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

IF 1 Q4 MEDICINE, RESEARCH & EXPERIMENTAL African Journal of Laboratory Medicine Pub Date : 2024-08-20 eCollection Date: 2024-01-01 DOI:10.4102/ajlm.v13i1.2415
Clinton van der Westhuizen, Mae Newton-Foot, Pieter Nel
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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 plus 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.

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南非一家学术医院呼吸道病毒三种商用多重分子检测板的性能比较。
背景:呼吸道感染是导致入院的主要原因。通过传统的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极具吸引力的替代方法,它力求快速、准确、简便:本研究旨在比较三种商用呼吸道病毒多重分子检测方法的临床性能:研究对象为南非西开普省泰格贝格医院的 48 份患者呼吸道标本。这些标本是在 2020 年 5 月至 2020 年 8 月期间采集的。根据重叠目标对 Seegene Anyplex™ II RV16、FilmArray® Respiratory 2.1 plus Panel (FARP) 和 QIAstat-Dx® Respiratory SARS-CoV-2 Panel (QRP) 的结果进行了分析。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分别有41.7%(5/12)和28.6%(4/14)的阳性标本未能检测出冠状病毒和副流感病毒,而FARP对鼻病毒/肠病毒的目标特异性最低,仅为88.4%(38/43):结论:三种平台的总体特异性相当,但 QRP 的灵敏度低于 ARV 和 FARP:本研究的意义:本研究丰富了呼吸道多重检测平台的性能特征,尤其是在传染病分子诊断技术日益发展的非洲地区。
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来源期刊
African Journal of Laboratory Medicine
African Journal of Laboratory Medicine MEDICINE, RESEARCH & EXPERIMENTAL-
CiteScore
1.70
自引率
9.10%
发文量
53
审稿时长
12 weeks
期刊介绍: The African Journal of Laboratory Medicine, the official journal of ASLM, focuses on the role of the laboratory and its professionals in the clinical and public healthcare sectors,and is specifically based on an African frame of reference. Emphasis is on all aspects that promote and contribute to the laboratory medicine practices of Africa. This includes, amongst others: laboratories, biomedical scientists and clinicians, medical community, public health officials and policy makers, laboratory systems and policies (translation of laboratory knowledge, practices and technologies in clinical care), interfaces of laboratory with medical science, laboratory-based epidemiology, laboratory investigations, evidence-based effectiveness in real world (actual) settings.
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