Department of infectious and tropical diseases, CHR Orléans, Orléans, France.
EDF Nuclear Plant, Saint-Laurent-des-Eaux, France.
PLoS One. 2021 Jan 28;16(1):e0245848. doi: 10.1371/journal.pone.0245848. eCollection 2021.
COVID-19 (COronaVIrus Disease 2019) is an infectious respiratory disease caused by the novel SARS-CoV-2 virus. Point of Care (POC) tests have been developed to detect specific antibodies, IgG and IgM, to SARS-CoV-2 virus in human whole blood. They need to be easily usable by the general population in order to alleviate the lockdown that many countries have initiated in response to the growing COVID-19 pandemic. A real-life study has been conducted in order to evaluate the performance of the COVID-PRESTO® POC test and the results were recently published. Even if this test showed very high sensitivity and specificity in a laboratory setting when used by trained professionals, it needs to be further evaluated for practicability when used by the general public in order to be approved by health authorities for in-home use.
143 participants were recruited between March 2020 and April 2020 among non-medical populations in central France (nuclear plant workers, individuals attending the Orleans University Hospital vaccination clinic and Orleans University Hospital non-medical staff). Instructions for use, with or without a tutorial video, were made available to the volunteers. Two separate objectives were pursued: evaluation of the capability of participants to obtain an interpretable result, and evaluation of the users' ability to read the results.
88.4% of the test users judged the instructions for use leaflet to be clear and understandable. 99.3% of the users obtained a valid result and, according to the supervisors, 92.7% of the tests were properly performed by the users. Overall, 95% of the users gave positive feedback on the COVID PRESTO® as a potential self-test. Neither age nor education had an influence.
COVID-PRESTO® was successfully used by an overwhelming majority of participants and its use was judged very satisfactory, therefore showing promising potential as a self-test to be used by the general population. This POC test can become an easy-to-use tool to help detect whether individuals are protected or not, particularly in the context of a second wave or a mass vaccination program.
COVID-19（COronaVIrus Disease 2019）是一种由新型 SARS-CoV-2 病毒引起的传染性呼吸道疾病。床边即时检测（POC）已被开发用于检测人体全血中针对 SARS-CoV-2 病毒的特定抗体 IgG 和 IgM。为了缓解许多国家因 COVID-19 大流行而启动的封锁，它们需要易于一般人群使用。为了评估 COVID-PRESTO®POC 检测的性能，已经进行了一项真实世界的研究，研究结果最近发表。尽管该检测在实验室环境中由经过培训的专业人员使用时显示出非常高的敏感性和特异性，但在一般人群中使用时需要进一步评估其实用性，以便获得卫生当局批准在家中使用。
2020 年 3 月至 2020 年 4 月期间，在法国中部的非医疗人群中（核电站工作人员、奥尔良大学医院接种诊所的个人和奥尔良大学医院非医疗人员）招募了 143 名参与者。向志愿者提供了使用说明，包括或不包括教程视频。有两个独立的目标：评估参与者获得可解释结果的能力，以及评估用户读取结果的能力。
88.4%的测试使用者认为使用说明单清晰易懂。99.3%的用户获得了有效结果，根据监督员的说法，92.7%的测试由用户正确进行。总体而言，95%的用户对 COVID PRESTO®作为一种潜在的自我检测给予了积极反馈。年龄和教育程度均无影响。
COVID-PRESTO®被绝大多数参与者成功使用，其使用被评为非常满意，因此作为一种潜在的自我检测方法，具有广泛的应用前景，可被一般人群使用。这种 POC 检测可以成为一种易于使用的工具，帮助检测个体是否受到保护，特别是在第二波疫情或大规模疫苗接种计划的背景下。
