False negative rate of COVID-19 PCR testing: a discordant testing analysis.
False negative rate of COVID-19 PCR testing: a discordant testing analysis.
复制标题
DOI：
10.1186/s12985-021-01489-0
复制
发表时间：
2021-01-09
期刊：
影响因子：
4.8
通讯作者：
Tipples G
中科院分区：
文献类型：
--
作者：
Kanji JN;Zelyas N;MacDonald C;Pabbaraju K;Khan MN;Prasad A;Hu J;Diggle M;Berenger BM;Tipples G
COVID-19是通过使用真实的时间逆转录聚合酶链反应（rtRT-PCR）检测SARS-CoV-2 RNA来诊断的。由于缺乏金标准，许多SARS-CoV-2 rt-PCR检测的性能尚不完全清楚。我们试图评估我们实验室开发的靶向包膜（E）和RNA依赖性RNA聚合酶（RdRp）基因的SARS-CoV-2 rtRT-PCR的假阴性率（FNR）和灵敏度。对2020年1月21日至4月18日公共卫生实验室（加拿大阿尔伯塔）的SARS-CoV-2 rt-PCR结果进行了审查，以确定初始rt-PCR阴性，随后在14天内重复检测结果为阳性的患者（定义为不一致结果）。使用三种替代rtRT-PCR检测试剂（靶向核衣壳基因的E基因和N1/N2区域）对这些不一致标本的阴性样本进行复检，以评估假阴性（FN）结果。在规定的时间段内，95，919名患者（100，001份样本）接受了SARS-CoV-2检测。其中，发现49例患者的结果不一致，包括49例阳性和52例阴性拭子。对52份阴性拭子进行重复检测，发现5个FN（来自5名不同患者）。假设诊断检测的特异性为100%，则该组不一致检测患者的FNR和灵敏度分别为9.3%（95% CI 1.5-17.0%）和90.7%（95% CI 82.6-98.9%）。了解常规使用的检测试剂盒的FNR的研究对于确认充分的临床性能非常重要。在这项研究中，大多数FN结果是由于在感染的不同阶段收集了多份标本的患者中SARS-CoV-2病毒浓度较低。建议对每位患者进行检测后临床评估，以确保rtRT-PCR结果不是排除COVID-19的唯一因素。
COVID-19 is diagnosed via detection of SARS-CoV-2 RNA using real time reverse-transcriptase polymerase chain reaction (rtRT-PCR). Performance of many SARS-CoV-2 rtRT-PCR assays is not entirely known due to the lack of a gold standard. We sought to evaluate the false negative rate (FNR) and sensitivity of our laboratory-developed SARS-CoV-2 rtRT-PCR targeting the envelope (E) and RNA-dependent RNA-polymerase (RdRp) genes. SARS-CoV-2 rtRT-PCR results at the Public Health Laboratory (Alberta, Canada) from January 21 to April 18, 2020 were reviewed to identify patients with an initial negative rtRT-PCR followed by a positive result on repeat testing within 14 days (defined as discordant results). Negative samples from these discordant specimens were re-tested using three alternate rtRT-PCR assays (targeting the E gene and N1/N2 regions of the nucleocapsid genes) to assess for false negative (FN) results. During the time period specified, 95,919 patients (100,001 samples) were tested for SARS-CoV-2. Of these, 49 patients were found to have discordant results including 49 positive and 52 negative swabs. Repeat testing of 52 negative swabs found five FNs (from five separate patients). Assuming 100% specificity of the diagnostic assay, the FNR and sensitivity in this group of patients with discordant testing was 9.3% (95% CI 1.5–17.0%) and 90.7% (95% CI 82.6–98.9%) respectively. Studies to understand the FNR of routinely used assays are important to confirm adequate clinical performance. In this study, most FN results were due to low amounts of SARS-CoV-2 virus concentrations in patients with multiple specimens collected during different stages of infection. Post-test clinical evaluation of each patient is advised to ensure that rtRT-PCR results are not the only factor in excluding COVID-19.
登录
查看更多内容
影响因子：
8.5
作者：
Sullivan, Patrick Sean;Sailey, Charles;Sanchez, Travis Howard
通讯作者：
Sanchez, Travis Howard
影响因子：
11.8
作者：
Long, Dustin R.;Gombar, Saurabh;Sunshine, Jacob E.
通讯作者：
Sunshine, Jacob E.
影响因子：
9.3
作者：
Pan, Yang;Long, Luyao;Ren, Simei
通讯作者：
Ren, Simei
影响因子：
3.7
作者：
Arevalo-Rodriguez I;Buitrago-Garcia D;Simancas-Racines D;Zambrano-Achig P;Del Campo R;Ciapponi A;Sued O;Martinez-García L;Rutjes AW;Low N;Bossuyt PM;Perez-Molina JA;Zamora J
通讯作者：
Zamora J
影响因子：
11.8
作者：
Jamal, Alainna J.;Mozafarihashjin, Mohammad;Mubareka, Samira
通讯作者：
Mubareka, Samira