Abstract

BackgroundThe Architect HIV Ag/Ab Combo has excellent performance for HIV screening; however, the false‐positive rate (FPR) was high in low HIV prevalence setting.ObjectivesThe purpose of this study was to analyze the influence of sample‐to‐cutoff (s/co) ratios by Architect HIV Ag/Ab Combo with the results of confirmatory test and explore the potential utility of s/co to predict HIV infection.MethodsA retrospective review on Architect HIV Ag/Ab Combo reactive results was performed at a teaching hospital in Xi'an. The s/co values in different groups, that is, true positives (TP) and false positives (FP), different Western blotting (WB) bands among WB‐positive cases, were compared. The receiver operating characteristic curve (ROC) analysis was used to determine the optimal cutoff value for predicting HIV infection.ResultsDuring the study period, 219 out of 84 702 patients were reactive by ARCHITECT with a 0.0992% of HIV prevalence and a 56.25% of FPR. The mean s/co ratios in TP were significantly higher than that in FP (458.15 vs 3.11, P < 0.0001). Among the WB‐positive cases, the s/co ratios increased significantly with the increase in the number of bands, P = 0.0065. The optimal cutoff (24.44) by ROC analysis can provide the highest sum of sensitivity (100%) and specificity (100%) with no FP results.ConclusionsFor Architect HIV Ag/Ab Combo, the FPR is reduced when s/co ratios increase, and the s/co ≥24.44 may be reliable to predict HIV infection.

Highlights

  • The Architect human immunodeficiency virus (HIV) Ag/Ab Combo has excellent performance for HIV screening; the false‐positive rate (FPR) was high in low HIV prevalence setting

  • The purpose of this study was to analyze the influence of sample‐to‐cut‐ off (s/co) ratios by Architect HIV Ag/Ab Combo with the results of confirmatory test and explore the potential utility of s/co to predict HIV infection

  • Data from World Health Organization (WHO) have shown that people living with HIV (PLWH) were more than 35 million and 940 000 people died from HIV‐related causes globally in 2017.1 Since the HIV/acquired immune deficiency syndrome (AIDS) was first reported in Beijing and Zhejiang Province in 1985,2-4 the spread rate of HIV in China is alarming

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Summary

Background

The Architect HIV Ag/Ab Combo has excellent performance for HIV screening; the false‐positive rate (FPR) was high in low HIV prevalence setting. Objectives: The purpose of this study was to analyze the influence of sample‐to‐cut‐ off (s/co) ratios by Architect HIV Ag/Ab Combo with the results of confirmatory test and explore the potential utility of s/co to predict HIV infection. The receiver operating character‐ istic curve (ROC) analysis was used to determine the optimal cutoff value for predict‐ ing HIV infection. Results: During the study period, 219 out of 84 702 patients were reactive by ARCHITECT with a 0.0992% of HIV prevalence and a 56.25% of FPR. Among the WB‐positive cases, the s/co ratios increased significantly with the in‐ crease in the number of bands, P = 0.0065. Conclusions: For Architect HIV Ag/Ab Combo, the FPR is reduced when s/co ratios increase, and the s/co ≥24.44 may be reliable to predict HIV infection. Linchuan Wang and Jing‐Yuan Wang contributed to this work

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