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南非一家学术医院中三种商用呼吸道病毒多重分子检测试剂盒的性能比较

Performance comparison of three commercial multiplex molecular panels for respiratory viruses at a South African academic hospital.

作者信息

van der Westhuizen Clinton, Newton-Foot Mae, Nel Pieter

机构信息

Division of Medical Microbiology, Department of Pathology, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.

Department of Medical Microbiology, Tygerberg Hospital, National Health Laboratory Service, Cape Town, South Africa.

出版信息

Afr J Lab Med. 2024 Aug 20;13(1):2415. doi: 10.4102/ajlm.v13i1.2415. eCollection 2024.

Abstract

BACKGROUND

Respiratory infections are a major contributor to hospital admissions. Identification of respiratory pathogens by means of conventional culture and serology methods remains challenging. Multiplex molecular assays are an appealing alternative that endeavours to be rapid, more accurate and less arduous.

OBJECTIVE

The study aimed to compare the clinical performance of three commercial multiplex molecular assays for respiratory viruses.

METHODS

Forty-eight respiratory specimens obtained from patients at Tygerberg Hospital in the Western Cape province of South Africa were studied. These specimens were collected between May 2020 and August 2020. The results of the Seegene Anyplex™ II RV16, FilmArray Respiratory 2.1 Panel (FARP), and QIAstat-Dx Respiratory SARS-CoV-2 Panel (QRP) were analysed based on the overlapping targets. A composite reference standard was applied to provide a standard reference for comparison.

RESULTS

The overall sensitivity of the Seegene Anyplex™ II RV16 was 96.6% (57/59), the FARP 98.2% (56/57) and the QRP 80.7% (46/57). The overall specificities were 99.8% (660/661), 99.0% (704/711) and 99.7% (709/711), respectively. The QRP failed to detect coronaviruses and parainfluenza viruses in 41.7% (5/12) and 28.6% (4/14) of positive specimens, respectively, while the FARP produced the lowest target specificity of 88.4% (38/43) for rhinovirus/enterovirus.

CONCLUSION

The overall specificity of all three platforms was comparable; however, the sensitivity of the QRP was inferior to that of the ARV and FARP.

WHAT THIS STUDY ADDS

This study adds to the body of performance characteristics described for respiratory multiplex panels, especially in the African context where molecular diagnostics for infectious diseases are gaining momentum.

摘要

背景

呼吸道感染是导致住院的主要原因。通过传统培养和血清学方法鉴定呼吸道病原体仍然具有挑战性。多重分子检测是一种有吸引力的替代方法,力求快速、更准确且不那么费力。

目的

本研究旨在比较三种用于呼吸道病毒的商用多重分子检测的临床性能。

方法

对从南非西开普省泰格伯格医院患者身上获取的48份呼吸道标本进行了研究。这些标本于2020年5月至2020年8月期间采集。基于重叠靶点分析了Seegene Anyplex™ II RV16、FilmArray Respiratory 2.1 Panel(FARP)和QIAstat-Dx Respiratory SARS-CoV-2 Panel(QRP)的结果。应用复合参考标准作为比较的标准参考。

结果

Seegene Anyplex™ II RV16的总体灵敏度为96.6%(57/59),FARP为98.2%(56/57),QRP为80.7%(46/57)。总体特异性分别为99.8%(660/661)、99.0%(704/711)和99.7%(709/711)。QRP分别在41.7%(5/12)的阳性标本中未能检测到冠状病毒,在28.6%(4/14)的阳性标本中未能检测到副流感病毒,而FARP对鼻病毒/肠道病毒的最低靶点特异性为88.4%(38/43)。

结论

所有三个平台的总体特异性相当;然而,QRP的灵敏度低于ARV和FARP。

本研究的新增内容

本研究增加了对呼吸道多重检测板性能特征的描述,特别是在非洲背景下,传染病分子诊断正在兴起。

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