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CareStart OTC COVID-19 Rapid Antigen Home 2-Pack Tests
$24.00 per package (2 tests per package)
This product is currently on backorder.
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- Fast and easy to self-test at anywhere
- Easy to interpret the results using mobile application
- Qualitatively detect the SARS-CoV-2 nucleocapsid protein
- Use for nasal swab specimen
- Fast results only in 10 minutes
- Identify an individual’s current infection status to COVID-19
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.
- Test Devices
- Extraction Vials and Caps
- Nasal Swab
- User Instructions with Fact Sheet for Individuals
- 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
Notices from AccessBio:
- The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
- This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.
- This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA.
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Want to learn more about picking the perfect COVID-19 test for your situation? Check out our blog on this topic here.
- CareStart COVID-19 Antigen Home Test – Emergency Use Authorization (EUA)
- Instructions for Use (IFU)
- Instructions for Use (IFU) (Home Test)
- Information for Healthcare Providers (HCP)
- Turnaround Time: 30 minutes
- Specificity: 87%
- Sensitivity: 98%
- Limit of Detection: 2.8×103 TCID50/ml
- Swabbing the nostrils is critical for obtaining an accurate result. If you do not swab your nose, the device will produce a false negative result.
- Credit Card
- HSA Card
- PO Number
Note: These products and services are not returnable. Check your kit expiration date upon receipt. Using expired test kits is not recommended because they may provide inaccurate results.