Analytical and clinical performance of the Flash10 molecular point-of-care system for detection of influenza A and B viruses.

OBJECTIVES

To evaluate the analytical performance and clinical workflow efficiency of the Flash10 molecular point-of-care testing (POCT) system for the detection of influenza A (FluA) and influenza B (FluB) viruses.

METHODS

Throat swab specimens from 178 individuals presenting with influenza-like symptoms were tested in parallel using the Flash10 system, GeneXpert, and real-time quantitative PCR (RT-PCR). Analytical performance was assessed in terms of precision, limit of detection (LOD), specificity, and contamination risk. Result agreement among platforms was evaluated using correlation analysis, Bland-Altman analysis, and Kappa statistics. Turnaround time (TAT) was retrieved from the laboratory information system to compare clinical workflow efficiency between Flash10 and conventional RT-PCR.

RESULTS

The Flash10 system demonstrated good precision, with intra-batch coefficients of variation (CVs) ranging from 0.79 % to 1.41 % and inter-batch CVs ranging from 2.62 % to 3.05 % at concentrations of 500 and 1,000 copies/mL. The LOD for both FluA and FluB was 500 copies/mL, with a positive detection rate of 100 %. No cross-reactivity was observed with 10 common respiratory pathogens, and no contamination was detected during testing. Ct values obtained by Flash10 showed strong correlations with those generated by RT-PCR and GeneXpert for both FluA (r=0.87-0.93, p<0.0001) and FluB (rs=0.86-0.90, p<0.0001). Bland-Altman analysis revealed consistent agreement, despite systematic Ct differences between methods. Qualitative agreement for positive and negative results was perfect (Kappa=1.000, p<0.0001). The median TAT for Flash10 was 66.0 min, significantly shorter than that of RT-PCR (1,184.0 min, p<0.0001).

CONCLUSIONS

The Flash10 molecular POCT system demonstrates analytical performance and result consistency comparable to established molecular diagnostic methods for the detection of FluA and FluB viruses. Its substantially shorter turnaround time supports its potential utility for rapid molecular testing in clinical point-of-care settings.