iHealth® COVID-19 Rapid Antigen Home Test
Fast, accurate, easy, and comfortable. For in-home, professional, or OSHA compliant employer use.
The iHealth® Covid-19 Antigen Rapid Test is authorized for home use by the FDA (EUA). Visual results in 15 minutes, lower nasal swab collection, 94% sensitivity and 98% specificity.
General Details
Test type: Antigen
Run time: 15 minutes
Collection type: Lower nasal swab
Authorization: FDA EUA for home and over-the-counter use. No CLIA certification required.
Intended Use: Lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein.
Manufacturer: iHealth Labs (USA) — contract manufactured in China
CPT Codes: Covid-19 87811QW
Clinical Details
SARS-CoV-2: 94% Sensitivity, 98% 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
Test devices (2)
Nasal collection swabs (2)
Solution vial (2)
Instructions For Use (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 iHealth® COVID-19 Antigen Rapid Test is a lateral flow assay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2.
This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 15 years or older with symptoms of COVID-19 within the first 7 days of symptom onset. This test is also authorized for non-prescription home use with adult-collected anterior nasal (nares) swab samples from individuals aged 2 years or older with symptoms of COVID-19 within the first 7 days of symptom onset.
This test is also authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 15 years or older, or adult-collected anterior nasal (nares) swab samples from individuals aged 2 years or older, with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests.