Action News Jax Investigates Jacksonville Chiropractor’s claims surrounding “… allergy testing that also detects COVID-19 …”

JACKSONVILLE, Fla. — In an email obtained by Action News Jax Investigates on Monday, Physical Healthcare of Jacksonville told its patients, in part, “… as a service, not only to our patients, but the entire Jacksonville community, we now provide allergy testing that also detects COVID-19…”

The email described a sample collection kit that would be sent to patients’ home, for them to mail to the lab for testing. The message said participants would have results sent to the chiropractor’s office within 48 hours.

Action News Jax called the office on Wednesday to get more information about the test described in the email.

Thursday afternoon, a Physical Healthcare of Jacksonville doctor returned our call, saying they wanted to help patients determine whether any symptoms they may have originated from allergies or COVID-19.

The doctor went on to say they’d decided to stop using the test to determine whether someone has been exposed to COVID-19, because the test hasn’t yet been reviewed by the FDA.

Action News Jax also obtained a follow-up email sent to Physical Healthcare of Jacksonville patients on Thursday, saying in part, “… our laboratory is awaiting one final step of approval in the testing process, so out of extreme caution for our patients we are halting that portion of our allergy testing…”

The doctor also pointed Action News Jax in the direction of the laboratory doing the testing --- the ‘Arrayit Corporation,’ based in California.

An Arrayit spokesperson tells Action News Jax their testing methods check blood samples for antibodies made in response to the presence of both allergies and the coronavirus.

“Blood will be taken; the sample will be then parsed into two different assays. One assay will be used to interrogate [Immunoglobulin E antibodies] for an allergic response. Arrayit will look at 48 different food allergens, and 72 different environmental allergens, and publish a report back to the doctor, that would be up to them to share with patient, that tells what the patient’s allergic responses are,” said spokesperson Paul K. Haje. “A second sample will be drawn from the card, and be used in another assay that will make a determination if the patient has an [Immunoglobulin G antibodies] response to one of 12 different unique markers for COVID-19.”

While the Arrayit test has not yet been reviewed by the FDA, the company is operating under FDA guidance.

According to its website, the FDA issued a policy on blood tests in March to allow “… developers to market their tests without prior FDA review if certain conditions outlined in the guidance document are met…” The FDA released a statement this week on its guidance surrounding blood tests, which can be found here.

Family Allergy and Asthma Consultants president, Dr. Sunil Joshi, explained what consumers should know before using an antibody test.

“It doesn’t tell you right now whether you’re infected, what it can do is tell you whether you have been infected in the past,” said Dr. Joshi. “But I think most people are concerned with, am I contagious, do I have COVID-19? Do I need to self-isolate? And those are the answers you’re not going to get from antibody test.”

On Friday, Haje sent Action News Jax the following statement:

“Thank you for the fair and unbiased reporting.

"As a result of your good work, Arrayit has put a review process in place to examine the messaging and educate the Clinics on how to properly communicate to their patient base. Arrayit has assigned an Executive with a degree in Journalism to conduct the reviews.

"This applies to all 1,400 clinics in the United States that offers the COVID-19 Antibody Screen in addition to the Allergy Test.

"Arrayit believes it is an important test to make available and wants the patients to be able to make an informed decision on the test should they decide to take it. Arrayit is using the news piece as a breeder document to help educate the Clinics offering the test.

"Thank you for your work and bringing this to our attention, these are scary times and precise and accurate reporting is critical for all of us, your viewers”

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