Diagnostic accuracy of Augurix COVID-19 IgG serology rapid test
Diagnostic accuracy of Augurix COVID-19 IgG serology rapid test
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DOI：
10.1111/eci.13357
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发表时间：
2020-08-11
影响因子：
5.5
通讯作者：
Vuilleumier, Nicolas
中科院分区：
文献类型：
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作者：
Andrey, Diego O.;Cohen, Patrick;Vuilleumier, Nicolas
目的验证Augurix SARS-CoV-2 IgM/IgG快速免疫诊断试验（RDT）对COVID-19诊断的准确性。方法采用1：1非匹配病例对照研究，对46例经实时荧光定量PCR（real-time RT-PCR）确诊的SARS冠状病毒2型（SARS-CoV-2）住院患者和45例健康献血员（阴性对照）的血液标本进行检测。根据内部重组加标表达免疫荧光试验（rIFA）（作为已确立的参考方法）（主要终点）和Euroimmun SARS-CoV-2 IgG酶联免疫吸附试验（ELISA）（次要终点）评估IgG RDT的诊断准确性。结果与对照组相比，COVID-19患者更可能是男性（61% vs 20%;P = .0001）和老年人（中位数66 vs 47岁;P < .001）。全血IgG-RDT结果与rIFA和IgG ELISA的总体Kendall一致率分别为86%和93%。血浆和全血之间的IgG RDT性能相似。总体而言，RDT敏感性为88%（95%置信区间[95%CI]：70-96），特异性为98%（95%CI：90-100），PPV为97%（95%CI：80-100），NPV为94%（95%CI：84-98）。在SARS-CoV-2 RT-PCR检测后0 - 6天、7 - 14天和> 14天进行的IgG-RDT在COVID-19组中的阳性率分别为30%、73%和100%。当考虑RT-PCR诊断后>14天采集的样本时，NPV为100%（95%CI：90-100），PPV为100%（95%CI：72-100）。结论在COVID-19高流行环境中，全血中进行的Augurix IgG-RDT对SARS-CoV-2 IgG具有较高的诊断准确性，在缺乏常规诊断血清学设施的情况下，可以考虑使用该方法。
Aims To validate the diagnostic accuracy of the Augurix SARS-CoV-2 IgM/IgG rapid immunoassay diagnostic test (RDT) for COVID-19. Methods In this unmatched 1:1 case-control study, blood samples from 46 real-time RT-PCR-confirmed SARS-CoV-2 hospitalized cases and 45 healthy donors (negative controls) were studied. Diagnostic accuracy of the IgG RDT was assessed against both an in-house recombinant spike-expressing immunofluorescence assay (rIFA), as an established reference method (primary endpoint), and the Euroimmun SARS-CoV-2 IgG enzyme-linked immunosorbent assays (ELISA) (secondary endpoint). Results COVID-19 patients were more likely to be male (61% vs 20%;P = .0001) and older (median 66 vs 47 years old;P < .001) than controls. Whole blood IgG-RDT results showed 86% and 93% overall Kendall concordance with rIFA and IgG ELISA, respectively. IgG RDT performances were similar between plasma and whole blood. Overall, RDT sensitivity was 88% (95% confidence interval [95%CI]: 70-96), specificity 98% (95%CI: 90-100), PPV 97% (95%CI: 80-100) and NPV 94% (95%CI: 84-98). The IgG-RDT carried out from 0 to 6 days, 7 to 14 days and > 14 days after the SARS-CoV-2 RT-PCR test displayed 30%, 73% and 100% positivity rates in the COVID-19 group, respectively. When considering samples taken >14 days after RT-PCR diagnosis, NPV was 100% (95%CI:90-100), and PPV was 100% (95%CI:72-100). Conclusions The Augurix IgG-RDT done in whole blood displays a high diagnostic accuracy for SARS-CoV-2 IgG in high COVID-19 prevalence settings, where its use could be considered in the absence of routine diagnostic serology facilities.