Validation and verification of the Abbott RealTime SARS-CoV-2 assay analytical and clinical performance
Detection Principle
NucleicAcid-PCR based
Target
N1 and N2
Testing Method Category
RT-PCR
Testing Method
RealTime SARS-CoV-2 assay EUA
Testing Method - Additional Info
Evaluation analytical and clinical performance of the RealTime SARS-CoV-2 assay compared to the SARS-CoV-2 CDC-based laboratory developed test
Reported Performance
LOD: 50 copies/ml; Sensitivity: 93%; Specificity: 100%
Sample Size
24 patients
Peer-reviewed
yes
The database contains available information from scientific literature that is being updated periodically. Please note that the provided information (as retrieved from analysed papers) is provided only for devices commercially available with CE-IVD mark. Acknowledgements