Description
Performance
Relative Sensitivity: 97.1% (83.8%-99.9%)*
Relative Specificity: 99.6% (97.7%-99.9%)*
Accuracy: 99.3% (97.5%-99.9%)*
*95% Confidence Intervals
Test Highlights
Cassette Format
Detects the nucleocapsid protein antigen from SARS-CoV-2
Nasal Specimen sample
Results in 15 minutes
Feature Specification
Test Format Cassette
Specimen Format Nasal Swab
Detects The nucleocapsid protein antigen from SARS-CoV-2
Sample Volume 4 to 5 drops of the prepared specimen
Relative Sensitivity 97.1% (83.8%-99.9%) 95% Confidence Intervals
Relative Specificity 99.6% (97.7%-99.9%) 95% Confidence Intervals
Accuracy 99.3% (97.5%-99.9%) 95% Confidence Intervals
LOD 1.6*102 TCID50/mL
Test Time 15 minutes
Shelf Life 24 Months
Store Temperature 2 – 30 °C
For professional in vitro diagnostic use only.
This product is CE-IVD marked for professional use and complies with the European In-Vitro Diagnostic Devices Directive (98/79/EC).