Assessing the Effectiveness of Fast-Track Diagnostic Kit for Detecting Viral Gastroenteritis Agents.

IF 0.7 4区医学 Q4 MEDICAL LABORATORY TECHNOLOGY Clinical laboratory Pub Date : 2025-01-01 DOI:10.7754/Clin.Lab.2024.240821

Ngan T K Pham, Nozomu Hanaoka, Quang D Trinh, Yuko Shimizu-Onda, Pattara Khamrin, Sheikh A Hoque, Shihoko Komine-Aizawa, Shoko Okitsu, Satoshi Hayakawa, Kazuaki Yoshimune, Hiroshi Ushijima

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Abstract

Background: Viral gastroenteritis is a significant global health concern. An effective, rapid, and easy-to-use diagnostic tool is essential for screening causative viruses.

Methods: Forty-eight samples, known to be infected with one of the following viruses: norovirus, group A rotavirus, astrovirus, adenovirus, and sapovirus determined by reverse transcription-PCR and nucleotide sequencing, were evaluated by the Fast Track Diagnostics (FTD) viral gastroenteritis assay.

Results: The assay demonstrated 100% specificity for all viruses and matched the RT-PCR sensitivity for norovi-rus GI, classic human astrovirus, adenovirus, and sapovirus. It identified norovirus GII and rotavirus with 87.5% and 85.7% sensitivity, respectively. However, its sensitivity for detecting novel human astrovirus MLB and VA was lower, at 35%.

Conclusions: The FTD viral gastroenteritis assay can effectively screen simultaneously for norovirus GI, GII, group A rotavirus, adenovirus, and sapovirus in clinical settings. The study also suggests that improved detection methods are necessary for novel astrovirus strains.

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评估快速诊断试剂盒检测病毒性肠胃炎病原体的效果。

背景：病毒性肠胃炎是全球关注的重大健康问题。一种有效、快速、易用的诊断工具对于筛查致病病毒至关重要：方法：快速诊断（FTD）病毒性肠胃炎检测法对 48 份样本进行了评估，这些样本通过反转录-PCR 和核苷酸测序确定感染了以下病毒之一：诺如病毒、A 组轮状病毒、星状病毒、腺病毒和沙波病毒：结果：该检测方法对所有病毒的特异性均为 100%，对诺如病毒 GI、典型人类星状病毒、腺病毒和沙波病毒的 RT-PCR 敏感性也与之相当。它识别诺如病毒 GII 和轮状病毒的灵敏度分别为 87.5% 和 85.7%。然而，其检测新型人类星状病毒 MLB 和 VA 的灵敏度较低，仅为 35%：结论：FTD 病毒性胃肠炎检测法可在临床环境中同时有效筛查诺如病毒 GI、GII、A 组轮状病毒、腺病毒和沙波病毒。该研究还表明，有必要改进新型星状病毒株的检测方法。

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来源期刊

Clinical laboratory 医学-医学实验技术

CiteScore

1.50

自引率

0.00%

发文量

494

审稿时长

3 months

期刊介绍： Clinical Laboratory is an international fully peer-reviewed journal covering all aspects of laboratory medicine and transfusion medicine. In addition to transfusion medicine topics Clinical Laboratory represents submissions concerning tissue transplantation and hematopoietic, cellular and gene therapies. The journal publishes original articles, review articles, posters, short reports, case studies and letters to the editor dealing with 1) the scientific background, implementation and diagnostic significance of laboratory methods employed in hospitals, blood banks and physicians'' offices and with 2) scientific, administrative and clinical aspects of transfusion medicine and 3) in addition to transfusion medicine topics Clinical Laboratory represents submissions concerning tissue transplantation and hematopoietic, cellular and gene therapies.