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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 SAR
...
S-CoV-2 in the laboratory;
updated assay decontamination 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.
more
8 January 2021
Sequencing enabled the world to rapidly identify SARS-CoV-2 and develop diagnostic tests and other tools for outbreak management. Continued genome sequencing supports the monitoring
...
of the disease’s spread and evolution of the virus. Accelerated integration of genome sequencing into the practices of the global health community is required if we want to be better prepared for the future threats. This document provides guidance for laboratories on maximizing the impact of SARS-CoV-2 sequencing now and other emerging pathogens in the future.
more
Guidelines for the prevention, care and treatment of persons with chronic hepatitis B infection
recommended
The recommendations in these guidelines promote the use of simple, non-invasive diagnostic tests to assess the stage of liver disease and eligibility for treatment; prioritize treatment for those wi
...
th most advanced liver disease and at greatest risk of mortality; and recommend the preferred use of nucleos(t)ide analogues with a high barrier to drug resistance (tenofovir and entecavir, and entecavir in children aged 2–11 years) for first- and second-line treatment. Recommendations for the treatment of HBV/HIV-coinfected persons are based on the WHO 2013 Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection, which will be updated in 2015.
more
The ongoing global pandemic of SARS-CoV-2 (Covid-19) poses unique diagnostic and clinical management challenges in regions where seasonal epidemic-prone diseases are endemic. Diseases such as dengue, malaria, seasonal influenza, leptospirosis, chiku
...
ngunya, scrub typhus and bacterial infections often present with febrile syndromes that mimic or co-exist with SARS-CoV-2 infection, complicating diagnosis and treatment. This document provides guidelines for preventing, diagnosing and managing such co-infections. A high level of suspicion is essential during the monsoon and post-monsoon seasons, taking into account region-specific disease prevalence. While the WHO's case definition for SARS-CoV-2 is broad and sensitive, the need for parallel testing for co-infections, in accordance with the protocols of the MoHFW, ICMR, NVBDCP and NCDC, is necessitated by overlapping clinical features. Ensuring the availability of reliable rapid diagnostic kits and applying integrated clinical and laboratory approaches are crucial to improving patient outcomes in the context of concurrent infections.
Accessed on 26/08/2025.
more
This policy guideIine is intended for use by healthcare professionals invoIved in the management of Covid-19 in South Africa. The document provides guidance on diagnostic tests available, on antigen
...
test performance and accessibility. 1t focuses on key issues such as when to
Perform antigen tests′ how to use and interpret results. Capturing and reporting testing information is also covered.
more
Cancer in sub-Saharan Africa
recommended
Lancet Oncol 2022; 23: e251–312Published OnlineMay 9, 2022 https://doi.org/10.1016/S1470-2045(21)00720-8
In sub-Saharan Africa (SSA), urgent action is needed to curb a growing crisis in cancer incidence and mortality.
Without rapid interventions
...
, data estimates show a major increase in cancer mortality from 520 348 in 2020 to about
1 million deaths per year by 2030. Here, we detail the state of cancer in SSA, recommend key actions on the basis of
analysis, and highlight case studies and successful models that can be emulated, adapted, or improved across the
region to reduce the growing cancer crises. Recommended actions begin with the need to develop or update national
cancer control plans in each country. Plans must include childhood cancer plans, managing comorbidities such as
HIV and malnutrition, a reliable and predictable supply of medication, and the provision of psychosocial, supportive,
and palliative care. Plans should also engage traditional, complementary, and alternative medical practices employed
by more than 80% of SSA populations and pathways to reduce missed diagnoses and late referrals. More substantial
investment is needed in developing cancer registries and cancer diagnostics for core cancer tests.
more
Laboratory diagnosis of Buruli ulcer
recommended
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 laboratory technicians and scientists working on this disease, the manual details the exac
...
t 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.
more
The WHO COVID-19 LENS (Living Evidence Synthesis) working group consolidated available evidence, based on rapid reviews of the literature and results of a living systematic review on pregnancy and COVID-19 (up to October 7, 2020), on potential mecha
...
