AP-HP, Hôpital Paul-Brousse, Virologie, Department of Virology, University Paris Saclay, INSERM U1193, 94804, Villejuif, France.
Département des Agents Infectieux, Service de Virologie, Hôpital Saint-Louis, Université de Paris, INSERM UMR 944, Paris, France.
Eur J Clin Microbiol Infect Dis. 2021 Oct;40(10):2235-2241. doi: 10.1007/s10096-021-04232-3. Epub 2021 Mar 29.
We report evaluation of 30 assays' (17 rapid tests (RDTs) and 13 automated/manual ELISA/CLIA assay (IAs)) clinical performances with 2594 sera collected from symptomatic patients with positive SARS-CoV-2 rRT-PCR on a respiratory sample, and 1996 pre-epidemic serum samples expected to be negative. Only 4 RDT and 3 IAs fitted both specificity (> 98%) and sensitivity (> 90%) criteria according to French recommendations. Serology may offer valuable information during COVID-19 pandemic, but inconsistent performances observed among the 30 commercial assays evaluated, which underlines the importance of independent evaluation before clinical implementation.
我们报告了对 30 种检测方法（17 种快速检测试剂盒（RDT）和 13 种自动化/手动酶联免疫吸附测定/化学发光免疫分析检测试剂盒（IA））的临床性能评估，这些检测方法使用了 2594 份来自呼吸道样本中 SARS-CoV-2 rRT-PCR 阳性的有症状患者的血清样本，以及 1996 份预计为阴性的流行前血清样本。只有 4 种 RDT 和 3 种 IA 符合法国推荐的特异性（>98%）和敏感性（>90%）标准。血清学可能在 COVID-19 大流行期间提供有价值的信息，但在评估的 30 种商业检测试剂盒中观察到的性能不一致，这突显出在临床应用之前进行独立评估的重要性。
