Clinical Evaluation of the New High-Throughput Luminex NxTAG Respiratory Pathogen Panel Assay for Multiplex Respiratory Pathogen Detection.
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.
Department of Microbiology, Queen Mary Hospital, Hong Kong Special Administrative Region, China.
Jonathan H K
http://orcid.org/0000-0002-7510-1696
JHK
Chen
Department of Pathology, Hong Kong Sanatorium and Hospital, Hong Kong Special Administrative Region, China.
Ho-Yin
HY
Lam
Department of Microbiology, Queen Mary Hospital, Hong Kong Special Administrative Region, China.
Cyril C Y
CCY
Yip
Department of Microbiology, Queen Mary Hospital, Hong Kong Special Administrative Region, China.
Sally C Y
SCY
Wong
Department of Microbiology, Queen Mary Hospital, Hong Kong Special Administrative Region, China.|State Key Laboratory of Emerging Infectious Diseases, The University of Hong Kong, Hong Kong Special Administrative Region, China.|Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region, China.
Jasper F W
JFW
Chan
Department of Pathology, Hong Kong Sanatorium and Hospital, Hong Kong Special Administrative Region, China.
Edmond S K
ESK
Ma
Department of Microbiology, Queen Mary Hospital, Hong Kong Special Administrative Region, China.
Vincent C C
VCC
Cheng
Department of Pathology, Hong Kong Sanatorium and Hospital, Hong Kong Special Administrative Region, China.
Bone S F
BSF
Tang
Department of Microbiology, Queen Mary Hospital, Hong Kong Special Administrative Region, China kyyuen@hku.hk.|State Key Laboratory of Emerging Infectious Diseases, The University of Hong Kong, Hong Kong Special Administrative Region, China.|Carol Yu Centre for Infection, The University of Hong Kong, Hong Kong Special Administrative Region, China.|The Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, Zhejiang University, Hanzhou, China.
Kwok-Yung
KY
Yuen
D001419:Bacteria / Q000145:classification / Q000235:genetics / Q000302:isolation & purification*; D001424:Bacterial Infections / Q000175:diagnosis*; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D012141:Respiratory Tract Infections / Q000175:diagnosis*; D012680:Sensitivity and Specificity; D014777:Virus Diseases / Q000175:diagnosis*; D014780:Viruses / Q000145:classification / Q000235:genetics / Q000302:isolation & purification*