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1
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
...
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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Guidelines for Good Clinical Laboratory Practices (GCLP) outlines the principles and procedures to be followed by medical laboratories involved in clinical research and/or patient care so as to prov
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ide quality data which can be used for health research and patient treatment. As the use of laboratory tests (often expensive) are increasingly becoming a part of medical diagnosis and research, generation of quality data would be a cost-effective and ethically sound strategy.
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Laboratory biosafety manual
recommended
4th edition
The WHO Laboratory Biosafety Manual (LBM) has been in broad use at all levels of clinical and public health laboratories, and other biomedical sectors globally, serving as a de facto global standard that presents best
...
practices and sets trends in biosafety.
LBM encouraged countries to accept and implement basic concepts in biological safety and to develop national codes of practice for the safe handling of biological agents in laboratories within their geographical borders.
This fourth edition of the manual builds on the risk assessment framework introduced in the third edition. A thorough, evidence-based and transparent assessment of the risks allows safety measures to be balanced with the actual risk of working with biological agents on a case-by-case basis.
This novel evidence- and risk-based approach will allow optimised resource use and sustainable laboratory biosafety and biosecurity policies and practices that are relevant to their individual circumstances and priorities, enabling equitable access to clinical and public health laboratory tests and biomedical research opportunities without compromising safety.
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The WHO laboratory biosecurity guidance follows and complements the revision of the Laboratory biosafety manual, fourth edition and provides principles and measures to prevent lapses and incidents t
...
hroughout the whole value chain of handling high-consequence biological material, technology and information. The document shares global best practice and covers the biosecurity part of the biological risk management lifecycle, starting from collection, transportation, storage and experiment, and in specific context such as every type of biomedical laboratory, research activities, repository and biobank. It also provides key considerations and best practices for institutional, national and international levels, including regulatory oversight.
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The Practical manual on laboratory strengthening, 2022 update provides practical guidance on implementation of WHO recommendations and best practices for TB
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laboratory strengthening. It is an updated 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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he Framework sets the requirements for facilities handling High Consequence Agents and Toxins (HCATs) and guides the implementation of laboratory biosafety and biosecurity practices associated with
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the design, commissioning, routine operation safe and secure biocontainment laboratories.
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The GTFCC Laboratory Support for Public Health Surveillance document provides guidelines on using DNA-based molecular techniques for identifying and monitoring Vibrio cholerae strains in cholera outbreaks. It highlights the importance of genetic seq
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uencing for tracking transmission, detecting new variants, and improving outbreak response. The report explains methods like PCR testing, whole genome sequencing (WGS), and multiple loci VNTR analysis (MLVA), detailing their advantages and applications. It also outlines best practices for sample collection, storage, and transportation, emphasizing collaboration between national and international laboratories to enhance cholera surveillance and control efforts.
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This online training is based on the Global Laboratory Initiative’s “Guide for providing technical support to TB laboratories in low- and middle-income countries”. This guide is intended to familiarize those who are providing technical assista
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nce to TB laboratories in low- and middle-income countries with WHO recommendations and international best practices.
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Prepared as an outcome of ICMR Expert Group on Immunophenotyping of Hematolymphoid Neoplasms | Coordinated by Division of Non Communicable Diseases | This document addresses on various issue related to good quality practices in
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laboratory work up of flow cytometric immunophenotyping and will be of use to pathologists, cytometrists, hematologists, technologists and scientists working in this field.
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n the countries of the Region of the Americas, there are different forms of organization of health services at the first level of care. Some countries include certain laboratory, dental and diagnostic imaging
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practices in the first level of care, while other countries centralize these practices in the second and third levels of care. Consequently, so that the List of Priority Medical Devices (LPMD) could be adapted to these different forms of organization of health systems in the region of the Americas, modular lists were developed that complement the main list. In this way, to use the LPMD, only those modules that are planned to be offered in a first-level care center are selected, and it is those lists that are analyzed.
