Performance Assessment of a Rapid Molecular Respiratory Syncytial Virus Point-of-Care Test: A Prospective Community Study in Older Adults.

Roy P Zuurbier, Koos Korsten, Theo J M Verheij, Chris Butler, Niels Adriaenssens, Samuel Coenen, Olivier Gruselle, Valerie Vantomme, Marlies A van Houten, Louis J Bont, Joanne G Wildenbeest
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引用次数: 4

Abstract

Background: Respiratory syncytial virus (RSV) causes a substantial burden in older adults. Viral load in RSV-infected adults is generally lower compared to young children, which could result in suboptimal sensitivity of RSV diagnostics. Although the Xpert® Xpress Flu/RSV assay has been used in routine clinical care, its sensitivity to diagnose RSV infection in older adults is largely unknown. We aimed to compare the performance of the Xpert® Xpress Flu/RSV assay with real-time reverse-transcription polymerase chain reaction (RT-PCR) in home-dwelling older adults (≥60 years of age).

Methods: Nasopharyngeal swabs were tested with Xpert® Xpress Flu/RSV and compared to RSV RT-PCR in older adults with acute respiratory tract infections with different levels of disease severity.

Results: We studied 758 respiratory samples from 561 older adults from 2 consecutive RSV seasons. Thirty-five (4.6%) samples tested positive for RSV by at least 1 of the assays, of which 2 samples were negative by Xpert® Xpress Flu/RSV and 3 samples by real-time RT-PCR. The positive percentage agreement (PPA) was 90.9% (95% confidence interval [CI], 76.4%-96.8%) and negative percentage agreement was 99.7% (95% CI, 99.0%-99.9%). Viral loads were low (≤103 copies/mL or cycle threshold value ≥34) in all cases with discordant results for the 2 assays.

Conclusions: The PPA of Xpert® Xpress Flu/RSV compared to routine RT-PCR is high for RSV detection in home-dwelling older adults. The assay is fast and easy to use at the point of care.

Clinical trials registration: NCT03621930.

Abstract Image

Abstract Image

快速分子呼吸道合胞病毒即时检测的性能评估:一项针对老年人的前瞻性社区研究
背景:呼吸道合胞病毒(RSV)对老年人造成重大负担。与幼儿相比,感染RSV的成人的病毒载量通常较低,这可能导致RSV诊断的灵敏度不理想。虽然Xpert®Xpress Flu/RSV检测已用于常规临床护理,但其诊断老年人RSV感染的敏感性在很大程度上尚不清楚。我们的目的是比较Xpert®Xpress流感/RSV检测与实时逆转录聚合酶链反应(RT-PCR)在居家老年人(≥60岁)中的表现。方法:采用Xpert®Xpress Flu/RSV对不同疾病严重程度的老年急性呼吸道感染患者进行鼻咽拭子检测,并与RSV RT-PCR进行比较。结果:我们研究了561名老年人连续2个RSV季节的758份呼吸道样本。35份(4.6%)样本经至少1项检测为RSV阳性,其中2份样本经Xpert®Xpress Flu/RSV检测为阴性,3份样本经实时RT-PCR检测为阴性。阳性一致百分比(PPA)为90.9%(95%置信区间[CI], 76.4% ~ 96.8%),阴性一致百分比为99.7% (95% CI, 99.0% ~ 99.9%)。所有病例的病毒载量都很低(≤103拷贝/mL或周期阈值≥34),两种检测结果不一致。结论:与常规RT-PCR相比,Xpert®Xpress Flu/RSV的PPA在居家老年人RSV检测中较高。该分析快速且易于在护理点使用。临床试验注册:NCT03621930。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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