Abstract
The point-of-care tests (POCTs) for HIV diagnosis have been widely used in Brazil in order to expand and to allow HIV diagnosis outside health units including remote areas, such as the Amazon region. In order to guarantee the quality of HIV diagnostics based on rapid tests, the Brazilian Ministry of Health (MoH) implemented the HIV POCT Evaluation Program. This study compiles the Brazilian experience acquired over the last 13 years conducting the HIV POCT Evaluation Program.
 
 Methods and Findings
 The selection of tests was based on the interest of manufacturers to qualify for the MoH tenders. Each round was performed with fresh whole blood and oral fluid samples, always including HIV positive and negative ones. In addition to the POCT, every sample was submitted to a reference testing protocol, based on an immunoassay followed by Western blot. The POCTs were evaluated for clinical sensitivity, clinical specificity, assay operational characteristics, detection of HIV-2 antibodies, sensitivity to subtypes panels; and sensitivity to seroconversion panels. Since its implementation in 2003, the POCT evaluation protocol has undergone some modifications aiming to improve and simplify the evaluation process, to know: (i) for HIV-positive samples, perform EIA and Western blot only if the POCT is non-reactive; (ii) reduction from 800 to 600 HIV negative samples; (iii) increase from one to three subtype panels (including HIV-2 samples); and (iv) inclusion of seroconversion panel. We evaluated six tests, four of which met the sensitivity criteria of 99.5%: BD Chek™ HIV Multi-test (whole blood), HIV 1/2 Colloidal Gold (whole blood), OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test (whole blood and oral fluid) and TR DPP HIV-1/2 (whole blood, plasma and oral fluid). Regarding other evaluated criteria, all assays met the requirements.
 
 Conclusions
 The successful Brazilian policy on POCT use for HIV infection diagnosis includes the evaluation of the POCT itself in addition to appropriate selection of tests to be acquired and nationwide distributed to the public health facilities, control of each test batch distributed by the MoH, proper and easily accessible training to all health professionals involved in rapid testing through distance learning tools, and continued evaluation of POCT use through external quality assessment.
Highlights
For most infectious diseases, prompt and accurate diagnosis is a crucial public health strategy for implementing early and more effective treatment and, interrupting transmission chains sustained by untreated unaware cases [1].According to the 2015 Brazilian HIV/AIDS Epidemiological Bulletin, since 1980, a total of 798,366 Acquired Immunodeficiency Syndrome (AIDS) cases and 290,929 AIDS related deaths have been registered in the country
The successful Brazilian policy on point-of-care tests (POCTs) use for HIV infection diagnosis includes the evaluation of the POCT itself in addition to appropriate selection of tests to be acquired and nationwide distributed to the public health facilities, control of each test batch distributed by the Ministry of Health (MoH), proper and accessible training to all health professionals involved in rapid testing through distance learning tools, and continued evaluation of POCT use through external quality assessment
The specificity for assays that used whole blood ranged from 99.50% (TR DPP HIV-1/2) to 99.94% (HIV 1/2 Colloidal Gold); and, for assays using plasma, it ranged from 99.17% (TR DPP HIV1/2) to 99.50% (Imuno-Rápido HIV 1/2)
Summary
Prompt and accurate diagnosis is a crucial public health strategy for implementing early and more effective treatment and, interrupting transmission chains sustained by untreated unaware cases [1].According to the 2015 Brazilian HIV/AIDS Epidemiological Bulletin, since 1980, a total of 798,366 Acquired Immunodeficiency Syndrome (AIDS) cases and 290,929 AIDS related deaths have been registered in the country. The Manual establishes six algorithms for HIV diagnosis, two of which are based on the use of point-of-care tests (POCTs). The main reasons for employing POCTs in Brazil are to expand and to allow HIV diagnosis outside health units including remote areas, such as the Amazon region. The point-of-care tests (POCTs) for HIV diagnosis have been widely used in Brazil in order to expand and to allow HIV diagnosis outside health units including remote areas, such as the Amazon region. In order to guarantee the quality of HIV diagnostics based on rapid tests, the Brazilian Ministry of Health (MoH) implemented the HIV POCT Evaluation Program. This study compiles the Brazilian experience acquired over the last 13 years conducting the HIV POCT Evaluation Program
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