Abstract
BackgroundThe recent approval of 4th generation HIV tests has forced many laboratories to decide whether to shift from 3rd to these tests. There are limited published studies on the comparative evaluation of these two different assays. We compare the performance of fourth-generation electrochemiluminescence immunoassay (ChIA) and third-generation enzyme linked immunosorbent assay (EIA) for human immunodeficiency virus (HIV) screening and gauge whether the shift from EIA to ChIA could be better in a multiethnic region of China.Methodology/Principal FindingsWe identified a large number of routine specimens (345,492) using two different assays from Jan 2008 to Aug 2011 in a teaching hospital with high sample throughput. Of the 344,596 specimens with interpretable HIV test results, 526(0.23%) of 228,761 using EIA and 303(0.26%) of 115,835 using ChIA were HIV-1 positive. The false-positive rate of EIA was lower than that of ChIA [0.03% vs. 0.08%, odds ratio 0.33 (95% confidence interval 0.24, 0.45)]. The positive predictive value (PPV) of EIA (89.6%) was significantly higher than that of ChIA (76.1%) (<0.001), reflecting the difference between the two assays. The clinical sensitivities of two assays in this study were 99.64% for EIA and 99.88% for ChIA.ConclusionCaution is needed before shifting from 3rd to 4th generation HIV tests. Since none of these tests are perfect, different geographic and ethnic area probably require different considerations with regard to HIV testing methods, taking into account the local conditions.
Highlights
Acquired Immunodeficiency Syndrome (AIDS) remains the most devastating outcome of human immunodeficiency virus (HIV) infection
Caution is needed before shifting from 3rd to 4th generation HIV tests
The positive predictive value (PPV) of enzyme linked immunosorbent assay (EIA) (89.6%) was significantly higher than that of compare the performance of fourth-generation electrochemiluminescence immunoassay (ChIA) (76.1%) (,0.001), reflecting the difference between the two assays (Table 1)
Summary
Acquired Immunodeficiency Syndrome (AIDS) remains the most devastating outcome of HIV infection. It has had a profound effect on human illness and death over the last 30 years and has close to a 100% fatality rate in untreated patients. Since the first HIV test was introduced, the performances of HIV screening assays have improved continuously. Third-generation assays using an antigen–antibody–antigen sandwich technique, have led to a big improvement in Se and Sp, and have, until recently, been the method of screening in most centers of China. We compare the performance of fourth-generation electrochemiluminescence immunoassay (ChIA) and third-generation enzyme linked immunosorbent assay (EIA) for human immunodeficiency virus (HIV) screening and gauge whether the shift from EIA to ChIA could be better in a multiethnic region of China
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