rapid diagnostic tests (RDTs)

False-negative HIV tests using oral fluid tests in children taking antiretroviral therapy from Harare, Zimbabwe

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Author
Ioana D. Olaru, Grace McHugh, Suba Dakshina, Edith Majonga, Ethel Dauya, Tsitsi Bandason, Katharina Kranzer, Hilda Mujuru, Rashida Ferrand

Rapid diagnostic tests (RDT) for HIV infection have high sensitivity and specificity, but in the setting of longstanding antiretroviral therapy (ART), can give false results that can lead to misinterpretation, confusion and inadequate management. The objective of this study was to evaluate the proportion of falsely negative results of a RDT performed on oral fluid in HIV-infected children on longstanding ART.

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Misdiagnosed HIV infection in pregnant women initiating universal ART in South Africa

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Yes
Author
Nei-yuan Hsiao, Allison Zerbe, Tamsin K. Phillips, Landon Myer, Elaine J. Abrams

Rapid diagnostic tests (RDTs) are the primary diagnostic tools for HIV used in resource-constrained settings. Without a proper confirmation algorithm, there is concern that false-positive (FP) RDTs could result in misdiagnosis of HIV infection and inappropriate antiretroviral treatment (ART) initiation, but programmatic data on FP are few.

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Misdiagnosis of HIV infection during a South African community-based survey: implications for rapid HIV testing

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Yes
Author
Tendesayi Kufa, Ayesha BM Kharsany, Cherie Cawood, David Khanyile, Lara Lewis, Anneke Grobler, Zawadi Chipeta, Alfred Bere, Mary Glenshaw, Adrian Puren

This study describes the overall accuracy and performance of a serial rapid HIV testing algorithm used in community-based HIV testing in the context of a population-based household survey conducted in two sub-districts of uMgungundlovu district, KwaZulu-Natal, South Africa, against reference fourth-generation HIV-1/2 antibody and p24 antigen combination immunoassays. We discuss implications of the findings on rapid HIV testing programmes.

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To err is human, to correct is public health: a systematic review examining poor quality testing and misdiagnosis of HIV status

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Yes
Author
Cheryl C. Johnson, Virginia Fonner, Anita Sands, Nathan Ford, Carla Makhlouf Obermeyer, Sharon Tsui, Vincent Wong, Rachel Baggaley

In accordance with global testing and treatment targets, many countries are seeking ways to reach the “90-90-90” goals, starting with diagnosing 90% of all people with HIV. Quality HIV testing services are needed to enable people with HIV to be diagnosed and linked to treatment as early as possible. It is essential that opportunities to reach people with undiagnosed HIV are not missed, diagnoses are correct and HIV-negative individuals are not inadvertently initiated on life-long treatment.

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Should trained lay providers perform HIV testing? A systematic review to inform World Health Organization guidelines

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Yes
Author
Kennedy, C.E., Yeh, P.T., Johnson, C., Baggaley, R.

New strategies for HIV testing services (HTS) are needed to achieve UN 90-90-90 targets, including diagnosis of 90% of people living with HIV. Task-sharing HTS to trained lay providers may alleviate health worker shortages and better reach target groups.

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Towards more accurate HIV testing in sub-Saharan Africa: a multi-site evaluation of HIV RDTs and risk factors for false positives

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Yes
Author
Cara S Kosack, Anne-Laure Page, Greet Beelaert, Tumwesigye Benson, Aboubacar Savane, Anne Ng’ang’a, Bita Andre, Jean-Paul BN Zahinda, Leslie Shanks, Katrien Fransen

Although individual HIV rapid diagnostic tests (RDTs) show good performance in evaluations conducted by WHO, reports from several African countries highlight potentially significant performance issues. Despite widespread use of RDTs for HIV diagnosis in resource-constrained settings, there has been no systematic, head-to-head evaluation of their accuracy with specimens from diverse settings across sub-Saharan Africa.

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Population coverage of artemisinin-based combination treatment in children younger than 5 years with fever and Plasmodium falciparum infection in Africa, 2003–2015: a modelling study using data from national surveys

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Yes
Author
Bennett, Adam et al.

Artemisinin-based combination therapies (ACTs) are the most effective treatment for uncomplicated Plasmodium falciparum malaria infection. A commonly used indicator for monitoring and assessing progress in coverage of malaria treatment is the proportion of children younger than 5 years with reported fever in the previous 14 days who have received an ACT. We propose an improved indicator that incorporates parasite infection status (as assessed by a rapid diagnostic test [RDT]), which is available in recent household surveys.

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Pfhrp2-deleted Plasmodium falciparum parasites in the Democratic Republic of Congo: A national cross-sectional survey

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Yes
Author
Jonathan B. Parr et al.

Rapid diagnostic tests (RDTs) account for more than two-thirds of malaria diagnoses in Africa. Deletions of the Plasmodium falciparum hrp2 (pfhrp2) gene cause false-negative RDT results and have never been investigated on a national level. Spread of pfhrp2-deleted P. falciparum mutants, resistant to detection by HRP2-based RDTs, would represent a serious threat to malaria elimination efforts.

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HIV rapid diagnostic tests for HIV self-testing

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Yes
Author
WHO and UNITAID

This report presents HIV self-testing (HIVST) as an innovative strategy with great potential to contribute to achieving the United Nations (UN) 90–90–90 targets by 2020. It provides updates on the landscape of technologies for HIVST originally presented in the first edition of the UNITAID/WHO Landscape on HIV self-testing (December 2015), as well as a summary of the existing and emerging market and projections of the demand for, and supply of, HIV rapid diagnostic tests (RDTs) for self-testing.

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