COVID-19 Testing Products

• Available products are for use in the following manner and intended for professional use (Healthcare Providers) and not for home use.
• These tests has been authorized by FDA under an EUA for emergency use limited by authorized laboratories and Point of Care (POC) settings as indicated.  Tests have not been FDA cleared or approved.  ​Antibody tests been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.
• Authorized Laboratories: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform high, moderate or waived complexity tests.  (ANTIGEN test only- is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.)
• ​These test are 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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
• Positive Antibody results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
• ​COVID-19 Antigen test is a lateral flow immunochromatographic assay, intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal swab specimens directly collected, or collected in BD universal transport media, from individuals suspected of COVID-19 by their healthcare provider within five days of symptom onset.  Please review Instructions for Use.

Contact 866-544-7678 for Questions

CareStart COVID-19 Antigen Test Kits by Access Bio
Order in Quantities of 20
Minimum order 20, 1 box
***due to demand, expect 7-14 days for delivery**
Call 866-544-7678 if ordering 640, 1 case or more