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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

Scientific literature on COVID-19 Test Methods and Devices - detail

Comparison of automated SARS-CoV-2 antigen test for COVID-19 infection with quantitative RT-PCR using 313 nasopharyngeal swabs, including from seven serially followed patients

Detection Principle
ImmunoAssay-Antigen
Target
Not specified
Testing Method Category
 
Testing Method
kit
Testing Method - Additional Info
LUMIPULSE antigen test (chemiluminescence enzyme immunoassay)
Reported Performance
sensitivity: 55.2% (vs RT-PCR); specificity: 99.6% (vs RT-PCR), overall agreement rate: 91.4% (vs RT-PCR), 100% (vs RT-PCR in samples >100 viral copies), 85% (vs RT-PCR in samples 0-100 viral copies)
Sample Size
313 samples
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