Laboratory Based Antibody Test

Antibody Test

New lab-based SARS-CoV-2 antibody test identifies the presence of antibodies to the virus and gives both qualitative and quantitative results to provide a more detailed understanding of antibody levels than previous tests.

KEY FEATURES & BENEFITS

Detects antibodies to the virus that causes COVID-19 to help identify persons previously infected who have an immune response.
May help persons vaccinated understand and monitor their immunity status.
Easy to order, uses a standard blood serum specimen.
Provides more accurate and quantitative result compared with point-of-care rapid test strips.
May allow persons to track their antibody levels over time.
EUA authorized for emergency use

SENTISTIVITY AND SPECIFICITY:

Sensitivity of 100% (for samples taken from patients at least 14 days after PCR confirmation of infection) and an overall specificity of 99.81% (over 5,000 samples tested)

No identified cross reactivity with samples containing antibodies to HIV, four other common cold coronaviruses, other pathogens, nor to 40 common cold samples.

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 detecting 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 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

HOME COLLECTION KIT – COMING SOON

A convenient home collection kit is currently under review that will allow a specimen to be self collected using a fingerstick or other capillary blood collection device. The specimen is mailed directly to our lab without the need for an office visit or going to a lab for a blood draw. Please contact us for more information and to be placed on our waiting list for when this home kit becomes available in the very near future.

Order Process

1

Order tests on our website

2

Collect patient serum sample and mail to 20/20’s CLIA Lab

3

Results reported within 2-3 days of arrival

Important Information

For use under Emergency Use Authorization only.
This test has not been FDA-cleared or -approved; this test has been authorized by FDA under an Emergency Use Authorization (EUA) for use by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform high complexity tests.
This test has been authorized only for detecting antibodies against SARS-CoV-2, not for any other viruses or pathogens.
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 Federal Food, Drug, and Cosmetic Act, 21 U.S.C § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
For in vitro diagnostic use.
For USA: Caution: Federal law restricts this device to sale by or on the order of a physician.

Resources

Healthcare provider fact sheet

Patient Fact Sheet

Roche Covid-19 FAQ’s

FDA Emergency Use Authorization (EUA)

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