Background Rapid detection of a wide range of etiologic agents is essential for appropriate treatment and control of gastrointestinal (GI) infections. A variety of microbial species including bacteria, viruses, parasites, and fungi have been recognized as diarrheagenic enteric pathogens. However, multiplex testing of various targets in a single reaction needs further improvement because of its limitation in species and throughput. Results This study aims at developing and evaluating a DNA microarray-based qualitative multiplexed polymerase chain reaction (PCR) assay, Vibrant GI pathogen panel (GPP), for simultaneous detection of 27 enteric GI pathogenic targets (16 bacteria, 5 viruses, 4 parasites, and 2 fungi) directly from stool specimens. Limits of detection ranged from 102 to 104 cells/mL for bacteria, 102 to 103 cells/mL for parasites, 102 to 103 RNA copies/mL for viruses, and 102 to 103 cells/mL for fungi. Performance characteristics were determined using 27 Quantitative Genomic DNAs, 212 spiked stool specimens, 1067 clinical and archived stool specimens. Overall sensitivity was 95.9% (95% CI 92.4-98.1) and specificity was 100% (95% CI 99.9-100). Polymicrobial detections contained either two or three organisms was 20.2% (35/173) of positive clinical specimens and 3.3% (35/1055) of all clinical specimens. Conclusion The Vibrant GPP is a comprehensive, high-throughput, and rapid DNA microarray to provide etiologic diagnosis of GI infections in the laboratory setting.

中文翻译：

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评估用于临床样本中肠道病原体高通量多重检测的 Vibrant DNA 微阵列。

背景 快速检测多种病原体对于适当治疗和控制胃肠道 (GI) 感染至关重要。包括细菌、病毒、寄生虫和真菌在内的多种微生物物种已被认为是引起腹泻的肠道病原体。然而，由于物种和通量的限制，单个反应中各种目标的多重测试需要进一步改进。结果 本研究旨在开发和评估基于 DNA 微阵列的定性多重聚合酶链反应 (PCR) 测定法，即充满活力的 GI 病原体面板 (GPP)，用于同时检测 27 种肠道 GI 致病靶标（16 种细菌、5 种病毒、4 种寄生虫、和 2 真菌）直接来自粪便标本。细菌的检测限为 102 至 104 个细胞/mL，寄生虫的检测限为 102 至 103 个细胞/mL，病毒为 102 至 103 个 RNA 拷贝/mL，真菌为 102 至 103 个细胞/mL。使用 27 个定量基因组 DNA、212 个加标粪便样本、1067 个临床和存档粪便样本确定了性能特征。总体敏感性为 95.9% (95% CI 92.4-98.1)，特异性为 100% (95% CI 99.9-100)。含有两种或三种微生物的多微生物检测结果为阳性临床标本的 20.2% (35/173) 和所有临床标本的 3.3% (35/1055)。结论 Vibrant GPP 是一种全面、高通量、快速的 DNA 微阵列，可在实验室环境中提供胃肠道感染的病因诊断。1067 份临床和存档的粪便标本。总体敏感性为 95.9% (95% CI 92.4-98.1)，特异性为 100% (95% CI 99.9-100)。含有两种或三种微生物的多微生物检测结果为阳性临床标本的 20.2% (35/173) 和所有临床标本的 3.3% (35/1055)。结论 Vibrant GPP 是一种全面、高通量、快速的 DNA 微阵列，可在实验室环境中提供胃肠道感染的病因诊断。1067 份临床和存档的粪便标本。总体敏感性为 95.9% (95% CI 92.4-98.1)，特异性为 100% (95% CI 99.9-100)。含有两种或三种微生物的多微生物检测结果为阳性临床标本的 20.2% (35/173) 和所有临床标本的 3.3% (35/1055)。结论 Vibrant GPP 是一种全面、高通量、快速的 DNA 微阵列，可在实验室环境中提供胃肠道感染的病因诊断。