Evaluation of STANDARDTM M10 SARS-CoV-2 assay as a diagnostic tool for SARS-CoV-2 in nasopharyngeal or oropharyngeal swab samples

IF 1.6 Q4 INFECTIOUS DISEASES

Journal of clinical virology plus Pub Date : 2023-02-01 DOI:10.1016/j.jcvp.2022.100129

Maria-Eleni Parakatselaki, Georgia Alexi, Alexandros Zafiropoulos, George Sourvinos

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引用次数: 1

Abstract

The SARS-CoV-2 pandemic led to an urgent need for rapid diagnostic testing in order to inform timely patients’ management. This study aimed to assess the performance of the STANDARD™ M10 SARS-CoV-2 assay as a diagnostic tool for COVID-19. A total of 400 nasopharyngeal or oropharyngeal swabs were tested against a reference real-time RT-PCR, including 200 positive samples spanning the full range of observed Ct values. The sensitivity of the STANDARD™ M10 SARS-CoV-2 assay was 98.00% (95% CI 94.96% to 99.45%, 196/200), while the specificity was also estimated at 97.50% (95% CI 94.26% to 99.18%, 195/200). The assay proved highly efficient for the detection of SARS-CoV-2, even in samples with low viral load (Ct>25), presenting lower Ct values compared to the reference method. We concluded that the STANDARD™ M10 SARS-CoV-2 assay has a similar performance compared to the reference method and other molecular point-of-care assays and can be a valuable tool for rapid and accurate diagnosis.

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STANDARDTM M10严重急性呼吸系统综合征冠状病毒2型检测作为鼻咽或口咽拭子样本中严重急性呼吸系综合征冠状病毒的诊断工具的评估

严重急性呼吸系统综合征冠状病毒2型大流行导致迫切需要快速诊断检测，以便及时为患者管理提供信息。本研究旨在评估STANDARD的性能™ M10 SARS-CoV-2检测作为新冠肺炎的诊断工具。共对400个鼻咽或口咽拭子进行了参考实时RT-PCR检测，其中包括200个涵盖观察到的全部Ct值范围的阳性样本。STANDARD的灵敏度™ M10严重急性呼吸系统综合征冠状病毒2型检测为98.00%（95%CI 94.96%至99.45%，196/200），而特异性也估计为97.50%（95%CI 9426%至99.18%，195/200）。该检测方法被证明对检测严重急性呼吸系统综合征冠状病毒2型非常有效，即使在病毒载量低（Ct＞25）的样本中也是如此，与参考方法相比，Ct值更低。我们得出的结论是™ M10严重急性呼吸系统综合征冠状病毒2型检测与参考方法和其他分子护理点检测相比具有相似的性能，是快速准确诊断的有价值工具。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of clinical virology plus Infectious Diseases

CiteScore

2.20

自引率

0.00%

发文量

审稿时长

66 days