Numerous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) rapid serological tests have been developed, but their accuracy has usually been assessed using very few samples, and rigorous comparisons between these tests are scarce. In this study, we evaluated and compared 10 commercially available SARS-CoV-2 rapid serological tests using the STARD (Standards for Reporting of Diagnostic Accuracy Studies) methodology. Two hundred fifty serum samples from 159 PCR-confirmed SARS-CoV-2 patients (collected 0 to 32 days after the onset of symptoms) were tested with rapid serological tests. Control serum samples (n = 254) were retrieved from pre-coronavirus disease (COVID) periods from patients with other coronavirus infections (n = 11), positivity for rheumatoid factors (n = 3), IgG/IgM hyperglobulinemia (n = 9), malaria (n = 5), or no documented viral infection (n = 226). All samples were tested using rapid lateral flow immunoassays (LFIAs) from 10 manufacturers. Only four tests achieved ≥98% specificity, with the specificities ranging from 75.7% to 99.2%. The sensitivities varied by the day of sample collection after the onset of symptoms, from 31.7% to 55.4% (days 0 to 9), 65.9% to 92.9% (days 10 to 14), and 81.0% to 95.2% (>14 days). Only three of the tests evaluated met French health authorities’ thresholds for SARS-CoV-2 serological tests (≥90% sensitivity and ≥98% specificity). Overall, the performances varied greatly between tests, with only one-third meeting acceptable specificity and sensitivity thresholds. Knowledge of the analytical performances of these tests will allow clinicians and, most importantly, laboratorians to use them with more confidence; could help determine the general population’s immunological status; and may help diagnose some patients with false-negative real-time reverse transcription-PCR (RT-PCR) results.

中文翻译：

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通过使用STARD（诊断准确性研究报告标准）方法评估10种市售SARS-CoV-2快速血清学检测

已经开发了许多严重的急性呼吸系统综合症冠状病毒2（SARS-CoV-2）快速血清学检测方法，但是通常只用很少的样品就可以评估其准确性，而且在这些检测方法之间进行严格的比较是很少的。在这项研究中，我们使用STARD（诊断准确性研究报告标准）方法评估并比较了10种市售SARS-CoV-2快速血清学检测。用快速血清学测试对159例经PCR确诊的SARS-CoV-2患者（症状发作后0至32天收集）的250份血清样品进行了检测。对照血清样品（Ñ = 254）从预冠状病（COVID）期间被检索来自患有其他冠状病毒感染（Ñ = 11），阳性的类风湿因子（n = 3），IgG / IgM高球蛋白血症（n = 9），疟疾（n = 5）或无记录的病毒感染（n= 226）。所有样品均使用来自10个制造商的快速侧流免疫分析（LFIA）进行了测试。只有四个测试达到了≥98％的特异性，特异性范围为75.7％至99.2％。症状发作后的敏感性随样本采集日的不同而不同，从31.7％至55.4％（第0至9天），65.9％至92.9％（第10至14天）和81.0％至95.2％（大于14天） ）。评估的测试中只有三项达到了法国卫生部门SARS-CoV-2血清学测试的阈值（灵敏度≥90％，特异性≥98％）。总体而言，测试之间的性能差异很大，只有三分之一满足可接受的特异性和敏感性阈值。了解这些测试的分析性能将使临床医生，最重要的是，实验室医生可以放心使用它们。可以帮助确定一般人群的免疫学状况；并可能有助于诊断某些患者，这些患者的实时阴性反转录PCR（RT-PCR）结果为假阴性。