Abstract
We evaluated the sensitivity and specificity of the Biomeme Franklin™ three9 Real-Time PCR Thermocycler and Biomeme SARS-CoV-2 Go-Strips in the detection of SARS-CoV-2. The Biomeme Franklin™ three9 platform is a portable, battery-operated system that could be used in remote settings. We assessed performance of the Biomeme SARS-CoV-2 detection system at a wide range of viral concentrations, examined cross-reactivity of the SARS-CoV-2 Go-Strips against several near-neighbor respiratory pathogens, and evaluated agreement against the BioFire® Respiratory Panel 2.1 in four clinical sample types. Our data indicate the Biomeme Go-Strips can reliably detect SARS-CoV-2 at a concentration of 4.2 × 10 3 copies/mL. No cross reactivity of the Go-Strips targets was detected against any of the tested near-neighbor respiratory pathogens. Cohen’s kappa statistics ranged from 0.68 to 0.92 between results from the Biomeme SARS-CoV-2 Go-Strips and the BioFire® Respiratory Panel 2.1 in all the different sample types. Compared to the BioFire® Respiratory Panel 2.1, the Biomeme SARS-CoV-2 Go-Strips demonstrated statistically significantly lower sensitivity in 3 out of 5 sample types. Overall, our study demonstrates the Biomeme Franklin™ three9 used with the SARS-CoV-2 Go-Strips is an effective system for the detection of SARS-CoV-2 that could potentially be used in a remote or austere environment.
Keywords: Austere environment; COVID19; Diagnostic testing; Polymerase chain reaction; SARS-CoV-2.
【저자키워드】 SARS-CoV-2, COVID19, polymerase chain reaction, diagnostic testing, Austere environment, 【초록키워드】 SARS-CoV-2, cross-reactivity, polymerase chain reaction, SARS-CoV-2 detection, sensitivity, PCR, Sensitivity and specificity, diagnostic testing, Respiratory pathogens, target, Pathogens, respiratory, platform, Cross reactivity, Concentration, Chain Reaction, viral concentrations, significantly lower, effective, tested, detect, examined, evaluated, demonstrated, ranged, statistically, Panel, the SARS-CoV-2, 【제목키워드】 SARS-CoV-2, Sensitivity and specificity, Real-time PCR, clinical sample, Evaluating,