Saliva as a diagnostic specimen for testing respiratory virus by a point-of-care molecular assay: a diagnostic validity study
Saliva as a diagnostic specimen for testing respiratory virus by a point-of-care molecular assay: a diagnostic validity study
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DOI：
10.1016/j.cmi.2018.06.009
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发表时间：
2019-03-01
影响因子：
14.2
通讯作者：
Yuen, K-Y
中科院分区：
文献类型：
--
作者：
To, K. K. W.;Yip, C. C. Y.;Yuen, K-Y
目的：自动化即时分子检测大大缩短了呼吸道病毒检测的周转时间。现在的主要瓶颈之一在于样本收集步骤，特别是在忙碌的临床环境中。唾液是一种方便的样本类型，成年患者可以很容易地提供。本研究评估了与使用唾液相关的诊断有效性、标本采集时间和成本。方法：这是一项前瞻性诊断有效性研究，比较了使用Xpert（R）Xpress Flu/RSV检测成人住院患者唾液和鼻咽抽吸物（NPA）中呼吸道病毒的检出率。结果：在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，kappa 0.851，95%CI 0.776-0.926）。唾液和NPA的呼吸道病毒检出率无显著差异（32.9%（69/210）vs 35.7%（75/210）; p 0.146）。唾液的总敏感性和特异性分别为90.8%（81.9%-96.2%）和100%（97.3%-100%），NPA的总敏感性和特异性分别为96.1%（88.9%-99.2%）和98.5%（94.7%-99.8%）。与唾液的收集相关的时间和成本分别为2.26倍和2.59倍，分别低于NPA。结论：唾液标本具有较高的灵敏度和特异性，在检测呼吸道病毒的自动化多重临床实验室改进修正案豁免点的护理分子检测相比，NPA。唾液的使用还减少了与样本收集相关的时间和成本。(c)2018年欧洲临床微生物学和传染病学会。由爱思唯尔有限公司出版。保留所有权利。
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 (R) 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, kappa 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. (c) 2018 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.