GeneXpert®Xpert®Xpress SARS-CoV-2/Flu/RSV PLUS联合检测的临床评价

IF 1.8 4区生物学 Q4 BIOTECHNOLOGY & APPLIED MICROBIOLOGY

Canadian journal of microbiology Pub Date : 2023-03-01 DOI:10.1139/cjm-2022-0204

Grant Johnson, Branden S J Gregorchuk, Arek Zubrzycki, Kurt Patrick Kolsun, Adrienne F A Meyers, Paul A Sandstrom, Michael Glen Becker

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引用次数: 0

摘要

GeneXpert®Xpert®Xpress SARS-CoV-2/Flu/RSV PLUS联合检测(PLUS检测)于2022年1月获得加拿大卫生部批准。PLUS检测类似于SARS-CoV-2/Flu/RSV联合检测，并进行了修改，以提高检测对循环和新出现变体的稳健性。PLUS测定法的性能特征在Lakeridge健康奥沙瓦医院中心和加拿大国家微生物实验室进行了评估。PLUS检测方法直接与SARS-CoV-2/Flu/RSV联合检测方法进行了比较，使用的是2019年冠状病毒大流行期间收集的5种变体和剩余临床标本中的SARS-CoV-2培养物。其中包括50份所有病原体均阴性的临床样本，110份SARS-CoV-2、甲型流感、乙型流感、RSVA和(或)RSVB阳性的临床样本，以及另外11份用于筛选目标相互作用的混合样本。PLUS试验与广泛使用的SARS-CoV-2/Flu/RSV联合试验的一致性很高。基于这些发现，PLUS检测和Xpert SARS-CoV-2/Flu/RSV联合检测结果在很大程度上是一致的，当受到各种SARS-CoV-2变体的挑战时，在敏感性、特异性或产生结果的时间上没有观察到差异。新的PLUS检测提供的报告周期阈值(Ct)值也没有变化，除了在有限的样本量中RSVA的Ct值可能下降1-2。

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Clinical evaluation of the GeneXpert^® Xpert^® Xpress SARS-CoV-2/Flu/RSV PLUS combination test.

The GeneXpert^® Xpert^® Xpress SARS-CoV-2/Flu/RSV PLUS combination test (PLUS assay) received Health Canada approval in January 2022. The PLUS assay is similar to the SARS-CoV-2/Flu/RSV combination test, with modifications to improve assay robustness against circulating and emerging variants. The performance characteristics of the PLUS assay were assessed at the Lakeridge Health Oshawa Hospital Centre and the National Microbiology Laboratory of Canada. The PLUS assay was directly compared to the SARS-CoV-2/Flu/RSV combination test using SARS-CoV-2 culture from five variants and remnant clinical specimens collected across the coronavirus disease 2019 pandemic. This included 50 clinical specimens negative for all pathogens, 110 clinical specimens positive for SARS-CoV-2, influenza A, influenza B, RSVA, and(or) RSVB and an additional 11 mixed samples to screen for target interactions. The PLUS assay showed a high % agreement with the widely used SARS-CoV-2/Flu/RSV combination test. Based on these findings, the PLUS assay and the Xpert SARS-CoV-2/Flu/RSV combination test results are largely consistent with no observed difference in sensitivity, specificity, or time to result when challenged with various SARS-CoV-2 variants. The reported cycle threshold (Ct) values provided by the new PLUS assay were also unchanged, with the exception of a possible 1-2 decrease reported in Ct for RSVA across a limited sample size.

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来源期刊

Canadian journal of microbiology 生物-免疫学

CiteScore

4.80

自引率

0.00%

发文量

审稿时长

2.5 months

期刊介绍： Published since 1954, the Canadian Journal of Microbiology is a monthly journal that contains new research in the field of microbiology, including applied microbiology and biotechnology; microbial structure and function; fungi and other eucaryotic protists; infection and immunity; microbial ecology; physiology, metabolism and enzymology; and virology, genetics, and molecular biology. It also publishes review articles and notes on an occasional basis, contributed by recognized scientists worldwide.