SARS-CoV-2抗原检测诊断急性SARS-CoV-2感染的关键文献综述及汇总分析

IF 2 4区 医学 Q4 BIOCHEMISTRY & MOLECULAR BIOLOGY
Giuseppe Lippi, Riccardo Nocini, Henry M Brandon
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引用次数: 5

摘要

背景:本研究旨在回顾和荟萃分析目前发表的关于Ortho VITROS SARS-CoV-2抗原检测诊断急性SARS-CoV-2感染的诊断准确性的数据。方法:在Scopus和Medline中以关键词“VITROS”、“antigen”和“COVID-19”或“SARS-CoV-2”和“immunoassay”在检索字段“TITLE”、“ABSTRACT”和“keywords”中进行电子检索,无日期(即截至2022年1月23日)或语言限制,旨在检测报道该SARSCoV-2免疫测定与参考分子诊断方法相比诊断准确性的文献。结果:总的来说,5项研究(n=2734份样本)最终被纳入我们的汇总分析,其中4项研究在高病毒载量的口腔和鼻咽样本中也提供了诊断敏感性。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),曲线下面积为0.995 (95%CI, 0.993-0.997),累积一致性为97.2% (95%CI, 965 -97.8%), kappa统计量为0.89 (95%CI, 0.86-0.91),与参考分子生物学技术几乎完全一致。高病毒载量样本的合并诊断敏感性高达0.98 (95%CI, 0.96-0.99)。结论:本研究结果证实,自动高通量体外SARS-CoV-2抗原检测可能是诊断急性SARS-CoV-2感染的有价值的分子检测替代方法,特别是在高病毒载量的受试者中。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Critical literature review and pooled analysis of diagnostic accuracy of Ortho VITROS SARS-CoV-2 antigen test for diagnosing acute SARS-CoV-2 infections.

Critical literature review and pooled analysis of diagnostic accuracy of Ortho VITROS SARS-CoV-2 antigen test for diagnosing acute SARS-CoV-2 infections.

Critical literature review and pooled analysis of diagnostic accuracy of Ortho VITROS SARS-CoV-2 antigen test for diagnosing acute SARS-CoV-2 infections.

Background: 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.

Methods: 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.

Results: 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).

Conclusions: 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.

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来源期刊
Journal of Medical Biochemistry
Journal of Medical Biochemistry BIOCHEMISTRY & MOLECULAR BIOLOGY-
CiteScore
3.00
自引率
12.00%
发文量
60
审稿时长
>12 weeks
期刊介绍: The JOURNAL OF MEDICAL BIOCHEMISTRY (J MED BIOCHEM) is the official journal of the Society of Medical Biochemists of Serbia with international peer-review. Papers are independently reviewed by at least two reviewers selected by the Editors as Blind Peer Reviews. The Journal of Medical Biochemistry is published quarterly. The Journal publishes original scientific and specialized articles on all aspects of clinical and medical biochemistry, molecular medicine, clinical hematology and coagulation, clinical immunology and autoimmunity, clinical microbiology, virology, clinical genomics and molecular biology, genetic epidemiology, drug measurement, evaluation of diagnostic markers, new reagents and laboratory equipment, reference materials and methods, reference values, laboratory organization, automation, quality control, clinical metrology, all related scientific disciplines where chemistry, biochemistry, molecular biology and immunochemistry deal with the study of normal and pathologic processes in human beings.
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