Allergy Samples for Component and Multiplex Assays: What to Consider

Allergies affect more people than ever before, but a positive allergy test does not always tell the full story. Through supplying human allergy samples to test developers and control manufacturers, we see the growing need for specimens with well-defined sensitisation profiles. These materials help developers evaluate assay performance and investigate cross-reactivity. Testing for individual allergen components is becoming an important part of that work, providing more detail about the IgE responses detected.

Are allergies increasing?

The evidence is particularly clear for recorded food allergy in England. A study of primary care records found that the rate of new, probable food allergy cases more than doubled between 2008 and 2018, rising from 75.8 to 159.5 cases per 100,000 people per year. Recorded prevalence was highest in children under five, reaching 4.0% in 2018.¹ Improved recognition or recording may account for some of the increase, but the findings point to a substantial and growing diagnostic workload.

The burden extends beyond food allergy. In the United States, 2024 survey data found that 20.6% of children had a diagnosed seasonal allergy, 12.7% had eczema and 5.3% had a diagnosed food allergy.² These conditions are biologically linked, sharing underlying mechanisms involving the skin and other protective barriers, immune regulation and the development of allergic sensitisation.

The rise in allergies is thought to be driven by a combination of genetic, environmental and lifestyle factors, including changes in diet, reduced exposure to diverse environmental microbes, air pollution and greater exposure to allergens. As allergies become more common, healthcare systems are also seeing more severe allergic reactions, with hospital admissions for food-induced anaphylaxis increasing substantially over recent decades.

Allergen-specific IgE positive results need context

An allergy investigation starts with the person’s symptoms and exposure history. Skin prick tests and blood tests for allergen-specific IgE can then help identify sensitisation. A positive result shows that the immune system recognises an allergen, it does not establish that exposure will elicit a reaction. This matters when an individual tests positive for several foods, pollens or other allergen sources. IgE may recognise similar allergen proteins across different sources, or shared carbohydrate structures known as cross-reactive carbohydrate determinants (CCDs). Allergen protein cross-reactivity can cause symptoms, whereas IgE binding to conventional CCDs usually has little clinical significance. Distinguishing these patterns helps determine whether multiple positive results indicate separate allergies, clinically relevant cross-reactivity or sensitisation without symptoms. ³

What does allergen component testing add?

Traditional extract-based tests measure IgE binding to a mixture of proteins from an allergen source. The individual may be allergic to one or more proteins contained within the source, but probably not all of them. Allergy component testing measures IgE to individual allergenic molecules. This additional detail can help identify whether a positive result reflects sensitisation to the suspected allergen or cross-reactivity with a similar allergen, particularly when test results do not match the patient’s clinical history.⁴ Peanut provides an example. IgE to the peanut component Ara h 2 can support a diagnosis of peanut allergy, while a response to Ara h 8 may be associated with birch pollen cross-reactivity.

The distinction has practical consequences. More precise information may help clinicians decide which results need further investigation and which foods a patient may need to avoid. However, component testing does not replace clinical assessment, and a component-specific IgE result cannot reliably predict the severity of a future reaction. ⁵

Allergy samples: Requirements behind different allergy assays

The global allergy IVD market includes established single-analyte testing systems as well as platforms that assess numerous allergens and components together. Their specimen needs overlap, but they are not interchangeable. A sample known only to be “allergy-positive” may be of limited use when a developer needs to investigate a particular molecule, concentration range or pattern of cross-reactivity.

Whole-allergen positive specimens can support development and evaluation of extract-based tests. High-titre specific-IgE specimens may be needed to assess the upper measuring range or manufacture controls. Component-characterised specimens allow researchers to investigate responses to defined targets, such as Ara h 1, 2, 3 and 6. Multi-sensitised specimens can be especially useful for multiplex platforms, where several results are generated from the same patient sample; a dust-mite profile, for example, may include reactivity to Der p 1, Der p 2 and Der p 23.

The value of each specimen depends on the supporting data. Relevant details may include specific-IgE results, tested components, concentration or titre, sample volume, matrix, date of collection and anonymised donor information. Access to specimens with different response levels and profiles helps developers assess analytical performance, investigate cross-reactivity and understand how results compare across methods.

Supporting the next generation of allergy tests

The rise in recorded allergy is increasing demand for testing, while component diagnostics are raising expectations for what those tests can explain. As allergy testing becomes more detailed, the most useful allergy samples are the ones characterised for the intended application. A whole-allergen assay, a peanut component test and a broad multiplex panel may all require different combinations of positive, low-positive, high-titre and multi-sensitised samples.

At Logical Biological we understand that access to well-characterised allergen materials is central to developing assays that deliver results clinicians can interpret with confidence. We provide serum and plasma specimens with documented reactivity, relevant component results and dependable access to material, helping developers build evidence for assay performance and control manufacturers produce consistent materials over time.

See our full list of Allergen material

References

1. P Turner et al. Time trends in the epidemiology of food allergy in England: an observational analysis of Clinical Practice Research Datalink data. Lancet Public Health. 2024 September;9(9):e664-e673. DOI: 1016/S2468-2667(24)00163-4
2. Diagnosed Allergic Conditions in Children Ages 0−17: United States, 2024. NCHS Data Brief No. 546, January 8, 2026. https://www.cdc.gov/nchs/products/databriefs/db546.htm
3. A Santos et al. EAACI guidelines on the diagnosis of IgE-mediated food allergy. Allergy 2023 December;78(12):3057-3076. https://doi.org/10.1111/all.15902
4. S Dramburg et al. EAACI Molecular Allergology User’s Guide 2.0. PAI 2023 April. https://doi.org/10.1111/pai.13854
5. H Sampson et al. AAAAI–EAACI PRACTALL: Standardizing oral food challenges – 2024 Update. PAI 2024 November. https://doi.org/10.1111/pai.14276