Performance evaluation of two SARS-CoV-2 IgG/IgM rapid tests (Covid-Presto and NG-Test) and one IgG automated immunoassay (Abbott)
Performance evaluation of two SARS-CoV-2 IgG/IgM rapid tests (Covid-Presto and NG-Test) and one IgG automated immunoassay (Abbott)
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DOI：
10.1016/j.jcv.2020.104618
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发表时间：
2020-11-01
影响因子：
8.8
通讯作者：
Fidouh-Houhou, Nadhira
中科院分区：
文献类型：
--
作者：
Charpentier, Charlotte;Ichou, Houria;Fidouh-Houhou, Nadhira
本研究的目的是评估两种快速检测（CovidPresto (R) 检测快速 Covid-19 IgG/IgM 和 NG-Test (R) IgM-IgG COVID-19）和一种自动免疫测定（Abbott SARS-CoV-2 IgG）用于检测抗 SARS-CoV-2 抗体的分析性能、灵敏度和特异性。这项研究是用以下材料进行的：(i) 由 88 份从 SARS-CoV-2 RTPCR 阳性患者采集的 SARS-CoV-2 样本组成的阳性组，以及 (ii) 由 120 份血清样本组成的阴性组，所有这些样本均在 2019 年 11 月之前收集，其中包括 64 个具有交叉反应性组的样本。 Covid-Presto (R) 检测对 IgM 和 IgG 的敏感性分别为 78.4% 和 92.0%。 NG-Test (R) 对 IgM 和 IgG 的灵敏度分别为 96.6% 和 94.9%。 Abbott IgG 检测的灵敏度为 96.5%，与两种快速检测高度一致（NGTest (R) 和 Covid-Presto (R) 检测的 kappa = 0.947 和 kappa = 0.936）。两次快速测试之间也观察到了极好的一致性（kappa = 0.937）。 Covid-Presto (R) 测试和 NG-Test (R) 的 IgM 特异性分别为 100% 和 86.5%。 Covid-Presto (R)、NGTest (R) 和 Abbott 的 IgG 特异性分别为 92.0%、94.9% 和 96.5%。 NG-Test (R) 观察到的大多数假阳性结果来自含有疟疾抗体的样本。总之，除了 NG-Test (R) 的 IgM 特异性外，这 2 种快速检测的性能非常好，与自动免疫分析获得的性能相当。因此，由于该测试可能出现假阳性反应，应谨慎解释分离的 IgM。最后，在大规模使用之前，必须使用足够的大型面板对快速检测进行可靠评估，包括早期血清转化和可能的交叉反应样本。
The aim of this study was to assess the analytical performances, sensitivity and specificity, of two rapid tests (CovidPresto (R) test rapid Covid-19 IgG/IgM and NG-Test (R) IgM-IgG COVID-19) and one automated immuno-assay (Abbott SARS-CoV-2 IgG) for detecting antiSARS-CoV-2 antibodies. This study was performed with: (i) a positive panel constituted of 88 SARS-CoV-2 specimens collected from patients with a positive SARS-CoV-2 RTPCR, and (ii) a negative panel of 120 serum samples, all collected before November 2019, including 64 samples with a cross-reactivity panel. Sensitivity of Covid-Presto (R) test for IgM and IgG was 78.4% and 92.0%, respectively. Sensitivity of NG-Test (R) for IgM and IgG was 96.6% and 94.9%, respectively. Sensitivity of Abbott IgG assay was 96.5% showing an excellent agreement with the two rapid tests (kappa = 0.947 and kappa = 0.936 for NGTest (R) and Covid-Presto (R) test, respectively). An excellent agreement was also observed between the two rapid tests (kappa = 0.937). Specificity for IgM was 100% and 86.5% for Covid-Presto (R) test and NG-Test (R), respectively. Specificity for IgG was 92.0%, 94.9% and 96.5% for Covid-Presto (R), NGTest (R), and Abbott, respectively. Most of the false positive results observed with NG-Test (R) resulted from samples containing malarial antibodies. In conclusion, performances of these 2 rapid tests are very good and comparable to those obtained with automated immunoassay, except for IgM specificity with the NG-Test (R). Thus, isolated IgM should be cautiously interpreted due to the possible false-positive reactions with this test. Finally, before their large use, the rapid tests must be reliably evaluated with adequate and large panel including early seroconversion and possible cross-reactive samples.