Allergen Profile, Sesame, IgE With Component Reflex

CPT: 86003
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Test Includes

Sesame IgE (whole). Reflex criteria: If Sesame (whole) IgE ≥0.10 kU/L, Ses i 1 will be performed at an additional charge.


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Specimen Requirements


Specimen

Serum


Volume

0.8 mL


Minimum Volume

0.6 mL (Note: This volume does not allow for repeat testing.)


Container

Gel-barrier serum separator tube


Collection

If a red-top tube is used, transfer separated serum to a plastic transport tube.


Storage Instructions

Room temperature


Stability Requirements

Temperature

Period

Room temperature

14 days

Refrigerated

14 days

Frozen

3 months

Freeze/thaw cycles

Stable x3


Test Details


Use

This test supports the diagnosis of sesame allergy by detection of sIgE antibodies to levels to Ses i 1.


Limitations

Allergen-specific IgE assays do not demonstrate absolute positive and negative predictive values for allergic disease. Clinical history must be incorporated into the diagnostic determination. Although the use of component resolved IgE testing may enhance the evaluation of potentially allergic individuals over the use of whole extracts alone, it cannot yet replace clinical history and oral food challenge in most cases. Sensitization against thus far unidentified determinants that are not found in the whole extract or in components might cause symptoms in rare cases.

Limited, but highly variable, immunological cross-reactivity has been observed between Ses i 1 and other allergen components, such as Cor a 14 (hazelnut), Ara h 2 (peanut), Jug r 1 (English walnut), Ber e 1 (Brazil nut), Ana o 3 (Cashew nut).1,2


Methodology

Thermo Fisher ImmunoCAP® Allergen-specific IgE


Additional Information

Sesame is one of the oldest known cultivated oilseed plants and both the seeds and oil are commonly used ingredients in African, Asian, Mediterranean and Middle Eastern cuisine. Traditionally it is consumed as tahini paste or halva sweets, and it is also used as toppings on bread and crackers. It may be a hidden allergen in processed foods such as dips, spreads, bakery goods and cereals when added as flour, paste or oil, and it may occur unintentionally due to cross contamination during production. Sesame is a common trigger of allergic symptoms such as wheezing, dyspnea, asthma, atopic dermatitis and anaphylaxis, likely due to its widespread use in the food, pharmaceutical and cosmetic industries.3-5 With the high risk of accidental intakes and reactions, many countries, including the US have recognized sesame as priority food allergen requiring labelling on the products.6,7 The FASTER Act was signed into law in April of 2021 and amends the list of major food allergens that manufacturers must declare under the Food Allergen Labeling and Consumer Protection Act of 2004 ("FALCPA') to include sesame, in addition to milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soybeans.7

The prevalence sesame allergy has been estimated to be between 0.1-0.2 percent in the US based on self-reported or probable diagnosis evaluated on the basis of symptoms and sensitization.8 Sesame allergy is considered the ninth most common childhood food allergy in the USA.3 Sesame can cause severe allergic reactions.9 Sesame allergy commonly co-exist with peanut and tree nut allergy, with 50-60% of patients also being allergic to peanut and/or tree nuts.9,10 Sesame allergy is often lifelong as only about 20-30% of children outgrow their sesame allergy.3

The diagnostic assessment of allergy starts with the patient’s clinical history and examination and is followed by an extract-based analysis to confirm the presence of specific IgE (sIgE) antibody.11,12 sIgE is necessary but not sufficient for eliciting an allergic response and thus generating a definitive diagnosis of allergic disease. Testing utilizing allergenic extracts does not lend itself to the differentiation of primary sensitization from a cross-reactivity-driven response because of the complexity of the extracts. Extracts contain most of the extractable allergenic components from the suspected sensitizer. However, it is often not possible to predict the relative risk of having a systemic allergic reaction using an extract-based diagnostic test. Component Resolved Diagnostics (CRD) refers to the use of purified or recombinant allergens in the serologic assessment of individuals who suffer reproducible hypersensitivity reactions with exposures to an allergen at a dose tolerated by non-allergic individuals.11 This approach offers advantages over the use of a complete extract, especially in polysensitized individuals, given its usefulness for distinguishing between sensitizations specific to singular species and sensitizations due to cross-reactivity.13 Allergic sensitization to sesame may be induced not only by direct/indirect exposure but also by a cross-reaction mechanism involving some families of allergenic proteins.

