Test for allergy to COVID-19 vaccines - Basophil activation test

Allergic reactions to the Covid-19 vaccines

To date, isolated cases of allergic reactions to COVID-19 vaccines have been reported. The first cases occurred in the USA and the UK after the approval of the Pfizer-BioNTech COVID-19 vaccine.

There are two vaccine types that can cause immediate allergic reactions:

• the ingredient PEG-2000 (polyethylene glycol-2000) contained in Pfizer-BioNTech and Moderna vaccines
• polysorbate 80, contained AstraZeneca and Johnson & Johnson vaccines.

An article published in January 2021 in the World Allergy Organization Journal reported the incidence of allergic reactions from the Pfizer-BioNTech vaccine in the U.S. was 1:200,000 doses and in Moderna’s vaccine 1:360,000.
Since then there have been reports in the international literature with the phenomenon not being considered common enough.

Which categories of patients are recommended to be tested for allergy to the coronavirus vaccine?

The Greek Allergy Society recommends that patients with the following history should be tested:

1. Reaction to products containing PEG, where sensitisation to the active ingredients has been excluded.
2. Reaction to gut formulations containing PEG.
3. Repeated reactions to unrelated medicines and products. Sometimes they are diagnosed as “idiopathic anaphylaxis”.
4. Reaction only to certain trade names or doses of the same medicines and therefore not to the active substance (therefore a possible reaction to excipients of a specific trade version of the medicine).
5. Reactions after invasive procedures or perioperative manipulations.

People with a history of allergic reactions to previous vaccinations and/or mast cell activation syndrome/idiopathic anaphylaxis are advised to contact an allergist before the upcoming vaccination.

How is the diagnosis of allergies to COVID-19 SaRs-Cov-2 vaccines made?

The basophil activation test (BAT test) is the only way to diagnose vaccine-associated allergies to COVID-19. The specific test, in addition to the coronavirus vaccines and their main excipients PEG-2000 (and the pfizer & moderna plasmid) and Polysorbates – 80,is also used to diagnose allergies to drugs, food allergens, insect venoms, etc.

Which people are entitled to a vaccine exemption for Covid-19 coronavirus?

Recently, this particular test – the Basophil Activation Test – BAT was included in the Government Gazette Issue B’ 3794/13.08.2021, which concerns the procedure and the reasons for exemption from the mandatory vaccination. Specifically, it states:

Natural persons shall be exempted from the application of the compulsory measure of vaccination against the coronavirus COVID-19 for the following reasons:

• Persons, who have displayed severe allergic reaction (e.g. anaphylaxis) after administration the previous dose of the vaccine. In this case, an opinion of an allergist specialist must be presented to the relevant health committee, certifying the severity of the reaction, the time of onset and duration of the reaction, as well as its association with a specific COVID-19 vaccine.
• persons with a diagnosed allergy (by in vivo dermal or in vitro basophil stimulation tests) to a component of the vaccine and in particular to the following ingredients: polyethylene glycol (PEG) 2000, for Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) vaccines, and polysorbate 80, for AstraZeneca (Vaxzevria) and Johnson & Johnson (Janssen) vaccines. In this case, an opinion of an allergy specialist shall be submitted to the relevant health committee certifying the diagnosis of the allergy and the severity of the reaction to the named component of a specific type of COVID-19 coronavirus vaccine, as appropriate.
• Individuals who developed Thrombosis with Thrombocytopenia Syndrome (TTS) after the first dose of Astra Zeneca and Johnson & Johnson COVID-19 corticovirus vaccines. In this case, an opinion from a medical specialist certifying the occurrence of the thrombosis syndrome, and the time of its onset after the first dose of the COVID-19 coronavirus vaccine, shall be submitted to the relevant health committee. As a contraindication and reason for exemption from vaccination, another adverse reaction of equivalent severity to the above, attributed by the attending physician with specific scientific documentation to the first dose of the vaccine, may be considered by the committee. In this case, the relevant committee shall assess the severity of the adverse reaction and its association with a specific type of vaccine or with all existing vaccines.
• Individuals with a history of heparin-induced thrombocytopenia (heparininduced thrombocytopenia), or with a history of antiphospholipid syndrome (antiphospholipid syndrome-APS), or capillary leak syndrome. In this case, an opinion of a medical specialist certifying the existence of the syndrome, its impact on the health of the applicant and the contraindication of a specific or any type of vaccine against COVID-19 coronavirus, with specific scientific documentation, shall be submitted to the relevant health committee.
• Persons with a history of myocarditis before vaccination against the COVID-19 coronavirus, provided that a medical certificate from a qualified cardiologist with a full report of the severity of the condition, the progress of rehabilitation and a parallel report of specific reasons for exemption or exclusion for a specific period of time, evaluated by the relevant health committee, is submitted. Individuals with a history of pericarditis prior to vaccination against COVID-19 coronavirus are not excluded.

