1887

Chapter 81 : Quantitation and Standardization of Allergens

MyBook is a cheap paperback edition of the original book and will be sold at uniform, low price.

Ebook: Choose a downloadable PDF or ePub file. Chapter is a downloadable PDF file. File must be downloaded within 48 hours of purchase

Buy this Chapter
Digital (?) $30.00

Preview this chapter:
Zoom in
Zoomout

Quantitation and Standardization of Allergens, Page 1 of 2

| /docserver/preview/fulltext/10.1128/9781555818722/9781555818715_CH81-1.gif /docserver/preview/fulltext/10.1128/9781555818722/9781555818715_CH81-2.gif

Abstract:

Allergic reactions and allergic diseases are the most common human disorders of immune regulation. Diseases may include localized responses in the skin and various portions of the airway, or systemic responses characterized by extensive skin involvement, severe airway compromise, or cardiovascular collapse. Mechanisms include mast cell or basophil activation by the cross-linking of allergen-specific homocytotropic IgE, cellular infiltration following mast cell or basophil mediator release, complement activation, the deposition of immune complexes in susceptible tissues, or the infiltration of activated T-lymphocytes. The degree of impairment from allergic disease varies widely, with most reactions posing minor inconvenience, but with rare episodes requiring intensive—and sometimes unsuccessful—interventions to prevent death.

Citation: Rabin R, Renn L, Slater J. 2016. Quantitation and Standardization of Allergens, p 784-794. In Detrick B, Schmitz J, Hamilton R (ed), Manual of Molecular and Clinical Laboratory Immunology, Eighth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555818722.ch81
Highlighted Text: Show | Hide
Loading full text...

Full text loading...

Figures

Image of FIGURE 1
FIGURE 1

Sample calculation of D. Serial 3-fold dilutions of test material—in this example, histamine base—were injected and the ΣE responses were plotted against the negative log dilutions. The D is determined from the best-fit line using the formula: D = (50 - Intercept)/slope. The calculated D of 5.56 corresponds to a value of −3 * 100,000 BAU/ml = 9.4 BAU/ml.

Citation: Rabin R, Renn L, Slater J. 2016. Quantitation and Standardization of Allergens, p 784-794. In Detrick B, Schmitz J, Hamilton R (ed), Manual of Molecular and Clinical Laboratory Immunology, Eighth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555818722.ch81
Permissions and Reprints Request Permissions
Download as Powerpoint
Image of FIGURE 2
FIGURE 2

Hypothetical parallel line bioassay curves. In panel A, the bioassay curves are parallel, and the difference of log dilutions resulting in the same diameters is constant at all diameters. The log relative potency (log RP) of test sample B compared to reference A is represented by the difference. In panel B, the curves are not parallel, and the differences vary with the strength of the reaction. Thus, the log RP of B′ compared to A cannot be calculated.

Citation: Rabin R, Renn L, Slater J. 2016. Quantitation and Standardization of Allergens, p 784-794. In Detrick B, Schmitz J, Hamilton R (ed), Manual of Molecular and Clinical Laboratory Immunology, Eighth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555818722.ch81
Permissions and Reprints Request Permissions
Download as Powerpoint
Image of FIGURE 3
FIGURE 3

Diameters are measured from the inner margins of the penned outline. Longest (A) plus midpoint orthogonal diameters (B) and summed (A + B).

Citation: Rabin R, Renn L, Slater J. 2016. Quantitation and Standardization of Allergens, p 784-794. In Detrick B, Schmitz J, Hamilton R (ed), Manual of Molecular and Clinical Laboratory Immunology, Eighth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555818722.ch81
Permissions and Reprints Request Permissions
Download as Powerpoint