Ses i 1

Ses i 1, is a major storage protein in sesame14 that is stable to heat and proteases.1,14 As a consequence, Ses i 1 allergenicity is maintained on cooking and survives the digestive process. Measurement of sIgE to Ses i 1 performed well compared to testing with whole sesame (both sIgE and skin prick testing) in the diagnosis of sesame allergy.2,15-20 Testing for Ses i 1 may therefore help facilitate decision when to perform sesame oral food challenge, especially in patients with high levels of specific IgE to Ses i 1 and a high probability to react.17-19 The majority of sesame allergic patients are sensitized to Ses i 1.14,17 Ses i 1 is also reported to be the most clinically relevant sesame allergen for laboratory identification of patients with higher likelihood of severe allergic reactions.14


Footnotes

1. Moreno FJ, Maldonado BM, Wellner N, Mills ENC. Thermostability and in vitro digestibility of a purified major allergen 2S albumin (Ses i 1) from white sesame seeds (Sesamum indicum L.). Biochim Biophys Acta. 2005;Sep 251752(2):142-153.16140598
2. Nachshon L, Goldberg MR, Levy MB, et al. Efficacy and Safety of Sesame Oral Immunotherapy – A Real-World, Single-Center Study. J Allergy Clin Immunol Pract. 2019 Nov-Dec;7(8):2775-81.e2.31150789
3. Adatia A, Clarke AE, Yanishevsky Y, Ben-Shoshan M. Sesame allergy: current perspectives. J Asthma Allergy. 2017 Apr 17;10:141-151.28490893
4. Sokol K, Rasooly M, Dempsey C, et al. Prevalence and diagnosis of sesame allergy in children with IgE-mediated food allergy. Pediatr Allergy Immunol. 2020 Feb;31(2):214-218.31657083
5. Protudjer JLP, Abrams EM. Sesame: The New Priority Allergen? JAMA Netw Open. 2019 Aug 2;2(8):e199149.31373645
6. European Food Safety Authority. Scientific opinion on the evaluation of allergic foods and food ingredients for labelling purposes. EFSA Journal. 2014;12(11):3894. Accessed at https://www.efsa.europa.eu/en/efsajournal/pub/3894.
7. Food Allergy Safety, Treatment, Education, and Research Act of 2021 (FASTER Act of 2021), Pub. L. No. 117-11, § 2, 135 Stat. 262 (2021). Accessed at https://www.congress.gov/bill/117th-congress/senate-bill/578.
8. Warren CM, Chadha AS, Sicherer SH, Jiang J, Gupta RS. Prevalence and Severity of Sesame Allergy in the United States. JAMA Netw Open. 2019 Aug 2;2(8):e199144.31373655
9. Brough HA, Caubet JC, Mazon A, et al. Defining challenge-proven coexistent nut and sesame seed allergy: A prospective multicenter European study. J Allergy Clin Immunol. 2020 Apr;145(4):1231-1239.31866098
10. Tuano KT, Dillard KH, Guffey D, Davis CM. Development of sesame tolerance and cosensitization of sesame allergy with peanut and tree nut allergy in children. Ann Allergy Asthma Immunol. 2016 Dec;117(6):708-710.28073703
11. Matricardi PM, Kleine-Tebbe J, Hoffmann HJ, et al. EAACI Molecular Allergology User’s Guide. Pediatr Allergy Immunol. 2016 May;27 Suppl 23:1-250.27288833
12. Borres MP, Maruyama N, Sato S, Ebisawa M. Recent advances in component resolved diagnosis in food allergy. Allergol Int. 2016;65(4):378-387.27543004
13. Dreskin SC, Koppelman SJ, Andorf S, et al. The importance of the 2S albumins for allergenicity and cross-reactivity of peanuts, tree nuts, and sesame seeds. J Allergy Clin Immunol. 2021 Apr;147(4):1154-1163.33217410
14. Pastorello EA, Varin E, Farioli L et al. The major allergen of sesame seeds (Sesamum indicum) is a 2S albumin. J Chromatogr B Biomed Sci Appl. 2001 May 25;756(1-2):85-93.11419730
15. Sato S, Yanagida N, Ebisawa M. How to diagnose food allergy? Curr Opin Allergy Clin Immunol. 2018 Jun;18(3):214-221.29601353
16. Foong RX, Dantzer JA, Wood RA, Santos AF. Improving Diagnostic Accuracy in Food Allergy. J Allergy Clin Immunol Pract. 2021 Jan;9(1):71-80.3342972
17. Maruyama N, Nakagawa T, Ito K, et al. Measurement of specific IgE antibodies to Ses i 1 improves the diagnosis of sesame allergy. Clin Exp Allergy. 2016 Jan;46(1):163-171.26310924
18. Yanagida N, Ejiri Y, Takeishi D, et al. Ses i 1-specific IgE and sesame oral food challenge results. J Allergy Clin Immunol Pract. 2019 Jul-Aug;7(6):2084-2086.e4.30836231
19. Saf S, Sifers TM, Baker MG, et al. Diagnosis of Sesame Allergy: Analysis of Current Practice and Exploration of Sesame Component Ses i 1. J Allergy Clin Immunol Pract. 2020 May;8(5):1681-1688.e3.31786253
20. Goldberg MR, Appel MY, Nachshon L, et al. Combinatorial advantage of Ses i 1-specific IgE and basophil activation for diagnosis of sesame food allergy. Pediatr Allergy Immunol. 2021 Oct;32(7):1482-1489.33955090

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
607740 Sesame, IgE w/Component Reflex 6242-2 602444 Class Description N/A
607740 Sesame, IgE w/Component Reflex 6242-2 607741 F010-IgE Sesame Seed kU/L 6242-2
Reflex Table for F010-IgE Sesame Seed
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 607742 F449-IgE Ses i 1 607742 F449-IgE Ses i 1 kU/L Pending

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