nisms of vertical transmission of infectious pathogens, feasibility of vertical transmission of SARS-CoV-2, data related to interpretation of positive SARS-CoV-2 virologic and serologic neonatal tests, lessons from diagnosis of other congenital infections, and existing proposed definitions to classify timing of vertical transmission of SARS-CoV-2.
more
Globally each year, millions of people suffer illness or lose their lives because the vaccines, medicines and diagnostic tests that they need are either unavailable or unaffordable – and this lack
...
of access to medicine is acute in low- and middle-in-
come countries (LMICs). While the COVID-19 pandemic laid this inequity bare, it also saw the pharmaceutical industry develop and bring new vaccines and treat- ments to market at unprecedented speed. As the world emerges from the worst
of this crisis, pharmaceutical companies are now at an important juncture, where lessons learned from the pandemic can prove pivotal in finding solutions to bridge long-standing gaps in access to medicine in LMICs.
more
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
...
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.
more
Whole-genome sequencing (WGS) provides a vast amount of information and the highest possible resolution for pathogen subtyping. The application of WGS for global surveillance can provide information on the early emergence and spread of AMR and further inform timely policy development on AMR control.
...
Sequencing data emanating from AMR surveillance may provide key information to guide the development of rapid diagnostic tools for better and more rapid characterization of AMR, and thus complement phenotypic methods. This document addresses the applications of WGS for AMR surveillance, including the benefits and limitations of current WGS technologies
more
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 updated version of the GLI Practical Guide to Laboratory Strengthening published in 2017 and provides the la
...
test 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.
more
Parasites & Vectors volume 11, Article number: 264 (2018)
Dengue creates a staggering epidemiological and economic burden for endemic countries. Without a specific therapy and with a commercial vaccine that presents some problems relative to its full effectiveness, initiatives to improve vector
...
control strategies, early disease diagnostics and the development of vaccines and antiviral drugs are priorities. In this study, we present the probable origins of dengue in America and the trajectories of its spread. Overall, dengue diagnostics are costly, making the monitoring of dengue epidemiology more difficult and affecting physicians’ therapeutic decisions regarding dengue patients, especially in developing countries. This review also highlights some recent and important findings regarding dengue in Brazil and the Americas. We also summarize the existing DENV polymerase chain reaction (PCR) diagnostic tests to provide an improved reference since these tests are useful and accurate at discriminating DENV from other flaviviruses that co-circulate in the Americas. Additionally, these DENV PCR assays ensure virus serotyping, enabling epidemiologic monitoring.
more
Yaws is targeted for eradication by 2030, using a strategy based on mass drug administration (MDA) with azithromycin. New diagnostics are needed to aid eradication. Serology is currently the mainstay for yaws diagnosis; however, inaccuracies associated with current serological
...
tests makes it difficult to fully assess the need for and impact of eradication campaigns using these tools. Under the recommendation of the WHO Diagnostic Technical Advisory Group (DTAG) for Neglected Tropical Diseases(NTDs), a working group was assembled and tasked with agreeing on priority use cases for developing target product profiles (TPPs) for new diagnostics tools.
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Quality Assurance Framework for SARS-CoV-2 Antigen Rapid Testing for Diagnosis of COVID-19
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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 f
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or Diagnosis of COVID-19. This framework aims to provide 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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Available in Arabic, Chinese, English, French, Portuguese, Russian and Spanish
https://apps.who.int/iris/handle/10665/334254
Available in English, French, Spanish, Chinese, Russian and Arabic
https://apps.who.int/iris/handle/10665/337832
The WHO standard: Universal access to rapid tuberculosis diagnostics sets benchmarks to achieve universal access to WHO-recommended rapid diagnostics (WRDs), increase bacteriologically confirmed tub
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erculosis and drug resistance detection, and reduce the time to diagnosis. WHO-recommended rapid diagnostics are highly accurate, cost-effective, reduce the time to treatment initiation, and impact patient-important outcomes.
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