Evaluation of the PowerChek™ Respiratory Virus Panel 1/2/3/4 for the Detection of 16 Respiratory Viruses: A Comparative Study with the Allplex™ Respiratory Panel Assay 1/2/3 and BioFire® Respiratory Panel 2.1 plus

초록

Background/Objectives: Acute respiratory infections remain a major global public health concern affecting individuals across all ages. Accurate and rapid diagnosis of respiratory pathogens is crucial for effective patient management and infection control. Multiplex real-time polymerase chain reaction (PCR) assays have gained prominence over conventional methods for routine viral detection in clinical laboratories owing to their enhanced sensitivity and specificity; however, comparative performance data for PowerChek (TM) RVP remain limited. This study aimed to evaluate the diagnostic performance of the PowerChek (TM) Respiratory Virus Panel 1/2/3/4, which detects 16 respiratory viruses, including SARS-CoV-2, in nasopharyngeal swab (NPS) specimens. Methods: Overall, 336 NPS specimens were analyzed using the PowerChek (TM) RVP, BioFire (R) RP 2.1plus, and Allplex (TM) RP assays, with nucleic acid extraction performed using the Advansure (TM) E3 system. The performance metrics were calculated using two-by-two contingency tables. Results: Among 336 NPS specimens (232 positive, 104 negative), PowerChek (TM) RVP detected 226 positives with minimal discrepancies, showing high concordance with BioFire (R) RP 2.1plus (accuracy 94.6%, kappa 0.843-1.000). Fifteen discordant cases were identified in this study. Eleven could not be sequenced because of amplification failure and most had high Ct values (>30). Sequencing of four samples confirmed concordance with BioFire (R) RP 2.1plus and PowerChek (TM) RVP, whereas Allplex (TM) RP showed false-negative results. Conclusions: The PowerChek (TM) RVP assay demonstrated a high level of relative sensitivity, specificity, accuracy, diagnostic predictive values and strong concordance with comparable reference assays in identifying its targets. This assay is a reliable and efficient diagnostic tool for clinical laboratories to facilitate the accurate identification of respiratory pathogens.

키워드