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Technical specifications series for submission to WHO prequalification: diagnostic assessment;TSS-3
This document provides technical guidance for manufacturers seeking World Health Organization (WHO) prequalification of in vitro diagnostic devices (IVDs) for malaria, with a focus on rapid
...
diagnostic tests (RDTs) for symptomatic patients. It summarises the minimum performance requirements, including analytical and clinical performance standards, and emphasises considerations relating to diverse specimen types, testing environments and user populations in low- and middle-income countries. The guidance is aligned with the criteria and prequalification processes of the WHO Global Malaria Programme, while clarifying that demonstration of clinical utility is outside the scope of prequalification.
more
Malaria remains a significant global health concern, with 249 million cases and 408,000 deaths reported in 2022, primarily in sub-Saharan Africa. The most vulnerable populations are children under five and pregnant women. Rapid and accurate diagnosi
...
s using microscopy or malaria rapid diagnostic tests (mRDTs) is essential to ensure timely treatment, prevent severe disease and promote the rational use of antimalarial drugs. This UNICEF Technical Bulletin provides guidance on the procurement, quality assurance and selection of WHO-prequalified mRDTs, including considerations for areas with a high prevalence of pfhrp2/3 gene deletions. The bulletin also highlights UNICEF’s approach to sustainability, product verification and long-term arrangements with manufacturers, which ensure a reliable supply while supporting integrated child health management programmes. The bulletin serves as a valuable resource for countries, partners and programmes involved in the implementation of malaria case management and diagnostics.
more
This document provides technical guidance for manufacturers seeking World Health Organization (WHO) prequalification of in vitro diagnostic devices (IVDs) for malaria, with a focus on rapid
...
diagnostic tests (RDTs) for symptomatic patients. It summarises the minimum performance requirements, including analytical and clinical performance standards, and emphasises considerations relating to diverse specimen types, testing environments and user populations in low- and middle-income countries. The guidance is aligned with the criteria and prequalification processes of the WHO Global Malaria Programme, while clarifying that demonstration of clinical utility is outside the scope of prequalification.
more
The Interim Guidance on Cholera Rapid Diagnostic Tests (RDTs) by the Global Task Force on Cholera Control (GTFCC) provides recommendations for usin
...
g RDTs to detect cholera in areas with limited laboratory capacity. It highlights the advantages of RDTs, such as rapid detection (within 30 minutes), ease of use by non-laboratory personnel, and their role in early outbreak identification and surveillance. However, it emphasizes that RDTs should not replace culture or PCR testing, as they vary in sensitivity (58-100%) and specificity (60-100%). The document advises on proper test selection, storage, training, and integration into national surveillance systems to enhance cholera response efforts.
more
Report for WHO Meningitis guideline revision
Dr Thomas Waite, April 2014
Field Epidemiology Services, Public Health England; UK
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 diagn
...
ostic 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.
more
Lateral-flow rapid diagnostic tests (RDTs) continue to play a vital role in global health in the management and diagnosis of infectious diseases, i
...
ncluding malaria, HIV and COVID-19. Visually interpreted RDTs, more than any other class of diagnostics, fulfil WHO’s ASSURED criteria,1 enabling their use at the lowest levels of health care and in self-testing.2 Their utility is, however, compromised every time a test is incorrectly performed or interpreted or its result is not available in a timely manner for clinical decisionmaking and surveillance.
more
Market and technology landscape HIV rapid diagnostic tests for self-testing
O. Ajose; C. Pérez Casas; H. Ingold; et al.
Unitaid (Innovation in Global Health); World Health Organization (WHO)
(2018)
C2
4th edition
This guide provides an overview of the major elements that must be considered before, during and after the implementation of antigen-detecting rapid diagnostic
...
tests (Ag-RDTs) for SARS-CoV-2. This guide is complementary to policy guidance issued by the World Health Organization (WHO). The guide may appeal to a range of audiences including Ministries of Health, donors, public and private organizations/agencies acting as implementing partners and community based and civil society organizations with experience working on health, especially organizations familiar with similar testing campaigns for other disease programmes like HIV and malaria
more
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.
more
9 March 2022, Timely and accurate diagnostic testing for SARS-CoV-2 is an essential part of a comprehensive COVID-19 response strategy. Ag-RDTs can be performed by individuals in which they collect their own specimen, perform a simple
...
rapid test and interpret their test result themselves at a time and place of their choosing, termed COVID-19 self-testing. This interim guidance provides a new recommendation that COVID-19 self-testing, using SARS-CoV-2 Ag-RDTs, should be offered as part of SARS-CoV-2 testing services. It also includes implementation considerations that can guide decisions on whether, and how, to adopt self-testing in different contexts, including the populations being prioritized; the disease prevalence in that population; and the impact on accessibility of testing, health care services and result reporting.
more
A GTFCC course on sample collection and testing with rapid diagnostic tests (or RDTs) for cholera, for healthcare workers.
Guidelines on lenacapavir for HIV prevention and testing strategies for long-acting injectable pre-exposure prophylaxis. Web Annex D
In most malaria-endemic countries, temperatures frequently exceed the recommended storage temperatures for malaria RDTs. Correct storage of the RDTs may be difficult, especially during transport and in locations where air-conditioning is unavailable.
This publication is intended to support health p
...
ersonnel who use RDTs. It describes the basic principles for management and storage of RDT stock; outlines practical solutions for protecting RDTs against high temperatures during storage and transport; and describes how to manage waste generated from RDT use in health clinics and central and peripheral storage facilities.
more
Limited coverage of laboratory services and long turnaround times from real-time reverse transcription-polymerase chain reaction (rRT-PCR) for the detection of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has been insufficient to meet the demands in many African countries in response
...
to the COVID-19 pandemic. Rapid antigen diagnostic tests (AgRDTs) are potentially useful as they can inform healthcare workers and individuals of their infection status at point-of-care testing
more
This Rapid Communication aims to inform national TB programmes and other stakeholders about the key implications of the latest evidence on the use of specific molecular assays as initial diagnostic
...
tests of pulmonary and extrapulmonary TB and RR-TB, in adults and children.
more
