These consolidated guidelines on HIV testing services (HTS) bring together existing and new guidance on HTS across different settings and populations.
The World Health Organization (WHO) first released consolidated guidelines on HTS in 2015, in response to requests from Member States, national pr...ogramme managers and health workers for support to achieve the United Nations (UN) 90–90–90 global HIV targets – and specifically the first target of diagnosing 90% of all people with HIV. In 2016, based on new evidence, WHO released a supplement to address important new HIV testing approaches – HIV self-testing (HIVST) and provider-assisted referral.
Since the release of 2015 and 2016 HTS guidelines, new issues and more evidence have emerged. To address this, WHO has updated guidance on HIV testing services. In this guideline, WHO updates recommendation on HIVST and provides new recommendations on social network-based HIV testing approaches and western blotting (see box, next page). This guideline seeks to provide support to Member States, programme managers, health workers and other stakeholders seeking to achieve national and international goals to end the HIV epidemic as a public health threat by 2030.
These guidelines also provide operational guidance on HTS demand creation and messaging; implementation considerations for priority populations; HIV testing strategies for diagnosis HIV; optimizing the use of dual HIV/syphilis rapid diagnostic tests; and considerations for strategic planning and rationalizing resources such as optimal time points for maternal retesting
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This manual describes some of the strategic, managerial, financial, technical and scientific aspects to be considered in establishing a national EQA programme for clinical laboratories and other testing services at all health care levels
The Republic of the Union of Myanmar’s National Strategic Plan on HIV/AIDS 2016–2020 is the strategic guide for the country’s response to HIV at national, state/regional and local levels. The framework describes the current dynamics of the HIV epidemic and articulates a strategy to optimize in...vestments through a fast track approach with the vision of ending HIV as a public health threat by 2030. Myanmar’s third National Strategic Plan (HIV NSP III) issues a call to all partners to front-load investments to close the testing gap and reach the 90–90–90 prevention and treatment targets to protect health for all.
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The Guide to operationalize HIV viral load testing HIV presents 60 lessons learnt from the project in a systemic approach including: viral load strategy, laboratories, procurement and supply management, patient care and economy.
Journal of the International AIDS Society, Volume 20, Issue 1 (2017)21796
Qualitative research on HIV self testing among men who have sex with men and transgender women in Yangon, Mynamar.
Global effort to increase early diagnosis and engagement in HIV care emphasize the importance ...of developing novel approaches to reaching those missed by traditional methods. Such needs are particularly great for men who have sex with men (MSM), transgender women (TW), and other populations who face stigma. Myanmar's HIV epidemic is concentrated among key populations and the revised National Strategy aims to reduce late diagnosis and barriers to care to curb HIV incidence among these groups. HIV self‐testing (HIVST) may be one method to improve testing and diagnosis among key populations, by placing HIV testing and disclosure within the individual's control.
https://doi.org/10.7448/IAS.20.01.21796
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Information note.
This information note provides a strategic overview of key implementation considerations for diagnostic integration using these devices, and is primarily intended for use by national laboratory services and TB, HIV, and hepatitis programme managers.
It may also be of inte...rest to managers of maternal, newborn and child health programmes and sexual and reproductive health programmes, international and bilateral agencies, and organizations that provide financial and technical support to the relevant national health programmes.
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October 2018
HIV testing services
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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HIV-1 drug resistance (HIVDR) genotyping is an essential component of the WHO global HIVDR surveillance strategy. Plasma “gold standard” specimen type for HIVDR genotyping, but its use may not be feasible in rural, remote areas in low- and middle-income countries, since preparing and storing it ...require personnel and laboratory infrastructure that are often lacking. An alternative specimen type is dried blood spots (DBS), which can be made without special laboratory processing. DBS are more easily transported than plasma because they can be shipped at ambient temperature as non-hazardous materials using regular mail or courier services.
3rd edition
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WHO has a unique combination of technical public health and scientific expertise, and a global operational footprint, with field offices in more than 150 countries. In 2020, this global, technical, and operational reach meant WHO was able to support countries around the world in every aspect of COVI...D-19 public health response, from surveillance and laboratory testing to maintaining essential health services in the most vulnerable and fragile contexts.
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Strategic communication is used to raise awareness of issues among specific target populations. It aims to provide timely, evidence-based, authoritative information and guidance needed for public health action. Proper implementation of strategic communication leads t...o sustained behaviour change and is essential in overcoming barriers to access to services or generating demand for such services.
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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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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 updated guidelines present a standard minimum dataset, priority indicators and recommendations to strengthen data use across HIV prevention, testing and treatment, and linkages to services for sexually transmitted infections, viral hepatitis, tuberculosis and cervical cancer. The guidelines also... cover the use of routinely collected data for HIV surveillance (including measurement of HIV prevalence and incidence) and emphasize the use of data from different sources to gain a better picture of epidemiologic trends. The whole collection you can download from here https://www.who.int/publications/i/item/9789240055315
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The updated guidelines present a standard minimum dataset, priority indicators and recommendations to strengthen data use across HIV prevention, testing and treatment, and linkages to services for sexually transmitted infections, viral hepatitis, tuberculosis and cervical cancer. The guidelines also... cover the use of routinely collected data for HIV surveillance (including measurement of HIV prevalence and incidence) and emphasize the use of data from different sources to gain a better picture of epidemiologic trends.
