Toolkit
HIV Treatment and Care
Guidelines
HIV testing services
July 2015
Testing and diagnosis of hepatitis B (HBV) and C (HCV) infection is the gateway for access to both prevention and treatment services, and is a crucial component of an effective response to the hepatitis epidemic. Early identification of persons with
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chronic HBV or HCV infection enables them to receive the necessary care and treatment to prevent or delay progression of liver disease. Testing also provides an opportunity to link people to interventions to reduce transmission, through counselling on risk behaviours and provision of prevention commodities (such as sterile needles and syringes) and hepatitis B vaccination.
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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 r
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esponse to requests from Member States, national programme 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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Molecular methods for antimicrobial resistance (AMR)diagnostics to enhance the Global Antimicrobial Resistance Surveillance System
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.
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
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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.
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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
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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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Tuberculosis (TB) is the deadliest infectious disease in most low- and middle-income countries, claiming more than 4,000 lives each day. The unprecedented COVID-19 pandemic has seriously impacted people with pre-existing health conditions. People with TB are usually more vulnerable to other infectio
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ns, including the novel coronavirus, due to pre-existing lung damage. They are also at higher risk of developing complications from COVID-19.
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The National Guidelines for HIV-1 Viral Load Laboratory Testing support plans to scale up viral load (VL) testing to reach the 90-90-90 targets in India. This phased scale-up includes the setup of 7
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0 additional VL testing laboratories nationally. These guidelines include laboratory design considerations, a summary of VL technologies, and specimen collection and handling as well as transportation and storage guidance. Quality control and quality assurance requirements are described as well as laboratory safety issues. The guidelines also describe the VL laboratory network to be developed with supply chain management issues and commodities described. Annexes include laboratory registers and reporting forms.
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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-
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testing. The Africa CDC recommends the use of rapid antigen self-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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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 inclu
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des 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
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Policy Brief. 24 June 2022. This policy brief, one of two on the updated hepatitis C (HCV) guidelines, focuses on the new recommendations on simplified service delivery for a public health approach to HCV testing, care and treatment. These recommend
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ations include decentralization, integration and task-sharing, in addition to the use of point-of-care (POC) HCV viral load assays and reflex viral load testing.
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This guideline is intended to provide requirements to applicants wishing to submit
applications for registration of medicines in Botswana.