COVID-19 SERUM ANTIBODY TESTING
ORDER YOUR ANTIBODY LAB TEST
Many INFECTED WITH COVID-19 (SARS-COV-2) ARE ASYMPTOMATIC. Have you been exposed? Do you have antibodies?
tests for previous exposure - not for present symptoms. Do not come in if you are showing present symptoms!
- Specimens are collected from a simple blood draw, not nasal swabs or finger pokes.
- TestSource Lab is proud to offer serum blood tests conducted by the Boston Heart Diagnostics, a highly complex reference lab.
- Results are assigned numerically Quantitative results, not just simple "pass or fail" results.
- Results are typically ready within 2 - 4 business days.
- You must be symptom-free for 10 - 14 days in order for TestSource Lab to draw your blood.
What is the COVID-19 IgG and IgM Detection Blood Antibody test?
The test is designed to detect antibodies (also known as immunoglobulins) against the virus that causes COVID-19. Antibodies are proteins produced by the immune system in response to an infection and are specific to that particular infection. Your serum specimen obtained from the blood draw will be tested for both immunoglobulin G (IgG) and immunoglobulin M (IgM).
IgM antibodies is usually the first antibody produced by the immune system when a virus attacks. A positive IgM test indicates that you may have been infected and that your immune system has started responding to the virus. When IgM is detected you may still be infected or you may have recently recovered from a COVID-19 infection.
It also detects IgG antibodies that develop in most patients within seven to 10 days after symptoms of COVID-19 begin. IgG antibodies remain in the blood after an infection has passed. These antibodies indicate that you may have had COVID-19 in the recent past and have developed antibodies that may protect you from future infection. It is unknown at this point how much protection antibodies might provide against another infection of COVID-19.
Cost: $135 - HSA's, Credit Cards, Debit Cards or Cash are Accepted
- TestSource Lab's hours for COVID-19 testing are from 8:00 am to 2:00 pm, Monday through Friday
- You must wear a mask while your blood is being drawn so please bring your own in.
- Feel free to call or email us, more information found in the Contact Us form.
- This test is not the PCR test to find out whether you are currently sick from the COVID-19 virus!
- Do not come in for testing if you have any of the symptoms! Contact the Health & Community Services Department at (269) 373-5200, your physician or a hospital.
Boston Heart Diagnostics & The FDA's Emergency Use Authorization (EUA)
Boston Heart Diagnostic's testing has not been reviewed by the FDA, but the manufacturer and laboratory have notified the FDA that test tests have been validated in accordance with Section IV.D. of the FDA's Policy for Diagnostic Tests for Coronavirus Disease-2019 (COVID-19) during the Public Health Emergency. Both the manufacturer and Boston Heart Diagnostics are listed on the FDA website as offering tests under this policy.
Boston Heart Diagnostics is operating under FDA guidance as having validated their results with FDA guidance.
real lab testing, not pass/fail instant results from a finger-stick kit
Detailed specifications on the Boston Heart Diagnostic Antibody test:
- No cross reactivity with antibodies for non-SARS-CoV-2 coronavirus strains HKU1, NL63, OC43, or 229E.
- No cross reactivity with antibodies for influenza A and B, parainfluenza, respiratory synctial virus, adenovirus, Epstein-Barr virus NA and VCA, measles virus, cytomegalovirus, varicella zoster, Mycoplasma pneumoniae, Chlamydia pnemoniae, and Candida albicans.
- Based on studies in China, the sensitivity of this IgG antibody test for identifying SARS-CoV-2 RNA positive subjects was reported to be 91.2%, and with both IgG and IgM antibody testing it was 95.6%
- Within run and between run CV's are <4.0% for both assays.
- The specificity in SARS-CoV-2 RNA negative subjects was reported to be 96.0% withe IgG and IgM were used in combination.
FDA's Policy for Diagnostic Tests for Coronavirus Disease - 2019
As stated in Section IV.D of the FDA's Policy for Diagnostic Tests for Coronavirus Disease-2019, the FDA does not intend to object to the development and distribution by commercial manufacturers, or development and use by laboratories, of serology tests to identify antibodies to SARS-CoV-2, where the test has been validated, notification is provided to FDA, and information along the lines of the following is included in the test reports:
- This test has not been reviewed by the FDA.
- Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
- Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
- Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
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