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Second edition. June 2022. This revised guidance recommends that access to COVID-19 testing is decentralized as far as possible and made available at health facilities, and through the use of self tests to enable access to care and the mitigation of transmission. Testing should be prioritized for hi...gh-risk and vulnerable individuals presenting with acute onset of respiratory illness so that those found to be infected can benefit from clinical care and access to COVID-19 therapeutics and vaccines
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This publication aims to provide updated guidance on the specific use of yellow fever laboratory assays in the context of surveillance to be used across the Global Yellow Fever Laboratory Network for disease surveillance. In the recent years, new commercial assays became available and are now recomm...ended for use by WHO and this publication will support national program on the use of compound laboratory assays as per the most recent recommended testing algorithms. This piece is aligned with the elimination effort set in the comprehensive global strategy to eliminate yellow fever epidemics (EYE) strategy 2017-2026 and where its advisory laboratory technical working group actively contributed to its development. The target audiences are policy-makers and health workers.
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Mpox is an emerging zoonotic disease caused by the mpox virus, a member of the Orthopoxvirus genus closely related to the variola virus that causes smallpox. Mpox was first discovered in 1958 when outbreaks of a pox-like disease occurred in monkeys kept for research. The first human case was recorde...d in 1970 in the Democratic Republic of the Congo (DRC) during a period of intensified effort to eliminate smallpox and since then the infection has been reported in a number of African countries. Mpox can spread in humans through close contact, usually skin-to-skin contact, including sexual contact, with an infected person or animal, as well as with materials contaminated with the virus such as clothing, beddings and towels, and respiratory droplets in prolonged face to face contact. People remain infectious from the onset of symptoms until all the lesions have scabbed and healed. The virus may spread from infected animals through handling infected meat or through bites or scratches. Diagnosis is confirmed by polymerase chain reaction (PCR) testing of material from a lesion for the virus’s DNA. Two separate clades of the mpox virus are currently circulating in Africa: Clade I, which includes subclades Ia and Ib, and Clade II, comprising subclades IIa and IIb. Clade Ia and Clade Ib have been associated with ongoing human-to-human transmission and are presently responsible for outbreaks in the Democratic Republic of the Congo (DRC), while Clade Ib is also contributing to outbreaks in Burundi and other countries.
In 2022‒2023 mpox caused a global outbreak in over 110 countries, most of which had no previous history of the disease, primarily driven by human-to-human transmission of clade II through sexual contact. In just over a year, over 90,000 cases and 150 deaths were reported to the WHO. For the second time since 2022, mpox has been declared a global health emergency as the virus spreads rapidly across the African continent. On 13 Aug 2024, Africa CDC declared the ongoing mpox outbreak a Public Health Emergency of Continental Security (PHECS), marking the first such declaration by the agency since its inception in 2017.7 This declaration empowered the Africa CDC to lead and coordinate responses to the mpox outbreak across affected African countries. On August 14, 2024, the WHO declared the resurgence of mpox a Public Health Emergency of International Concern (PHEIC) emphasizing the need for coordinated international response.
As of August 2024, Mpox has expanded beyond its traditional endemic regions, with new cases reported in countries including Sweden, Thailand, the Philippines, and Pakistan. Sweden has confirmed its first case of Clade 1 variant, which has been rapidly spreading in Africa, particularly in DRC. The emergence of this new variant raises concerns about its potential for higher lethality and transmission rates outside Africa.
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HIV testing programmes need to ensure that all clients who test for HIV are provided with correct diagnoses. The accuracy of HIV testing is critical to prevent misdiagnosis, as the consequences of giving an incorrect test result can be serious for clients, HIV testing services, HIV programmes and pu...blic health.
With the evolution of global HIV epidemiology, HIV testing approaches must also evolve to maintain accuracy and efficiency in population-level diagnosis. Reports suggest that misdiagnosis of HIV status may occur when suboptimal testing algorithms and out-of-date testing strategies are used. As a result of changing epidemiology and declining HIV positivity in testing, WHO recommends all countries use a standard three-test strategy to ensure a PPV of at least 99%, minimizing false-positive misdiagnosis. The WHO-recommended HIV testing strategy, along with quality assurance measures such as retesting to verify a positive diagnosis prior to initiation of HIV treatment, is cost-effective as it prevents misdiagnosis and unnecessary initiation of costly lifelong treatment.
This implementation guide provides practical advice on switching to a three-test strategy and instituting other measures that can help national HIV programmes deliver high-quality, accurate HIV testing services and ensure that misdiagnosis is minimized.
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