CHU de Rennes, Univ Rennes, Inserm, EHESP, Irset (Institut de recherche en santé, environnement et travail), Rennes, France.
CHU de Rennes, Rennes, France.
Emerg Microbes Infect. 2020 Dec;9(1):2547-2549. doi: 10.1080/22221751.2020.1852893.
The objective of this study was to evaluate the validity and reliability of NG-Test® when used as a finger-prick test on healthcare workers and to compare it to the ELISA Wantai Immunoassay. Fifty-one healthcare workers who were RT-PCR SARS-CoV-2 positive and 59 who were RT-PCR SARS-CoV-2 negative accepted to participate in this study. They were subjected to an NG-Test® finger-prick test and collection of a blood sample on the same day. A second NG-Test® on another finger was performed for the first 30 cases and controls and read blinded to the first. Sera obtained from blood samples were used to perform the Wantai SARS-CoV-2 ELISA. The interobserver agreement for the NG-Test® test was perfect (kappa coefficient = 100% [98%-100%]). The sensitivity of NG-Test® was estimated to be 85% [71.9%-92.3%] and the specificity 98.3% [95.0%-100.0%]) for both IgG and IgM. The percentage of agreement between the Wantai immunoassay and NG-Test® was 92.73% for IgG (Kappa = 0.85 [0.75-0.95]) and 65.45% (Kappa = 0.42 [0.26-0.58]) for IgM. Our study highlights the need to validate rapid immunoassay tests under real-life conditions. If NG-Test® is used in seroprevalence surveys, we recommend that its diagnostic performance be taken into consideration to obtain a reliable estimation.
本研究旨在评估 NG-Test®作为指尖采血检测在医护人员中的有效性和可靠性，并与 ELISA 万泰免疫测定法进行比较。51 名 RT-PCR SARS-CoV-2 阳性和 59 名 RT-PCR SARS-CoV-2 阴性的医护人员同意参与本研究。他们当天接受了 NG-Test®指尖采血检测，并采集了血液样本。前 30 例和对照组进行了第二次 NG-Test®，对第二个手指进行了检测，检测结果对第一个结果进行了盲法读取。从血液样本中获得的血清用于进行万泰 SARS-CoV-2 ELISA。NG-Test®检测的观察者间一致性为完美（kappa 系数=100%[98%-100%]）。NG-Test®的敏感性估计为 85%[71.9%-92.3%]，特异性为 98.3%[95.0%-100.0%]），IgG 和 IgM 均如此。万泰免疫测定法和 NG-Test®的 IgG 之间的一致性百分比为 92.73%（kappa =0.85[0.75-0.95]），IgM 为 65.45%（kappa =0.42[0.26-0.58]）。本研究强调了在现实条件下验证快速免疫检测的必要性。如果在血清流行率调查中使用 NG-Test®，我们建议考虑其诊断性能以获得可靠的估计。
