COVID-19 RAPID TESTS

iHealth® Home Test

(2 Tests)

COVID-19 Rapid Test

iHealth® Home Test

COVID-19 antigen test with rapid results in 15 minutes.
Suitable for home use or business/event screening.

Downloadable app with individual or group results portal.

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

Box components

      • Test devices (2)

      • Nasal collection swabs (2)

      • Solution vial (2)

      • Instructions For Use (1)

iHealth® Home Test

Manuals + Instructions

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 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.

CONTACT

Direct Connect

12 + 1 =

Phone

(310) 957-9891