About Our Laboratory: Vibrant America
Vibrant America is certified under the Clinical Laboratory Improvements Amendment of 1988 (CLIA ’88), accredited by the College of American Pathologists (CAP), and has over 5 year’s experience designing, validating, and performing Laboratory Developed Tests (LDTs) for physicians and patients. Maintaining accreditation through the CAP requires that LDTs are validated to standards exceeding those listed in CLIA ’88 which defines the minimum standards that must be met in order to perform LDTs for diagnostic purposes.
Intended Use of this test: Vibrant COVID-19 Ab assay is an in-vitro diagnostic test intended for the qualitative and semi-quantitative detection of IgG and IgM antibodies to SARS-CoV-2 in human serum or dried blood spot (DBS) collected from individuals who are suspected of COVID-19.
Current Status of Vibrant COVID-19 Ab Test:Vibrant America had submitted initial validation materials to the FDA as of 3/30/2020.
The independent review of this validation by the FDA is pending. Upon completion of validation and notifying FDA, Vibrant started offering the COVID-19 Ab test. This test was based on a qualitative determination of IgG, IgA and IgM antibodies against 4 COVID-19 antigens in serum.
As of 04/26/2020, Vibrant America has updated its assay and notified FDA of this update. This assay will be performed either in a serum or a dried blood spot finger-prick test and determine semi-quantitative IgG and IgM antibodies to 4 COVID-19 antigens. The independent review of this validation by the FDA is pending. Please see attached for the updated Validation.
The fingerprick collection can only be performed at the point-of-care and NO AT-HOME Collection.
The Vibrant America COVID-19 Ab test is performed at a single testing location in San Carlos, CA. While Vibrant America offers testing services, Vibrant America is not a test manufacturer or distributor.Vibrant America does not require EUA-approval for diagnostic testing of SARS-CoV-2 as the test has been validated as an LDT under the College of American Pathologists accrediting body, however, final EUA-approval is being sought because of increased recognition by healthcare professionals.
Please note: there is no such title as an ‘FDA-Approved COVID-19 test.’ There is no FDA approval being granted for any COVID-19 testing. The only designation a COVID-19 test can receive from the FDA currently is ‘FDA Emergency Use Authorized (FDA EUA).