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Self Test for COVID-19 Infection with CareStart™ Antigen Home Test
- FAST - Result in 10 minutes
- CONVENIENT - No prescription required
- EASY - Self-test with shallow nasal swab
- Detects known variants
- PPA: 87%, NPA: 98%
- For Use Under FDA Emergency Use Authorization (EUA) only
- Made in U.S.A.
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, 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.
FRAUD ALERT!The manufacturer, Access Bio, has become aware of potential fraud schemes related to Antigen Home Tests for COVID-19. KarmaCare Direct is a division of KPC Biotech, Inc., and we are an authorized distributor of CareStart™ COVID-19 Antigen Home Test. We highly encourage consumers to pay close attention to the markings on the boxes to verify that the product is legitimate. Click here for details.
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FACT SHEET FOR HEALTHCARE PROVIDERS
USER INSTRUCTIONS (QRI) AND FACT SHEET FOR INDIVIDUALS
INSTRUCTIONS FOR USE (IFU) FOR HEALTHCARE PROVIDERS
FDA EMERGENCY USE AUTHORIZATION LETTER
| CATALOG NO. | RCPM-00271 |
|---|---|
| PACKAGE UNIT | 2 Tests Per Pack |
| KIT COMPONENTS | 2 Test Devices 2 Extraction Vials and Caps 2 Nasal Swabs 1 User Instructions with Fact Sheet for Individuals |