Heart of the Rockies Regional Medical Center (HRRMC) has announced it is now equipped to perform coronavirus antibody testing. This specific antibody test is performed through a regular intravenous blood draw, assessing for IgG antibodies to the nucleocapsid protein of the COIVD-19 (SARS-CoV-2) virus.
Allison Gergley, HRRMC Marketing, and Public Relations Director said the antibody test is only available via a doctor’s prescription.
“The test is not approved or cleared by the FDA at this time,” Gergley said in a press release, “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 reinfected, the release stated.
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 the history of clinical signs and symptoms – in mind. The presence of antibodies strongly suggests that the patient has been exposed to the SARS-CoV-2 virus in the past.
The medical provider who orders 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,” said Dr. Erika Gelgand, HRRMC lead physician for COVID-19. “For these reasons, we will not be using the results of these tests to make staffing decisions or decisions about the utilization of our personal protective equipment.”
A fact sheet for healthcare providers discussing answers to commonly-asked antibody questions is available on the Laboratory page at HRRMC.com. Patients can obtain their fact sheet online or also request a copy in person.