FDA Authorized Point-of-Care Antibody Test for COVID-19
- 20 tests per box.
- FDA EUA.
- Authorized for use in POINT-OF-CARE SETTINGS (CLIA).
- For medical professional use only (verification required).
- Reimbursement/Billing Code (CPT) 86328QW.
-
Not for home use.
** Call now to order 888-562-5852 **
Use of this test with all authorized specimen types is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform moderate or high complexity tests.
This test is also authorized for use with fingerstick whole blood specimens only 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.
FACT SHEET (TEST RECIPIENTS)
FACT SHEET (HEALTHCARE PROVIDERS)
IFU (INSTRUCTIONS FOR USE (PACKAGE INSERT)
FDA EMERGENCY USE AUTHORIZATION (EUA) LIST
COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a solid phase immunochromatographic assay for the rapid, qualitative and differential detection of IgG and IgM antibodies to 2019 Novel Coronavirus in human whole blood, serum or plasma. This test provides only a preliminary test result and is for professional use only.
This is a blood test that will screen for antibodies to help determine if you have been exposed to the virus. This test is highly sensitive and specific.
TEST PROCEDURE
MATERIALS SUPPLIED
20 sealed pouches each containing test cassette and dropper
20 lancets
20 alcohol prep pads
1 bottle of buffer solution
1 package insert
** Call now to order 888-562-5852 **
- This test has not been FDA cleared or approved;
-
This test has been authorized by FDA under an EUA for use by authorized
laboratories; -
This test has been authorized only for the presence of IgM and IgG antibodies
against SARS-CoV-2, not for any other viruses or pathogens; and - This test 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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
