Andrey Diego O, Cohen Patrick, Meyer Benjamin, Torriani Giulia, Yerly Sabine, Mazza Lena, Calame Adrien, Arm-Vernez Isabelle, Guessous Idris, Stringhini Silvia, Roux-Lombard Pascale, Fontao Lionel, Agoritsas Thomas, Stirnemann Jerôme, Reny Jean-Luc, Siegrist Claire-Anne, Eckerle Isabella, Kaiser Laurent, Vuilleumier Nicolas
Division of Laboratory Medicine, Department of Diagnostics, Geneva University Hospitals and Geneva University, 1205 Geneva, Switzerland.
Division of Infectious Diseases, Department of Medicine, Geneva University Hospitals, 1205 Geneva, Switzerland.
J Clin Med. 2020 Jul 24;9(8):2369. doi: 10.3390/jcm9082369.
Comparative data of SARS-CoV-2 IgM/IgG serology rapid diagnostic tests (RDTs) is scarce. We thus performed a head-to-head comparison of three RDTs.
In this unmatched case-control study, blood samples from 41 RT-PCR-confirmed COVID-19 cases and 50 negative controls were studied. The diagnostic accuracy of three commercially available COVID-19 RDTs: NTBIO (RDT-A), Orient-Gene (RDT-B), and MEDsan (RDT-C), against both a recombinant spike-expressing immunofluorescence assay (rIFA) and Euroimmun IgG ELISA, was assessed. RDT results concordant with the reference methods, and between whole blood and plasma, were established by the Kendall coefficient.
COVID-19 cases' median time from RT-PCR to serology was 22 days (interquartile range (IQR) 13-31 days). Whole-blood IgG detection with RDT-A, -B, and -C showed 0.93, 0.83, and 0.98 concordance with rIFA. Against rIFA, RDT-A sensitivity (SN) was 92% (95% CI: 78-98) and specificity (SP) 100% (95% CI: 91-100), RDT-B showed 87% SN (95% CI: 72-95) and 98% SP (95% CI: 88-100), and RDT-C 100% SN (95% CI: 88-100) and 98% SP (95% CI: 88-100). Against ELISA, SN and SP were above 90% for all three RDTs.
RDT-A and RDT-C displayed IgG detection SN and SP above 90% in whole blood. These RDTs could be considered in the absence of routine diagnostic serology facilities.
严重急性呼吸综合征冠状病毒2（SARS-CoV-2）IgM/IgG血清学快速诊断试验（RDT）的比较数据稀缺。因此，我们对三种RDT进行了直接比较。
在这项非匹配病例对照研究中，研究了41例经逆转录聚合酶链反应（RT-PCR）确诊的新型冠状病毒肺炎（COVID-19）病例和50例阴性对照的血样。评估了三种市售COVID-19 RDT（NTBIO（RDT-A）、东方基因（RDT-B）和MEDsan（RDT-C））相对于重组刺突蛋白表达免疫荧光测定法（rIFA）和欧蒙IgG酶联免疫吸附测定（ELISA）的诊断准确性。RDT结果与参考方法之间以及全血和血浆之间的一致性通过肯德尔系数确定。
COVID-19病例从RT-PCR到血清学检测的中位时间为22天（四分位间距（IQR）13 - 31天）。RDT-A、-B和-C对全血IgG的检测与rIFA的一致性分别为0.93、0.83和0.98。相对于rIFA，RDT-A的灵敏度（SN）为92%（95%置信区间：78 - 98），特异性（SP）为100%（95%置信区间：91 - 100）；RDT-B的SN为87%（95%置信区间：72 - 95），SP为98%（95%置信区间：88 - 100）；RDT-C的SN为100%（95%置信区间：88 - 100），SP为98%（95%置信区间：88 - 100）。相对于ELISA，三种RDT的SN和SP均高于90%。
RDT-A和RDT-C在全血中检测IgG的SN和SP高于90%。在没有常规诊断血清学设施的情况下，可以考虑使用这些RDT。
