Performance characteristics of a high throughput automated transcription mediated amplification test for SARS-CoV-2 detection
Detection Principle
NucleicAcid-PCR based
Target
ORF1ab gene
Testing Method Category
RT-PCR
Testing Method
in house
Testing Method - Additional Info
in house developed and validated a high-throughput, fully automated nucleic acid amplification test (NAAT) for direct amplification and detection of SARS-CoV-2 RNA from specimens of infected individuals comparated with other NAAT (EUA Panther Fusion SARS-CoV-2 reverse transcription-PCR (RT-PCR) assay (Hologic, Inc.))
Reported Performance
LoD: 25 copies/ml ; PPA: 100% ; NPA: 98.7% ; overall agreement: 99.3%
Sample Size
140 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