What's included in my test?
- Physician order. One of our physicians will review your information and write a prescription for your lab test.
- Blood draw. A certified healthcare provider will administer a blood draw. Choose between an in-home appointment and a visit to our convenient Melrose office location.
- Lab test. Your sample will be sent to one of our CLIA and FDA certified labs for testing.
- Results. You will receive your results via our secure client portal one business day after your appointment. As with any medical test, you should discuss your results with your physician.
Is the antibody test right for me?
This test is best if you believe that you have previously been exposed to COVID-19, but have either recovered, or had little to no symptoms. The antibody test is a serology test that detects antibodies, which the body manufactures after exposure to the virus. These antibodies tend to appear 7-10 days after exposure, and are an indication that you may now be immune. If you have active symptoms, or believe that you were recently exposed to the virus, the PCR Swab Test may be a better fit for you. Please consult with your physician.
How is this different than a "rapid test"?
A rapid test is typically administered as a finger prick, while our antibody test is administered as a blood draw. As a result, a serology antibody test is generally more accurate than a rapid test. Patients who receive a positive result from a rapid test are frequently directed to have a serology test performed as a follow up in order to confirm the results.
Getting tested can help end the crisis
Testing empowers individuals to prevent the spread and protect their loved ones, while also ensuring that scientists and public health experts have the data needed to allocate resources and set policies need to save lives while helping our economy and community return to normal.
Antibody testing may be particularly important, since the presence of COVID-19 antibodies are an indication of immunity, which may mean that those with the antibodies could safely return to work. As always, you should follow the advice of your physician, public health experts, and government mandates.
Which tests are offered through our partner labs?
Covid-19 Laboratory Developed PCR Test
Covid-19 virus is known scientifically as SARS-CoV-2. Primex, Roche, Thermo Fisher, Ortho Clinical are listed on the FDA Emergency Use Authorization at the FDA website, under FAQs on Diagnostic Testing for SARS-CoV-2.
All swab tests have high sensitivity and high specificity.
Sensitivity - The Primex LDT assay reads the viral copies to 250 copies/mL.
Specificity - The Primex LDT assay reported “Not Detected” on samples with known positives for associated viral pathogens, but reported “Detected” on known positive samples for SARS-CoV-2.
SARS-CoV-2 (COVID-19) Antibody, IgG and IgM Tests
Primex is performing the SARS-CoV-2 Antibody, IgG and IgM Tests in combination. Below is some background information on this testing.
After infection with SARS-CoV-2, viral antigens stimulate the body’s immune system to produce antibodies. The virus incubation period and the days/weeks when the antibodies appear in the blood are defined below.
SARS-CoV-2 virus Antibodies, IgM and IgG
- IgM appears early in the blood circulation after an infection (as early as 3-5 days).
- IgG appears later in the blood circulation after an infection (within 3-4 weeks).
The medical device manufacturer for the SARS-CoV-2 IgM and IgG CLIA Kits that Primex is evaluating provides the following information:
"The IgM and IgG tests are able to detect the antibodies to the SARS-CoV-2 virus and the kits have high specificity, sensitivity and clinical agreement with samples confirmed with PCR methods (RT-qPCR)".
Sensitivity with the SARS-CoV-2 IgM and IgG CLIA Kits
- IgM - When ordered with the IgG test, sensitivity was 89.9%.
- IgG - When ordered with the IgM test, sensitivity was 95.6%.
Specificity with the SARS-CoV-2 IgM and IgG CLIA Kits
- IgM - When ordered with the IgG test, specificity was 96.5%.
- IgG - When ordered with the IgM test, specificity was 96.0%.
The kit manufacturers are also listed on the FDA’s EUA website under FAQs on Diagnostic Testing for SARS-CoV-2.
Incubation Period for Covid-19 virus
- Median Incubation period: 5.1 days (95% confidence interval, 4.5 to 5.8 days)
- 97.5 % of those who develop symptoms do so within 11.5 days (CI 8.2 to 15.6 days)
Ortho Clinical Antibody Test
“Ortho is proud that both of our COVID-19 total and IgG tests are achieving 100% specificity,” said Chris Smith, Ortho Clinical Diagnostics’ Chief Executive Officer. “During this health crisis, good is simply not good enough. This high level of specificity is a testament to Ortho’s strong belief that every test is a life.”
Ortho’s COVID-19 IgG antibody test detects the IgG antibody. It closely follows the introduction of Ortho’s COVID-19 Total test and the two tests offer greater choice in tracking and surveillance, patient management, and screening convalescent plasma. Both of Ortho’s tests help health care professionals understand if a patient has been exposed to and has developed antibodies to the SARS-CoV-2 virus.
Ortho’s COVID-19 IgG antibody test received Emergency Use Authorization from the U.S. Food and Drug FDA administration on April 24, 2020. Ortho’s total antibody test received CE Mark on May 8, 2020 and FDA Emergency Use Authorization on April 14, 2020.
The CLIA lab validated diagnostic tests being offered by this site are in accordance with the FDA’s Emergency Use Notification and Authorization process as provided in the FDA’s “Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency” (March 16, 2020) for laboratories certified under CLIA and FDA standards to perform high-complexity testing. Our test’s manufacturing lab has notified the FDA as required and has been listed on the FDA’s website accordingly.
- 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.
- This test is not for the screening of donated blood