Nucleic acid amplification techniques (NAATs) for early diagnosis of HIV-1 and HIV-2 infections: a systematic review of diagnosis tests

Abstract

The tests used in diagnosing HIV infection in a particular person require both a high sensitivity and specificity. The NAATs received attention as a diagnostic test for HIV infection, primarily due to multiple reports suggesting that months may elapse between HIV infection and the time of seroconversion. The implementation of NAATs revolutionized the field of medicine. However, the growing acceptance of NAATs in community diagnosis requires continuing education, convincing demonstrations of its accuracy, reliability and clinical relevance to improve the diagnosis and treatment of patients with HIV. Our primary objective is to assess the diagnostic accuracy (sensitivity and specificity) of NAATs (both quantitative and qualitative) for early diagnosis of people of all ages with suspected HIV-1 and -2 infections through a systematic review of diagnosis studies. We hypothesize that their accuracy for early diagnosis will be as good as the diagnosis at a later stage. The secondary objective of this review is to assess the influence of sources of heterogeneity on the diagnostic accuracy of tests performed, in particular the type of HIV (HIV-1 orHIV-2), different cut-off values, different samples, the healthcare setting, age of the participants, and other. This is the first diagnosis systematic review registered in the Cochrane HIV/AIDS Group (cochrane.hiv@gmail.com; hiv.cochrane.org) with the published protocol (please find it attached). Furthermore, this project has the collaboration of the following international researches Mariska M Leeflang (Nethrelands), Joseph L Mathew (India) e Anil Kapoor (Canada).