabetes in humanitarian contexts and resource poor settings.
more
The document provides a standardized protocol for evaluating the Early Warning Alert and Response Network (EWARN), a surveillance system used during humanitarian emergencies when regular national health surveillance may be disrupted. The purpose of EWARN is to detect outbreaks of communicable diseas
...
es early and enable rapid public health response. The guidance explains how the system should be assessed in terms of its structure, implementation, effectiveness, and usefulness. It outlines the key steps of evaluation: preparation, system description, data collection, and post-evaluation reporting. The protocol highlights common challenges observed in previous EWARN implementations, such as delays in establishing the system, limited data quality, weak outbreak response, and lack of clear transition plans back to routine surveillance systems. It emphasizes the need to evaluate both weekly disease reporting and alert verification processes, and to review attributes such as simplicity, data quality, timeliness, sensitivity, and stability. The document also provides templates for interviews, data review forms, and laboratory assessment, as well as guidance on conducting remote evaluations when access is limited. The overall goal of the protocol is to ensure that EWARN functions effectively to detect and respond to outbreaks and that practical recommendations are developed to improve the system’s performance and sustainability in emergency settings.
more
Improve identification, verification, communication and coordination.
Specifications and quantities for efficient procurement of essential equipment and laboratory commodities for HIV
Francis Aboagye-Nyame, Heather Alexander, Zelalem Gizachew Belachew et al.
World Health Organization
(2015)
C_WHO
Second Edition
AIDS Medicines and diagnostics services
July 2015
"Achieving, maintaining and improving accuracy, timeliness and reliability are major challenges for health laboratories. Countries worldwide committed themselves to build national capacities for the detection of, and response to, public health events of international concern when they decided to eng
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age in the International Health Regulations implementation process. Only sound management of quality in health laboratories will enable countries to produce test results that the international community will trust in cases of international emergency. This handbook is intended to provide a comprehensive reference on Laboratory Quality Management System for all stakeholders in health laboratory processes, from management, to administration, to bench-work laboratorians. This handbook covers topics that are essential for quality management of a public health or clinical laboratory. They are based on both ISO 15189 and CLSI GP26-A3 documents"--Page 7.
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This guidance synthesizes current evidence on dengue laboratory testing and diagnostics and provides practical recommendations for laboratories, clinicians, public health officials, and programme managers involved in dengue diagnosis, surveillance,
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and control, in the context of the global emergency. It includes a diagnostic algorithm for suspected cases, outlining appropriate testing methods based on days post symptom onset.
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Zika and dengue viruses remain significant public health threats. These viruses share the same Aedes (Stegomyia) mosquito vectors and geographic distributions but infections cannot be readily distinguished clinically and need to be differentiated from each other, and from other circulating arboviral
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and non-arboviral pathogens, using laboratory tests. This document provides guidance on current testing strategies for Zika and dengue virus infections with updates to the previous interim guidance for laboratory testing for ZIKV, addressing pregnant and non-pregnant patients respectively, and incorporates current guidance for dengue virus diagnostic testing. The choice of laboratory assays and interpretation of test results require careful consideration of epidemiology, patient history, and limitations of existing diagnostic tests.
This interim guidance is for use by staff of laboratories testing for Zika and dengue virus infections and for clinical practitioners and public health professionals providing clinical management or surveillance.
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SOP- Quality Assurance of Malaria Diagnostic Tests
