Product Information
- Product Code: COV-19C25IND
- Quantity: 25 Tests/ Kit
- Sample: Anterior nasal swab
- Format: Cassette
- Time-to-Result: 20 minutes
- Storage Condition: 2-30°C (36-86°F)
- Test Principle: Lateral Flow Immunoassay
Contents
- Test devices
- Buffer solution vials
- Nasal swabs
- Package insert
The INDICAID™ COVID-19 Rapid Antigen Test is a non-invasive rapid point-of-care diagnostic test for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal swab specimens collected from individuals who are suspected of COVID-19 by their healthcare provider within the first five (5) days of symptoms onset when tested at least twice over three days with at least 48 hours between tests or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested at least three times over five days with at least 48 hours between tests. The INDICAID™ COVID-19 Rapid Antigen Test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. For use under Emergency Use Authorization (EUA) only. For in vitro diagnostic use only. For prescription use only.
- CLIA Waived for Point of Care Testing
- SARS-CoV-2 nucleocapsid antigen is generally detectable in direct anterior nasal swab specimens during the acute phase of infection.
- Nasal swab specimens may be self-collected by the patient (age 18 years or older) if the collection procedure is instructed and observed by a healthcare professional.
- Results in 20 minutes.
- For in vitro diagnostic use only under the Food and Drug Administration’s Emergency Use Authorization. This product has not been FDA cleared or approved.
- The INDICAID™ COVID-19 Rapid Antigen Test does not differentiate between SARS-CoV and SARS-CoV-2 viruses.
- CPT Code 87811QW
Product Documentation
Disclaimers
- This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories;
- This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and,
- The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.