Brazilian Program For HIV Point-Of-Care Test Evaluation: A Decade’s Experience

Abstract

Background: 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™ IntroductionFor most infectious diseases, prompt and accurate diagnosis is a crucial public health strategy for implementing early and more effective treatment and, consequently, 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. Over the last decade, AIDS detection rates have shown that HIV/AIDS epidemic in Brazil has been relatively stable (with an AIDS incidence rate of 20.5 per 100,000 inhabitants), although there were important differences among Brazilian states, ranging from 9.2 AIDS cases per 100,000 inhabitants (Acre state) to 39.2 AIDS cases per 100,000 inhabitants (Amazonas state) [2].In Brazil, HIV diagnostic is regulated by the Ministerial Directive MS/SVS n° 29 [3], which approved the Technical Manual for the Diagnosis of HIV Infection in Adults and Children. 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. Indeed, HIV POCTs have been widely used to test parturient and puerperal women unaware of their serological status, patients attending emergency clinics, campaigns...