Ecole Doctorale Régionale D'Afrique Centrale en Infectiologie Tropicale, Franceville, Gabon.
Faculty of Medicine and Pharmacy, University of Kisangani, Kisangani, The Democratic Republic of the Congo.
PLoS One. 2020 Oct 15;15(10):e0240779. doi: 10.1371/journal.pone.0240779. eCollection 2020.
The practicability of a prototype capillary whole-blood IgG-IgM COVID-19 self-test (Exacto® COVID-19 self-test, Biosynex Swiss SA, Freiburg, Switzerland) as a serological screening tool for SARS-CoV-2 infection adapted to the general public was evaluated in a cross-sectional, general adult population study performed between April and May 2020 in Strasbourg, France, consisting of face-to-face, paper-based, semi-structured, and self-administrated questionnaires. Practicability was defined as the correct use of the self-test and the correct interpretation of the result. The correct use of self-test was conditioned by the presence of the control band after 15-min of migration. The correct interpretation of the tests was defined by the percent agreement between the tests results read and interpret by the participants compared to the expected results coded by the numbers and verified by trained observers. A total of 167 participants (52.7% female; median age, 35.8 years; 82% with post-graduate level) were enrolled, including 83 and 84 for usability and test results interpretation substudies, respectively. All participants (100%; 95% CI: 95.6-100) correctly used the self-test. However, 12 (14.5%; 95% CI: 8.5-23.6) asked for verbal help. The percent agreement between the tests results read and interpret by the participants compared to the expected results was 98.5% (95% CI: 96.5-99.4). However, misinterpretation occurred in only 2.3% of positive and 1.2% of invalid test results. Finally, all (100%) participants found that performing the COVID-19 self-test was easy; and 98.8% found the interpretation of the self-test results easy. Taken together, these pilot observations demonstrated for the first-time, high practicability and satisfaction of COVID-19 self-testing for serological IgG and IgM immune status, indicating its potential for use by the general public to complete the arsenal of available SARS-CoV-2 serological assays in the urgent context of the COVID-19 epidemic.
一种用于 SARS-CoV-2 感染的血清学 IgG 和 IgM 免疫状态检测的毛细血管全血 COVID-19 自我检测试剂盒（Exacto® COVID-19 自我检测试剂盒，Biosynex Swiss SA，Freiburg，瑞士）的实用性评估，该研究是在 2020 年 4 月至 5 月间在法国斯特拉斯堡进行的横断面、一般成年人群研究中进行的，该研究采用面对面、纸质、半结构化和自我管理的问卷调查。实用性定义为自我检测的正确使用和结果的正确解读。自我检测的正确使用取决于 15 分钟迁移后是否出现对照带。测试结果的正确解读定义为参与者读取和解释测试结果与预期结果的百分比一致，这些预期结果是由编码数字和经过培训的观察者验证的。共纳入 167 名参与者（52.7%为女性；中位年龄为 35.8 岁；82%具有研究生学历），分别有 83 名和 84 名参与者参加了可用性和测试结果解释亚研究。所有参与者（100%；95%CI：95.6-100）均正确使用了自我检测试剂盒。然而，有 12 名（14.5%；95%CI：8.5-23.6）参与者要求口头帮助。参与者读取和解释测试结果与预期结果的百分比一致性为 98.5%（95%CI：96.5-99.4）。然而，仅在 2.3%的阳性和 1.2%的无效测试结果中出现错误解读。最后，所有（100%）参与者都认为进行 COVID-19 自我检测很容易；98.8%的参与者认为自我检测结果的解释很容易。综上所述，这些初步观察结果首次表明 COVID-19 自我检测在血清 IgG 和 IgM 免疫状态方面具有很高的实用性和满意度，表明其有可能被公众用于在 COVID-19 疫情的紧急情况下补充现有的 SARS-CoV-2 血清学检测方法。
