Clinical Laboratory Microbiology Department, Hospital Israelita Albert Einstein, São Paulo, São Paulo, Brazil.
Becton and Dickinson Company, BD Life Sciences - Integrated Diagnostic Solutions, São Paulo, São Paulo, Brazil.
Microbiol Spectr. 2022 Oct 26;10(5):e0019022. doi: 10.1128/spectrum.00190-22. Epub 2022 Aug 29.
This study evaluated the BD Veritor system for rapid detection of SARS-CoV-2, an immunochromatographic point-of-care test, by comparing it with a standard reverse transcription-PCR (RT-PCR) methodology using samples from symptomatic patients. Samples from 146 symptomatic and 2 asymptomatic patients between the 1st and the 40th day of infection were evaluated. The nasopharyngeal and/or oropharyngeal swabs were inserted in a tube containing 0.9% saline solution and stored at refrigerator temperature until the moment of use. The samples were first tested with the Xpert Xpress SARS-CoV-2 (GeneXpert) kit (RT-PCR method), and the cycle thresholds (s) for the E and N2 genes encoding the SARS-CoV-2 envelope and nucleoprotein, respectively, were established. Subsequently, the same samples were tested using the Veritor rapid test. We analyzed the s of the N2 gene, which is detected in both methodologies, and observed sensitivities of 100%, 98.8%, 89.6%, and 82.7% for the s of <25, <27, and <30 and all the s, respectively. The greatest sensitivity was observed when we performed the test on patients within 5 days of symptom onset. The BD Veritor system's workflow is simple and fast, taking approximately 16 min from sample preparation to obtaining the test result. In addition to its satisfactory sensitivity, with results that correlate with those of the RT-PCR, the BD Veritor analyzer instrument reduces the subjectivity of unaided visual readings and consequent potential variation in result interpretation. Therefore, our results showed that the BD Veritor diagnostic test can provide a rapid and accurate diagnosis for SARS-CoV-2. This study provides important and useful information, especially for diagnostic laboratories, since the results show that the BD Veritor system can provide a fast and safe point-of-care antigen diagnostic test for rapid detection of COVID-19 that has high sensitivity, reproducibility, and accuracy.
本研究评估了 BD Veritor 系统（一种免疫层析即时检测技术）对 SARS-CoV-2 的快速检测能力，将其与使用症状患者样本的标准逆转录实时聚合酶链反应（RT-PCR）方法进行比较。评估了 146 例症状患者和 2 例无症状患者第 1 天至第 40 天的样本。将鼻咽和/或口咽拭子插入含 0.9%生理盐水的管中，在冰箱温度下储存直至使用时。首先使用 Xpert Xpress SARS-CoV-2（GeneXpert）试剂盒（RT-PCR 方法）对样本进行检测，并确定分别编码 SARS-CoV-2 包膜和核衣壳的 E 和 N2 基因的循环阈值（Ct）。随后，使用 Veritor 快速检测对相同的样本进行检测。我们分析了两种方法均检测到的 N2 基因的 Ct 值，并观察到 Ct 值<25、<27 和<30 以及所有 Ct 值的灵敏度分别为 100%、98.8%、89.6%和 82.7%。在症状出现后 5 天内进行检测时，灵敏度最高。BD Veritor 系统的工作流程简单快速，从样本制备到获得检测结果大约需要 16 分钟。除了具有令人满意的灵敏度外，BD Veritor 分析仪的结果与 RT-PCR 相关，还减少了未经辅助的视觉读数的主观性以及由此导致的结果解释的潜在差异。因此，我们的结果表明，BD Veritor 诊断检测可快速准确地诊断 SARS-CoV-2。本研究提供了重要且有用的信息，特别是对于诊断实验室而言，因为结果表明 BD Veritor 系统可以提供一种快速、安全的即时 COVID-19 抗原诊断检测方法，具有高灵敏度、重现性和准确性。
