Laboratory Based Antibody Test
for antibodies to SARS-CoV-2
20/20 is now offering Roche Diagnostics’ highly accurate serology test which received Emergency Use Authorization from the FDA on May 2, 2020. The antibody test runs in our high-complexity CLIA certified laboratory, located in Rockville, MD where we also offer OneTest, a blood test to aid in the early detection of multiple cancers.
KEY FEATURES & BENEFITS
- Qualitative detection of IgM and IgG antibodies that bind to the virus that causes COVID-19
- Provides high standard of reliability using instruments by leading global manufacturer
- 100% sensitivity
- Lower cost than most PCR tests
- Authorized by FDA for emergency use only (EUA )
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
To place an order for the Roche test, please call (240) 453-6339 or use the form below to contact us.
Order tests on our website
Collect patient serum sample and mail to 20/20’s CLIA Lab
Results reported within 2-3 days of arrival
Information about FDA oversight of serology tests for SARS-CoV-2
20/20 BioResponse is complying with the May 4, 2020 Guidance from the FDA policy. 20/20 BioResponse has notified the FDA and is in compliance with this guidance. The FDA has issued information on the use of serological (antibody) tests to help identify people who may have been exposed to the SARS-CoV-2 virus or have recovered from the COVID-19 infection. This information includes:
- Important Information on the Use of Serological (Antibody) Tests for COVID-19 – Letter to Health Care Providers;
- FDA Fact Sheet – Serological Testing for Antibodies to SARS-CoV-2 Infection; and
- Serology/Antibody Test FAQs in the FAQs on Diagnostic Testing for SARS-CoV-2.
Healthcare provider fact sheet
Patient Fact Sheet
Roche Covid-19 FAQ’s
FDA Emergency Use Authorization (EUA)