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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 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.
more
SARS-COV-2 antigen rapid diagnostic tests are an alternative option for diagnosing active SARS-CoV-2 infection through detection of viral proteins.
...
Rapid antigen tests revolutionize the response to COVID-19 by providing accurate test results in 10 to 20 minutes instead of days, allowing tests to be done at point of care, and dramatically lowering the price of the tests.
Proper training on the safe use and implementation of antigen tests is vital to ensuring quality testing. A comprehensive training package around safety, sample collection, testing, reporting and management of antigen tests can be found below.
The training package includes facilitators’ guides for master trainers and trainers, training presentations, and supplementary materials to aid in the delivery of this training.
more
All personnel performing SARS-CoV-2 antigen rapid diagnostic tests (Ag-RDT) need to understand how to safely perform testing, ensure quality testin
...
g and interpret results. This course is developed to provide theoretical knowledge on SARS-CoV-2 Ag-RDT testing. The learning package consists of 10 modules, which include recorded presentations and videos.
Availble in different languages
more
HIV rapid diagnostic test market landscape
recommended
The analysis includes the three most commonly used HIV rapid diagnostic test
(RDT) categories: HIV-only professional use RDTs, dual HIV/syphilis professional use
RDTs, and HIV self-
...
tests (HIVST).
more
The purpose of this manual is to train health workers to use G6PD rapid diagnostic tests (RDTs) safely and effectively, so as to inform appropriate
...
decision making for P. vivax radical cure. This manual should be used with the accompanying job aid. The job aid is a set of step-by-step instructions about how to use a G6PD RDT. It contains both words and pictures.
more
The speed of developing diagnostics for SARS-CoV-2, the causative agent of coronavirus disease 2019 (COVID-19), has been quite remarkable. Diagnostics have focused on nucleic acid amplification testing (NAAT) to identify infected individuals in acute-phase disease for timely implementation of mitiga
...
tion strategies and case management. More and more immunodiagnostics, mostly rapid diagnostic tests, are being made available as an alternative to NAATs. This type of test can be used out-of-laboratory conditions at large scale.
more
Version 46 22 Dec 2025. his document provides an overview of malaria rapid diagnostic tests (RDTs) for Principal Recipients (PRs) of Global Fund gr
...
ants, indicating their eligibility for procurement under the Global Fund's Quality Assurance Policy. The included products have been assessed and approved by the WHO Prequalification of Diagnostics Programme (WHO PQ), the relevant regulatory authorities of the GHTF founding members or the Global Fund Expert Review Panel for Diagnostics (ERPD). Updates are made based on new evidence and regulatory assessments.
more
The WHO Cholera Rapid Diagnostic Test (RDT) Target Product Profile outlines the key requirements for developing improved cholera RDTs. It highlights the need for fast, accurate, and easy-to-use
...
tests for early outbreak detection in resource-limited settings. The document sets desired and acceptable performance criteria, including high sensitivity and specificity, rapid results (under 15 minutes), and usability by non-laboratory personnel. The tests should be affordable, stable in extreme conditions, and require minimal training. The goal is to enhance cholera surveillance and outbreak response, ensuring quick containment and improved public health outcomes.
more
This course will provide you with the knowledge and skills needed to implement WHO-recommended TB tests and algorithms. It includes the latest recommendations for novel tests for TB diagnosis and de
...
tection of drug resistance, as well as the most recent WHO policy guidance for the use of those tests. The course also describes the processes and steps for implementing a new diagnostic test for routine use within the TB diagnostic network
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 the 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
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
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
Prevention and Control of Cholera Uganda
recommended
Operational Guidelines for the national and district health workers & planners.
These new approaches include use of selective chemotherapy, Rapid Diagnostic
...
Tests (RDTs), Zinc for treatment of cholera in children and complementary use of OCV
more
The meeting was held from 26 to 27 March 2018 to review and discuss the following topics:
Advances and challenges in the use of fTLC, and new approaches to detecting mycolactone using monoclonal antibodies (mAbs).
The status of development of rap
...
id diagnostic tests (RDTs) targeting the MUL_3720 protein.
The role of PCR as a reference test, and hurdles in providing a confirmatory diagnosis and in establishing a quality assurance programme.
New molecular tools with potential for implementation at a level lower than in the national or regional reference laboratory, such as loop-mediated isothermal amplification (LAMP) and recombinase polymerase amplification (RPA).
The need to harmonize and standardize methods for collection and preparation of specimens, so samples can be referred for diagnosis and stored for evaluation of new diagnostic tests in optimal conditions.
Barriers to accessing early diagnosis and treatment, including coordination at the programme level, and lack of adequate diagnostic tools.
Defining target product profiles (TPPs) to guide the development of new diagnostic tools that can be applied at different levels of the health system. Participants agreed that two TPPs would be developed to address the current gaps: (i) a rapid test for BU diagnosis at the primary health-care level; and (ii) a test for diagnosis of BU that can also assist in treatment monitoring and differential diagnosis at the district hospital or reference centre.
more
The TACT training manuals and patient leaflet were developed as part of the ACT Consortium's initiative to improve malaria case management by promoting the correct use of rapid diagnostic
...
tests (RDTs). The TACT ("Targeting ACTs") initiative aims to ensure that artemisinin-based combination therapies (ACTs) are used appropriately, treating only confirmed malaria cases and guiding alternative care for other febrile illnesses.
Please download the manuals and leaflets from the website
more
HAT diagnosis relies on laboratory techniques because clinical signs and symptoms are unspecific. Serodiagnostic tests exist only for Tbg and are based on the detection of specific antibodies, thus they are not confirmatory of infection. With the cu
...
rrent low disease prevalence, the positive predictive value of serological tests is particularly low. Field-applicable tools include the card agglutination test for trypanosomiasis (CATT) used mainly in active screening by specialized mobile teams, and the rapid diagnostic tests that are more suitable for individual testing at point-of-care. Confirmation of Tbg infection requires microscopic examination of body fluids necessitating specific training. The best performing methods are laborious and reach 85–95% diagnostic sensitivity when performed by skilled personnel.
more
HAT diagnosis relies on laboratory techniques because clinical signs and symptoms are unspecific. Serodiagnostic tests exist only for Tbg and are based on the detection of specific antibodies, thus they are not confirmatory of infection. With the cu
...
rrent low disease prevalence, the positive predictive value of serological tests is particularly low. Field-applicable tools include the card agglutination test for trypanosomiasis (CATT) used mainly in active screening by specialized mobile teams, and the rapid diagnostic tests that are more suitable for individual testing at point-of-care.
more
Gambiense human African trypanosomiasis is a deadly infectious disease affecting West and Central Africa, South Sudan and Uganda, and transmitted between humans by tsetse flies. The disease has caused several major epidemics, the latest one in the 1990s. Thanks to recent innovations such as
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rapid diagnostic tests for population screening, a single-dose oral treatment and a highly efficient vector control strategy, interruption of transmission of the causative parasite is now within reach. If indeed gHAT has an exclusively human reservoir, this could even result in eradication of the disease. Even if there were an animal reservoir, on the basis of epidemiological data, it plays a limited role. Maintaining adequate postelimination surveillance in known historic foci, using the newly developed tools, should be sufficient to prevent any future resurgence.
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