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基于自动聚合酶链反应/核酸微阵列平台进行肠道病原体检测的前瞻性研究。

Prospective Investigation of an Automated PCR/Nucleic Acid Microarray-Based Platform for Enteric Pathogen Testing.

作者信息

Beckman Amy K, Ferrieri Patricia

机构信息

Department of Laboratory Medicine and Pathology, University of Minnesota Medical School, Minneapolis.

出版信息

Lab Med. 2019 Oct 10;50(4):390-395. doi: 10.1093/labmed/lmz022.

DOI:10.1093/labmed/lmz022
PMID:31065712
Abstract

BACKGROUND

The Verigene Enteric Pathogens Test (Luminex Corporation) is a polymerase chain reaction (PCR)/nucleic acid microarray-based assay targeting 8 bacterial and viral pathogens that cause diarrhea.

OBJECTIVE

To compare traditional enteric culture methods with stool testing by Verigene EP (PCR/microarray).

METHODS

Tests were performed using PCR/microarray between February and August 2016. All specimens also underwent culture for Salmonella and Shigella; specimens that tested positive for bacterial pathogen(s) had confirmatory cultures.

RESULTS

Valid results were obtained for 99.3% of the 3795 stool specimens. Among these, 497 (13.2%) specimens tested positive for at least 1 pathogen by PCR/microarray; 45.5% of these tested positive for 1 or more bacterial pathogens. Agreement between positive bacterial PCR/microarray results and culture-based testing was 85.3%. Compared with cultures, PCR/microarray demonstrated 95.2% and 87.5% sensitivity and 99.8% and 99.8% specificity for Salmonella and Shigella, respectively.

CONCLUSIONS

The Verigene EP generated evaluable results for most stool specimens tested and demonstrated good agreement with bacterial cultures.

摘要

背景

Verigene肠道病原体检测(Luminex公司)是一种基于聚合酶链反应(PCR)/核酸微阵列的检测方法,可检测8种引起腹泻的细菌和病毒病原体。

目的

比较传统肠道培养方法与Verigene EP(PCR/微阵列)粪便检测方法。

方法

在2016年2月至8月期间使用PCR/微阵列进行检测。所有标本均进行沙门氏菌和志贺氏菌培养;检测出细菌病原体呈阳性的标本进行确证培养。

结果

3795份粪便标本中有99.3%获得了有效结果。其中,497份(13.2%)标本通过PCR/微阵列检测至少1种病原体呈阳性;其中45.5%检测出1种或更多种细菌病原体呈阳性。细菌PCR/微阵列阳性结果与基于培养的检测结果之间的一致性为85.3%。与培养方法相比,PCR/微阵列对沙门氏菌和志贺氏菌的敏感性分别为95.2%和87.5%,特异性分别为99.8%和99.8%。

结论

Verigene EP对大多数检测的粪便标本产生了可评估的结果,并与细菌培养结果具有良好的一致性。

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