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Clinical Evaluation of the BIOFIRE SPOTFIRE Respiratory Panel
Wai-Sing Chan1, Christy Wing-Yiu Ho1, Tsz-Ching Chan1
1Department of Pathology, Hong Kong Sanatorium & Hospital, Hong Kong SAR, China.
Abstract:
The BIOFIRE SPOTFIRE Respiratory (R) Panel is a novel, in vitro diagnostic PCR assay with 15 pathogen targets. The runtime is about 15 min which is the shortest among similar panels in the market. We evaluated the performance of the SPOTFIRE R Panel with 151 specimens, including 133 collected from the upper respiratory tract (URT), 13 from the lower respiratory tract (LRT) and 5 external quality assessment program (EQAP) samples. The respiratory specimens were enrolled throughout the first two post-COVID-19 influenza seasons in Hong Kong (March to December 2023). For URT specimens, full concordance was observed between the SPOTFIRE R Panel and the standard-of-care FilmArray Respiratory 2.1 plus Panel (RP2.1plus) for 109 specimens (109/133, 81.95%). After discrepant analysis, the SPOTFIRE R Panel identified more pathogens than the RP2.1plus in 15 specimens and vice versa in 3 specimens. The per-target negative and positive percentage agreement (NPA and PPA) were 92.86-100% except the PPA of adenovirus (88.24%). For LRT and EQAP samples, all results were fully concordant. To conclude, the performance of the SPOTFIRE R Panel was comparable to the RP2.1plus.
Insights
The novel BIOFIRE SPOTFIRE Respiratory (R) Panel offers rapid, 15-minute multiplex PCR testing for 15 respiratory pathogens. Its performance is comparable to existing panels, making it a promising tool for respiratory illness diagnosis.
Area of Science:
- Clinical Microbiology
- Infectious Diseases
- Molecular Diagnostics
Background:
- The BIOFIRE SPOTFIRE Respiratory (R) Panel is a new in vitro diagnostic assay.
- It targets 15 common respiratory pathogens using PCR technology.
- The panel boasts a rapid 15-minute runtime, significantly faster than existing market options.
Purpose of the Study:
- To evaluate the clinical performance of the BIOFIRE SPOTFIRE Respiratory (R) Panel.
- To compare its accuracy against the established FilmArray Respiratory 2.1 plus (RP2.1plus) Panel.
- To assess its utility during recent post-COVID-19 influenza seasons.
Main Methods:
- Performance evaluation using 151 respiratory specimens (133 upper respiratory tract, 13 lower respiratory tract) and 5 external quality assessment program samples.
- Comparison with the FilmArray Respiratory 2.1 plus (RP2.1plus) Panel as the standard of care.
- Discrepant analysis was performed for differing results.
Main Results:
- Full concordance was observed for 109 of 133 upper respiratory tract specimens (81.95%) when compared to the RP2.1plus.
- The SPOTFIRE R Panel identified additional pathogens in 15 specimens, while the RP2.1plus identified more in 3.
- Per-target negative and positive percentage agreement ranged from 92.86-100%, with adenovirus PPA at 88.24%. All lower respiratory tract and EQAP samples showed full concordance.
Conclusions:
- The BIOFIRE SPOTFIRE Respiratory (R) Panel demonstrates performance comparable to the FilmArray Respiratory 2.1 plus (RP2.1plus) Panel.
- Its rapid turnaround time offers a significant advantage in clinical settings.
- The panel is a reliable tool for the detection of multiple respiratory pathogens.
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