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The INDICAID™ COVID-19 Rapid Antigen Test is a lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 in direct anterior nasal swab specimens from individuals who are suspected of COVID-19 by their healthcare provider within the first five (5) days of symptom onset.
Storage
Store the test kit in a cool, dry place between 2-30°C (36-86°F). Do not freeze. Avoid direct sunlight.
The INDICAID™ COVID-19 Rapid Antigen Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal swab specimens from individuals who are suspected of COVID-19 by their healthcare provider within the first five (5) days of symptom onset. Anterior nasal swab specimens may be collected by a healthcare provider (HCP) or self-collected (by individuals 18 years of age or older, under the supervision of an HCP). Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate complexity, high complexity, or waived tests. This 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.
Kit Component | Quantity | Description |
Test Devices | 25 | Individually foil pouched test device containing one test strip in a plastic device cassette. Each strip has one control line and one test line. |
Buffer Solution Vials | 25 | Vial with cap and integrated dispensing tip, containing 400μL of buffer solution. |
Nasal Swabs | 25 | Individually wrapped, sterile specimen collector. |
Package Insert | 1 Instructions for use 1 Quick Reference Guide |
Instructions for use and Quick Reference Guide |