Allergy Asthma Immunol Res.  2019 May;11(3):422-432. 10.4168/aair.2019.11.3.422.

Validation of PROTIA™ Allergy-Q 64 Atopy® as a Specific IgE Measurement Assay for 10 Major Allergen Components

Affiliations
  • 1Division of Allergy and Immunology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea. PARKJW@yuhs.ac
  • 2Institute of Allergy, Yonsei University College of Medicine, Seoul, Korea.
  • 3Proteometech Inc., Seoul, Korea.

Abstract

PURPOSE
Component-resolved diagnostics (CRD) is expected to provide additional diagnostic information in allergic patients. PROTIAâ„¢ Allergy-Q 64 Atopy®, a recently developed CRD-based multiplex specific immunoglobulin E (sIgE) assay, can quantitatively measure sIgE to major allergen components.
METHODS
The sIgE detection by PROTIAâ„¢ Allergy-Q 64 Atopy® and ImmunoCAP® assays was compared using the sera of 125 Korean allergic patients. Group 1 and 2 allergens of house dust mites (HDMs; Dermatophagoides farinae (Der f) 1 and Der f 2 in PROTIAâ„¢ Allergy-Q 64 Atopy®, Dermatophagoides pteronyssinus (Der p) 1 and Der p 2 in ImmunoCAP®), Bet v 1, Fel d 1, Que a 1, ω-5 gliadin, α-lactalbumin, β-lactoglobulin, casein and α-Gal were measured by both assays.
RESULTS
Comparing the results from the 2 assays, the agreement rate for all the 10 allergens was > 88% (group 1 HDM allergen, 100%; group 2 HDM allergen, 94.6%; Bet v 1, 97.4%; Fel d 1, 90.5%; Que a 1, 89.2%; α-lactalbumin, 96%; β-lactoglobulin, 88%; casein, 88%; ω-5 gliadin, 96%; α-Gal, 100%). Correlation analysis indicated that, all the 10 allergen sIgEs showed more than moderate positive correlation (Pearson correlation coefficients > 0.640). Additionally, intra-class comparison showed more than high correlation for all the 10 allergens (Spearman's rank correlation coefficients > 0.743).
CONCLUSIONS
PROTIAâ„¢ Allergy-Q 64 Atopy® is reliable and comparable to the ImmunoCAP® assay for component-resolved diagnosis.

Keyword

Immunoassay; immunoglobulin E; allergens

MeSH Terms

Allergens
Caseins
Dermatophagoides farinae
Dermatophagoides pteronyssinus
Diagnosis
Gliadin
Humans
Immunoassay
Immunoglobulin E*
Immunoglobulins
Pyroglyphidae
Allergens
Caseins
Gliadin
Immunoglobulin E
Immunoglobulins

Figure

  • Figure Intra-class comparison of ImmunoCAP® with PROTIATM Allergy-Q 64 Atopy®. Measured sIgEs were classified as class 0: below 0.35 kUA/L, class 1: 0.35-0.7 kUA/L, class 2: 0.7-3.5 kUA/L, class 3: 3.5-17.5 kUA/L, class 4: 17.5-50 kUA/L, class 5: 50-100 kUA/L and class 6: above 100 kUA/L. Statistical values for intra-class comparison are shown in Table 4. Der p, Dermatophagoides pteronyssinus; Der f, Dermatophagoides farina.


