Analytical performance evaluation of the biofire SPOTFIRE respiratory and sore throat panel.

The new SPOTFIRE Respiratory/Sore Throat (R/ST) Panel, approved as a Point of Care Test (POCT), enables the detection of 15 respiratory pathogens from nasopharyngeal swabs (NPS) or throat swabs (TS) within 17 min. This study aimed to verify the performance of the assay. A total of 28 NPS specimens (23 positive for 1 or 2 targets; 5 negative) and 37 TS (20 culture positive for Streptococcus pyogenes or Streptococcus dysgalactiae; 17 culture negative) were analyzed. Results were compared to the BioFire respiratory panel 2.1 (RP2.1) for NPS and S. pyogenes and S. dysgalactiae culture for TS. Contrived TS were created to assess the detection of influenza A/B and SARS-CoV-2, as well as the limit of detection (LoD) of the Streptococcus targets. For NPS, the SPOTFIRE R menu demonstrated 100 % positive percent agreement (PPA) with reference results for all targets included, and 92-100 % negative percent agreement (NPA). The PPA and NPA for the detection of S. pyogenes and S. dysgalactiae from TS and culture were 100 %. All TS replicates at concentrations around the LoD for S. pyogenes and S. dysgalactiae yielded positive results. Data from this study suggest that influenza A/B, RSV and SARS-CoV-2 are effectively detected from TS by the SPOTFIRE. In conclusion, the SPOTFIRE R/ST Panel demonstrated high agreement with the reference methods for the detection of viral and bacterial targets from NPS and the detection of S. pyogenes and S. dysgalactiae from TS Additionally, prospective studies will be required to establish the clinical impact of ultra-rapid POCT.