Department of Infectious and Tropical Diseases, CHR Orléans, Orléans, France.
Department of Virology, CHR Orleans, Orléans, France.
PLoS One. 2020 Sep 17;15(9):e0237694. doi: 10.1371/journal.pone.0237694. eCollection 2020.
The SARS-CoV-2 (Severe Acute Respiratory Syndrome CoronaVirus 2) is responsible for the infectious respiratory disease called COVID-19 (COronaVIrus Disease 2019). In response to the growing COVID-19 pandemic, point-of-care (POC) tests have been developed to detect specific antibodies, IgG and IgM, to SARS-CoV-2 virus in human whole blood. We conducted a prospective observational study to evaluate the performance of two POC tests, COVID-PRESTO® and COVID-DUO®, compared to the gold standard, RT-PCR (real-time reverse transcriptase polymerase chain reaction).
RT-PCR testing of SARS-Cov-2 was performed from nasopharyngeal swab specimens collected in adult patients visiting the infectious disease department at the hospital (Orléans, France). Capillary whole blood (CWB) samples from the fingertip taken at different time points after onset of the disease were tested with POC tests. The specificity and sensitivity of the rapid test kits compared to test of reference (RT-PCR) were calculated.
Among 381 patients with symptoms of COVID-19 who went to the hospital for a diagnostic, 143 patients were RT-PCR negative. Results of test with POC tests were all negative for these patients, indicating a specificity of 100% for both POC tests. In the RT-PCR positive subgroup (n = 238), 133 patients were tested with COVID-PRESTO® and 129 patients were tested with COVID-DUO® (24 patients tested with both). The further the onset of symptoms was from the date of collection, the greater the sensitivity. The sensitivity of COVID-PRESTO® test ranged from 10.00% for patients having experienced their 1st symptoms from 0 to 5 days ago to 100% in patients where symptoms had occurred more than 15 days before the date of tests. For COVID-DUO® test, the sensitivity ranged from 35.71% [0-5 days] to 100% (> 15 days).
COVID-PRESTO® and DUO® POC tests turned out to be very specific (none false positive) and to be sensitive enough after 15 days from onset of symptom. These easy to use IgG/IgM combined test kits are the first ones allowing a screening with CWB sample, by typing from a finger prick. These rapid tests are particularly interesting for screening in low resource settings.
SARS-CoV-2（严重急性呼吸系统综合征冠状病毒 2）是引起称为 COVID-19（2019 年冠状病毒病）的传染性呼吸道疾病的罪魁祸首。为应对日益严重的 COVID-19 大流行，已经开发了即时护理（POC）检测方法，以检测人全血中针对 SARS-CoV-2 病毒的特异性抗体 IgG 和 IgM。我们进行了一项前瞻性观察性研究，以评估两种 POC 检测方法 COVID-PRESTO®和 COVID-DUO®与金标准 RT-PCR（实时逆转录聚合酶链反应）相比的性能。
对在医院（奥尔良，法国）传染病科就诊的成年患者进行鼻咽拭子标本的 SARS-CoV-2 RT-PCR 检测。在疾病发作后不同时间点从指尖采集毛细血管全血（CWB）样本，并用 POC 检测进行检测。计算快速检测试剂盒与参考检测（RT-PCR）相比的特异性和敏感性。
在因 COVID-19 症状前往医院就诊的 381 名患者中，有 143 名患者 RT-PCR 检测结果为阴性。这些患者的 POC 检测结果均为阴性，表明两种 POC 检测的特异性均为 100%。在 RT-PCR 阳性亚组（n=238）中，有 133 名患者接受了 COVID-PRESTO®检测，有 129 名患者接受了 COVID-DUO®检测（24 名患者同时接受了两种检测）。从标本采集日期起，症状出现的时间越久，检测的敏感性越高。COVID-PRESTO®检测的敏感性范围为 10.00%（第 1 天至第 5 天）至 100%（第 16 天至第 20 天）。对于 COVID-DUO®检测，敏感性范围为 35.71%（第 0 天至第 5 天）至 100%（第 16 天至第 20 天）。
COVID-PRESTO®和 DUO®POC 检测结果特异性非常高（无一例假阳性），在症状出现 15 天后具有足够的敏感性。这些易于使用的 IgG/IgM 联合检测试剂盒是第一款允许使用指尖采血的 CWB 样本进行筛查的试剂盒。这些快速检测方法在资源匮乏的环境中进行筛查时特别有用。
