Is this an FDA authorized test kit?

​​​​​​​The manufacturer of the test kit is Diazyme Laboratories, Inc. Poway, California. They are listed under the notifications to FDA for the Emergency Use Authorization (EUA) pursuant to Section IV.D.

This test is a chemiluminescent immunoassay which is more sensitive for IgM and IgG antibodies than calorimetric ELISA tests. (The rapid tests are typically ELISA so not as sensitive or specific usually in the high 80s).

Sensitivity and Specificity:

Sensitivity is the true positive rate. This is the ability of the test to correctly identify those with the disease.

Specificity is the true negative rate. This is the ability of the test to correctly identify those without the disease.

According to the manufacturer, this test is validated by RT-PCR results. This test has a Sensitivity of 95% and Specificity of 97%. Anything over 90% is considered a good diagnostic test.

Is it Insurance reimbursable?

The Families First Coronavirus Response Act does not specifically mention coverage of COVID-19 Antibody Testing.

Payment is due at the time of testing and we will supply a receipt for insurance submission.

If you have a Health Savings account, you may use it.

Turnaround Time: 2-3 Days once the sample is submitted.

What the test tells us: Clinical information

Whether you have been exposed to COVID-19.

Based on the patterns of IgG and IgM antibodies we can detect roughly what time frame the patient was exposed to COVID-19.

IgM antibody levels tend to last approximately 20-40 days after exposure.

High IgG antibody levels develop approximately 3 weeks after the start of an infection. This response is considered protective and it gives what is called presumptive immunity. No one is sure how long the immunity protection may last.

This is based on early COVID 19 studies and early reports showing that people are testing RT-PCR positive for the virus again, but not necessarily getting sick again.

Who should be tested?

Anyone with a history of COVID 19 like symptoms, but subsequent recovery.

Anyone with concerns about their ability to mount an immune response.

Anyone who wants confirmation of exposure and possible immunity to COVID-19

What About Symptomatic patients?

Symptomatic patients should wait until they are symptom-free to be tested.


Can the antibodies indicate past infection with a different Coronavirus?

Yes, it is possible in theory. However not likely. COVID 19 is a beta coronavirus and most of the other coronaviruses are alpha so they are genetically a little bit different. This test is very sensitive to COVID 19 coronavirus.

Are the results required to be reported to CDC?

No, antibody testing is not reportable. This information stays private.

Any further questions please contact the office: 630-479-9355

We are currently taking appointments for Friday, April 24 beginning at 2:00 pm.

Monday, April 27th at 6:00 pm. Appointment times may vary from week to week.

Please call the office to make an appointment.

We stagger appointments to adhere to social distancing and it allows time between patients to sanitize.

Thank you and stay safe and healthy!

Your Nourishing Medicine Team

none 8:00 AM - 4:00 PM 8:30 AM - 1:00 PM 10:00 AM - 6:00 PM 10:00 AM - 5:00 PM Closed By Appointment Only Closed nurse practitioners # # # 200 West lincoln Highway,
Waterman, IL 60556