References

/content/book/10.1128/9781555818722.ch81
1. Yunginger JW. 1983. Allergenic extracts: characterization, standardization, and prospects for the future. Pediatr Clin North Am 30:795805.[PubMed]
2. Food and Drug Administration. 1985. Biological Products; Allergenic Extracts; lmplementation of Efficacy Review. Fed Regist 50:3082.
3. Slater JE, Menzies SL, Bridgewater J, Mosquera A, Zinderman CE, Ou AC, Maloney D, Cook CM, Rabin RL. 2012. The US Food and Drug Administration review of the safety and effectiveness of nonstandardized allergen extracts. J Allergy Clin Immunol 129:10141019.[CrossRef].[PubMed]
4. Baer H, Godfrey H, Maloney CJ, Norman PS, Lichtenstein LM. 1970. The potency and antigen E content of commercially prepared ragweed extracts. J Allergy 45:347354.[PubMed].[CrossRef]
5. Baer H, Maloney CJ, Norman PS, Marsh DG. 1974. The potency and Group I antigen content of six commercially prepared grass pollen extracts. J Allergy Clin Immunol 54:157164.[PubMed].[CrossRef]
6. Slater JE, Gam AA, Solanki MD, Burk SH, May FM, Pastor RW. 1999. Statistical considerations in the establishment of release criteria for allergen vaccines in the USA. Arb Paul Ehrlich Inst Bundesamt Sera Impfstoffe Frankf A M 93:4755, discussion 56.[PubMed]
7. Patterson ML, Slater JE. 2002. Characterization and comparison of commercially available German and American cockroach allergen extracts. Clin Exp Allergy 32:721727.[PubMed].[CrossRef]
8. Yunginger JW. 1988. Allergens: recent advances. Pediatr Clin North Am 35:981993.[PubMed]
9. Turkeltaub PC,. 1988. In-vivo standardization, p 388401. In Middleton EJ, Reed CE, Ellis EF (ed), Allergy, Principles and Practice, 3rd ed. CV Mosby Co, St. Louis, MO.
10. Turkeltaub PC. 1989. Biological standardization of allergenic extracts. Allergol Immunopathol (Madr) 17:5365.[PubMed]
11. Turkeltaub PC. 1997. Biological standardization. Arb Paul Ehrlich Inst Bundesamt Sera Impfstoffe Frankf A M 91:145156.[PubMed]
12. Turkeltaub PC,. 1999. Allergen vaccine unitage based on biological standardization: clinical significance p 321340. In Lockey R, Bukantz SC (ed), Allergens and Allergen Immunotherapy, 2nd ed. Marcel Dekker, Inc, New York, NY.
13. Food and Drug Administration. 1994. Methods of the allergenic products testing laboratory (Docket 94N-0012). Fed Regist 59:6036260363.
14. Turkeltaub PC, Rastogi SC, Baer H, Anderson MC, Norman PS. 1982. A standardized quantitative skin-test assay of allergen potency and stability: studies on the allergen dose-response curve and effect of wheal, erythema, and patient selection on assay results. J Allergy Clin Immunol 70:343352.[PubMed].[CrossRef]
15. Turkeltaub PC. 1986. In vivo methods of standardization. Clin Rev Allergy 4:371387.[PubMed]
16. Rabin RL, Slater JE, Lachenbruch P, Pastor RW. 2003. Sample size considerations for establishing clinical bioequivalence of allergen formulations. Arb Paul Ehrlich Inst Bundesamt Sera Impfstoffe Frankf A M 94:2433.[PubMed]
17. Schuirmann DJ. 1987. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm 15:657680.[PubMed].[CrossRef]
18. Committee for Medicinal Products for Human Use. 2008. Guideline on allergen products: production and quality issues, November 2008. European Medicines Agency. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003333.pdf
19. Malling HJ. 1997. Skin prick testing in biological standardization of allergenic products. Arb Paul Ehrlich Inst Bundesamt Sera Impfstoffe Frankf A M 91:157163.[PubMed]
20. Slater JE, James R, Pongracic JA, Liu AH, Sarpong S, Sampson HA, Satinover SM, Woodfolk JA, Mitchell HE, Gergen PJ, Eggleston PA. 2007. Biological potency of German cockroach allergen extracts determined in an inner city population. Clin Exp Allergy 37:10331039.[CrossRef].[PubMed]
21. Matthews J, Turkeltaub PC. 1992. The assignment of biological allergy units (AU) to standardized cat extracts. J Allergy Clin Immunol 89:151.
22. Turkeltaub PC, Matthews J. 1992. Determination of compositional differences (CD) among standardized cat extracts by in vivo methods. J Allergy Clin Immunol 89:151.
