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.
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Annex to Selection and use of Ebola in vitro diagnostic assays
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
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.
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Весь персонал, проводящий экспресс-диагностику антигена SARS-CoV-2 (Ag-RDT), должен понимать, как безопасно проводить тестирование, обеспечивать качество тестирования и и...нтерпретировать результаты. Этот курс был разработан ВОЗ и FIND, Глобальным альянсом по диагностике, для предоставления теоретических знаний по тестированию SARS-CoV-2 Ag-RDT. Учебный пакет состоит из 10 модулей, включающих видео и презентации
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All personnel performing SARS-CoV-2 antigen rapid diagnostic tests (Ag-RDT) need to understand how to safely perform testing, ensure quality testing and interpret results. This course is developed to provide theoretical knowledge on SARS-CoV-2 Ag-RDT testing. The learning package consists of 10 modu...les, which include recorded presentations and videos.
Availble in different languages
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WHO recommends replacing western blotting and line immunoassays with simpler tests in HIV testing services. These simpler tests include rapid diagnostic tests (RDTs) that can be used at the point-of-care, and enzyme immunoassays (EIAs).
These tests get results to the client faster, produce accura...te results more often, cost less, can be performed by various cadres of health providers, and can thus facilitate greater access and uptake of HIV testing services among those who need it most.
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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.
FIND and Standard Diagnostics (SD) have developed a lateral flow rapid diagnostic test (RDT) to screen for
T.b. gambiense HAT that is cheap and easy to use. The tests are packed individually and are stable at 40°C for
up to 25 months; they are performed on fresh blood obtained from a finger prick..., and no instrument or electricity is required. The RDT detects host antibodies to infection in populations that are at risk, or in suspect individuals. Positive cases are subjected to further confirmatory methods to identify HAT patients.
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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 a...nd 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.
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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 a...bout how to use a G6PD RDT. It contains both words and pictures.
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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
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 rapid diagnostic tests (RDTs) targeting the M...UL_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.
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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.
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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
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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 for Diagnosis of COVID-19. This framework aims to pr...ovide 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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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 for Diagnosis of COVID-19. This framework aims to pr...ovide 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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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 diagnostic 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.
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1.0 PURPOSE
To define the procedure for the conduct of in-person meetings in both healthcare and community settings in response to COVID-19 and with respect to Public Health and Social Measures (PHSMs) to reduce the risk of disease transmission. A general risk assessment must be conducted to inform... context specific recommendations.
2.0 SCOPE
The procedure in this document is applicable to all meetings that require convening people
together physically.
3.0 SAFETY AND HYGIENE PROCEDURE
Before entry into the meeting room/venue:
• Presentation of evidence for complete doses of COVID-19 vaccination (depending on COVID-19 vaccine taken) or negative COVID-19 PCR test done within the last 72 hours, or where applicable proof of daily negative RDT result. The Africa Union Trusted Travel platform, with technical support from the PanaBIOS Consortium has implemented an online system that allows Airlines and Port Health services to authenticate and verify traveler’s COVID-19 results certificates in line with international standards, across Africa and beyond.
• Hand hygiene stations should be available at the points of entry.
• All participants must wear a well fitted mask that covers the nose and mouth. Medical masks should be provided all meeting participants.
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