Copenhagen University Hospital Hvidovre, Department of Clinical Microbiology, Kettegaard Alle 30, 2650 Hvidovre, Denmark.
Copenhagen University Hospital Hvidovre, Department of Clinical Microbiology, Kettegaard Alle 30, 2650 Hvidovre, Denmark.
J Clin Virol. 2022 Aug;153:105214. doi: 10.1016/j.jcv.2022.105214. Epub 2022 Jun 8.
The SARS-CoV-2 pandemic has resulted in massive testing by Rapid Antigen Tests (RAT) without solid independent data regarding clinical performance being available. Thus, decision on purchase of a specific RAT may rely on manufacturer-provided data and limited peer-reviewed data.
This study consists of two parts. In the retrospective analytical part, 33 RAT from 25 manufacturers were compared to RT-PCR on 100 negative and 204 positive deep oropharyngeal cavity samples divided into four groups based on RT-PCR Cq levels. In the prospective clinical part, nearly 200 individuals positive for SARS-CoV-2 and nearly 200 individuals negative for SARS-CoV-2 by routine RT-PCR testing were retested within 72 h for each of 44 included RAT from 26 manufacturers applying RT-PCR as the reference method.
The overall analytical sensitivity differed significantly between the 33 included RAT; from 2.5% (95% CI 0.5-4.8) to 42% (95% CI 35-49). All RAT presented analytical specificities of 100%. Likewise, the overall clinical sensitivity varied significantly between the 44 included RAT; from 2.5% (95% CI 0.5-4.8) to 94% (95% CI 91-97). All RAT presented clinical specificities between 98 and 100%.
The study presents analytical as well as clinical performance data for 44 commercially available RAT compared to the same RT-PCR test. The study enables identification of individual RAT that has significantly higher sensitivity than other included RAT and may aid decision makers in selecting between the included RAT.
The study was funded by a participant fee for each test and the Danish Regions.
SARS-CoV-2 大流行导致了大量的快速抗原检测（RAT），但缺乏关于临床性能的可靠独立数据。因此，购买特定 RAT 的决定可能依赖于制造商提供的数据和有限的同行评审数据。
本研究包括两部分。在回顾性分析部分，将来自 25 家制造商的 33 种 RAT 与 RT-PCR 对 100 个阴性和 204 个阳性的深部口咽腔样本进行比较，根据 RT-PCR 的 Cq 值将样本分为四组。在前瞻性临床部分，对近 200 名通过常规 RT-PCR 检测呈 SARS-CoV-2 阳性和近 200 名 SARS-CoV-2 阴性的个体，在 72 小时内对来自 26 家制造商的 44 种 RAT 中的每一种进行重复检测，使用 RT-PCR 作为参考方法。
33 种 RAT 的总体分析灵敏度差异显著；从 2.5%（95%CI 0.5-4.8）到 42%（95%CI 35-49）。所有 RAT 的分析特异性均为 100%。同样，44 种 RAT 的总体临床灵敏度差异显著；从 2.5%（95%CI 0.5-4.8）到 94%（95%CI 91-97）。所有 RAT 的临床特异性均在 98%至 100%之间。
本研究提供了 44 种市售 RAT 与同一 RT-PCR 检测相比的分析性能和临床性能数据。该研究可以确定个别 RAT 的灵敏度明显高于其他 RAT，并有助于决策者在这些 RAT 之间进行选择。
该研究由每个测试的参与者费用和丹麦地区资助。
