Antibody test products can only be used in Laboratories certified under the Clinical Laboratories Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a to perform moderate or high complexity tests.
FDA EUA approved
CLIA complexity: MODERATE and HIGH
Samples used: Whole Blood/Serum/Plasma
10 minutes turnaround time
Box includes: test device, buffer, and IFU
25 tests per box
FDA EUA is authorized for Point-of-Care use by qualified healthcare professionals test that shows results at 10 minutes
Sample type is direct Nasopharyngeal Swab or Anterior Nasal Swab specimen
Box includes test device, extraction vial, positive and negative controls, IFU and swabs.
20 tests per box
Access Bio CareStart Tests are only authorized for Point-of-Care use by qualified healthcare professionals;
This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories;
This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens;
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;