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COVID-19 Antibody Testing (Blood Test) |
COVID-19 Antibody Testing
Blood samples are drawn from the patient and shipped to our CLIA certified, CAP accredited, High Complexity lab in Richmond, VA.
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What Are Antibodies?Antibodies, also known as immunoglobulins, are proteins that are produced by the immune system to help stop intruders (like viruses) from causing bodily harm. If you have been Infected by the SARS-CoV-2 virus, you will begin to develop antibodies 7-14 days after contracting the virus. SARS-CoV-2 IgG/IgM antibodies can be detected in your blood.
Why Are Antibody Tests Important?
Antibody tests may assist in understanding a patients previous COVID-19 infection status. Emerging evidence indicates that patients who have contracted the virus may develop immunity for a period of time. Tracking people who showed minor or no symptoms will provide additional data as to how far the virus has spread. |
Monitoring Active & Previous Infections
Source: Sethuraman, N. JAMA 2020
About the TestsBeckman Coulter Access SARS-CoV-2 IgM & IgG Antibody Tests Provide Individual Results with High Sensitivity and Specificity
SZLS is pleased to provide the Beckman Coulter Access SARS-CoV-2 Antibody Tests. Beckman Coulter has received EUA approval from the FDA for the Access SARS-CoV-2 Antibody Test, a highly sensitive and specific antibody test to identify individuals who have potentially developed an immune response to the SARS-CoV-2 virus. The Access SARS-CoV-2 tests looks for two types of antibodies in your blood sample: IgM antibodies indicates recent infection and IgG antibodies gradually appear and increase in the later stage of coronavirus infection. Armed with this insight, individuals with coronavirus antibodies can make informed decisions about returning to work and other activities. Patients will continue to get superior testing for coronavirus antibodies with high sensitivity and specificity, communicated through an easy to read report. Both tests have a high sensitivity and specificity. Sensitivity is the ability of a test to correctly identify patients with a disease. Specificity is the ability of a test to correctly identify people without the disease.
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Test Descriptions
Beckman Access SARS-CoV-2 IgM Test Developed by Beckman Coulter, the Access SARS-CoV-2 IgM assay is a paramagnetic particle, chemiluminescent immunoassay intended for the qualitative detection of IgM antibodies to SARS-CoV-2 in serum, serum separator tubes and plasma from individuals with current or prior COVID-19 infection. The Access SARS-CoV-2 IgM assay is intended for use as an aid in identifying patients with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. Results are for the detection of SARS CoV-2 antibodies. IgM antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post-infection is not well characterized. Patients may have detectable virus present for several weeks following seroconversion. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.
Beckman Access SARS-CoV-2 IgG Test Developed by Beckman Coulter, the Access SARS-CoV-2 IgG assay is a paramagnetic particle, chemiluminescent immunoassay intended for the qualitative detection of IgG antibodies to SARS-CoV-2 in serum, serum separator tubes and plasma from individuals with current or prior COVID-19 infection. The Access SARS-CoV-2 IgG assay is intended for use as an aid in identifying patients with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. Results are for the detection of SARS CoV-2 antibodies. IgG antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post-infection is not well characterized. Patients may have detectable virus present for several weeks following seroconversion. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.
Beckman Access SARS-CoV-2 IgG Test Developed by Beckman Coulter, the Access SARS-CoV-2 IgG assay is a paramagnetic particle, chemiluminescent immunoassay intended for the qualitative detection of IgG antibodies to SARS-CoV-2 in serum, serum separator tubes and plasma from individuals with current or prior COVID-19 infection. The Access SARS-CoV-2 IgG assay is intended for use as an aid in identifying patients with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. Results are for the detection of SARS CoV-2 antibodies. IgG antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post-infection is not well characterized. Patients may have detectable virus present for several weeks following seroconversion. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.
Test Disclaimers
The FDA has issued Emergency Use Authorization (EUA) for the Access SARS-CoV-2 IgM and IgG tests..
Beckman Access SARS-CoV-2 IgM Test 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 IgM 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 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.
Beckman Access SARS-CoV-2 IgG Test 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 IgG 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 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.
The FDA has issued Emergency Use Authorization (EUA) for the Access SARS-CoV-2 IgM and IgG tests..
Beckman Access SARS-CoV-2 IgM Test 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 IgM 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 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.
Beckman Access SARS-CoV-2 IgG Test 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 IgG 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 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.
