SARS-CoV-2 Identification and Characterization on the Biomeme Franklin Polymerase Chain Reaction System
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 x 103 copies/mL. No cross reactivity of the Go-Strips targets was detected against any of the tested near-neighbor respiratory pathogens. Cohens 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.
Document Details
- Document Type
- Technical Report
- Publication Date
- Nov 30, 2021
- Accession Number
- AD1153956
Entities
People
- Anna R. Ochoa
- August N. Blackburn
- Chet R. Voelker
- Jennifer S. McDaniel
- La'quita Armstrong-spenrath
- Lauren E. Cornell
- Rachel Mahoney
- Susana N. Asin
Organizations
- 59th Medical Wing