• SARS-CoV2 Antibody (IgG), Spike, Semi-Quantitative Test

    Information provided by Quest Diagnostics

    Quest Diagnostics has released a new semi-quantitative antibody test that detects immunoglobulin G (IgG) antibodies in blood samples. The new SARS-CoV-2 Antibody (IgG), Spike, Semi-Quantitative test (test code 34499) expands beyond the qualitative antibody offering from Quest Diagnostics and provides a numerical result that may be useful in providing evidence of immune response over time (when the same test is used for comparison purposes). This could be especially valuable for individuals enrolled in clinical trials and for vulnerable patient populations.

    The new SARS-CoV-2 Antibody (IgG), Spike, Semi-Quantitative test result is reported as positive at an index1,2 of ≥1.00. This positive result indicates that an individual has developed an immune response to a SARS-CoV-2 infection or a SARS-CoV-2 spike vaccine within the limits of the assay.1,2

    Conversely, a negative result is reported at an index3,4 of <1.00. A negative semi-quantitative antibody result means that the patient serum specimen had no SARS-CoV-2 spike IgG antibodies or that the relative level of antibodies in the patient specimen was below the index cutoff.1-4

    Learn more about SARS-CoV-2 antibody tests from Quest Diagnostics that provide the insights you need to improve patient care and manage the spread of COVID-19.

    All SARS-CoV-2 antibody tests must be ordered by a physician, at which time patients may make an appointment at one of Quest’s 2,250 Patient Service Centers.

    The FDA requires companies to submit Emergency Use Authorization (EUA) applications for all SARS-CoV-2 antibody tests. The antibody test systems that are used by Quest Diagnostics have been granted EUAs.5 Please note the following: 

    • The antibody tests have not been FDA cleared or approved;
    • The antibody tests have been authorized by the FDA under an EUA for use by authorized laboratories;
    • The antibody tests have been authorized only for the detection of IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens; and, 
    • The antibody tests are 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. 

    Learn more about how Quest is delivering the crucial insights you need to make the best decisions for your patients during the COVID-19 pandemic.

    References 

    1. FDA. Fact sheet for healthcare providers: Siemens Healthcare Diagnostics Inc. ADVIA Centaur® SARS-CoV-2 IgG (COV2G). Updated July 31, 2020. Accessed January 22, 2021. https://www.fda.gov/media/140702/download
    2. FDA. Fact sheet for healthcare providers: Siemens Healthcare Diagnostics Inc. Atellica® IM SARS-CoV-2 IgG (COV2G). Updated July 31, 2020. Accessed January 22, 2021. https://www.fda.gov/media/140698/download
    3. FDA. ADVIA Centaur® SARS-CoV-2 IgG (COV2G). Instructions for use. Siemens Healthcare Diagnostics Inc; 2020. Accessed February 14, 2021. https://www.fda.gov/media/140704/download
    4. FDA. Atellica® IM SARS-CoV-2 IgG (COV2G). Instructions for use. Siemens Healthcare Diagnostics Inc; 2020. Accessed February 14, 2021. https://www.fda.gov/media/140699/download
    5. FDA. Emergency Use Authorization (EUA) information and list of all current EUAs. Updated February 4, 2021. Accessed February 5, 2021. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

    Test codes may vary by location. Please contact your local laboratory for more information.  Image content features a model and is intended for illustrative purposes only.

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