Gulmez Abdurrahman, Appak Ozgur, Zeka Arzu Nazli, Esen Nuran, Sayiner Ayca Arzu
Istanbul Basaksehir Cam and Sakura City Hospital, Medical Microbiology Laboratory, Istanbul, Turkey.
Department of Medical Microbiology, Faculty of Medicine, Virology Unit, Dokuz Eylul University, Izmir, Turkey.
Iran J Public Health. 2024 Jul;53(7):1569-1577. doi: 10.18502/ijph.v53i7.16051.
We aimed to evaluate the performance of the current algorithm the HIV diagnosis that has been performed for four years. Results of HIV Ag/Ab tests, anti-HIV 1/2 confirmatory tests, HIV-1 RNA tests and the time for official results to be approved were evaluated.
The relationship of HIV Ag/Ab tests, anti-HIV 1/2 confirmation tests and HIV-1 RNA PCR tests, their result times and suitability to the algorithm were examined at Izmir Dokuz Eylül University between May 2017 and June 2021.
HIV Ag/Ab ELISA was reactive repetitively in 165/54628 (0.30%) serum samples. Anti-HIV 1/2 confirmation test was reactive in 54.42% (80/147) of samples. The most common pattern (18.2%) in the confirmation tests was the positivity of the antibodies against gp160 - gp41 envelope glycoproteins together. The mean reporting time of the confirmation test result was 3h 50 min after the ELISA test. The mean reporting time of the HIV-1 RNA PCR was 12.79 d (±10.22) after the ELISA test and 12.63 (± 10.12) day after the confirmation test. In ROC analysis, the estimated rate of the ELISA test for the confirmation test was highest when S/CO was >13.16 (sensitivity: 97.59 %, specificity: 97.59%).
The confirmation test in the current algorithm enabled the rapid test results, early diagnosis of HIV and early antiretroviral therapy. To use the new algorithm effectively, decentralization of the validation tests would be appropriate.
我们旨在评估已实施四年的当前艾滋病病毒(HIV)诊断算法的性能。对HIV抗原/抗体检测、抗HIV 1/2确证检测、HIV-1 RNA检测结果以及官方结果获批时间进行了评估。
于2017年5月至2021年6月在伊兹密尔多库兹艾吕尔大学检查了HIV抗原/抗体检测、抗HIV 1/2确证检测与HIV-1 RNA聚合酶链反应(PCR)检测之间的关系、它们的结果时间以及与该算法的适用性。
在54628份血清样本中,HIV抗原/抗体酶联免疫吸附测定(ELISA)有165份(0.30%)呈反复反应性。抗HIV 1/2确证检测在54.42%(80/147)的样本中呈反应性。确证检测中最常见的模式(18.2%)是针对gp160 - gp41包膜糖蛋白的抗体同时呈阳性。确证检测结果的平均报告时间为ELISA检测后3小时50分钟。HIV-1 RNA PCR的平均报告时间为ELISA检测后12.79天(±10.22),确证检测后12.63天(±10.12)。在受试者工作特征(ROC)分析中,当S/CO>13.16时,ELISA检测对确证检测的估计率最高(敏感性:97.59%,特异性:97.59%)。
当前算法中的确证检测能够实现快速检测结果、HIV的早期诊断以及早期抗逆转录病毒治疗。为有效使用新算法,验证检测的去中心化是合适的。