Covid-19 Antibody Test
Antibodies have been found to be highly sensitive biomarkers in infectious disease diagnosis. Previous studies on SARS, MERS, and more recently the ones on SARS-CoV2 have shown IgM antibodies to appear about 3 days from infection and IgG antibodies appear after 8 days.
Profiling an individual’s antibody response is the only way to determine infections with few or no symptoms.
Exceptional degree of sensitivity 98.1% and specificity 98.6% with a venipuncture-based SST collection.
According to the CDC, “the signs and symptoms of COVID-19 present at illness onset vary, but over the course of the disease, most persons with COVID-19 will experience the following.”
**If you present with these symptoms, please seek immediate health advice by contacting your primary care provider or Urgent Care as this test in not appropriate for symptomatic/active infections.
As of June 4, 2020 Vibrant America is the First and Only Lab to obtain FDA EUA approval for Covid-19 dried blood spot antibody collection.
Please call the office at 916-984-4128 to schedule as well as any questions that you may have regarding testing.
Vibrant America COVID-19 test has been validated as an LDT under the College of American Pathologists accrediting body and CLIA certified.
“Our test was internally developed and validated according to FDA EUA requirements. The only designation a COVID-19 test can receive from the FDA is ‘FDA Emergency Use Authorized (FDA EUA).’ Upon completion of validation on 3/30/2020 and notifying FDA, Vibrant started offering the COVID-19 test against 4 COVID-19 antigens in serum.”
This test does not require confirmation by CDC prior to reporting.
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 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 diagnostic tests 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.