Reuter Tom, Lange Constanze, Zeyher Sharay, Wölk Benno, Kramer Jan
LADR Zentrallabor Dr. Kramer & Kollegen, Lauenburger Str. 67, 21502, Geesthacht, Deutschland.
Universität zu Lübeck, Lübeck, Deutschland.
Pravent Gesundh. 2022 Aug 9:1-7. doi: 10.1007/s11553-022-00970-0.
For detection of SARS-CoV-2-infected persons ("severe acute respiratory syndrome coronavirus 2") quantitative Real-Time PCR (qRT-PCR) remains the gold standard. SARS-CoV‑2 antigen-detecting rapid diagnostic tests (Ag-RDTs) have the advantage of being fast and simple to use at any location. According to previous studies, Ag-RDTs seem to have poorer sensitivity and specificity. There are currently a few hundred Ag-RDTs available, but many of them have not been independently evaluated.
Evaluation of diagnostic performance of rapid antigen tests detecting SARS-CoV‑2 from 6 different manufacturers.
We performed Ag-RDTS with naso- and oropharnygeal swabs from laboratory routine which had had already resulted in a positive qRT-PCR test. To exclude possible dilution effects when samples were used for a second time, we also performed qRT-PCR analytics for already used samples. The initially measured Ct values could be confirmed.
Ag-RDTs showed differences in discrimination between positive and negative results. In samples with lower virus concentrations (Ct value > 30), the results were not reliable and the discrimination between negative and positive results was not unambigious.
Ag-RDTs with high sensitivity allow the identification of highly contagious patients anywhere. There are differences between manufacturers which are important when testing patients. An independent transparent evaluation of Ag-RDTs is necessary.
对于严重急性呼吸综合征冠状病毒2（SARS-CoV-2）感染者的检测，定量实时荧光定量聚合酶链反应（qRT-PCR）仍然是金标准。SARS-CoV-2抗原检测快速诊断试验（Ag-RDTs）具有快速且可在任何地点使用的优点。根据以往研究，Ag-RDTs的敏感性和特异性似乎较差。目前有数百种Ag-RDTs可供使用，但其中许多尚未经过独立评估。
评估6家不同制造商生产的检测SARS-CoV-2的快速抗原检测的诊断性能。
我们使用实验室常规采集的鼻咽拭子进行Ag-RDT检测，这些样本的qRT-PCR检测结果已呈阳性。为排除样本再次使用时可能产生的稀释效应，我们还对已使用的样本进行了qRT-PCR分析。最初测得的Ct值能够得到确认。
Ag-RDTs在区分阳性和阴性结果方面存在差异。在病毒浓度较低（Ct值>30）的样本中，结果不可靠，阴性和阳性结果的区分不明确。
高灵敏度的Ag-RDTs能够在任何地点识别出高传染性患者。不同制造商的产品存在差异，这在检测患者时很重要。对Ag-RDTs进行独立透明的评估是必要的。
