March 2018, Vol. 108, (3 Suppl 1)
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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Following review of the latest evidence, WHO recommends that TB-LAMP can be used as a replacement for microscopy for the diagnosis of pulmonary TB in adults with signs and symptoms of TB. It can also be considered as a follow-on test to microscopy in adults with signs and symptoms of pulmonary TB, e...specially when further testing of sputum smear-negative specimens is necessary.
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National Tuberculosis Programme
The National Strategic Plan (NSP) for Tuberculosis (TB) 2016-2020 builds on the past experiences for the National Tuberculosis Programme and its partners. This NSP provides a roadmap for delivering quality TB prevention and care service to the entire population, ...as an integral part of the country's move toward Universal Health Coverage. Between 1990 and 2015, Myanmar reduced the prevalence of TB by 50%, meeting the targets set by the Millennium Development Goals. Going forward, the country aims to further accelerate the rate decline.
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Policy brief.
Globally, one in five people with HIV are unaware of their status, despite considerable scale up of HIV testing, treatment and prevention services. Many of those unreached by HIV testing services (HTS) are from key populations, partners of people with HIV and, in Eastern and southern ...Africa, men and young people. Improving the availability, accessibility, friendliness and quality of services is important to address these testing gaps.
At the same time, tools and interventions that increase the demand for HTS are needed to reach people who are uninformed about HTS options and advances in treatment and prevention, people who are not motivated to seek HTS and those who are hesitant to test because of fear of an HIV diagnosis or other reasons.
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This report investigates the impact of potential misclassification of samples on HIV prevalence estimates for 23 surveys conducted from 2010-2014. In addition to visual inspection of laboratory results, we examined how accounting for potential misclassification of HIV status through Bayesian latent ...class models affected the prevalence estimates. Two types of Bayesian models were specified: a model that only uses the individual dichotomous test results and a continuous model that uses the quantitative information of the EIA (i.e., the signal-to-cutoff values). Overall, we found that adjusted prevalence estimates matched the surveys’ original results, with overlapping uncertainty intervals. This suggested that misclassification of HIV status should not affect the prevalence estimates in most surveys. However, our analyses suggested that two surveys may be problematic. The prevalence could have been overestimated in the Uganda AIDS Indicator Survey 2011 and the Zambia Demographic and Health Survey 2013-14, although the magnitude of overestimation remains difficult to ascertain. Interpreting results from the Uganda survey is difficult because of the lack of internal quality control and potential violation of the multivariate normality assumption of the continuous Bayesian latent class model. In conclusion, despite the limitations of our latent class models, our analyses suggest that prevalence estimates from most of the surveys reviewed are not affected by sample misclassification.
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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.
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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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The purpose of this document is to provide guidance on the use of pooled sample testing strategy in coronavirus disease (COVID-19)
testing laboratories of the African Union Member States for scaling up SARS-CoV-2 nucleic acid testing capacity with the available resources. The current document descr...ibes the effect of factors such as the prevalence of COVID-19 in the population to be tested, the homogeneity of pools, and the sensitivity of the molecular test in optimal pool size determination. It also highlights the importance of monitoring the prevalence of COVID-19 in a population to be tested and proper validation of the test, to limit the potential for false-negative results. Validation studies to determine the optimal pool size by testing laboratories are recommended as the optimum approach. A safe, simple ‘two-stage pooling’ option has been indicated in this guidance to be used by laboratories until such validation can be achieved.
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16 Dec. 2020
This document provides guidance to Ministries of Health (MOHs), laboratory personnel and implementing partners in African Union Member States on the application of rapid antigen tests to COVID-19 testing. The guidance serves as reference for policymakers, laboratory leads, implementing... partners, and experts on use case scenarios and associated testing algorithms for COVID-19 antigen tests. It recommends the use of antigen tests to increase access to testing and enable timely results for persons with or without symptoms in specific settings. The document will be reviewed and updated as more evidence becomes available regarding the use of rapid antigen tests for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) from global studies and evaluation efforts.
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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
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Many critical questions remain about the effectiveness of COVID-19 vaccines in real-world settings. These questions can only be answered in post-introduction vaccine effectiveness studies.This guidance document outlines an approach to leverage existing surveillance systems for Severe Acute Respirato...ry Infection (SARI) to estimate COVID-19 vaccine effectiveness (VE) in preventing SARI associated with laboratory-confirmed SARS-CoV-2 using existing SARI surveillance systems. The approach uses the test-negative design to evaluate VE; cases are SARI patients who tested positive for SARS-CoV-2, and controls are SARI patients who tested negative for SARS-CoV-2.
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6 July 2021. The “WHO consolidated guidelines on tuberculosis. Module 3: Diagnosis - Rapid diagnostics for tuberculosis detection 2021 update” is the latest document replacing the one issued in 2020. Three new nucleic acid amplification test (NAAT) classes are endorsed by WHO and included in the... latest consolidated guideline
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The COVID-19 pandemic arrived in an evolving epidemiological context where some countries are experiencing a progressive decrease in HIV positivity in their testing programme as they are moving closer to the first 95 target. Distinguishing changes in HIV testing services due to the COVID-19 pandemic... from those resulting from evolving HIV testing strategies is crucial for adapting services and helping countries define their strategic mix of testing options moving forward. There is a need to focus, prioritize and plan for strategic efforts to prevent going further off the track toward achieving global targets and goals.
To support these efforts, WHO in partnership with ministries of health conducted an in-depth analysis of HIV testing services and antiretroviral therapy (ART) initiation prior to and during reported COVID-19 disruptions. Additional publicly available Global Fund and PEPFAR data was also reviewed and analysed. This analysis, and coordination with ministries of health, identified key service delivery adaptations utilized during COVID-19-related disruptions and formed the basis of this strategic guide.
This document focuses on current country needs, as well as plans for prioritization and potential surge support needs in the event of future disruptions. Although the data and implications are specific to sub-Saharan Africa, key principles and lessons can be applied elsewhere.
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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.
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This guidance addresses rationale, risk-based scenarios, practical considerations prior to adoption of the self-testing products, quality assurance, safety and ethical considerations, and data management considerations for COVID-19 self-testing. The Africa CDC recommends the use of rapid antigen sel...f-testing within two key scenarios. The first includes testing for case identification within scenarios with a high risk of infection, including symptomatic cases and contacts of a confirmed case. The second scenario involves general screening within scenarios of low or unknown risk exposure allowing for self-care such as before gatherings with at-risk individuals and prior to participation in events involving members of different households. Within these scenarios, a positive test result indicates likelihood of current infection, while a negative test result indicates a lower risk of active infection, though it does not rule out infection altogether. All positive cases should be managed following the national COVID-19 management protocol of Member States.ssur
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Cervical cancer continues to be a significant public health problem and a major cause of premature mortality among women, disproportionately affecting the socioeconomically disadvantaged population in low- and middle-income countries (LMICs). In the absence of implementing the known evidence-based, ...cost-effective interventions, the number of deaths per year is projected to reach approximately 416 000 globally in 2035. It was estimated in 2020 that 32% of incident cervical cancer cases and 34% of cervical cancer deaths in the world occurred in the 11 Member States of the WHO South-East Asia (SEA) Region. In 2020, 190 874 new cases and 116 015 deaths were estimated due to cervical cancer, which is the third commonest cancer in the Region
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