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即时分子检测法以唾液为标本检测呼吸道病毒的诊断准确性研究。

Saliva as a diagnostic specimen for testing respiratory virus by a point-of-care molecular assay: a diagnostic validity study.

机构信息

Department of Microbiology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pokfulam, Hong Kong, China; Department of Microbiology, Queen Mary Hospital, Pokfulam, Hong Kong, China; State Key Laboratory for Emerging Infectious Diseases, The University of Hong Kong, Pokfulam, Hong Kong, China; Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong, China; Department of Clinical Microbiology and Infection Control, The University of Hong Kong-Shenzhen Hospital, Shenzhen, China.

Department of Microbiology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pokfulam, Hong Kong, China; Department of Microbiology, Queen Mary Hospital, Pokfulam, Hong Kong, China.

出版信息

Clin Microbiol Infect. 2019 Mar;25(3):372-378. doi: 10.1016/j.cmi.2018.06.009. Epub 2018 Jun 12.

DOI:10.1016/j.cmi.2018.06.009
PMID:29906597
Abstract

OBJECTIVES

Automated point-of-care molecular assays have greatly shortened the turnaround time of respiratory virus testing. One of the major bottlenecks now lies at the specimen collection step, especially in a busy clinical setting. Saliva is a convenient specimen type that can be provided easily by adult patients. This study assessed the diagnostic validity, specimen collection time and cost associated with the use of saliva.

METHODS

This was a prospective diagnostic validity study comparing the detection rate of respiratory viruses between saliva and nasopharyngeal aspirate (NPA) among adult hospitalized patients using Xpert Xpress Flu/RSV. The cost and time associated with the collection of saliva and nasopharyngeal specimens were also estimated.

RESULTS

Between July and October 2017, 214 patients were recruited. The overall agreement between saliva and NPA was 93.3% (196/210, κ 0.851, 95% CI 0.776-0.926). There was no significant difference in the detection rate of respiratory viruses between saliva and NPA (32.9% (69/210) versus 35.7% (75/210); p 0.146). The overall sensitivity and specificity were 90.8% (81.9%-96.2%) and 100% (97.3%-100%), respectively, for saliva, and were 96.1% (88.9%-99.2%) and 98.5% (94.7%-99.8%), respectively, for NPA. The time and cost associated with the collection of saliva were 2.26-fold and 2.59-fold lower, respectively, than those of NPA.

CONCLUSIONS

Saliva specimens have high sensitivity and specificity in the detection of respiratory viruses by an automated multiplex Clinical Laboratory Improvement Amendments-waived point-of-care molecular assay when compared with those of NPA. The use of saliva also reduces the time and cost associated with specimen collection.

摘要

目的

床边即时分子检测极大地缩短了呼吸道病毒检测的周转时间。目前的主要瓶颈之一在于标本采集步骤,尤其是在繁忙的临床环境中。唾液是一种方便的标本类型,成人患者易于提供。本研究评估了使用唾液进行呼吸道病毒检测的诊断准确性、标本采集时间和成本。

方法

这是一项前瞻性诊断准确性研究,比较了使用 Xpert Xpress Flu/RSV 对住院成年患者的呼吸道病毒在唾液和鼻咽抽吸物(NPA)之间的检测率。还估计了收集唾液和鼻咽标本的成本和时间。

结果

2017 年 7 月至 10 月期间,共招募了 214 名患者。唾液与 NPA 之间的总体一致性为 93.3%(196/210,κ 0.851,95%CI 0.776-0.926)。唾液和 NPA 之间呼吸道病毒的检测率无显著差异(32.9%(69/210)与 35.7%(75/210);p 0.146)。唾液的总体敏感性和特异性分别为 90.8%(81.9%-96.2%)和 100%(97.3%-100%),NPA 的分别为 96.1%(88.9%-99.2%)和 98.5%(94.7%-99.8%)。与 NPA 相比,收集唾液的时间和成本分别降低了 2.26 倍和 2.59 倍。

结论

与 NPA 相比,自动化多重临床实验室改进修正案豁免床边即时分子检测中,唾液标本在检测呼吸道病毒方面具有较高的敏感性和特异性。使用唾液还可以减少与标本采集相关的时间和成本。

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