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分析鉴定一种旨在检测和识别多种播散性病毒感染因子的检测方法。

Analytical characterization of an assay designed to detect and identify diverse agents of disseminated viral infection.

机构信息

Ibis Biosciences, a Division of Abbott, 2251 Faraday Ave, Ste 150, Carlsbad, CA 92008, United States.

Ibis Biosciences, a Division of Abbott, 2251 Faraday Ave, Ste 150, Carlsbad, CA 92008, United States.

出版信息

J Clin Virol. 2014 Mar;59(3):177-83. doi: 10.1016/j.jcv.2013.12.005. Epub 2013 Dec 29.

DOI:10.1016/j.jcv.2013.12.005
PMID:24440177
Abstract

BACKGROUND

Diverse viruses often reactivate in or infect cancer patients, patients with immunocompromising infections or genetic conditions, and transplant recipients undergoing immunosuppressive therapy. These infections can disseminate, leading to death, transplant rejection, and other severe outcomes.

OBJECTIVES

To develop and characterize an assay capable of inclusive and accurate identification of diverse potentially disseminating viruses directly from plasma specimens.

STUDY DESIGN

We developed a PCR/electrospray ionization mass spectrometry (PCR/ESI-MS) assay designed to simultaneously detect and identify adenovirus, enterovirus, polyomaviruses JC and BK, parvovirus B19, HSV-1, HSV-2, VZV, EBV, CMV, and herpesviruses 6-8 in plasma specimens. The assay performance was characterized analytically, and the results from clinical plasma samples were compared to the results obtained from single-analyte real time PCR tests currently used in clinical practice.

RESULTS

The assay demonstrated sensitivity and specificity to diverse strains of the targeted viral families and robustness to interfering substances and potentially cross reacting organisms. The assay yielded 94% sensitivity when testing clinical plasma samples previously identified as positive using standard-of-care real-time PCR tests for a single target virus (available samples included positive samples for 11 viruses targeted by the assay).

CONCLUSIONS

The assay functioned as designed, providing simultaneous broad-spectrum detection and identification of diverse agents of disseminated viral infection. Among 156 clinical samples tested, 37 detections were made in addition to the detections matching the initial clinical positive results.

摘要

背景

多种病毒常在癌症患者、免疫功能低下或有遗传条件的感染者、接受免疫抑制治疗的移植受者中重新激活或感染。这些感染可能会扩散,导致死亡、移植排斥和其他严重后果。

目的

开发并描述一种能够直接从血浆样本中全面、准确识别多种潜在传播病毒的方法。

研究设计

我们开发了一种 PCR/电喷雾电离质谱(PCR/ESI-MS)检测方法,旨在同时检测和识别血浆样本中的腺病毒、肠道病毒、JC 和 BK 多瘤病毒、细小病毒 B19、单纯疱疹病毒 1 型、单纯疱疹病毒 2 型、水痘带状疱疹病毒、EB 病毒、巨细胞病毒和疱疹病毒 6-8。该方法的性能进行了分析,并将临床血浆样本的结果与目前临床实践中使用的单分析物实时 PCR 检测结果进行了比较。

结果

该检测方法对靶向病毒家族的多种毒株具有敏感性和特异性,对干扰物质和潜在交叉反应的生物体具有稳健性。当检测使用标准护理实时 PCR 检测单一靶病毒(可获得的样本包括该检测方法针对的 11 种病毒的阳性样本)先前确定为阳性的临床血浆样本时,该检测方法的敏感性为 94%。

结论

该检测方法按预期运行,可同时广泛检测和识别多种播散性病毒感染的病原体。在 156 个临床样本中,除了与初始临床阳性结果相匹配的检测结果外,还检测到了 37 个结果。

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