Lippi Giuseppe, Nocini Riccardo, Brandon Henry M
University of Verona, Section of Clinical Biochemistry and School of Medicine, Verona, Italy.
University of Verona, Department of Surgery, Dentistry, Paediatrics and Gynaecology, Unit of Otorhinolaryngology, Verona, Italy.
J Med Biochem. 2022 Oct 15;41(4):540-548. doi: 10.5937/jomb0-36107.
The present study is aimed at reviewing and meta-analyzing the currently published data on the diagnostic accuracy of Ortho VITROS SARS-CoV-2 antigen test for diagnosing acute SARS-CoV-2 infections.
An electronic search was conducted in Scopus and Medline with the keywords "VITROS" AND "antigen" AND "COVID-19" OR "SARS-CoV-2" AND "immunoassay" within the search fields "TITLE" AND "ABSTRACT" AND "KEYWORDS", without no date (i.e., up to January 23, 2022) or language restrictions, aimed at detecting documents reporting the diagnostic accuracy of this SARSCoV-2 immunoassay compared with reference molecular diagnostic methods.
Overall, 5 studies (n=2734 samples) were finally included in our pooled analysis, four of which also provided diagnostic sensitivity in oro-and nasopharyngeal samples with high viral load. The pooled cumulative diagnostic sensitivity and specificity were 0.82 (95%CI, 0.78-0.86) and 1.00 (95%CI, 1.00-1.00), respectively, whilst the area under the curve was 0.995 (95%CI, 0.993-0.997), the cumulative agreement 97.2% (95%CI, 96.5-97.8%), with 0.89 (95%CI, 0.86-0.91) kappa statistics, thus reflecting an almost perfect concordance with reference molecular biology techniques. The pooled diagnostic sensitivity in samples with high viral load was as high as 0.98 (95%CI, 0.96-0.99).
These results confirm that the automated and high-throughput Ortho VITROS SARS-CoV-2 antigen test may represent a valuable surrogate of molecular testing for diagnosing acute SARS-CoV-2 infections, especially in subjects with high viral load.
本研究旨在回顾和荟萃分析目前已发表的关于奥森多VITROS新型冠状病毒2抗原检测诊断急性新型冠状病毒2感染的诊断准确性的数据。
在Scopus和Medline数据库中进行电子检索，检索词为“VITROS”、“抗原”、“COVID-19”或“新型冠状病毒2”以及“免疫测定”，检索字段为“标题”、“摘要”和“关键词”，无日期（即截至2022年1月23日）或语言限制，旨在检测报告该新型冠状病毒2免疫测定与参考分子诊断方法相比诊断准确性的文献。
总体而言，5项研究（n = 2734个样本）最终纳入我们的汇总分析，其中4项研究还提供了高病毒载量的口咽和鼻咽样本的诊断敏感性。汇总的累积诊断敏感性和特异性分别为0.82（95%CI，0.78 - 0.86）和1.00（95%CI，1.00 - 1.00），而曲线下面积为0.995（95%CI，0.993 - 0.997），累积一致性为97.2%（95%CI，96.5 - 97.8%），kappa统计量为0.89（95%CI，0.86 - 0.91），因此反映出与参考分子生物学技术几乎完美的一致性。高病毒载量样本中的汇总诊断敏感性高达0.98（95%CI，0.96 - 0.99）。
这些结果证实，自动化且高通量的奥森多VITROS新型冠状病毒2抗原检测可能是诊断急性新型冠状病毒2感染的分子检测有价值的替代方法，尤其是在病毒载量高的受试者中。
