COVID-19 Antibodies Testing

COVID-19

RAPID lgM/lgG Antibody Testing

Our COVID-19 Rapid Test is a highly sensitive and accurate serum assay for viral antibodies proven to be 96.1% sensitive, 96.7% specific, and 97.41% accurate.

What is the COVID-19 Rapid Antibody Test?
The COVID-19 Rapid Antibody Test is designed to detect antibodies that are produced by the body in response to the virus that causes COVID-19. COVID-19 antibodies are proteins which the body produces days or weeks after fighting the infection, and typically indicate an individual has developed an immune response after recovering from the virus, even if a person didn’t exhibit any symptoms of the COVID-19 disease.
How accurate are the IgM/IgG Antibody Tests results?

Developed by Ray Biotech and manufactured in the USA, the first validation study was submitted to the FDA in March 2020. The relative accuracy of the test was 95.72%.

Relative accuracy is a reflection of “specificity” and “sensitivity”:

Specificity refers to the detection of antibodies developed specifically in response to SARS-CoV-2, the virus that causes COVID-19 (and reflects potential for false positive results): 100% (0% false positives)

Sensitivity refers to the test’s ability to detect antibodies (and reflects potential for false negative results): 94% (6% false negatives due to several samples read 4-6 days post infection)

How is the COVID-19 Rapid Antibody Test administered?

A fingerstick is used to collect a small amount of blood from your finger to be tested. The healthcare professional will then apply your blood on the Test, which will show results within 15 minutes.

Why Test for Antibodies to COVID-19?

Antibodies have been found to be highly sensitive biomarkers in infectious disease diagnosis. Previous studies on SARS, MERS, and more recently the ones on SARS-CoV2 have shown IgM antibodies to appear about 3 days from infection and IgG antibodies appear after 8 days. Profiling an individual’s antibody response is the only way to determine infections with few or no symptoms.

What does it mean if the test is positive (IgG and IgM)?

Your result may indicate that you have contracted COVID-19 and that you may need to quarantine to avoid spreading the virus to other individuals. The exposure likely happened 7-40 days before the test was taken. We will recommend an immediate nasal swab to confirm if you are currently infectious or not as false positives are possible. We will recommend you to self-quarantine for two weeks and retest at that time unless your nasal swab comes back negative.

A positive result may also indicate previous infection that is no longer active. There is also the small chance that this Test provided a false positive result, which could be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E, or such false positive could arise from other factors.

What does it mean if I test negative (IgG and IgM)?

A negative (IgG and IgM) test results means the antibodies to the virus that causes COVID-19 were not detected in your sample. You have not had COVID-19, are not immune to it, and are not currently creating an antibody response, which likely means you are not infectious. However, if you have been exposed in the last 3-5 days you may not show up positive even if you are carrying the virus. A false negative could also arise from other facts involving the Test, the blood sample or the testing procedures. This false negative result means that you could possibly still have contracted COVID-19 even though the Test result is negative.

What does it mean if the test is positive (IgG)?

A positive lgG Test result means that you were exposed to COVID-19 in the past and may be immune moving forward, although the research is still unclear. It is unlikely that you are infectious, however, please continue adequate hygiene and distancing measures. If you would like to further discuss what this means please schedule with one of our doctors.

What does it mean if the test is positive (IgM)?

A positive lgM Test result means that you may have had a recent exposure (3-10 days ago) to COVID-19 and may be infectious. We will recommend an immediate nasal swab to confirm if you are infectious or not as false positives are possible. We will recommend you self-quarantine for 3 weeks and retest at that time, unless your nasal swab comes back negative.If you experience symptoms of fever, cough, or shortness of breath please contact your local ER.

What is the difference between PCR testing, antigen testing and antibody testing?

Both PCR and antigen testing are intended to diagnose active COVID-19 infections, using saliva or a nasal swab. While an individual has an active infection, both PCR and antigen test will be positive. Once an individual has recovered, both the PCR and antigen test will be negative. Antibody tests do not detect active infection. Instead, they are designed to detect an immune response to a past exposure to COVID-19. Antibody tests conducted too early following an infection (<7 days) will read negative. Once an individual develops an immune response, the antibody test will read positive.

Is the test covered by insurance?

We do not accept insurance at the moment; however, we will provide supporting materials to help you file a claim, including the physician order and invoice with billing codes. We can not guarantee reimbursement.

Is this test FDA approved?

While the Test has been submitted for FDA review, it is not yet cleared or approved by the US FDA. In instances where there are no FDA-approved or cleared tests available, the FDA can make tests available under Emergency Use Authorization (EUA). The EUA for this rapid Test is supported by the Secretary of Health and Human Services.

In March 2020, the manufacturer of the Test submitted an Emergency Use Authorization (EUA) to the FDA. While this application is under review, please note the following information:

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 or immunity.
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.

How can I get more information about the test and my rights?

The most current information on COVID-19 is available on the CDC General webpage: https://www.cdc.gov/coronavirus/2019-ncov/

If you have more questions about the test, please ask our medical personnel or call your local health department.

NOTE: This test has been notified and validated to the FDA. Pursuant to FDA’s guidance as clarified by the April 22, 2020 FDA Town Hall and the May 4, 2020 statement issued by CDRH, this test is being distributed on the basis that it has been validated and submitted to FDA for an EUA according to the templates required for validation. The test is pending EUA FDA authorization. We do not claim that the test can diagnose COVID or that it should be used for diagnostic purposes. We note FDA’s May 4, 2020 statement ‘Antibody tests should only be used as part of a well-conceived testing plan and why the results should always be interpreted by appropriate experts.

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