The Practical manual on laboratory strengthening, 2022 update provides practical guidance on implementation of WHO recommendations and best practices for TB laboratory strengthening. It is an update
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d version of the GLI Practical Guide to Laboratory Strengthening published in 2017 and provides the latest practical guidance on use of newly recommended diagnostics as well as guidance in key technical areas, including quality assurance and quality management systems, specimen collection and registration, procurement and supply-chain management, diagnostic connectivity, biosafety, data management, human resources, strategic planning, and model algorithms. The key changes are:
inclusion of recent or updated WHO recommendations for tests to diagnose TB and detect drug resistance;
alignment with the latest WHO critical concentrations for phenotypic drug-susceptibility testing (DST) and the new definitions of pre-XDR-TB and XDR-TB;
updated information on building quality-assured TB testing and management capacity using the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) approach (Score-TB package1);
updated information on assessing, analysing and optimising TB diagnostic networks; and
updated information on the use of next-generation sequencing (NGS) to detect mutations associated with drug resistance for surveillance purposes.
The document also provides references to resources and tools relevant for work on laboratory strengthening.
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Second Edition
AIDS Medicines and diagnostics services
July 2015
Due to the anticipated significant rise in VL testing occasioned by Ghana’s adaptation of 2016 ART guidelines, it has become necessary to develop this VL scale-up and operational plan to assure complete client access to laboratory monitoring towar
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ds the achievement of the third 90 of the HIV care cascade. The plan will enhance VL testing, monitoring whilst improving the clinical and laboratory interface for improved client care.
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This guide includes information relevant for tuberculosis (TB) program and laboratory managers, as well as Ministry of Health officials across disease programs interested in establishing integrated solutions for specimen referral. Though TB-focused
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in name, it offers integration-oriented assessment, design, and monitoring guidance related to improving coordination and efficiency, and is relevant for other programs as well. Country case studies include viral load and early infant diagnosis (EID) in Uganda and EID in Ethiopia.
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This document updates recommendations for HIV testing by laboratories in the United States and offers approaches for reporting test results to persons ordering HIV tests and to public health authorities. The recommended algorithm is a sequence of tests used in combination to improve the accuracy of
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the laboratory diagnosis of HIV based on testing of serum or plasma specimens. The updated recommendations also include tests for HIV antigens and HIV nucleic acid because studies from populations at high risk for HIV demonstrate that antibody testing alone might miss a considerable percentage of HIV infections detectable by virologic tests
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Expert opinion of the European Tuberculosis Laboratory Initiative core group members for the WHO European Region.
A manual for health care providers.
This manual provides expert guidance on the laboratory techniques and procedures used in the diagnosis of Buruli ulcer, a disease caused by Mycobacterium ulcerans. Aimed at
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laboratory technicians and scientists working on this disease, the manual details the exact procedures to follow when performing a range of diagnostic tests. Recommended procedures, intended for use throughout the health system, are presented at levels appropriate for peripheral, district and central services and in accordance with the varying resources, skills and equipment typically found in countries where Buruli ulcer is endemic.
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Polymerase Chain Reaction (PCR) has significantly helped in early diagnosis and commencement of specific interventions for diseases control. It also plays a critical role in understanding the disease epidemiology and unraveling the transmission dynamics of the disease. This manual intends to p
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rovide primary guidelines to assist health lab personnel in developing countries to establish a PCR diagnostic facility for efficient support to patient care as well as public health actions.
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Copenhagen, Denmark, 24–25 August 2017
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
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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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The use of the World Health Organization Health System Performance Assessment Framework
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
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their 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.
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18 Janaury 2021
EU/EEA Member States and the UK have increased their laboratory capacity tremendously over the past 11 months as the majority of the Member States reported sufficient testing capacity until March 2021.
Many countries are ad
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ding rapid antigen detection tests (RADT) to their testing strategies in order to reduce pressure on RT-PCR testing.
Some Member States have already included RADT in their case definition.
The main bottlenecks, such as shortages of laboratory consumables and human resources, as well as sample storing facilities, continue to exist and may affect the overall laboratory response to COVID-19.
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