Institute of Clinical Chemistry and Biochemistry, University Medical Centre Ljubljana, LjubljanaSlovenia.
Faculty of Pharmacy, University of Ljubljana, Ljubljana, Slovenia.
Lab Med. 2023 Mar 7;54(2):e44-e48. doi: 10.1093/labmed/lmac079.
The purpose of this study was to compare Quidel's rapid antigen test Sofia SARS antigen Fluorescent Immunoassay (FIA) (Sofia) with the real-time reverse transcription-polymerase chain reaction (rRT-PCR) test.
Two samples were taken from each test subject-1 for testing with the Sofia test and 1 for testing with the rRT-PCR test. In total, swabs were taken from 146 subjects who presented symptoms of infection (group 1) and 672 subjects who were tested regardless of symptoms (group 2).
In group 1, the sensitivity of the antigen test was 90.0% and its specificity 97.5%. In group 2, however, the sensitivity of the antigen test was 81.4% and the specificity 98.9%. In addition to asymptomatic patients, false-negative results of rapid antigen tests also occurred in subjects with high threshold values (cycle threshold > 30).
Our results show that the Sofia test meets the standards for diagnostic tests according to the criteria of the World Health Organization, as they show high sensitivity and specificity, and perhaps most importantly, a high negative predictive value (> 95%).
本研究旨在比较 Quidel 快速抗原检测 Sofia SARS 抗原荧光免疫分析（FIA）（Sofia）与实时逆转录聚合酶链反应（rRT-PCR）检测。
每个测试对象采集 2 个样本，一个用于 Sofia 测试，另一个用于 rRT-PCR 测试。总共对 146 名有感染症状的患者（第 1 组）和 672 名不论症状如何接受检测的患者（第 2 组）进行了拭子采样。
第 1 组中，抗原检测的灵敏度为 90.0%，特异性为 97.5%。然而，在第 2 组中，抗原检测的灵敏度为 81.4%，特异性为 98.9%。除无症状患者外，高阈值（循环阈值>30）患者也会出现快速抗原检测的假阴性结果。
我们的结果表明，Sofia 试验符合世界卫生组织标准的诊断检测标准，因为其具有高灵敏度和特异性，也许最重要的是，具有高阴性预测值（>95%）。
