SARS-CoV-2 IgG Antibody; Serum

SKU: COVID1 $79.00
PLEASE NOTE: This test is NOT done through LabCorp. This is a test kit that will be shipped to you.

Identify front line healthcare providers, patients, and community populations who have potentially developed an immune response to the SARS-CoV-2 virus.

SARS-CoV-2 antibody testing could be used as a tool to determine who has already been infected, and might have immunity to the virus. Doctor’s Data is utilizing a SARS-CoV-2 IgG qualitative immunoassay from Beckman Coulter that offers a confirmed 99.6% specificity and 100% sensitivity at 18 days post PCR confirmed positive test. Currently, this is the only IgG assay from the top four in vitro diagnostic manufacturers that detects antibodies targeting the receptor binding domain (RBD) on the spike protein. It is believed that these antibodies have the potential to be neutralizing antibodies, and may play a role in lasting immunity. This is also a reason many vaccine developers are also targeting the RBD spike protein due to its neutralizing potential.

Henry Ford Health System recently performed an independent validation of the assay’s performance. When running the assay on 204 PCR-confirmed COVID-19 samples, the test sensitivity was 100% at 14 days post-PCR. When testing 80 patient samples from the pre-COVID era, this assay produced a specificity of 100%.

Serology testing can be beneficial as nearly 81% of infected people are asymptomatic or have mild to moderate symptoms. Generally, IgG is developed against an antigen 7-14 days after infection, and can remain detectable for months and years, depending upon the specific antigen and the patient.

This test targets antibodies to the RBD of the SARS-CoV-2 spike protein that may be more likely to confer immunity, based on laboratory studies. The spike protein in a coronavirus is the major surface protein that is uses to bind to a receptor. This spike protein mediates entry into host cells by attaching to a receptor on respiratory cells called angiotensin-converting enzyme 2, or ACE2.6. Antibodies against the RBD may promote neutralization of SARS-CoV-2, indicating an effective measure of immunity when compared to antibodies against other SARS-CoV-2 viral proteins.

However, immunity, in terms of timing and characteristics, are still uncertain due to the limited experience with SARS-CoV-2. Results from antibody testing should not be used as the sole basis to diagnose or exclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 via PCR is recommended. False positive results may occur due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.

This test has not been FDA cleared or approved. This test has been authorized by FDA under an Emergency Use Authorization (EUA). 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.
Category:All Lab Tests, COVID

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