This manual describes some of the strategic, managerial, financial, technical and scientific aspects to be considered in establishing a national EQA programme for clinical laboratories and other testing services at all health care levels
Toolkit
HIV Treatment and Care
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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July 2018
This fourth edition of the Unitaid/WHO market and technology landscape: HIV rapid diagnostic tests for self-testing report summarizes the current HIV testing gap; the challenges facing efforts to scale up; and the potential role HIV self-testing (HIVST) could play to achieve the United... Nation’s 90-90-90 targets. In particular, the report synthesises the existing and emerging market demand and supply of kits.
The information in this report is intended for manufacturers, donors, national programmes, researchers and other global health stakeholders who are exploring the potential role of HIVST.
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Interim Recommendation published 19 September 2014. These recommendations reflect current understanding of Ebola virus disease (EVD) and are intended for national laboratory staff performing diagnostic testing to detect Ebola virus.
Antimicrobial Resistance Surveillance and Research Network | This manual describes well accepted methods to carry out drug susceptibility testing on important gram positive and gram negative clinically relevant bacteria. Methods of specimen collection, transport, culture, anti-microbial drug suscept...ibility testing (common, special phenotypic and
molecular techniques) as well as quality control and quality assurance have been described in a concise manner.
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Policy Brief.
WHO recommends that pregnant women receive testing for HIV, syphilis and hepatitis B (HBSAg) at least once during pregnancy, preferably in the first trimester.
Dual HIV/syphilis rapid diagnostic tests (RDTs) can be used as the first test for pregnant women as part of antenatal care (...ANC).
These simple tests can be used at the point-of-care and are cost-saving compared to standard testing in ANC. They enable more women to be diagnosed with HIV and syphilis so that they can access treatment and prevent transmission to their children.
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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.
Module 10
Testing providers
July 2017
Module 10: Testing providers. This module is for people who provide testing services at PrEP sites and laboratories. It offers guidance in selecting testing services, including screening of individuals before PrEP is initiated and monitoring while they ar...e taking PrEP. Information is provided on HIV testing, creatinine, HBV and HCV, pregnancy and STIs.
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The speed of developing diagnostics for SARS-CoV-2, the causative agent of coronavirus disease 2019 (COVID-19), has been quite remarkable. Diagnostics have focused on nucleic acid amplification testing (NAAT) to identify infected individuals in acute-phase disease for timely implementation of mitiga...tion strategies and case management. More and more immunodiagnostics, mostly rapid diagnostic tests, are being made available as an alternative to NAATs. This type of test can be used out-of-laboratory conditions at large scale.
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July 2021. This publication brings together important clinical and programmatic updates produced by WHO since 2016 and provides comprehensive, evidence-informed recommendations and good practice statements within a public health, rights-based and person-centred approach.
These guidelines bring in... the most recent guidance on HIV testing strategies - the entry point for HIV prevention and treatment - and include comprehensive guidance on infant diagnosis. Key recommendations are presented on rapid antiretroviral therapy (ART) initiation and the use of dolutegravir. Updated recommendations are included on the timing of ART for people with TB, and the use of point-of-care technologies for treatment monitoring.
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Über SARS-CoV-2-Testsysteme informieren das Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) und das Paul-Ehrlich-Institut. Die Informationen ergänzen sich, den rechtlichen Rahmen bietet u.a. die Coronavirus-Testverordnung-TestV.
Das BfArM bietet eine Liste von Antigen-Tests zum dir...ekten Erregernachweis des Coronavirus SARS-CoV-2 an. In dieser Liste befinden sich diejenigen Tests, die sich laut Herstellerangaben gemäß den Vorgaben des Medizinproduktegesetzes (MPG) rechtmäßig in Europa bzw. Deutschland in Verkehr befinden und alle vom Paul-Ehrlich-Institut in Abstimmung mit dem Robert Koch-Institut (RKI) festgelegten Mindestkriterien für Antigen-Tests erfüllen.
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It has been over a year since Kenya identified the first case of COVID-19 in the country. The Government formed the National COVID-19 task force, which supported the country's response through multi-sectoral technical working groups on testing, case management, risk communication and community engag...ement among others. An earlier version of the COVID case management guideline was released in April 2020 and capacity building of health care workers on diagnosis and treatment of COVID-19 was quickly carried out, even as counties prepared themselves by setting up isolation centres and supplies
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7 April 2022. Aimed at national policymakers, public health and healthcare planners, staff working in reception centres, and healthcare staff caring for displaced persons, the information note concludes that universal testing of incoming refugees from Ukraine for tuberculosis (TB) infection is not r...ecommended. Specific groups, such as household contacts of bacteriologically confirmed pulmonary cases, or those who are immunocompromised should however be considered for TB infection testing.
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By end of March 2022:
42 COVID-19 detection laboratories were assessed in the 1st Quarter 2022.
23 (55%) Labs are reported fully functional, while 19 (45%) requires assistance to fully operate (i.e., medical supplies, equipment, maintenance, and staffing).
34 (89%) labs have RT-...PCR machines, while 4 (11%) doesn’t have.
Most laboratories operate 1 shift of 8 hours 13 (34%), followed by 2 shifts of 16 hours 11 (29%).
Over 1000 testing capacity per day is reported in Tripoli Biotechnical Centre Lab (5,000), Azzawya NCDC Lab (2,500), Tripoli NCDC public health lab (1500), Misrata NCDC Lab (1,300), and Misrata Medical centre Lab (1,300).
The reported needs ranked per priority are equipment, consumables, and staff training; consequently.
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This document aims to provide interim guidance for microbiology and virology experts, other laboratory professionals, laboratory managers, infectious disease programme managers, public health professionals and other stakeholders that provide primary, confirmatory or advanced testing for SARS-CoV-2, ...including genomic sequencing, or are involved in making decisions on establishing or scaling up capability and capacity to detect and characterize circulating SARS-CoV-2 variants.
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This document is a guide defining requirements for quality and safety for malaria rapid diagnostic testing services to safeguard the quality of the results, the safety of the operators and patients and that of the environment for use by national malaria control programmes, regulators, implementers a...nd rapid diagnostic providers.
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