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COVID-19 Antibody Testing

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COVID-19 Antibody Testing
There is a significant lack of testing in the US, leading to an inability for society to return to normal function. Our mission here is to provide a service for our patients, our friends, and our community, by educating and providing data in a responsible way.

The COVID-19 test detects two antibodies – IgM and IgG – when tested at least 7-10 days after the beginning of symptoms. This can help determine if you have potentially been exposed to the Sars-CoV-2 Coronavirus.

There is a lot of media about the lack of accuracy of testing kits. While there are certain limitations, they can still provide relevant and important information. When combined with a detailed medical and social history, our physicians can help with the interpretation of these results. This test is not intended to be used as the sole basis to diagnose disease, and is not proof that one is “immune” yet.

We have evaluated many of the antibody test kits allowed under the FDA Emergency Utilization Authorization, and reviewed the performance analytics of each. We are running an internal study comparing the results from the different tests. While no test is perfect, we are running multiple tests on samples to have the highest probability of an accurate result. We are currently utilizing high-quality S. Korean based testing kits by SD Biosensor. This test is FDA EUA Approved, and is being used by US FEMA (Federal Emergency Management Agency).

A positive antibody test, if you have had recent symptoms, represents a high probability that you were exposed to COVID-19 . A negative antibody test can mean one of these possibilities: 1. You were never exposed 2. Your body has not produced enough antibodies to be detected 3. Your body needs more time to produce antibodies after the exposure 4. False negatives – testing limitations. Note that up to 1/3 of people have low-titers or even absent antibodies after recovering from COVID.

For those that test positive and have recovered, we urge you to donate plasma to aid other critically ill patients.

As of 05/21/2020: 21.51% of our tests have been Positive
Testing can be authorized by our Physicians When:

+ If you had symptoms, and want to know whether it was COVID-19
+ If you are asymptomatic, but may have potentially been exposed (close or proximate contact with a person known to be positive with COVID-19
+ Individuals subject to precautionary or mandatory quarantine
+ Individuals employed as a health care worker, first responder, or essential workers who directly interacts with the public
+ Individuals present with a case where facts and circumstances warrant testing as determined by clinician or health officials
+ If you tested Positive for COVID-19 via Nasal Swab PCR – and want to see if you have produced antibodies that can be detected

Who Should Not Take This Test?

+ If you are actively having symptoms. Seek medical attention right away if you are experiencing severe symptoms
+ If you had symptoms, please wait at least 7-10 days to take the test counting from the START of your symptoms. Sensitivity is higher 15-20 days onwards. Antibodies take time to develop – taking the test too early may not give accurate results.

Click here to read more:

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Please refer to the WHO Statement on Antibodies and Immunity.

This following article also contains some good information:
https://www.nytimes.com/2020/04/19/us/coronavirus-antibody-tests.html

We are offering a limited amount of testing to our patients on a sign-up list. To enroll in our study please sign up.

Sign Up Now If you are experiencing active symptoms of potential COVID-19 such as fever and difficulty breathing, seek medical attention right away.

LIMITATIONS OF THE TEST
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LIMITATIONS OF THE TEST
1. This test detects the presence of SARS-CoV-2 IgM/IgG in the specimen and should not be used as the sole criteria for the diagnosis of SARS-CoV-2 infection.
2. Test results must be considered with other clinical data available to the physician.
3. For more accuracy of immune status, additional follow-up testing using other laboratory methods is recommended.
4. Neither the quantitative value nor the rate anti- SARS-CoV-2 IgM/IgG concentration can be determined by this qualitative test.

NOTIFICATION FOR COVID-19 ANTIBODY TESTS
1. This test has not been reviewed by the FDA.
2. 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.
3. 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.
4. 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 or past or present infection with SARS virus (no. 6).
5. Not for the screening of donated blood.
The test we offer is not intended to diagnose or treat disease. This test is not intended to be a substitute for seeking professional medical advice, help, diagnosis, or treatment.

FAQs

If you have any questions or concerns that are not addressed below, please email us at covid19@hudsonmedical.com.
Is this Test FDA Authorized?

This COVID-19 IgM/IgG Rapid Test is being made available under Emergency Use Authorization, per guidance issued by the U.S. Food and Drug Administration (FDA) titled “Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency,” which was issued on March 16, 2020. FDA issued this guidance to help accelerate the availability of novel coronavirus (COVID-19) diagnostic tests developed by laboratories and commercial manufacturers during the public health emergency. These tests have not been reviewed by the FDA.

Why do you measure Antibodies?

The detection of antibodies in blood serum can help assess the likelihood of past as well as present infection, and are meant to be used as an aid to health care professionals in diagnosing the mid- to later stages of the viral infection. Along with other information, such as the presence of symptoms, the tests may help health care professionals assess whether individuals (including health care workers) have recovered from the virus. Follow-up testing with a molecular diagnostic should be considered to confirm or rule out infection.

What can I do if my results show I have immunity?

If you test positive for the antibodies, please consider contacting a blood bank or hospital to donate blood. New York City hospitals have started isolating blood plasma (where all the antibodies are contained) from patients who are immune to COVID-19. The plasma is then transferred to critically ill patients to boost their immune systems, to help them fight against the infection.

Please refer to your local guidelines on Return to Work or Release from Home Isolation protocols.