1. Evaluating sensitivity and specificity of the Biomeme Franklin™ three9 real-time PCR device and SARS-CoV-2 go-strips assay using clinical samples
- Author
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Lisa Lott, Rachel Mahoney, August N. Blackburn, Jennifer S. McDaniel, Susana N. Asin, La'Quita Armstrong-Spenrath, Anna R. Ochoa, Lauren E. Cornell, and Chet R. Voelker
- Subjects
2019-20 coronavirus outbreak ,Coronavirus disease 2019 (COVID-19) ,COVID19 ,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ,viruses ,Real-Time Polymerase Chain Reaction ,Sensitivity and Specificity ,Article ,Cohen's kappa ,Virology ,Medicine ,Humans ,Respiratory system ,skin and connective tissue diseases ,Austere environment ,business.industry ,Diagnostic Tests, Routine ,SARS-CoV-2 ,fungi ,COVID-19 ,Respiratory pathogens ,Polymerase chain reaction ,body regions ,Diagnostic testing ,Infectious Diseases ,Real-time polymerase chain reaction ,business ,Sensitivity (electronics) - Abstract
We evaluated the sensitivity and specificity of the Biomeme FranklinTM three9 Real-Time PCR Thermocycler and Biomeme SARS-CoV-2 Go-Strips in the detection of SARS-CoV-2. The Biomeme FranklinTM 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 × 103 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 FranklinTM 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.
- Published
- 2021