Diagnostic Efficacy of Photostimulated Chemiluminescence Assay for Detecting Anti-HIV Antibodies: A Retrospective Study.

Abstract

The transmission of human immunodeficiency virus (HIV) through blood poses a slightly increased risk. As a result, patients requiring blood transfusions should be screened for HIV antibodies. This study examined the diagnostic effectiveness of the photostimulated chemiluminescence assay in detecting anti-HIV antibodies and determined the cut-off value for this method. The performance of the fully automated photostimulated chemiluminescence assay system was validated according to CNAS-GL038:2019 (2020) and CNAS-GL037:2019 (2019) guidelines. A retrospective study was conducted at the Department of Medical Laboratory, Nanjing Tongren Hospital, affiliated with Southeast University, from January 2020 to December 2022. A total of 77,386 cases were tested for anti-HIV antibodies using the photostimulated chemiluminescence assay, with 79 cases initially testing positive. The method's performance in detecting anti-HIV antibodies was evaluated using the Receiver Operating Characteristic (ROC) curve and the average Coefficient of Variation (CV) value of 3-year in-house quality control. The precision, detection limit, coincidence rate, and critical value of the performance verification results met the requirements. Using Western blotting (WB) as the reference method, positive cases were initially screened using the light-induced chemiluminescence method to determine the cut-off index (COI) value and draw the ROC curve. The maximum area under the ROC curve using the chemiluminescence method was 0.997, with a cutoff value of < 28.56, sensitivity of 98%, specificity of 100%, Jordan index of 0.98, and an average CV value of 3.55%. In conclusion, the photostimulated chemiluminescence assay has good diagnostic efficacy in detecting anti-HIV antibodies and is suitable for rapid screening before blood transfusion and surgery.