Evaluating sensitivity and specificity of the Biomeme Franklin™ three9 real-time PCR device and SARS-CoV-2 go-strips assay using clinical samples
| Autor: | Lisa Lott, Rachel Mahoney, August N. Blackburn, Jennifer S. McDaniel, Susana N. Asin, La'Quita Armstrong-Spenrath, Anna R. Ochoa, Lauren E. Cornell, Chet R. Voelker |
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| Rok vydání: | 2021 |
| Předmět: |
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) |
| Zdroj: | Journal of Clinical Virology |
| ISSN: | 1873-5967 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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