Reference

1. Hamilton RG, Adkinson NF Jr, Golden DB. Serological methods in the diagnosis and management of human allergic disease. Crit Rev Clin Lab Sci. 1984; 21:1–18.
Article
2. Heinzerling L, Mari A, Bergmann KC, Bresciani M, Burbach G, Darsow U, et al. The skin prick test - European standards. Clin Transl Allergy. 2013; 3:3.
Article
3. Park KH, Lee J, Lee SC, Son YW, Sim DW, Lee JH, et al. Comparison of the ImmunoCAP assay and AdvanSure™ AlloScreen advanced multiplex specific IgE detection assay. Yonsei Med J. 2017; 58:786–792.
Article
4. Wide L, Bennich H, Johansson SG. Diagnosis of allergy by an in-vitro test for allergen antibodies. Lancet. 1967; 2:1105–1107.
5. Treudler R, Simon JC. Overview of component resolved diagnostics. Curr Allergy Asthma Rep. 2013; 13:110–117.
Article
6. Mari A, Iacovacci P, Afferni C, Barletta B, Tinghino R, Di Felice G, et al. Specific IgE to cross-reactive carbohydrate determinants strongly affect the in vitro diagnosis of allergic diseases. J Allergy Clin Immunol. 1999; 103:1005–1011.
7. Platts-Mills TA, Chapman MD. Allergen standardization. J Allergy Clin Immunol. 1991; 87:621–625.
8. Constantin C, Quirce S, Poorafshar M, Touraev A, Niggemann B, Mari A, et al. Micro-arrayed wheat seed and grass pollen allergens for component-resolved diagnosis. Allergy. 2009; 64:1030–1037.
Article
9. Treudler R. Update on in vitro allergy diagnostics. J Dtsch Dermatol Ges. 2012; 10:89–97.
10. Ferreira F, Wolf M, Wallner M. Molecular approach to allergy diagnosis and therapy. Yonsei Med J. 2014; 55:839–852.
Article
11. Stringari G, Tripodi S, Caffarelli C, Dondi A, Asero R, Di Rienzo Businco A, et al. The effect of component-resolved diagnosis on specific immunotherapy prescription in children with hay fever. J Allergy Clin Immunol. 2014; 134:75–81.
Article
12. Crameri R. The crux with a reliable in vitro and in vivo diagnosis of allergy. Allergy. 2013; 68:693–694.
13. Lee JH, Park HJ, Park KH, Jeong KY, Park JW. Performance of the PROTIA™ Allergy-Q® system in the detection of allergen-specific IgE: a comparison with the ImmunoCAP® system. Allergy Asthma Immunol Res. 2015; 7:565–572.
14. Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977; 33:159–174.
Article
15. Mukaka MM. Statistics corner: a guide to appropriate use of correlation coefficient in medical research. Malawi Med J. 2012; 24:69–71.
16. Calderón MA, Kleine-Tebbe J, Linneberg A, De Blay F, Hernandez Fernandez de Rojas D, Virchow JC, et al. House dust mite respiratory allergy: an overview of current therapeutic strategies. J Allergy Clin Immunol Pract. 2015; 3:843–855.
Article
17. Ree HI, Jeon SH, Lee IY, Hong CS, Lee DK. Fauna and geographical distribution of house dust mites in Korea. Korean J Parasitol. 1997; 35:9–17.
Article
18. Jeong KY, Park JW, Hong CS. House dust mite allergy in Korea: the most important inhalant allergen in current and future. Allergy Asthma Immunol Res. 2012; 4:313–325.
Article
19. Jeong KY, Son M, Park JH, Park KH, Park HJ, Lee JH, et al. Cross-reactivity between oak and birch pollens in Korean tree pollinosis. J Korean Med Sci. 2016; 31:1202–1207.
Article
20. Park HJ, Lee JH, Park KH, Kim KR, Han MJ, Choe H, et al. A six-year study on the changes in airborne pollen counts and skin positivity rates in Korea: 2008–2013. Yonsei Med J. 2016; 57:714–720.
Article
21. Asam C, Hofer H, Wolf M, Aglas L, Wallner M. Tree pollen allergens-an update from a molecular perspective. Allergy. 2015; 70:1201–1211.
Article
22. Vieths S, Hoffmann A, Holzhauser T, Müller U, Reindl J, Haustein D. Factors influencing the quality of food extracts for in vitro and in vivo diagnosis. Allergy. 1998; 53:65–71.
23. Rashid RS, Smith KA, Nambiar KZ, Frew AJ, Tarzi MD. Pollen-food syndrome is related to Bet v 1/PR-10 protein sensitisation, but not all patients have spring rhinitis. Allergy. 2011; 66:1391–1392.
Article
24. Chan SK, Leung DYM. Dog and cat allergies: current state of diagnostic approaches and challenges. Allergy Asthma Immunol Res. 2018; 10:97–105.
