Ann Lab Med.  2017 May;37(3):267-271. 10.3343/alm.2017.37.3.267.

Comparison of Luminex NxTAG Respiratory Pathogen Panel and xTAG Respiratory Viral Panel FAST Version 2 for the Detection of Respiratory Viruses

• Lee CK
• Lee HK
• Ng CW
• Chiu L
• Tang JW
• Loh TP
• Koay ES

• KMID: 2369753
• DOI: http://doi.org/10.3343/alm.2017.37.3.267

Abstract

Owing to advancements in molecular diagnostics, recent years have seen an increasing number of laboratories adopting respiratory viral panels to detect respiratory pathogens. In December 2015, the NxTAG respiratory pathogen panel (NxTAG RPP) was approved by the United States Food and Drug Administration. We compared the clinical performance of this new assay with that of the xTAG respiratory viral panel (xTAG RVP) FAST v2 using 142 clinical samples and 12 external quality assessment samples. Discordant results were resolved by using a laboratory-developed respiratory viral panel. The NxTAG RPP achieved 100% concordant negative results and 86.6% concordant positive results. It detected one coronavirus 229E and eight influenza A/H3N2 viruses that were missed by the xTAG RVP FAST v2. On the other hand, the NxTAG RPP missed one enterovirus/rhinovirus and one metapneumovirus that were detected by FAST v2. Both panels correctly identified all the pathogens in the 12 external quality assessment samples. Overall, the NxTAG RPP demonstrated good diagnostic performance. Of note, it was better able to subtype the influenza A/H3N2 viruses compared with the xTAG RVP FAST v2.

Keyword

Respiratory tract infections; Respiratory viral panel; Evaluation; Molecular diagnostics

MeSH Terms

Coronavirus
Hand
Influenza, Human
Metapneumovirus
Pathology, Molecular
Respiratory Tract Infections
United States Food and Drug Administration

Figure

• 

  Fig. 1 High background noise observed with the Luminex bead hybridization technology in a run. (A) Sample A initially tested positive for coronavirus HKU1 with the xTAG respiratory viral panel (RVP) FAST v2 (top left). Of note, the internal control signal intensity was higher than that in previous runs. After repeating the bead hybridization step, sample A was negative for all viral targets (false-positive) and the internal control signal intensity was within the expected range (bottom left). (B) Sample B initially tested positive for seasonal influenza A/H1N1 virus, influenza A/H1N1/2009 virus, and enterovirus/rhinovirus (top right). Again, the internal control signal intensity was higher than that in previous runs. After repeating the bead hybridization step, seasonal influenza A/H1N1 virus signal was found to be negative (false-positive), and the internal control signal intensity was within the expected range (bottom right). Subsequent investigation revealed that the high background is likely due to operator variations.Abbreviations: Corona, coronavirus; RSV, respiratory syncytial virus; Para, parainfluenza virus; MFI, median fluorescence intensity.

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