23. Turkeltaub PC, Anderson MC, Baer H. 1987. Relative Potency (RP), compositional differences (CD), and assignment of allergy units (AU) to mite extracts (Dp and Df) assayed by parallel line skin test (PLST). J Allergy Clin Immunol 79:235.
24. Turkeltaub PC. 1994. Use of skin testing for evaluation of potency, composition, and stability of allergenic products. Arb Paul Ehrlich Inst Bundesamt Sera Impfstoffe Frankf A M 87:7987, 114–117.[PubMed]
25. Laboratory of Immunobiochemistry CBER FDA. Standard Operating Procedures - 5 and 6. 1993 Nov.
26. Rabin RL Allergenic Products Advisory Committee. 2011. Meeting Materials, Allergenic Products Advisory Committee. http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/AllergenicProductsAdvisoryCommittee/ucm247212.htm.
27. deVore NC, Huynh S, Dobrovolskaia EN, Slater JE. 2010. Multiplex microbead measurements for the characterization of cat and ragweed allergen extracts. Ann Allergy Asthma Immunol 105:351358.[CrossRef].[PubMed]
28. Weeke B. 1973. Crossed immunoelectrophoresis. Scand J Immunol Suppl 1:4756.[PubMed].[CrossRef]
29. Weeke B. 1973. A manual of quantitative immunoelectrophoresis. Methods and applications. 1. General remarks on principles, equipment, reagents and procedures. Scand J Immunol Suppl 1:1535.[PubMed].[CrossRef]
30. Løwenstein H. 1978. Quantitative immunoelectrophoretic methods as a tool for the analysis and isolation of allergens. Prog Allergy 25:162.[PubMed]
31. Laboratory of Immunobiochemistry CBER FDA. Standard Operating Procedures - 1 and 2. 1995 Jan.
32. Lin Y, Miller CA. 1997. Standardization of allergenic extracts: An update on CBER's standardization program. Arb Paul Ehrlich Inst Bundesamt Sera Impfstoffe Frankf A M 91:127130.[PubMed]
33. Wide L, Bennich H, Johansson SG. 1967. Diagnosis of allergy by an in-vitro test for allergen antibodies. Lancet 2:11051107.[PubMed]
34. Jeep S, Kirchhof E, O'Connor A, Kunkel G. 1992. Comparison of the Phadebas RAST with the Pharmacia CAP system for insect venom. Allergy 47:212217.[PubMed].[CrossRef]
35. Leimgruber A, Lantin JP, Frei PC. 1993. Comparison of two in vitro assays, RAST and CAP, when applied to the diagnosis of anaphylactic reactions to honeybee or yellow jacket venoms. Correlation with history and skin tests. Allergy 48:415420.[PubMed].[CrossRef]
36. Bousquet J, Chanez P, Chanal I, Michel FB. 1990. Comparison between RAST and Pharmacia CAP system: A new automated specific IgE assay. J Allergy Clin Immunol 85:10391043.[PubMed].[CrossRef]
37. Ewan PW, Coote D. 1990. Evaluation of a capsulated hydrophilic carrier polymer (the ImmunoCAP) for measurement of specific IgE antibodies. Allergy 45:2229.[PubMed].[CrossRef]
38. Nalebuff DJ, Fadal RG, May BC. 1993. A comparative study of the diagnostic characteristics of the modified RAST and Pharmacia CAP System. Otolaryngol Head Neck Surg 109:601605.[PubMed]
39. Pastorello EA, Incorvaia C, Pravettoni V, Marelli A, Farioli L, Ghezzi M. 1992. Clinical evaluation of CAP System and RAST in the measurement of specific IgE. Allergy 47:463466.[PubMed].[CrossRef]
40. Laboratory of Immunobiochemistry CBER FDA. Standard Operating Procedures - 13. 1998 Oct.
41. Laboratory of Immunobiochemistry CBER FDA. Standard Operating Procedures - 7. 1998 Nov.
42. Slater JE, Gam AA, Solanki MD, Burk SH, May FM, Pastor RW. 1999. Statistical considerations in the establishment of release criteria for allergen vaccines in the USA. Arb Paul Ehrlich Inst Bundesamt Sera Impfstoffe Frankf A M 93:4755, discussion 56.[PubMed]
43. Katz G, Cohen S. 1941. Experimental evidence for histamine release in allergy. JAMA 117:17821783.[CrossRef]
44. Noah JW, Brand A. 1954. Release of histamine in the blood of ragweed-sensitive individuals. J Allergy 25:210214.[PubMed].[CrossRef]
45. Lichtenstein LM, Osler AG. 1964. Studies on the mechanisms of hypersensitivity phenomena. IX. Histamine release from human leukocytes by ragweed pollen antigen. J Exp Med 120:507530.[PubMed].[CrossRef]
