Issues surrounding consumer‐bought food‐allergy testing

Abstract

Summary Background Allergy is increasingly reported by patients and members of the public, and there is evidence that the prevalence is increasing. Not all diagnoses have been made by clinicians, as direct‐to‐consumer (DTC) allergy tests are widely available online. Aim To determine if DTC allergy tests are processed in accredited laboratories and utilize validated methods, while providing an overview of the DTC allergy tests available. Methods Internet searches using ‘allergy test kit’ and ‘intolerance test’ were performed to identify DTC food‐allergy tests. Each company was contacted to enquire if they had ISO15189 accreditation, what methods of testing they used and what was the extent of individual clinical input used to guide the test requested or result interpretation. Results In total, 24 online companies providing DTC food‐allergy testing were identified, of which 22 were contactable. One laboratory had ISO15189 accreditation, which was also the only laboratory using clinically recognized specific IgE testing and had a clinician involved in the process. Other laboratories used bioresonance or IgG and involved a nutritionist at most. Conclusion Online DTC food‐allergy tests are largely misleading to the consumer and provided by unaccredited laboratories using controversial methodology. The dermatologist must politely discount these results and assess the role of food allergy in a patient’s skin disease on the merit of clinical history, supported by specific IgE testing as appropriate.

Direct-to-consumer tests advertised online in Australia and their implications for medical overuse: systematic online review and a typology of clinical utility

“…This may often target consumers on ‘diagnostic odysseys’ who are seeking answers for unexplained symptoms or unsatisfactory diagnosis in conventional medicine. For example, a number of tests in category 4 were tests for gastrointestinal conditions, which are known to be difficult to diagnose even in a clinical setting 8. However, providing non-evidence-based diagnosis and treatments may further harm consumers already in a vulnerable position.…”

“…While this study is set in Australia, the growing availability of DTC testing is a topic that is receiving increasing attention internationally 2 41 50–52. Earlier studies in the USA,6 UK7 8 and Europe53 also show a large variety and volume of DTC tests on sale. What is available to consumers, as reported in this study is time and jurisdiction-specific, due to the different IVD and laboratory regulations that influence the type and manner in which DTC tests can be sold and used 2 54.…”

“…For example, a number of tests in category 4 were tests for gastrointestinal conditions, which are known to be difficult to diagnose even in a clinical setting. 8 However, providing non-evidence-based diagnosis and treatments may further harm consumers already in a vulnerable position.…”

“…5 Studies of DTC tests in the USA and UK show a wide variety of diagnostic, screening and risk monitoring tests being available for direct purchase, suggesting consumers with and without symptoms are targeted. [6][7][8] However, only 15% of the DTC screening tests found in the USA were supported by evidence-based recommendations, 6 and in the UK, only 1 out of 24 companies offering allergy testing used approved methods from an accredited laboratory. 8 These findings suggest the need to scrutinise the clinical utility of DTC tests: whether the product leads to useful clinical decision-making and improved health outcomes.…”

“…[6][7][8] However, only 15% of the DTC screening tests found in the USA were supported by evidence-based recommendations, 6 and in the UK, only 1 out of 24 companies offering allergy testing used approved methods from an accredited laboratory. 8 These findings suggest the need to scrutinise the clinical utility of DTC tests: whether the product leads to useful clinical decision-making and improved health outcomes. Clinical utility depends on getting the right test for the right person at the right time.…”