Health ministries currently lack effective tools for monitoring and evaluation of schistosomiasis control programmes. Egg detection can be used, but the cost, challenges of obtaining samples, and the need for trained personnel and equipment limit the frequency of monitoring. The purpose of this TPP ...is to guide the development of new diagnostic tools to reliably measure when prevalence is above or below a cut-off of 10% in school-aged children. Communities remaining above 10% require annual MDA, while communities below 10% can reduce MDA frequency as long as < 10% prevalence can be maintained. However, the lack of a reliable test has hindered the development of maintenance strategies. The test is also needed to track changes of prevalence > 10% to ensure that annual MDA is reducing overall prevalence.
more
Lateral-flow rapid diagnostic tests (RDTs) continue to play a vital role in global health in the management and diagnosis of infectious diseases, including 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
Three classess of tests are now recommended in the latest consolidated guideles on tests for tuberculosis infection. It includes for the first-time a new class of Mycobacterium tuberculosis antigen-based skin tests (TBSTs), and the two existing classes of tests: the tuberculin skin test (TST) and t...he interferon-gamma release assays (IGRAs).
IGRAs and TBSTs use Mycobacterium tuberculosis complex specific antigens and represent a significant advancement to TST which has been used for over half a century.
more
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.
more
Interim guidance, 6 October 2021
Direct detection of SARS-CoV-2 viral proteins (antigens) in nasal swabs and other respiratory secretions using lateral flow immunoassays (also known as rapid diagnostic tests, RDTs) offers a faster and less expensive method to test for SARS-CoV-2 than the reference ...method, nucleic acid amplification tests (NAATs). This interim guidance offers recommendations on the priority uses of antigen-detecting rapid diagnostic tests (Ag-RDTs) in specific populations and settings, including (i) for primary case detection in symptomatic individuals suspected to be infected and asymptomatic individuals at high risk of COVID-19, (ii) for contact tracing, (iii) during outbreak investigations and (iv) to monitor trends of disease incidence in communities. Ag-RDTs meeting minimum performance requirements can be used outside of clinical and laboratory settings, including in communities, by trained operators in accordance with instructions. The guidance additionally provides recommendations on implementation, product selection and storage.
more
Information Note
Advice for countries using or planning
to introduce dual HIV/syphilis RDT in antenatal services and other testing sites.
WHO/RHR/17.01
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.
Clinical guideline, Methods, Evidence and Recommendations
In this guideline the following is covered: information needs of people with chronic hep
titis B and their carers; where children, young people and adults with chronic hepatitis B a-
should be assessed; assessment of liver disease, includi...ng the use of non-invasive tests and genotype testing; criteria for offering antiviral treatment; the efficacy, safety and cost effectiveness of currently available treatments; selection of first-line therapy; management of treatment failure or drug resistance; prophylactic treatment during im-
munosuppressive therapy; and monitoring for treatment response
more
On 13 August 2024, Africa Centres for Disease Control and Prevention (Africa CDC) declared the ongoing Mpox outbreak a Public Health Emergency of Continental Security (PHECS). This was followed the next day by the World Health Organization (WHO), which extended the alert internationally as a public ...health emergency of international concern (PHEIC). After these declarations, many countries have made efforts to mobilize resources to introduce or expand laboratory testing, surveillance, and response activities. In particular, as the number of suspected cases surges in the Democratic Republic of Congo (DRC), Burundi, and the Central African Republic, and an increasing number of new countries report cases, there is an urgent need to implement testing to strengthen the Mpox response. However, access to appropriate quality assured diagnostics is a challenge. There is limited information on important characteristics, such as available test kits’ performance and ability to detect relevant clades.
To address the challenge of mpox access in the continent, the Africa CDC Diagnostic Advisory Committee (DAC) met in Kigali from 19-23 August 2024 to review the available evidence on molecular tests for Mpox and to shortlist tests that may be useful for Mpox testing in countries. The shortlist aims to provide guidance to Africa CDC, countries and partners on appropriate high-quality molecular tests to procure and use for the mpox response.
more
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.
more
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 purpose of this TPP is to communicate the minimum and ideal characteristics desired to meet the need for discriminating low levels of risk for transmission, i.e. targeted prevalence thresholds in the surveyed areas. An in vitro diagnostic test is needed for the detection of analyte(s) specific t...o Wuchereria bancrofti, Brugia malayi, and Brugia timori to aid in the surveillance of defined geographic areas as to whether infection and/or transmission potential has increased (recrudescence) or decreased (elimination of transmission).
more
Interium guidance, 25 June 2021Timely and accurate diagnostic testing is an essential tool in preventing and controlling the spread of COVID-19. This document describes recommendations for national testing strategies and the use of PCR and rapid antigen tests in different transmission scenarios of t...he COVID-19 outbreak, including how testing might be rationalized in low resource settings. All testing should be followed by a strong public health response including isolating those who test positive and providing them care, contact tracing and quarantine of contacts.
more
Following review of evidence and advice from the Technical Advisory Group (TAG) on Tuberculosis (TB) Diagnostics and Laboratory Strengthening, the World Health Organization (WHO) announces that current WHO recommendations for the use of interferon-gamma release assays (IGRA) are also valid for Beij...ing Wantai’s TB-IGRA and Qiagen QuantiFERON-TB Gold Plus products. This expands the range of tests available to detect TB infection. Full details are provided in this WHO policy statement.
more
6 July 2021. Three new nucleic acid amplification test (NAAT) classes are endorsed by WHO and included.
The latest operational handbook includes the new classes recommended by WHO. It aims at facilitating the implementation of the WHO recommendations by the Member States, technical partners, and ot...hers involved in managing patients with TB and DR-TB. The operational handbook provides practical information on existing and new tests recommended by WHO, step-by-step advice on implementing and scale-up testing to achieve local and national impact and lastly, model diagnostic algorithms, which are updated to incorporate the latest recommendations. An overview of budgetary considerations and information sheets on each of the newly recommended tests is provided.
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
This guidance is intended to be used by programme managers following the decision to introduce human papillomavirus (HPV) virological testing as a screening assay in their national cervical cancer prevention and control programme. The guidance includes a step-by-step process to be followed after the... decision has been made to specifically introduce and/or scale-up HPV virological testing for screening, which would be followed up with adequate management within the context of cervical cancer prevention
more
Qualitative assay for use on the cobas®6800/8800 Systems. For in vitro diagnostic use