In the context of the Covid-19 pandemic, the development and validation of rapid and easy-to-perform diagnostic methods are of high priority. We compared the performance of four rapid antigen detection tests for SARS-CoV-2 in respiratory samples. Immunochromatographic SARS-CoV-2 assays from RapiGEN, Liming bio, Savant, and Bioeasy were evaluated using universal transport medium containing naso-oropharyngeal swabs from suspected Covid-19 cases. The diagnostic accuracy was determined in comparison to SARS-CoV-2 RT-PCR. A total of 111 samples were included; 80 were RT-PCR positive. Median patients' age was 40 years, 55% were female, and 88% presented within the first week after symptom onset. The evaluation of the Liming bio assay was discontinued due to insufficient performance. The overall sensitivity values of RapiGEN, Liming bio, and Bioeasy tests were 62.0% (CI95% 51.0–71.9), 16.7% (CI95% 10.0–26.5), and 85.0% (CI95% 75.6–91.2), respectively, with specificities of 100%. Sensitivity was significantly higher in samples with high viral loads (RapiGEN, 84.9%; Bioeasy, 100%). The study highlighted the significant heterogeneity of test performance among evaluated assays, which might have been influenced by the use of a non-validated sample material. The high sensitivity of some tests demonstrated that rapid antigen detection has the potential to serve as an alternative diagnostic method, especially in patients presenting with high viral loads in early phases of infection. This is particularly important in situations with limited access to RT-PCR or prolonged turnaround time. Further comparative evaluations are necessary to select products with high performance among the growing market of diagnostic tests for SARS-CoV-2.

中文翻译：

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四种基于抗原的快速检测测试对呼吸道样本中SARS-CoV-2的诊断的正面对比

在Covid-19大流行的背景下，开发和验证快速且易于执行的诊断方法是当务之急。我们比较了呼吸道样本中针对SARS-CoV-2的四种快速抗原检测测试的性能。RapiGEN，Liming bio，Savant和Bioeasy的免疫色谱SARS-CoV-2分析方法是使用含有怀疑Covid-19病例鼻鼻咽拭子的通用转运介质进行评估的。与SARS-CoV-2 RT-PCR相比，确定了诊断准确性。总共包括111个样本；RT-PCR阳性80例。患者中位年龄为40岁，女性占55％，在症状发作后的第一周内占88％。由于性能不足，中断了对Liming生物测定的评估。RapiGEN，Liming bio，和Bioeasy测试分别为62.0％（CI95％51.0-71.9），16.7％（CI95％10.0-26.5）和85.0％（CI95％75.6-91.2），特异性为100％。在高病毒载量的样品中，敏感性显着更高（RapiGEN，84.9％； Bioeasy，100％）。该研究强调了在评估的测定中测试性能的显着异质性，这可能已受到使用未经验证的样品材料的影响。一些测试的高灵敏度表明，快速抗原检测有潜力作为替代诊断方法，特别是对于在感染早期具有高病毒载量的患者。这在访问RT-PCR受限或周转时间较长的情况下尤其重要。