Background: Over the last years, allergy diagnostics has significantly advanced with the introduction of multiplex tests, which enable the simultaneous detection of specific IgE to multiple allergens in a single step of analysis. This approach offers several advantages over singleplex tests, including reduced sample volume, costs and a more precise characterization of the sensitization profile of the patient. However, the adoption of multiplex testing in Italian clinical laboratories is influenced by various factors, including its inclusion within the Essential Levels of Care (LEA), associated costs, clinician prescriptions, and the technological choices of individual laboratories. This survey aimed to assess the current prevalence of multiplex testing in Italian laboratories, evaluating selection criteria, implementation methods, operational and administrative barriers, and future prospects in comparison to singleplex testing. Methods: A 36-question survey, divided into five sections and designed on the SurveyMonkey platform, was distributed via e-mail in July 2024 to public and private nationwide laboratories. The questionnaire covered aspects such as the inclusion of multiplex tests within regional LEA frameworks, the number of annual tests, technologies employed, and the rationale behind the choice of specific diagnostic platforms. Additionally, pricing models and administrative procedures for test provision were explored. Another section investigated laboratory perspectives on the future of multiplex testing relative to singleplex, assessing perceived obstacles and potential developments. Results: Analysis of responses from 44 participating laboratories, based on data from 2023, revealed considerable variability in the adoption of multiplex testing. Only 30.95% of laboratories reported that the test is included in their regional LEA catalog, while 64.29% indicated that it is not currently reimbursed at an institutional level. Consequently, more than half of the laboratories offer the test exclusively as a paid service. In terms of execution, 59.09% of laboratories conduct multiplex testing in-house, whereas the remaining 40.91% outsource samples to reference laboratories, primarily due to low demand or a lack of internal expertise. From a technological standpoint, the two most commonly used platforms are the ISAC Microarray (ImmunoCAP ISAC, Thermo Fisher Scientific, Uppsala, Sweden) (57.14%) and the Macroarray ALEX (MacroArray Diagnostics, Wien, Austria) (33.33%), with a smaller proportion of laboratories utilizing both (9.52%). The choice of platform is influenced by various factors: laboratories favoring ALEX highlight its ability to measure a larger number of molecules (86.67%) and analyze allergen extracts (60.00%), whereas those preferring ISAC emphasize its strong scientific validation (52.63%) and good test reproducibility (42.11%). Regarding future perspectives, 25.64% of respondents believe that multiplex testing will become more widespread only if included in the LEA, while 28.21% do not anticipate significant growth in its adoption. Additionally, 17.95% predict that multiplex testing will gradually replace singleplex, although 7.69% believe this will only occur if associated costs decrease. Conclusions: While multiplex testing represents a major innovation in allergy diagnostics, its adoption remains limited due to regulatory, economic, and organizational challenges. The lack of a standardized reimbursement code within regional LEA systems leads to disparities in test accessibility, complicating both clinical prescriptions and financial viability for laboratories. Nonetheless, most respondents anticipate increased use of multiplex testing in the future, particularly for complex or unresolved cases where other diagnostic methods fall short. In some instances, it is already being used as a first-line test, especially in the context of food allergies.
National survey on behalf of the Italian Study Group of Allergy (GdS-All) on the use of the multiplex allergy test In Italian laboratories in 2024 [indagine nazionale 2024 sull’utilizzo del test multiplex per la determinazione di IgE specifiche nei Laboratori italiani di allergologia]
CAPONI, Laura;
2025-01-01
Abstract
Background: Over the last years, allergy diagnostics has significantly advanced with the introduction of multiplex tests, which enable the simultaneous detection of specific IgE to multiple allergens in a single step of analysis. This approach offers several advantages over singleplex tests, including reduced sample volume, costs and a more precise characterization of the sensitization profile of the patient. However, the adoption of multiplex testing in Italian clinical laboratories is influenced by various factors, including its inclusion within the Essential Levels of Care (LEA), associated costs, clinician prescriptions, and the technological choices of individual laboratories. This survey aimed to assess the current prevalence of multiplex testing in Italian laboratories, evaluating selection criteria, implementation methods, operational and administrative barriers, and future prospects in comparison to singleplex testing. Methods: A 36-question survey, divided into five sections and designed on the SurveyMonkey platform, was distributed via e-mail in July 2024 to public and private nationwide laboratories. The questionnaire covered aspects such as the inclusion of multiplex tests within regional LEA frameworks, the number of annual tests, technologies employed, and the rationale behind the choice of specific diagnostic platforms. Additionally, pricing models and administrative procedures for test provision were explored. Another section investigated laboratory perspectives on the future of multiplex testing relative to singleplex, assessing perceived obstacles and potential developments. Results: Analysis of responses from 44 participating laboratories, based on data from 2023, revealed considerable variability in the adoption of multiplex testing. Only 30.95% of laboratories reported that the test is included in their regional LEA catalog, while 64.29% indicated that it is not currently reimbursed at an institutional level. Consequently, more than half of the laboratories offer the test exclusively as a paid service. In terms of execution, 59.09% of laboratories conduct multiplex testing in-house, whereas the remaining 40.91% outsource samples to reference laboratories, primarily due to low demand or a lack of internal expertise. From a technological standpoint, the two most commonly used platforms are the ISAC Microarray (ImmunoCAP ISAC, Thermo Fisher Scientific, Uppsala, Sweden) (57.14%) and the Macroarray ALEX (MacroArray Diagnostics, Wien, Austria) (33.33%), with a smaller proportion of laboratories utilizing both (9.52%). The choice of platform is influenced by various factors: laboratories favoring ALEX highlight its ability to measure a larger number of molecules (86.67%) and analyze allergen extracts (60.00%), whereas those preferring ISAC emphasize its strong scientific validation (52.63%) and good test reproducibility (42.11%). Regarding future perspectives, 25.64% of respondents believe that multiplex testing will become more widespread only if included in the LEA, while 28.21% do not anticipate significant growth in its adoption. Additionally, 17.95% predict that multiplex testing will gradually replace singleplex, although 7.69% believe this will only occur if associated costs decrease. Conclusions: While multiplex testing represents a major innovation in allergy diagnostics, its adoption remains limited due to regulatory, economic, and organizational challenges. The lack of a standardized reimbursement code within regional LEA systems leads to disparities in test accessibility, complicating both clinical prescriptions and financial viability for laboratories. Nonetheless, most respondents anticipate increased use of multiplex testing in the future, particularly for complex or unresolved cases where other diagnostic methods fall short. In some instances, it is already being used as a first-line test, especially in the context of food allergies.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
