Indicaid Covid-19 Antigen Test

Specifications

• CLIA Waived

• Test type: Rapid Antigen

• Run time: 20 minutes

• Collection type: Lower nasal swab

• SARS-CoV-2: 89.1% PPA, 99.8% NPA

• CPT Codes: Covid-19 87811QW

• Manufacturer: Phase Scientific.

Storage & Expiration

• Store at 2-30°C (35-86°F)

• Do not freeze any contents of the kit.

• Reagents and materials are stable until expiration date printed on outer packaging.

• Test device must remain in the sealed pouch until use.

Box Components

• Nasopharyngeal swabs (25)

• Test cassettes (25)

• Extraction reagent capsules (25)

• Workstation for mass testing (1)

• Instructions for use (1)

• Quick Reference Guide (1)

Manuals & Documents

• Instructions for Use

• Quick Reference Guide

• Provider Fact Sheet

• Patient Fact Sheet

• FDA EUA Letter

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.