RAPID DIAGNOSTIC TEST FOR THE DETECTION OF SARS-COV-2 ANTIGEN

CareStart™ Rapid Antigen Test

Self-Test at Home
Results in minutes.

CareStart™ RAPID ANTIGEN TEST FOR

COVID-19

CareStart™ COVID-19 Antigen Test

The CareStart™ COVID-19 Antigen Home Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigens from SARS-CoV-2.

Under FDA’s EUA, the CareStart™ COVID-19 Antigen Home Test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 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 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 14 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.

RAPID DIAGNOSTIC TEST FOR THE DETECTION OF SARS-COV-2 ANTIGEN iHealth® Rapid Antigen Home Test – 2ct. Two (2) individual test per box. Rapid point-of-care (POC) test with results in minutes

CareStart™ COVID-19 ANTIGEN RAPID TEST DEVICE DEMONSTRATION

Resources

PRODUCT INFORMATION

CareStart™ COVID-19 Antigen Rapid Test Product Information

FDA EMERGENCY USE AUTHORIZATION

FDA Authorizes Made in the USA Point-of-Care Antigen Test for COVID-19

CareStart™ COVID-19 Antigen Test

FDA EUA: Letter of Authorization

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Healthcare Providers Fact Sheet

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Patients Fact Sheet

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