COVID-19 RAPID TESTS

Indicaid™ Rapid Antigen Test

(Box of 25)

COVID-19 Rapid Test

Indicaid™ Rapid Antigen Test

Fast. Easy. Comfortable.

The Indicaid Covid-19 rapid antigen test is authorized for professional use by the FDA (EUA) in point-of-care settings by organizations with CLIA certification. With visual results in 15 minutes and lower nasal swab collection, Indicaid is fast and comfortable for patients.

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)

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
      • CPT Codes: Covid-19 87811QW

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 and 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.

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.

 

CONTACT

Direct Connect

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Phone

(310) 957-9891