Basophil Activation Test (BAT) for allergies to COVID-19 vaccines at StartBio

StartBio, from 2017 to date, performs the Basophil Activation Test (BAT test) for the diagnosis of allergies. In fact, since 2019 we have been able to identify the need to diagnose the specific drug allergy to polyethylene glycol PEG-4000 when it was announced at the European Congress of Allergy and Clinical Immunology (Anaphylaxis To Oral Administration Of A PEG Laxative Product Confirmed With Oral Challenge)

For more information about the diagnosis of allergy to COVID-19 vaccines and more specifically about the basophil activation test you can call the contact numbers:

• Landline: 211-4025423
• Mobile: 6932488458

Our main prioroty is the quality of our services and the provision of a timely result for our patients. We follow strictly certified protocols with the help of the most sophisticated analysis systems. More specifically:

• Use exclusively the kit of the Swiss BUHLMANN LABORATORIES: Flow CAST® Basophil Activation Test. This kit is the only one that has CE for diagnostic purposes and carries the patent for this application (US 8,563,258 B2; EP 2 037 269 B1).
• The analysis is performed with an Omnicyt™ CE-IVD cytometer (ISO 13485:2016).The Omnicyt™ cytometer provides a combination of accuracy, performance and reproducibility of clinical cell analysis. It includes a highly stable, state-of-the-art optical module consisting of a highly accurate and sensitive three-laser system capable of detecting 13 individual parameters simultaneously. In addition, it provides the possibility of acoustic-assisted hydrodynamic focusing for higher reproducibility and accuracy, even at high sample flow rates, suitable for detection of very small/rare cell populations.

Procedure for carrying out the basophil activation test (BAT test):

• Diagnosis is made by blood sampling – complete blood count in EDTA
• The sample is processed immediately
• Results are sent electronically within 48 hours after the blood draw

Instructions to patients before the basophil activation test is performed:

• The patient should not have taken systemic steroids, cyclosporine A, chromoglycic acid. In addition, he or she must not have taken cortisone for at least 24 hours.
• The patient should not have had any infection (bacterial or viral) for 3-4 weeks
• The patient should not have had any allergic reaction for 3-4 weeks
• Regarding patients under the care of an allergist, blood sampling should be done before applying skin tests and before any allergen challenge.

Diagnostic methodology of the BAT method (Basophil Activation Test)

1. The patient’s basophils are stimulated with the allergen polyethylene glycol PEG 2000.
2. Stimulated basophils versus unstimulated basophils are separated by flow cytometry.
3. If the stimulated basophils exceed 5% of the total basophils or the stimulation is >2 times the basal basophils (stimulation index SI>2 ) then the patient has a serious chance of reacting during vaccine application.

See more about the BAT Test (Basophil Activation Test) here

A few words about the founder of StartBio

Dr. Stella Taka is a molecular biologist with many years of research activity as a postdoctoral researcher at the Laboratory of Allergy and Clinical Immunology, at the 2nd Pediatric Clinic of the National and Kapodistrian University of Athens (NKUA). In recent years her main research activities have focused on the interaction between human respiratory pathogens (viruses and bacteria), and natural immunity in both healthy and allergic patients. She has participated as principal investigator in European projects NANOMYC, MIDAS, PREDICTA, iFaam, CURE. He has more than 25 scientific articles (h-index 8) and over 200 references , and is one of the inventors of the patent (Application number: 12001210.9) “Detection of leishmania”. She is an active member of the European Academy of Allergy and Clinical Immunology – EAACI. She has been involved in the field of diagnostics since 2009, responsible for molecular screening, mainly through genetic and molecular analyses of various diseases such as cystic fibrosis, thrombophilia, sexually transmitted diseases and in recent years since 2012 mainly with allergies and respiratory pathogens. More about Stella Taka’s research work on Google Scholar and ResearchGate.