46. Gibbs BF, Noll T, Falcone FH, Haas H, Vollmer E, Vollrath I, Wolff HH, Amon U. 1997. A three-step procedure for the purification of human basophils from buffy coat blood. Inflamm Res 46:137142.[CrossRef].[PubMed]
47. Kepley C, Craig S, Schwartz L. 1994. Purification of human basophils by density and size alone. J Immunol Methods 175:19.[PubMed].[CrossRef]
48. Tanimoto Y, Takahashi K, Takata M, Kawata N, Kimura I. 1992. Purification of human blood basophils using negative selection by flow cytometry. Clin Exp Allergy 22:10151019.[PubMed].[CrossRef]
49. Barsumian EL, Isersky C, Petrino MG, Siraganian RP. 1981. IgE-induced histamine release from rat basophilic leukemia cell lines: isolation of releasing and nonreleasing clones. Eur J Immunol 11:317323.[CrossRef].[PubMed]
50. Lowe J, Jardieu P, VanGorp K, Fei DT. 1995. Allergen-induced histamine release in rat mast cells transfected with the alpha subunits of Fc epsilon RI. J Immunol Methods 184:113122.[PubMed].[CrossRef]
51. Dibbern DA Jr, Palmer GW, Williams PB, Bock SA, Dreskin SC. 2003. RBL cells expressing human Fc epsilon RI are a sensitive tool for exploring functional IgE-allergen interactions: studies with sera from peanut-sensitive patients. J Immunol Methods 274:3745.[PubMed].[CrossRef]
52. Asero R, Lorini M, Chong SU, Zuberbier T, Tedeschi A. 2004. Assessment of histamine-releasing activity of sera from patients with chronic urticaria showing positive autologous skin test on human basophils and mast cells. Clin Exp Allergy 34:11111114.[CrossRef].[PubMed]
53. Levy DA, Osler AG. 1966. Studies on the mechanisms of hypersensitivity phenomena. XIV. Passive sensitization in vitro of human leukocytes to ragweed pollen antigen. J Immunol 97:203212.[PubMed]
54. Siraganian RP, Brodsky MJ. 1976. Automated histamine analysis for in vitro allergy testing. I. A method utilizing allergen-induced histamine release from whole blood. J Allergy Clin Immunol 57:525540.[PubMed].[CrossRef]
55. Hoffmann A, Vogel L, Scheurer S, Vieths S, Haustein D. 1997. Potency determination of allergenic extracts using mediator release of rat basophil leukemia cells. Arb Paul Ehrlich Inst Bundesamt Sera Impfstoffe Frankf A M 91:203208.[PubMed]
56. Kordash TR, Freshwater LL, Amend MJ. 1995. Standardization of allergenic extracts by basophil histamine release. Ann Allergy Asthma Immunol 75:101106.[PubMed]
57. Poulsen LK, Pedersen MH, Platzer M, Madsen N, Sten E, Bindslev-Jensen C, Dircks CG, Skov PS. 2003. Immunochemical and biological quantification of peanut extract. Arb Paul Ehrlich Inst Bundesamt Sera Impfstoffe Frankf A M 94:97105, discussion 106.[PubMed]
58. Chen X, Wang Q, El-Mezayen R, Zhuang Y, Dreskin SC. 2013. Ara h 2 and Ara h 6 have similar allergenic activity and are substantially redundant. Int Arch Allergy Immunol 160:251258.[CrossRef].[PubMed]
59. McGowan EC, Saini S. 2013. Update on the performance and application of basophil activation tests. Curr Allergy Asthma Rep 13:101109.[CrossRef].[PubMed]
60. Ebo DG, Hagendorens MM, Bridts CH, Schuerwegh AJ, De Clerck LS, Stevens WJ. 2004. In vitro allergy diagnosis: should we follow the flow? Clin Exp Allergy 34:332339.[CrossRef].[PubMed]
61. Yunginger JW, Adolphson CR,. 1992. Standardization of allergens, p 678684. In Rose NR, de Macario EC, Fahey JL, Friedman H, Penn GM (ed), Manual of Clinical Laboratory Immunology, 4th ed. American Society for Microbiology, Washington, DC.

Tables

Generic image for table
TABLE 1

Allergenic extracts currently standardized in the U.S.

Citation: Rabin R, Renn L, Slater J. 2016. Quantitation and Standardization of Allergens, p 784-794. In Detrick B, Schmitz J, Hamilton R (ed), Manual of Molecular and Clinical Laboratory Immunology, Eighth Edition. ASM Press, Washington, DC. doi: 10.1128/9781555818722.ch81

This is a required field
Please enter a valid email address
Please check the format of the address you have entered.
Approval was a Success
Invalid data
An Error Occurred
Approval was partially successful, following selected items could not be processed due to error