About AllerDetect

It has been over fifty years since the discovery of IgE, and we are celebrating not only IgE but also the first laboratory test for allergy diagnosis, the RAST. The development of this assay allowed the first reliable identification of allergen-specific IgE. Since then, in vitro determination of allergen-specific IgE levels and accurate clinical history of allergy have been cornerstones of clinical diagnosis. During the last few decades, in vitro allergy technologies have improved laboratory aspects, such as automation and sample throughput. These advances in allergy in vitro diagnostics have led to an alarming increase in the ability to obtain testing for individuals suspected of suffering from allergic symptoms. Many of the tests are developed “in-house” and in some cases lack substantial scientific evidence. This is a major issue because these tests, in most cases, require sophisticated interpretation. The improper use of certain tests to make diagnoses, in the absence of supporting clinical evidence, can lead to poor patient care and can have a serious adverse impact on patient quality of life.

Issues with IgE Blood Testing

IgE Blood Sample, collection, storage, and shipment times are critical to ensure accurate and reliable results
IgE Blood Serum samples have a half-life of 3-4 days, a common crux of serological-based allergy testing.

Solution Using AllerDetect

Independent clinical publications have proven Dry Blood Spot (DBS) samples are stable up to 84 days.
Once received, our new fast track analysis will get results back sooner.
AllerDetect provides your clinic with reliable, accurate IgE blood testing without the former time constraint.

Our Dry Blood Spot (DBS) System uses whole blood to analyze a patient’s immune responsiveness for dietary antigens and environmental allergens.

One of the most comprehensive allergy tests currently available.
Designed to complement a formal diagnosis.
Simple to use Dry Blood Spot (DBS) test is performed quickly, without the need to draw blood.
DBS testing eliminates constraints associated with other types of tests.
Selection of test profiles – DIETARY & ENVIRONMENTAL
Complete Picture
- IgE – true/specific allergy
Enables the healthcare practitioner to develop personalized immune-therapeutic treatment and/or dietary plans.
A detailed report is produced for each patient.

Discussion

AllerDetect provides a cost-effective solution for clinicians When investigating symptoms associated with dietary and environmental substances that may cause IgE mediated (True Allergies). True Allergies, which represent only 2% of all allergic reactions, occur within minutes of ingestion or exposure. Common symptoms range from hives, rash and swelling of the lips or face to swelling of the throat, wheezing, sudden shortness of breath, eczema, bloating, diarrhea, constipation, and in more severe cases, pain, inflammation or weight problems, and other potentially

life-threatening reactions

AllerDetect uses whole blood extracted from a blood card to monitor a patient’s immune response to over food and environmental allergens using the AllerDetect in collaboration with the patient report. The AllerDetect is an ELISA-based multiplex assay for the identification of allergen-specific IgE immune complexes that trigger immediate allergy symptoms, “true allergies”. The early detection of the allergen-specific IgE immune complexes may prove to be invaluable in the identification of dietary antigens that may trigger an immune response that can affect multiple organs in some cases, be severe or even life-threatening. In addition to the sensitive and specific detection of allergen-specific IgE molecules, the AllerDetect simultaneously monitors the immune response (exposure) to the said allergen.

AllerDetect takes a snapshot of your immune response by surveying whole blood extracted from DBS cards for IgE markers associated with true allergies. A true allergy is an immune system response. It is caused by the body mistaking a food or item as a harmful substance and releasing antibodies to fight it. The adverse reaction is usually rapid and can be life-threatening, even at microscopic levels.

Differentiating Food Allergies And Food Intolerance - How to Read AllerDetect smart report

Confusion about the dietary allergy and dietary intolerance leaves the door open for misinterpretation. You may think the terms are synonymous, making them interchangeable but they are two very different conditions that require different therapeutic approaches to improve the wellness of the suffering individual. The term “food allergy” is often confused with the term “food intolerance”. The latter is a more general term used to describe a range of reproducible responses, including not only food allergy, but also adverse reactions arising from enzyme deficiencies (e.g., lactose intolerance), pharmacological effects (e.g., caffeine sensitivity), and non-defined idiosyncratic responses occurring when an offending food is given without a person’s knowledge (i.e., intolerance includes responses that do not involve the immune system). Misunderstanding food allergy and food intolerance may lead to unnecessary dietary restrictions. The AllerDetect and accompanying Smart Report provide clinicians with a tool to clear up the confusion.

The AllerDetect Report shows the results of the laboratory Allergy Test that provide evidence regarding the subject tested hypersensitivity to allergens. This is a brief explanation of the meaning of the numbers (the statistical certainty of the result) and other items that appear in the AllerDetect Report.

Our laboratory uses the AllerDetect for whole blood (DBS Cards) for IgE molecules (sIgE) that are specific for dietary allergens from individuals suffering from allergy symptoms. The AllerDetectpanels can be used to access an individual’s hypersensitivity to allergens. Analysis of the individual allergens may provide an early indication of a problem that may be brewing or in conjunction with other clinical factors may confirm the causative agent behind the allergy symptoms being displayed.

