Anti-SARS-CoV-2 Rapid Test, COVID-19
1. Easier: No special equipment needed, Intuitive visual interpretation.
2. Rapid: Quick sampling by fingertip blood, Results in 10-15min.
3. Accurate: Results with IgG and IgM respectively.
4. Application: as screening tool for potential suspect patients in large numbers.

Testing kit is FDA Emergency Use Authorization (EUA) Approved
Testing kit is CE MARKED-IVD

* Instruction for Use
* Interpretation Guide
* SARS-CoV-2 immunoassays
* Accuracy of the Anti-SARS-CoV-2 Rapid Test Kit
* Anti-SARS Rapid Test Brochure
* COVID-19 Catalog
* EUA Approval Letter
* Fact Sheet for Healthcare Providers
* FDA Letter
* Fact Sheet for Recipients
* FAQ
* CE IVD Notification Certificate

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgM Sensitivity (PPA) 95.7% (289/302) (92.8%; 97.5%)
IgM Specificity (NPA) 99.7% (311/312) (98.2%; 99.9%)
IgG Sensitivity (PPA) 99.0% (299/302) (97.1%; 99.7%)
IgG Specificity (NPA) 99.4% (310/312) (97.7%; 99.8%)
Combined Sensitivity (PPA) 99.0% (299/302) (97.1%; 99.7%)
Combined Specificity (NPA) 99% (309/312) (97.2%; 99.7%)
Combined PPV at prevalence = 5% 84.4% (64.6%; 94.6%)
Combined NPV at prevalence = 5% 99.9% (99.8%; 100%)
Testing kit is FDA Emergency Use Authorization (EUA) Approved
Testing kit is CE MARKED-IVD

* Instruction for Use
* Interpretation Guide
* SARS-CoV-2 immunoassays
* Accuracy of the Anti-SARS-CoV-2 Rapid Test Kit
* Anti-SARS Rapid Test Brochure
* COVID-19 Catalog
* EUA Approval Letter
* Fact Sheet for Healthcare Providers
* FDA Letter
* Fact Sheet for Recipients
* FAQ
* CE IVD Notification Certificate