Scientists call for standardisation of allergy tests after laboratory trials showed commercially available tests are not uniformly reliable

Published

Friday, September 1, 2023 - 9:00 AM

Dr Thimo Ruethers from James Cook University’s Australian Institute of Tropical Health and Medicine (AITHM) and JCU’s Tropical Futures Institute (TFI) in Singapore led the study.

He said shellfish allergy affects up to three per cent of the general population, is usually lifelong and commonly triggers anaphylaxis – a condition that leads to respiratory collapse and can be fatal. In Australia, shellfish allergy is the number one trigger of food-related fatal anaphylaxis.

“Skin prick testing (SPT) is often the preferred first-line diagnostic approach. This involves a health worker placing a drop of allergen extract on the surface of the arm then pricking through it into the arm. If you are allergic to the allergen you will have a small, itchy swelling and a reddening of the skin after 10-15 minutes,” said Professor Dianne Campbell, Centre for Allergy Research Chief Investigator from The Children’s Hospital at Westmead, Sydney.

But Dr Ruethers warned that widely utilised allergen extracts in commercial SPT kits are generally not standardised, limiting the diagnostic value of results.

“In 2019, we demonstrated considerable variability in effectiveness for 27 commercial SPT extracts for fish allergy.

“In the current study, using biochemical and immunological methods and mass spectrometry, we tested 11 commercial crustacean and five mollusc SPT extracts and found even greater, critical variability in their reliability,” said JCU’s group leader Professor Andreas Lopata.

The scientists concluded that some of the SPT extracts lacked the sufficient amount and diversity of important shellfish allergens, meaning test results could be falsely negative, putting lives at risk.

“Standardisation of allergen extracts is urgently needed to improve the accuracy and reliability of SPTs.

“Also, improvements in blood tests, along with the development of region-specific allergen extracts with known quantities of clinically well-characterised allergen components, are critical to achieve considerable improvements in allergy testing,” said Dr Ruethers.

He said developing more reliable allergy diagnostics requires further interdisciplinary research and is urgently needed to safeguard allergy sufferers globally.

Dr Ruethers said food allergies pose major public health concerns, lower the quality of life and can be fatal.

This research received funding from the National Health Medical Research Council (NHMRC).  Dr Ruethers is being supported by CFAR to present his findings at the Hot Publications session at the upcoming ASCIA conference in Sydney (5-8 Sep).