Sensitivity of ID NOW and RT-PCR for detection of SARS-CoV-2 in an ambulatory population.
Sensitivity of ID NOW and RT-PCR for detection of SARS-CoV-2 in an ambulatory population.
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DOI：
10.7554/elife.65726
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发表时间：
2021-04-20
期刊：
影响因子：
7.7
通讯作者：
O'Leary T
中科院分区：
文献类型：
--
作者：
Tu YP;Iqbal J;O'Leary T
SARS-CoV-2（COVID-19）的诊断需要通过逆转录-聚合酶链反应（RT-PCR）进行确认。Abbott ID NOW提供快速结果，但因灵敏度低而受到批评。在这里，我们确定了ID NOW在流动人群中进行检测的灵敏度。该研究招募了785名有症状的患者，其中21名通过ID NOW和RT-PCR均呈阳性，2名仅通过RT-PCR呈阳性。所有189名无症状患者检测均为阴性。ID NOW检测试剂盒和RT-PCR检测试剂盒之间的阳性一致率为91.3%，阴性一致率为100%。将当前研究的结果纳入更大的文献系统综述中，其中至少20例受试者同时使用ID NOW和RT-PCR进行检测。ID NOW检测试剂盒的总体灵敏度计算为84%（95%置信区间55-96%），在最可能与传染性感染相关的病毒载量下与RT-PCR的相关性最高。
Diagnosis of SARS-CoV-2 (COVID-19) requires confirmation by reverse transcription–polymerase chain reaction (RT–PCR). Abbott ID NOW provides fast results but has been criticized for low sensitivity. Here we determine the sensitivity of ID NOW in an ambulatory population presented for testing. The study enrolled 785 symptomatic patients, of whom 21 were positive by both ID NOW and RT–PCR, and 2 only by RT–PCR. All 189 asymptomatic patients tested negative. The positive percent agreement between the ID NOW assay and the RT–PCR assay was 91.3%, and negative percent agreement was 100%. The results from the current study were included into a larger systematic review of literature where at least 20 subjects were simultaneously tested using ID NOW and RT–PCR. The overall sensitivity for ID NOW assay was calculated at 84% (95% confidence interval 55–96%) and had the highest correlation to RT–PCR at viral loads most likely to be associated with transmissible infections.