Abstract
The use of conventional (serologically based) HIV 1/2 diagnostic algorithms has become controversial in recent years. Sera from patients who underwent verification tests were evaluated because repeated ELISA-reactive results demonstrated a HIV1+HIV2 positive band pattern. The line immunoassay (LIA) test was used for repeated HIV enzyme immunoassays (EIA)-reactive sera in patients at three centers. The Bio-Rad Geenius™ HIV 1/2 and the HIV-1 RNA tests were used. HIV-1 and RNA HIV-2 were investigated using PCR. LIA was used to evaluate 3,224 out of 10,591 samples with repeated ELISA reactivity (30%). We found that 32 (1%) of the sera, along with HIV1 bands and HIV2 gp36 bands, were positive. Only 28 of the 32 verified serum samples with gp36 bands were repeated, and no gp36 band positivity was detected using the Bio-Rad Geenius™ HIV-1/2 confirmatory assay in these serum samples. The HIV-2 proviral DNAs were also negative. Therefore, we excluded the possibility of HIV1+2 co-infection. All samples from the 32 patients were positive for HIV-1 RNA. Our findings highlight the need to exclude confirmatory tests like the LIA test from the current diagnostic HIV algorithm and replace it with rapid HIV-1 and HIV-2 confirmatory immunochromotographic tests.
Highlights
Acquired immune deficiency syndrome (AIDS), caused by the human immunodeficiency virus (HIV), has been a globally important health problem for the last 30–35 years[1]
The prevalence of patients with dual HIV-1 and HIV-2 patterns has increased in response to the indeterminate test results because of the lack of differentiation between HIV-1 and HIV-2 infections in the current diagnostic HIV algorithms in Turkey
When the last two years’ worth of HIV infection data were evaluated from Istanbul, the largest city and the one that receives the most national/international immigrants in Turkey, we found that indeterminate results constituted 271 out of 10,591 cases (2.5%) using a line immunoassay (LIA) test
Summary
Acquired immune deficiency syndrome (AIDS), caused by the human immunodeficiency virus (HIV), has been a globally important health problem for the last 30–35 years[1]. Because of problems (such as indeterminate western blot results, HIV 1/2 cross-reactions) that are experienced when diagnosing HIV-1 infections in vitro, new research and approaches for diagnostic algorithms. From 1989 to the present, the diagnostic algorithm for HIV-1 infections has been primarily based on the repeating reactivity of anti-HIV Ab/Ag tests and the reactivity of Western blot (WB) and line immunoassay (LIA) tests, according to Centers for Disease Control and Prevention (CDC) criteria[7]. Because of the above-mentioned problems, the conventional diagnostic HIV algorithm needs to be updated according to the CDC recommendations on problems associated with the in vitro diagnosis of HIV-1 and HIV-2 infections using WB/LIA tests based on immunoblotting. Methods: The line immunoassay (LIA) test was used for repeated HIV enzyme immunoassays (EIA)-reactive sera in patients at three centers. Problems encountered in conventional HIV 1/2 Algorithms: lack of necessity for immunoblot assays to confirm repeated
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