How reliable is the Siemens SARS-CoV-2 Total Antibody test?
Siemens evaluated the clinical performance of the Total Antibody Assay through a retrospective analysis of >1,000 patient specimens. The results demonstrated the following:
Sensitivity: 100% clinical performance in identifying detectable levels of SARS-CoV-2 antibodies (≥ 14 days post COVID-positive PCR test).
Specificity: 99.8%, determined by testing 1,091 patient samples collected prior to the COVID-19 outbreak (before November 2019).
Additional validation studies were performed by Dominion Diagnostics, utilizing in-house specimens collected prior to November 2019, as well as specimens provided by a CLIA/CAP-certified reference lab. 100% correlation was observed.
When is the Total Antibody test indicated?
For most accurate results, antibody testing is recommended at least 10 days AFTER the potential exposure or onset of symptoms to allow for development IgM and IgG antibodies. Early-published literature showed that within 8-10 days after symptom onset, 75% of patients tested positive for SARS-Co-V-2 IgG and/or IgM antibodies1.
Why test for SARS-CoV-2 antibodies?
Antibody testing may be useful in determining whether an individual was previously exposed to the SARS-CoV-2 virus and produced antibodies. While currently it is unknown whether these antibodies provide long-term protection from reinfection, the CDC has stated that recurrence of COVID-19 illness appears to be uncommon. This observation suggests antibodies may provide some level of short-term immunity to SARS-CoV-2 2; however, the level and length of any theorized protection is still unknown.
As scientific studies continue to evolve, there will likely be additional clinical applications for antibody testing beyond what is currently available.
How should Total Antibody test results be interpreted?
The serological assay results are qualitative, reported as Detected or Not Detected.
Detected: Indicates that an individual has likely had exposure to SARS-CoV-2 and produced an immune response
Not Detected: Indicates that an individual has not developed detectable antibodies at the time of testing due to one or more of the following:
- absence of exposure to SARS-CoV-2
- testing being performed too early during an active infection
- lack of an adequate immune response, which may be due to conditions or treatments that suppress immune function
What are the payment options for the Total Antibody test?
Dominion Diagnostics will bill patient insurance when medically indicated or a client account directly for all testing performed.
We are not currently offering this test directly to patients without a physician’s order.
1 Long, Q., Liu, B., Deng, H. et al. Antibody responses to SARS-CoV-2 in patients with COVID-19, Nat Med (2020). https://doi.org/10.1038/s41591-020-0897-1.