Evaluation of the Visby medical COVID-19 point of care nucleic acid amplification test

Autor: Amy M. Wockenfus, Brad S. Karon, Leslie J. Donato, Brandon R. Kelley, Brooke M. Katzman
Rok vydání: 2021
Předmět:
Emergency Use Authorization
NAAT
nucleic acid amplification test
Coronavirus disease 2019 (COVID-19)
Serial dilution
Nucleic acid amplification test (NAAT)
Concordance
Clinical Biochemistry
LoD
limit of detection
POC
point-of-care
Roche Diagnostics
NPA
negative percent agreement
SARS-CoV-2
severe acute respiratory syndrome coronavirus 2
Article
WHO
World Health Organization
EUA
emergency use authorization
TaqMan
Medicine
Cp
crossing point
RT-qPCR
reverse transcription quantitative polymerase chain reaction
PPA
positive percent agreement
Point of care (POC)
Point of care
Rapid test
business.industry
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
HRP
horseradish peroxidase
General Medicine
FDA
Food and Drug Administration
Test (assessment)
CI
confidence interval
business
Nuclear medicine
NP
nasopharyngeal
IRB
institutional review board
VTM
viral transfer media
Zdroj: Clinical Biochemistry
ISSN: 1873-2933
Popis: Rapid and widespread diagnostic testing is critical to providing timely patient care and reducing transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Recently, the Visby Medical COVID-19 point of care (POC) test was granted emergency use authorization (EUA) for qualitative detection of SARS-CoV-2 nucleic acid at the point of care. We evaluated its performance characteristics using residual specimens (n = 100) collected from Mayo Clinic patients using nasopharyngeal (NP) swabs and placed in viral transport media (VTM). The same specimen was tested using both the laboratory reference method (RT-qPCR) and Visby test. The reference methods utilized included a laboratory developed test with EUA (Mayo Clinic Laboratories, Rochester, MN) using the TaqMan assay on a Roche Light Cycler 480 or a commercially available EUA platform (cobas® SARS-CoV-2; Roche Diagnostics, Indianapolis, IN). Positive, negative, and overall percent agreement between the Visby COVID-19 test and the reference method were calculated. Additionally, the limit of detection (LoD) claimed by the manufacturer (1112 copies/mL) was verified with serial dilutions of heat inactivated virus. The Visby COVID-19 test correctly identified 29/30 positive samples and 69/70 negative samples, resulting in an overall concordance of 98.0%, positive percent agreement of 96.7%, and negative percent agreement of 98.6%. The abbreviated LoD experiment showed that the analytical sensitivity of the method is as low as or lower than 500 copies/mL. Our study demonstrated that Visby COVID-19 is well-suited to address rapid SARS-CoV-2 testing needs. It has high concordance with central laboratory-based RT-qPCR methods, a low rate of invalid results, and superior analytical sensitivity to some other EUA POC devices.
Databáze: OpenAIRE
Externí odkaz: