Recent studies have demonstrated that the FDA Emergency Use Authorized CareStart™ rapid antigen test accurately detects new SARS-CoV-2 variants, including Delta, Delta Plus, Lambda, Alpha, Beta, Gamma, and Kappa.
This product has not been FDA cleared or approved; but has been authorized by FDA under an EUA; This product has been authorized only for the detection of proteins from SARS- CoV-2, not for any other viruses or pathogens; and, 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. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
Each box of CareStart COVID-19 Antigen Rapid Test Kit includes 20 Tests:
- 20 Covid-19 Antigen Tests Devices
- 20 CareStart COVID-19 Ag Extraction Vials (or 1 Bottle)
- 20 Nasal Swabs for Specimen Collection
- 20 Caps for Extraction Vials
- 1 Positive Control Swab
- 1 Negative Control Swab
Because of the extremely contagious nature and worldwide health emergency, SARS-CoV-2 has been nominated as a pandemic by the WHO (World Health Organization) and remains to have devastating influences on health care systems and the world economy including the United States. To efficiently fight against the SARS-CoV-2 pandemic, regular examination and detection of both clinical and asymptomatic COVID-19 cases are crucial.
As an intentional point-of-care (POC) specified test with a 10 minute processing time, CareStart COVID-19 Antigen Test makes the available efficient screening of COVID-19 infection on a large scale.
Nasopharyngeal Swab Sample Collection Procedure with CareStart COVID-19 Antigen Test
- Process the test sample immediately after collection.
- Use only provided or recommended nasopharyngeal swab for specimen collection.
- Collect the specimen wearing safety gloves to avoid contamination.
- Do not touch the tip (specimen collection area) of the swab.
- Collect samples as soon as possible after the onset of symptoms.
The current inventory of these tests show it expires 06/30/2021, but FDA approved manufacturers letter extends it for 6 months.