Multicenter Evaluation of the QIAstat-Dx and the BioFire Multiplex Panel Tests for the Detection of Respiratory Pathogens

Abstract

Syndromic multiplex panel testing enables simultaneous detection of multiple respiratory pathogens, but limited data is available on the comparative diagnostic performance of different testing systems. In this multicenter prospective study, we aimed to compare the QIAstat-Dx Respiratory Panel 2.0 (QIAstat-Dx-RP2.0) with the widely used BioFire-RP2.1, using 269 respiratory clinical specimens. Concordant test results were obtained in 232 (86.3%) cases. Discordant test results included 33 BioFire-RP2.1(+)/QIAstat-Dx-RP2.0(-) and 4 BioFire-RP2.1(-)/QIAstat-Dx-RP2.0(+) results. Discordant samples showed significantly lower pathogen loads than concordant ones (p < 0.01). Overall, the QIAstat-Dx-RP2.0 showed an analytical sensitivity of 50%-100% depending on the respiratory target, with an analytical specificity ≥ 99.0%. Most significant differences were found for the detection of adenovirus, human coronaviruses, respiratory syncytial virus, human rhinovirus/enterovirus and SARS-CoV-2 (kappa-score: 0.67-0.91). Co-detections of respiratory pathogens were identified in 47 cases by BioFire-RP2.1 and 29 by QIAstat-Dx-RP2.0. Agreement rates between the two multiplex panel tests decreased from 91.8% for single pathogen detections to 65.0% and 42.9% for co-detecting two and three pathogens, respectively. Pathogen loads were significantly lower in co-detections compared to single pathogen detections (p < 0.01), potentially explaining the lower detection rates with the QIAstat-Dx-RP2.0 in cases of multiple pathogens. In conclusion, our prospective multicenter evaluation showed good diagnostic performance of the QIAstat-Dx-RP2.0 assay, but lower detection rates for some respiratory targets compared to BioFire-RP2.1. As QIAstat-Dx-RP2.0 offers advantages in handling, noise emission, cost effectiveness, and provides semi-quantitative results compared to BioFire-RP2.1 an updated version with enhanced analytical sensitivity would be a viable alternative syndromic testing system for detecting respiratory pathogens.

Keywords: BioFire; QIAstat‐Dx; RSV; SARS‐CoV‐2; adenovirus; influenza; respiratory pathogen; respiratory tract infection; rhinovirus/enterovirus; syndromic multiplex panel testing.

Figure 1

Respiratory pathogen detection by BioFire‐RP2.1 and QIAstat‐Dx‐RP2.0 multiplex panel tests. (A) Detection of respiratory pathogens in 269 respiratory samples from 259 patients using BioFire‐RP2.1 (orange) and QIAstat‐Dx‐RP2.0 (blue) between November 2023 and February 2024. (B) Age distribution of patients who tested positive for the respective respiratory pathogens (median, 25% and 75%). (C) Respiratory pathogen loads in patient samples that tested positive with both the BioFire‐RP2.1 and QIAstat‐Dx‐RP2.0 (yellow), or were detected exclusively in one of the multiplex panel tests (red; median, 25% and 75%). p values of the Mann‐Whitney U‐test, with a single asterisk (*) indicating a significance level of less than 0.05, a double asterisk (**) indicating a significance level of less than 0.01, and a triple asterisk (***) indicating a significance level of less than 0.001. HAdV, adenovirus (HAdV); HBoV, human bocavirus; HCoV, human coronavirus (types ‐229E, ‐HKU1, ‐NL63 and ‐OC43); hMPV, human metapneumovirus A and B; HPIV, human parainfluenzavirus; HRV/HEV, human rhino‐/enterovirus; IV‐A, influenzavirus A; IV‐B, influenzavirus B; M. pneu, Mycoplasma pneumoniae; MERS, Middle East respiratory syndrome coronavirus; RSV, respiratory syncytial virus A and B (RSV); SCoV2/SARS‐CoV‐2, severe respiratory syndrome coronavirus.

Figure 2

Co‐detection of respiratory pathogens by BioFire‐RP2.1 and QIAstat‐Dx‐RP2.0 multiplex panel tests. (A) Number of single detections, and the co‐detection of two or three respiratory pathogens in the same patient sample using BioFire‐RP2.1 (orange) and QIAstat‐Dx‐RP2.0 (blue). Comparison of co‐detection of respiratory pathogens by percent agreement. B. Age distribution of patients who tested positive for a single, two or three respiratory pathogens in the same patient sample (median, 25% and 75%). C. Respiratory pathogen loads in patient samples with a single detection, and the co‐detection of two or three respiratory pathogens (median, 25% and 75%). p values of the Mann‐Whitney U‐test indicate a statistically significant difference when compared to single respiratory pathogen detection. A single asterisk (*) denotes a significance level of less than 0.05, and a double asterisk (**) indicates a significance level of less than 0.01.