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Recent systematic reviews and meta-analysis of the impact of chemical-based mollusciciding (King et al., 2015, Sokolow et al., 2016) have concluded that regular mollusciciding is likely to contribute significantly towards elimination of schistosomiasis in high-risk areas. The WHO roadmap’s new foc
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us on “transmission control, wherever possible” (WHO, 2012a) reinforces the need to promote intermediate-host snail control to prevent schistosomiasis transmission.
This operational manual is intended to facilitate the reintroduction of practices and protocols for use of molluscicides in the field in schistosomiasis control programmes. It is complemented by guidelines on the laboratory and field testing of the efficacy of molluscicides for schistosomiasis control (WHO, 2017 [in preparation]). more
This operational manual is intended to facilitate the reintroduction of practices and protocols for use of molluscicides in the field in schistosomiasis control programmes. It is complemented by guidelines on the laboratory and field testing of the efficacy of molluscicides for schistosomiasis control (WHO, 2017 [in preparation]). more
On 4 September 2025, the Ministry of Health of the Democratic Republic of the Congo (DRC) declared an outbreak of Ebola Virus Disease (EVD) in Kasai Province, following confirmation of Zaire ebolavirus by the National Institute of Biomedical Research (INRB) in Bulape and Mweka Health Zones. As of 19
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September, there have been 48 total cases (38 confirmed, 10 probable) with 31 deaths (21 confirmed, 10 probable) and a CFR of 64.5%. Among laboratory confirmed cases, 16 deaths were recorded (CFR: 45.7%). Four deaths occurred among health workers, underscoring the risk of nosocomial transmission. Most cases (39.7%) are among adults aged 20 years and above, in a densely populated, remote, and under-resourced area.
The outbreak is driven by multiple risk factors, including transmission in health facilities with limited infection prevention and control (IPC) measures and personal protective equipment (PPE), incomplete contact tracing, delayed detection, and unsafe burial practices. High population mobility between Bulape and Tshikapa, reliance on traditional healers, and the concurrent mpox outbreak are further straining the fragile health system and increasing the risk of geographic spread.
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The manufacturing process is one of the key steps where quality control is required to ensure quality of medicinal products, including herbal medicines. Good manufacturing practices (GMP) is one of the most important tools for this measure.
Licensed pharmaceutical products (marketing authorization) should be manufactured only by licensed manufacturers (holders of a manufacturing authorization) whose activities are regularly inspected by competent national authorities. This guide to GMP shall be used as a standard to justify GMP status,
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which constitutes one of the elements of the WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce, through the assessment of applications for manufacturing authorizations and as a basis for the inspection of manufacturing facilities. It may also be used as training material for government medicines inspectors, as well as for production, QC and QA personnel in the industry
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The Virtual cGMP Training Marathon for Vaccine Manufacturing: Principles into Practice took place from 12 Sep to 10 Oct 2023 to continue to provide manufacturers & regulators with a comprehensive array of topics to build understanding of current WHO & international GMP standards, technological advan
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cements, industry practices and regulatory expectations specific to the vaccine manufacturing context. Some of the topics include computer system validation, data integrity, challenges in lyophilization and others. Real world examples and case studies will be used to show how to interpret current and recently new good manufacturing practices requirements from a practical point of view and to implement appropriate approaches.
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Laboratory biosafety guidance related to coronavirus disease (COVID-19): Interim guidance, 28 January 2021
recommended
The latest update (28 January 2021) includes the following addition and revision:
biosafety aspects for working with antigen-detecting rapid diagnostic test;
handling new variants of SARS-CoV-2 in the laboratory;
updated assay decon
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tamination before disposal;
personal protective equipment (PPE) for specimen collection;
addressing chemical hazards and their safe disposal; and
the fourth edition of the WHO Laboratory Biosafety Manual (LBM4) is now available and the terminology in this guidance was aligned with the LBM4.
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SOP- Quality Assurance of Malaria Diagnostic Tests
