Indicaid™ COVID-19 Rapid Antigen Test
General Details
Test type: Antigen
Run time: 15-25 minutes
Collection type: Lower nasal swab
Authorization: FDA EUA for professional use. CLIA required.
Intended Use: Lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein.
Manufacturer: Phase Scientific (USA)
CPT Codes: Covid-19 87811QW
Clinical Details
SARS-CoV-2: 84.4% Sensitivity, 96.8% Specificity (Self-Collected)
Specificity: No cross-reaction with species tested
Interference: No interfering factors tested
*See Instructions For Use for detailed clinical data.
Box Components
Lower nasal swabs (25)
Test cassettes (25)
Extraction reagent capsules (25)
Dock for mass sample testing (1)
Instructions for use (1)
Quick reference guide (1)
Storage & Handling
Test kits should be stored at 2-30°C (35-86°F). Reagents and materials are stable until the expiration date printed on the outer packaging. Do not use beyond the expiration date. The test device must remain in the sealed pouch until use. Do not freeze any contents of the kit.
Manuals and Instructions
Product Images
Intended Use
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.