In the chart displayed in Table 1. Levels of IgE for a particular allergen are also divided into semi-quantitative classes, from class I to class V or VI. In general, class I and class II correlate with a low level of allergen sensitization and, often, with a low likelihood of a clinical reaction. On the other hand, classes V and VI reflect higher degrees of sensitization and generally correlate with IgE-mediated clinical reactions upon allergen exposure. The interpretation of a positive (i.e. “nonzero”) test result must be individualized on the basis of clinical presentation and risk factors. A specialist can make an important contribution by helping to interpret any positive test result or a negative test result that does not correlate with the patient’s history. The chart in table 1 correlates AllerDetect Dietary allergen results in ng/ml to the associated class, with a suggested interpretation.

Considerations

What does it mean to be positive to a specific dietary or environmental allergen?

A major problem with this question is the fact that for every lab there may be a different platform used to evaluate an individual’s hypersensitivity to a specific allergen by reactivity to IgE or IgG. Many of these platforms don’t employ the universal standardization system for reporting allergen-specific IgE test results. In most cases, these non-standard reference ranges are not supported by clinically relevant data and/or properly managed clinical studies.The monitoring of a patient’s hypersensitivity is accomplished by testing in collaboration with the AllerDetect Report.

AllerDetect Tests for the in vitro diagnosis of allergen-specific IgE molecules has developed in parallel to Stapel et al Position Paper regarding IgG4, and without reiterating the entire document, the following points were emphasized by AllerDetect:

It is neither possible nor appropriate to use serum antibody tests to diagnose a food allergy in the absence of a good history and possible challenge testing.

We agree that it is not appropriate to use the AllerDetect for the detection of dietary allergen-specific IgE (sIgE) molecules to diagnose food allergies in the absence of a good history and possible challenge testing.

Serum antibody levels for IgE or IgG4 (or other IgG subclasses) indicate the presence of a specific antibody but do not make a diagnosis. The presence of antibodies does not indicate disease.

The IgG4 subclass is considered immunologically inert and functionally monovalent due to structural differences when compared to other IgG subclasses (IgG 1,2,3). IgG4 usually arises after chronic exposure to an antigen and competes with other antibody species, thus “blocking” their pathogenic effector mechanisms. For example, increased serum allergen-specific IgG4 levels are associated with allergen immunotherapy and healthy subjects who have been exposed to relatively high doses of allergens, such as nonallergic beekeepers and cat owners. Moreover, due to IgG4 mono-specific binding capability, it cannot cross-link two different antigens, instead, it binds two antigens of the same kind. As a consequence, IgG4 is not able to activate the classic complement pathway or active immune cells. The detection of allergen-specific IgG4 or IgE (or other IgG subclasses) indicates the presence of a specific antibody but does not make a diagnosis. The presence of an antibody is not indicative of disease. Hence, the purpose of monitoring the presence of allergen-specific IgE molecules using AllerDetect is to quantify the immune response (exposure) to the said allergen.

It is common for primary care providers to order serum antibody tests (usually IgE) for food allergy in the absence of a thorough history and without a skilled background for interpretation. These tests are often obtained as panels rather than being selected based on history. The results may then lead to confusion when incriminated foods that are well tolerated by patients are removed from the diet. Well-tolerated foods should not be removed from the diet even in the presence of positive tests.

AllerDetect IgE ELISA-based assays for the identification of dietary allergen-specific IgE immune complexes that trigger immediate allergy symptoms, “true allergies”. The early detection of the allergen-specific IgE immune complexes proves to be invaluable in the identification of dietary antigens that may trigger an immune response that affects multiple organs in some cases and be severe or even life-threatening. An extensive panel of food, allows the IgE to identify cross-reacting proteins in different food sources. As a result, the immune system sees them as the same. In the case of food allergies, cross-reactivity can occur between one food and another. Individual reactions vary when it comes to food allergies and cross-reactivity and with the additional challenges in diagnostic testing posed by allergen cross-reactivity, it is important to talk with your medical professional about your symptoms with foods. For example, people with birch or grass pollen allergies may have a positive skin test for peanuts as well. Your medical professional has expertise in the area of allergen cross-reactivity and can help in making an accurate diagnosis and providing guidance as to whether a cross-reactive food needs to be eliminated or not.

Summary

AllerDetect responses in this document support the American Academy of Allergy, Asthma & Immunology & the European Academy of Allergy and Clinical Immunology position on IgG4 submitted by the adverse reactions to Foods committee 2009 European Academy of Allergy and Clinical Immunology (EAACI) Journal of Allergy and Clinical Immunology (JACI).2 AllerDetect agrees with these organizations and reiterates that the detection of food-specific IgE or IgG in patient sera does not necessarily indicate food allergy or intolerance, but rather a physiologic response of the immune system to exposure to food. For IgG and more specifically IgG4, this may be the normal human response. Although the detection of specific IgE antibodies may indicate the potential for a reaction to occur, at times, there is no clinical consequence to the presence of these antibodies so the test needs to be interpreted with a patient's healthcare professional

Conclusion

A combined relationship of the AllerDetect Dietary Report and other relevant clinical information available for the subject is required before implementing the next step in patient care. This test was developed and its performance characteristics were determined by AllerDetect and/or third-party reference affiliates. FDA clearance is not currently required for clinical use. However, these results are not intended to be used as the sole source for clinical diagnosis. Clinical correlation is required.

References

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American Academy of Allergy, Asthma & Immunology support of the European Academy of Allergy and Clinical Immunology position paper on IgG4: Submitted by the Adverse Reactions to Foods Committee 2009 European Academy of Allergy and Clinical Immunology (EAACI) Journal of Allergy and Clinical Immunology (JACI)

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