This antibody test is only available via a doctor’s prescription.
SALIDA, Colo.–Heart of the Rockies Regional Medical Center is now equipped to perform antibody testing. This specific antibody test is performed through a regular intravenous blood draw, assessing for IgG antibodies to the nucleocapsid protein of the SARS-CoV-2 virus.
This antibody test is only available via a doctor’s prescription. The test is not approved nor cleared by the FDA at this time, but the FDA has granted Emergency Use Authorization (EUA) access to this test. Please note that antibody testing is not used to diagnose an active COVID-19 infection; that can only be performed via a nasopharyngeal swab molecular RNA test. Additionally, the presence of antibodies does not imply that the patient has developed protective immunity against the virus; one must still assume that the patient could be re-infected.
Antibodies typically take 10 to 14 days after the onset of symptoms to be detectable in blood. Test results are only reported as “antibody detected,” or “antibody not detected. ”False positives(i.e., if the patient has antibodies to other common coronaviruses, such as the common cold) and false negatives occur, so the test must be interpreted by the medical provider keeping the patient’s medical history-including history of clinical signs and symptoms–in mind. The presence of antibodies strongly suggest that the patient has been exposed to the SARS-CoV-2 virus in the past. The medical provider who ordered the test on behalf of the patient will be responsible for providing the test results to the patient and explaining the significance and limitations of the test results to the patient. “Antibody detected” results will be shared with Chaffee County Public Health for epidemiological purposes only.
“This antibody test is not FDA approved. It is not an appropriate test to diagnose active disease, and does not show immunity to COVID-19. It is used to show possible previous exposure to the virus, however, false positive and false negative results occur. For these reasons, we will not be using the results of these tests to make staffing decisions, or decisions about utilization of our personal protective equipment,” said HRRMC lead physician for COVID-19 Erika Gelgand.
A face sheet for patients and recipients, and a fact sheet for healthcare providers discussing answers to commonly-asked antibody questions are available on the Laboratory subpage of hrrmc.com. Patients can also request a copy of the fact sheet in person.
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