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 performance of these laboratories improved ov...er 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.
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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 their performance in a standardized way to distingu...ish 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.
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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.
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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 nutrition 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.
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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.
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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.
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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.
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On 13 August 2024, Africa Centres for Disease Control and Prevention (Africa CDC) declared the ongoing Mpox outbreak a Public Health Emergency of Continental Security (PHECS). This was followed the next day by the World Health Organization (WHO), which extended the alert internationally as a public ...health emergency of international concern (PHEIC). After these declarations, many countries have made efforts to mobilize resources to introduce or expand laboratory testing, surveillance, and response activities. In particular, as the number of suspected cases surges in the Democratic Republic of Congo (DRC), Burundi, and the Central African Republic, and an increasing number of new countries report cases, there is an urgent need to implement testing to strengthen the Mpox response. However, access to appropriate quality assured diagnostics is a challenge. There is limited information on important characteristics, such as available test kits’ performance and ability to detect relevant clades.
To address the challenge of mpox access in the continent, the Africa CDC Diagnostic Advisory Committee (DAC) met in Kigali from 19-23 August 2024 to review the available evidence on molecular tests for Mpox and to shortlist tests that may be useful for Mpox testing in countries. The shortlist aims to provide guidance to Africa CDC, countries and partners on appropriate high-quality molecular tests to procure and use for the mpox response.
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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.
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Improve identification, verification, communication and coordination.
Training laboratory managers, senior biologists, and technologists in quality management systems is a step towards obtaining international recognition; it is a step that all countries should take. This training toolkit is intended to provide comprehensive materials that will allow for designing and ...organizing training workshops for all stakeholders in health laboratory processes, from management, to administration, to bench-work laboratorians
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Accessed 3rd of October 2015
Second Edition
AIDS Medicines and diagnostics services
July 2015
The BRM ATP is an advanced course in biorisk management. The 10-day train-the-trainer course introduces the concept of biorisk management, which combines risk assessment, risk mitigation, and performance systems (AMP). The course also includes a cutting-edge training component based on the latest sc...ience and theory behind accelerated and adult learning
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FIND conducted independent evaluations at the University Hospitals of Geneva (HUG), to verify the limit of detection (LOD) and the clinical performance (as reported by the manufacturers) of the following molecular test kits. The LOD analysis was performed using cultured viral stocks from a clinical ...isolate from Switzerland, and quantified using an E gene standard. The clinical performance analysis was conducted on extracted samples from individuals suspected to have COVID-19 that were tested using an in-house PCR protocol that was optimized based on the Tib Molbiol assay.
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This WHO information note provides an updated list of recommended criteria for selecting RDTs for malaria, and highlights the performance of RDTs evaluated by the WHO malaria RDT product testing programme. It also provides an overview of additional considerations in the procurement of rapid tests.
Au total, 18 laboratoires de 13 pays ont participé aux quatre cycles d'AQE : 10 laboratoires de huit pays africains endémiques, dont quatre ont participé aux quatre cycles et trois à trois cycles. Les résultats globaux ont montré que la performance médiane de ces laboratoires s'est amélioré...e au cours des quatre cycles. Cependant, la proportion de laboratoires rapportant des cas faussement positifs reste élevée et indique un problème de spécificité probablement dû à une contamination. La proportion de laboratoires rapportant à la fois des résultats faussement positifs et faussement négatifs soulève la question de la qualité des données rapportées par l'OMS en Afrique ainsi que des résultats des études menées dans ces différents laboratoires dans divers pays.
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La détection directe des protéines virales du SRAS-CoV-2 (antigènes) dans les écouvillons nasaux et autres sécrétions respiratoires à l'aide de tests immunologiques à flux latéral (également appelés tests de diagnostic rapide, TDR) offre une méthode plus rapide et moins coûteuse pour te...ster le SRAS-CoV-2 que la méthode de référence, les tests d'amplification des acides nucléiques (TAAN). Ces lignes directrices provisoires offrent des recommandations sur les utilisations prioritaires des tests de diagnostic rapide à détection d'antigène (TDR-Ag) dans des populations et des contextes spécifiques, notamment (i) pour la détection primaire des cas chez les personnes symptomatiques suspectées d'être infectées et les personnes asymptomatiques à haut risque de COVID-19, (ii) pour la recherche des contacts, (iii) pendant les enquêtes sur les épidémies et (iv) pour surveiller les tendances de l'incidence de la maladie dans les communautés. Les TDR-AG répondant aux exigences minimales de performance peuvent être utilisés en dehors des milieux cliniques et des laboratoires, y compris dans les communautés, par des opérateurs formés conformément aux instructions. Le guide fournit en outre des recommandations sur la mise en œuvre, la sélection des produits et le stockage
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