Service of Laboratory Medicine, Pederzoli Hospital, Peschiera del Garda, Italy.
Section of Clinical Biochemistry, University of Verona, Verona, Italy.
Diagnosis (Berl). 2021 Jan 18;8(3):322-326. doi: 10.1515/dx-2020-0154. Print 2021 Aug 26.
Novel point-of-care antigen assays present a promising opportunity for rapid screening of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections. The purpose of this study was the clinical assessment of the new Roche SARS-CoV-2 Rapid Antigen Test.
The clinical performance of Roche SARS-CoV-2 Rapid Antigen Test was evaluated vs. a reverse transcription polymerase chain reaction (RT-PCR) laboratory-based assay (Seegene AllplexTM2019-nCoV) in nasopharyngeal swabs collected from a series of consecutive patients referred for SARS-CoV-2 diagnostics to the Pederzoli Hospital (Peschiera del Garda, Verona, Italy) over a 2-week period.
The final study population consisted of 321 consecutive patients (mean age, 46 years and IQR, 32-56 years; 181 women, 56.4%), with 149/321 (46.4%) positive for SARS-CoV-2 RNA via the Seegene AllplexTM2019-nCoV Assay, and 109/321 (34.0%) positive with Roche SARS-CoV-2 Rapid Antigen Test, respectively. The overall accuracy of Roche SARS-CoV-2 Rapid Antigen Test compared to molecular testing was 86.9%, with 72.5% sensitivity and 99.4% specificity. Progressive decline in performance was observed as cycle threshold (Ct) values of different SARS-CoV-2 gene targets increased. The sensitivity was found to range between 97-100% in clinical samples with Ct values <25, between 50-81% in those with Ct values between 25 and <30, but low as 12-18% in samples with Ct values between 30 and <37.
The clinical performance of Roche SARS-CoV-2 Rapid Antigen Test is excellent in nasopharyngeal swabs with Ct values <25, which makes it a reliable screening test in patients with high viral load. However, mass community screening would require the use of more sensitive techniques.
新型即时抗原检测为快速筛查严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）感染提供了一个有希望的机会。本研究旨在评估罗氏 SARS-CoV-2 快速抗原检测的临床性能。
在为期两周的时间内，对来自意大利维罗纳佩德佐利医院（Pederzoli Hospital）因 SARS-CoV-2 诊断而就诊的一系列连续患者的鼻咽拭子，使用罗氏 SARS-CoV-2 快速抗原检测与基于逆转录聚合酶链反应（RT-PCR）的实验室检测（Seegene AllplexTM2019-nCoV）进行了临床性能评估。
最终研究人群由 321 例连续患者组成（平均年龄为 46 岁，IQR 为 32-56 岁；女性 181 例，占 56.4%），其中 149/321（46.4%）通过 Seegene AllplexTM2019-nCoV 检测呈 SARS-CoV-2 RNA 阳性，109/321（34.0%）通过罗氏 SARS-CoV-2 快速抗原检测呈阳性。与分子检测相比，罗氏 SARS-CoV-2 快速抗原检测的总体准确率为 86.9%，灵敏度为 72.5%，特异性为 99.4%。随着不同 SARS-CoV-2 基因靶标循环阈值（Ct）值的增加，检测性能逐渐下降。在 Ct 值<25 的临床样本中，检测的灵敏度范围在 97-100%之间，在 Ct 值为 25-<30 的样本中为 50-81%，但在 Ct 值为 30-<37 的样本中灵敏度较低，为 12-18%。
罗氏 SARS-CoV-2 快速抗原检测在 Ct 值<25 的鼻咽拭子中具有出色的临床性能，使其成为高病毒载量患者可靠的筛查检测方法。然而，大规模社区筛查将需要使用更敏感的技术。
