Clinical Evaluation of the New High-Throughput Luminex NxTAG Respiratory Pathogen Panel Assay for Multiplex Respiratory Pathogen Detection

• Published in: Journal of clinical microbiology Vol. 54; no. 7; pp. 1820 - 1825
• Main Authors: Chen, Jonathan H K, Lam, Ho-Yin, Yip, Cyril C Y, Wong, Sally C Y, Chan, Jasper F W, Ma, Edmond S K, Cheng, Vincent C C, Tang, Bone S F, Yuen, Kwok-Yung
• Format: Journal Article
• Language: English
• Published: United States American Society for Microbiology 01-07-2016
• Subjects: Bacteria - classification; Bacteria - genetics; Bacteria - isolation & purification; Bacterial Infections - diagnosis; Humans; Molecular Diagnostic Techniques - methods; Respiratory Tract Infections - diagnosis; Sensitivity and Specificity; Virology; Virus Diseases - diagnosis; Viruses - classification; Viruses - genetics; Viruses - isolation & purification
• ISSN: 0095-1137; 1098-660X
• DOI: 10.1128/jcm.00517-16

A broad range of viral and bacterial pathogens can cause acute respiratory tract infection. For rapid detection of a broad respiratory pathogen spectrum, multiplex real-time PCR is ideal. This study evaluated the performance of the new Luminex NxTAG Respiratory Pathogen Panel (NxTAG-RPP) in comparison with the BioFire FilmArray Respiratory Panel (FA-RP) or singleplex real-time PCR as reference. A total of 284 clinical respiratory specimens and 3 influenza A/H7N9 viral culture samples were tested. All clinical specimens were processed and analyzed in parallel using NxTAG-RPP and the reference standard method. The H7N9 viral culture samples were tested using NxTAG-RPP only. Overall, the NxTAG-RPP demonstrated ≥93% sensitivity and specificity for all respiratory targets except human coronavirus OC43 (HCoV-OC43) and HCoV-HKU1. The H7N9 virus was detected by the influenza A virus matrix gene target, while other influenza A virus subtyping gene targets in the panel remained negative. Complete concordance between NxTAG-RPP and FA-RP was observed in 98.8% (318/322) of positive results (kappa = 0.92). Substantial agreement was found for most respiratory targets, but significant differences were observed in human metapneumovirus (P = 0.001) and parainfluenza virus type 3 (P = 0.031). NxTAG-RPP has a higher sample throughput than FA-RP (96 samples versus 1 sample per run) while the turnaround times for NxTAG-RPP and FA-RP were 5 h (up to 96 samples) and 1 h (for one sample), respectively. Overall, NxTAG-RPP demonstrated good diagnostic performance for most respiratory pathogens. The high sample throughput with reasonable turnaround time of this new assay makes it a suitable multiplex platform for routine screening of respiratory specimens in hospital-based laboratories.