Article
25. Ownby D, Johnson CC. Recent understandings of pet allergies. F1000Res. 2016; 5:F1000 Faculty Rev-108.
Article
26. Commins SP, Satinover SM, Hosen J, Mozena J, Borish L, Lewis BD, et al. Delayed anaphylaxis, angioedema, or urticaria after consumption of red meat in patients with IgE antibodies specific for galactose-α-1, 3-galactose. J Allergy Clin Immunol. 2009; 123:426–433.
27. Michel S, Scherer K, Heijnen IA, Bircher AJ. Skin prick test and basophil reactivity to cetuximab in patients with IgE to alpha-gal and allergy to red meat. Allergy. 2014; 69:403–405.
Article
28. Sim DW, Lee JS, Park KH, Jeong KY, Ye YM, Lee JH, et al. Accurate assessment of alpha-gal syndrome using cetuximab and bovine thyroglobulin-specific IgE. Mol Nutr Food Res. 2017; 61:1601046.
Article
29. Brestoff JR, Zaydman MA, Scott MG, Gronowski AM. Diagnosis of red meat allergy with antigen-specific IgE tests in serum. J Allergy Clin Immunol. 2017; 140:608–610.e5.
Article
30. Sicherer SH. Epidemiology of food allergy. J Allergy Clin Immunol. 2011; 127:594–602.
Article
31. Hochwallner H, Schulmeister U, Swoboda I, Spitzauer S, Valenta R. Cow's milk allergy: from allergens to new forms of diagnosis, therapy and prevention. Methods. 2014; 66:22–33.
Article
32. D'Urbano LE, Pellegrino K, Artesani MC, Donnanno S, Luciano R, Riccardi C, et al. Performance of a component-based allergen-microarray in the diagnosis of cow's milk and hen's egg allergy. Clin Exp Allergy. 2010; 40:1561–1570.
33. Ito K, Futamura M, Movérare R, Tanaka A, Kawabe T, Sakamoto T, et al. The usefulness of casein-specific IgE and IgG4 antibodies in cow's milk allergic children. Clin Mol Allergy. 2012; 10:1.
Article
34. Martorell A, García Ara MC, Plaza AM, Boné J, Nevot S, Echeverria L, et al. The predictive value of specific immunoglobulin E levels in serum for the outcome of the development of tolerance in cow's milk allergy. Allergol Immunopathol (Madr). 2008; 36:325–330.
Article
35. Tosca MA, Pistorio A, Rossi GA, Ciprandi G. Cow's milk allergy: the relevance of IgE. Allergy Asthma Immunol Res. 2016; 8:86–87.
Article
36. Caubet JC, Nowak-Wegrzyn A, Moshier E, Godbold J, Wang J, Sampson HA. Utility of casein-specific IgE levels in predicting reactivity to baked milk. J Allergy Clin Immunol. 2013; 131:222–224.e1-4.
Article
37. Matsui E, Kagey-Sobotka A, Chichester K, Eggleston PA. Allergic potency of recombinant Fel d 1 is reduced by low concentrations of chlorine bleach. J Allergy Clin Immunol. 2003; 111:396–401.
Article
38. Kosloff M, Kolodny R. Sequence-similar, structure-dissimilar protein pairs in the PDB. Proteins. 2008; 71:891–902.
Article
39. Rogers BL, Morgenstern JP, Garman RD, Bond JF, Kuo MC. Recombinant Fel d.I: expression, purification, IgE binding and reaction with cat-allergic human T cells. Mol Immunol. 1993; 30:559–568.
40. Melioli G, Bonifazi F, Bonini S, Maggi E, Mussap M, Passalacqua G, et al. The ImmunoCAP ISAC molecular allergology approach in adult multi-sensitized Italian patients with respiratory symptoms. Clin Biochem. 2011; 44:1005–1011.
Article
41. Health Insurance review & Assessment Service (HIRA). Healthcare bigdata hub [Internet]. Wonju: Health Insurance review & Assessment Service;2018. cited 2018 Sep 8. Available from: http://opendata.hira.or.kr/op/opc/olap4thDsInfo.do.
42. Chruszcz M, Pomés A, Glesner J, Vailes LD, Osinski T, Porebski PJ, et al. Molecular determinants for antibody binding on group 1 house dust mite allergens. J Biol Chem. 2012; 287:7388–7398.
Article
43. Johannessen BR, Skov LK, Kastrup JS, Kristensen O, Bolwig C, Larsen JN, et al. Structure of the house dust mite allergen Der f 2: implications for function and molecular basis of IgE cross-reactivity. FEBS Lett. 2005; 579:1208–1212.
Article
44. Jeong KY, Son M, Choi SY, Park KH, Park HJ, Hong CS, et al. Standardization of weed pollen extracts, Japanese hop and mugwort, in Korea. Yonsei Med J. 2016; 57:399–406.
Article
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