热带草原HSV 1+2/VZV检测的临床性能和可重复性验证。

IF 3.4 3区 医学 Q1 PATHOLOGY
Matthew L Faron, Jane M Caldwell, Lavannya Sabharwal, Amorina Purpora, Jennifer Meece, Puspa Bhattarai, Julie O'Neill, Melody Christian, Neelam X Dhiman, Jennifer Halliday, Jessica S Hoff, Carrie V Vause, Paul A Granato
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引用次数: 0

摘要

单纯疱疹病毒1型(HSV-1)、单纯疱疹病毒2型(HSV-2)和水痘-带状疱疹病毒(VZV)感染引起难以描述的皮肤和粘膜病变,需要快速鉴别识别,以确保适当的诊断和患者咨询。可在中心实验室之外使用的对这些病原体的多重分子分析可能比现有方法提供更快的结果,但它们需要临床验证。本多中心研究比较了Savanna HSV 1+2/VZV检测与Lyra Direct HSV 1+2/VZV实时PCR核酸检测(NAAT)在临床标本中检测HSV-1、HSV-2和VZV的临床表现。Savanna HSV 1+2/VZV检测是一种自动化的、中等复杂程度的实时PCR检测方法,最近被美国食品和药物管理局批准,用于同时检测和分化从病变拭子中分离的HSV-1、HSV-2和VZV DNA。本研究共收集744例临床标本,其中女性531例,男性213例,并与Lyra进行比较。采用美国食品药品监督管理局批准的中等复杂度Solana HSV 1+2/VZV等温核酸检测进行差异结果分析。在744份临床样本中,Savanna对HSV-1的总体、阳性和阴性百分比的一致性分别为99.5%、100%和99.3%;2型单纯疱疹病毒感染率分别为99.9%、100%和99.8%;VZV是100%,100%,100%Savanna HSV 1+2/VZV检测在多中心临床研究中表现优异。Savanna可以在中心实验室之外提供与实验室相当的结果,并有可能在患者就诊期间提供准确的结果。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Validation of the Clinical Performance and Reproducibility of the Savanna HSV 1+2/VZV Assay.

Herpes simplex virus 1 (HSV-1), HSV 2 (HSV-2), and varicella-zoster virus (VZV) cause nondescript cutaneous and mucocutaneous lesions requiring rapid, differential identification for appropriate diagnosis and patient counseling. Decentralized multiplex molecular assays may provide more rapid results than existing methodologies but require clinical validation. This multicenter study evaluated the clinical performance of the Savanna HSV 1+2/VZV Assay against the high-complexity Lyra Direct HSV 1+2/VZV real-time PCR nucleic acid test for the detection of HSV-1, HSV-2, and VZV from clinical specimens. The Savanna HSV 1+2/VZV Assay is an automated, moderate-complexity, real-time PCR assay recently cleared by the US Food and Drug Administration for the simultaneous detection and differentiation of HSV-1, HSV-2, and VZV DNA isolated from lesion swabs. In this study, 744 clinical specimens (531 female, 213 male) were evaluated by Savanna and compared with Lyra. Discrepant result analysis was conducted with the moderate-complexity Solana HSV 1+2/VZV isothermal nucleic acid test. For 744 clinical samples, Savanna exhibited overall, positive, and negative percent agreement of 99.5%, 100%, and 99.3% for HSV-1; 99.9%, 100%, and 99.8% for HSV-2; and 100%, 100%, and 100% for VZV. The Savanna HSV 1+2/VZV Assay exhibited excellent performance in a multicenter, clinical study. Savanna can provide laboratory-equivalent results outside of the central laboratory with the potential to deliver accurate results during the patient visit.

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来源期刊
CiteScore
8.10
自引率
2.40%
发文量
143
审稿时长
43 days
期刊介绍: The Journal of Molecular Diagnostics, the official publication of the Association for Molecular Pathology (AMP), co-owned by the American Society for Investigative Pathology (ASIP), seeks to publish high quality original papers on scientific advances in the translation and validation of molecular discoveries in medicine into the clinical diagnostic setting, and the description and application of technological advances in the field of molecular diagnostic medicine. The editors welcome for review articles that contain: novel discoveries or clinicopathologic correlations including studies in oncology, infectious diseases, inherited diseases, predisposition to disease, clinical informatics, or the description of polymorphisms linked to disease states or normal variations; the application of diagnostic methodologies in clinical trials; or the development of new or improved molecular methods which may be applied to diagnosis or monitoring of disease or disease predisposition.
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