Abstract：
We aimed to assess the performance of Ag-RDT and RT-qPCR with regard to detecting infectious SARS-CoV-2 in cell cultures, as their diagnostic test accuracy (DTA) compared to virus isolation remains largely unknown. We searched three databases up to 15 December 2021 for DTA studies. The bivariate model was used to synthesise the estimates. Risk of bias was assessed using QUADAS-2/C. Twenty studies (2605 respiratory samples) using cell culture and at least one molecular test were identified. All studies were at high or unclear risk of bias in at least one domain. Three comparative DTA studies reported results on Ag-RDT and RT-qPCR against cell culture. Two studies evaluated RT-qPCR against cell culture only. Fifteen studies evaluated Ag-RDT against cell culture as reference standard in RT-qPCR-positive samples. For Ag-RDT, summary sensitivity was 93% (95% CI 78; 98%) and specificity 87% (95% CI 70; 95%). For RT-qPCR, summary sensitivity (continuity-corrected) was 98% (95% CI 95; 99%) and specificity 45% (95% CI 28; 63%). In studies relying on RT-qPCR-positive subsamples (n = 15), the summary sensitivity of Ag-RDT was 93% (95% CI 92; 93%) and specificity 63% (95% CI 63; 63%). Ag-RDT show moderately high sensitivity, detecting most but not all samples demonstrated to be infectious based on virus isolation. Although RT-qPCR exhibits high sensitivity across studies, its low specificity to indicate infectivity raises the question of its general superiority in all clinical settings. Study findings should be interpreted with caution due to the risk of bias, heterogeneity and the imperfect reference standard for infectivity.
摘要：
我们旨在评估Ag-RDT和RT-qPCR在检测细胞培养物中传染性SARS-CoV-2方面的性能，因为与病毒分离相比，它们的诊断测试准确性（DTA）仍然未知。我们搜索了截至2021年12月15日的三个数据库进行DTA研究。双变量模型用于综合估计。使用QUADAS-2/C评估偏倚风险。鉴定了使用细胞培养和至少一种分子测试的20项研究(2605个呼吸样品)。所有研究在至少一个领域都有高或不清楚的偏倚风险。三个比较DTA研究报告了针对细胞培养物的Ag-RDT和RT-qPCR的结果。两项研究仅针对细胞培养物评估了RT-qPCR。15项研究针对RT-qPCR阳性样品中作为参考标准的细胞培养物评估了Ag-RDT。对于Ag-RDT，总敏感性为93%(95%CI78;98%),特异性为87%(95%CI70;95%).对于RT-qPCR，综合敏感性(连续性校正)为98%(95%CI95;99%),特异性为45%(95%CI28;63%).在依赖于RT-qPCR阳性子样本的研究中(n=15)，Ag-RDT的总敏感性为93%(95%CI92;93%),特异性为63%(95%CI63;63%).Ag-RDT显示中等高灵敏度，根据病毒分离，检测大多数但不是所有证明具有传染性的样品。尽管RT-qPCR在研究中表现出高灵敏度，其指示感染性的低特异性提出了其在所有临床环境中的普遍优越性的问题。由于存在偏见的风险，研究结果应谨慎解释，异质性和不完善的传染性参考标准。
