Antibody Testing Information
At this time, Centura Health is not offering antibody tests for COVID-19 (also known as serological tests). Due to the lack of precision of these tests, which includes the potential for false positives/negatives and misleading results, we continue to rely on PCR testing (nasal swab). We are eager to deploy a clinically-proven antibody test and continue to monitor the reliability of each product as they are brought to market. Please find answers to many of your antibody testing questions below.
Antibody Testing FAQs
Q1: Can I get tested for COVID-19 antibodies at Centura Health?
A1: At this time, we are not offering antibody tests for COVID-19 (also known as serological tests) which look for antibodies for this virus in your blood. Due to the lack of precision of these tests, which includes the potential for false positives/negatives and misleading results, we continue to rely on PCR testing (nasal swab). We are eager to deploy a clinically-proven antibody test and continue to monitor the reliability of each product as they are brought to market.
Q2: What is a serological test?
A2: Serology tests, also called antibody tests, test for the presence of recently-produced anti- antibodies, which the body produces to fight infection.
Q3: Are COVID-19 antibody tests effective?
A3: There are now over 70 “rapid” devices marketed that claim to detect IgG and/or IgM antibodies to SARS-CoV-2 (the virus that causes COVID-19 infection) in minutes. However, many of these tests are not FDA approved, and interpreting results is challenging since we do not know the source or make up of the antigens used in the tests. Therefore, a positive test cannot be used to infer immunity or even definite exposure to SARS-CoV-2, as most of these tests also produce positive results if they detect the presence of antibodies against other endemic coronaviruses (HKU1, OC43) that predictably circulate in the U.S annually.
Q4: Are existing antibody tests FDA approved?
A4: To date, only four vendors of antibody tests have applied for and received FDA Emergency Use Authorization (EUA) clearance.
For the remaining tests being brought to market, we do not understand how their test was put together, validated or how their performance claims were determined. This means the results of these tests provide unreliable clinical data.
Additionally, current FDA guidance documents state that non-EUA cleared serology tests can only be performed in CLIA-certified or CAP-accredited high complexity laboratories; these are not considered point-of-care or waived tests by the FDA.
Q5: Why are there so many types of antibody tests available if they’re not FDA approved?
A5: It is important to understand that during this public health emergency, the FDA has suspended the normal rigid manufacturing oversight, clinical trials and review processes required for approval of diagnostic laboratory tests. Regarding COVID-19, this allows companies to develop and distribute any serology assay provided the vendor has “validated” performance, results are released with test limitations and the FDA has been notified. But importantly, simple notification is not the same as obtaining Emergency Use Authorization (EUA) from the FDA, which requires the product manufacturer to submit performance data to the FDA for review.
Q6: If I test positive for antibodies, should I quarantine myself?
A6: At this time, we do not recommend patients be placed in COVID-19 isolation based solely on antibody testing they may have had. Serology is not diagnostic. If a patient presents to the Emergency Department at one of our Centura facilities, they will be assessed using our current guidelines which are based on the patient’s current symptoms and medical and exposure history. They should be isolated if there is concern or if they have signs or symptoms that would suggest an active infection.
Q7: Does a positive antibody test mean I’m safe from COVID-19?
A7: In addition to the concerns about effectiveness of the tests, as outlined above, immunity to endemic (Non SARS-CoV-2) coronaviruses is incomplete and re-infection can occur. At present, we need to assume this may also be true for SARS-CoV-2, so a positive antibody test doesn’t indicate complete protection from re-infection.