Analytical validation of a highly sensitive microparticle-based immunoassay for the quantitation of IL-13 in human serum using the Erenna® immunoassay system

Journal of Immunological Methods

Volumn 350, Issue 1-2, 2009, Pages 161-170

  St Ledger, Katie ^a   Agee, Sara J ^b   Kasaian, Marion T ^a   Forlow, Stephen B ^a   Durn, Billie L ^a   Minyard, Jennifer ^b   Lu, Quynh Anh ^b   Todd, John ^b   Vesterqvist, Ole ^a   Burczynski, Michael E ^a  

^a PFIZER INC   (United States)

^b SINGULEX INC   (United States)

Author keywords

Asthma; Interleukin 13; Pharmacodynamic assays; Respiratory inflammation; Ultra sensitive immunoassay

Indexed keywords

ANTIBODY; BETA ADRENERGIC RECEPTOR STIMULATING AGENT; CORTICOSTEROID; INTERLEUKIN 13;

ACCURACY; ADULT; ARTICLE; ASTHMA; BLOOD SAMPLING; CALIBRATION; CONTROLLED STUDY; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; MICROPARTICLE ENZYME IMMUNOASSAY; PRIORITY JOURNAL; PROTEIN BLOOD LEVEL; PROTEIN DETERMINATION; SENSITIVITY ANALYSIS; VALIDATION PROCESS;

ASTHMA; CALIBRATION; ENZYME-LINKED IMMUNOSORBENT ASSAY; FLUORESCENT ANTIBODY TECHNIQUE, DIRECT; HUMANS; INTERLEUKIN-13; REAGENT KITS, DIAGNOSTIC; SENSITIVITY AND SPECIFICITY;

ERENNA;

EID: 70349754675     PISSN: 00221759     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jim.2009.08.012     Document Type: Article

References (36)

1. Batra V., Musani A.I., Hastie A.T., Khurana S., Carpenter K.A., Zangrilli J.G., and Peters S.P. Bronchoalveolar lavage fluid concentrations of transforming growth factor (TGF)-beta1, TGF-beta2, interleukin (IL)-4 and IL-13 after segmental allergen challenge and their effects on alpha-smooth muscle actin and collagen III synthesis by primary human lung fibroblasts. Clin. Exp. Allergy 34 (2004) 437
2. Baumann A. Early development of therapeutic biologics-pharmacokinetics. Curr. Drug Metab. 7 (2006) 15
3. Becker A.B. Challenges to treatment goals and outcomes in pediatric asthma. J. Allergy Clin. Immunol. 109 (2002) S533
4. Bree A., Schlerman F.J., Wadanoli M., Tchistiakova L., Marquette K., Tan X.Y., Jacobson B.A., Widom A., Cook T.A., Wood N., Vunnum S., Krykbaev R., Xu X., Donaldson D.D., Goldman S.J., Sypek J., and Kasaian M.T. IL-13 blockade reduces lung inflammation after Ascaris suum challenge in cynomolgus monkeys. J. Allergy Clin. Immunol. 119 (2007) 1251
5. Feleszko W., Zawadzka-Krajewska A., Matysiak K., Lewandowska D., Peradzyńska J., Dinh Q.T., Hamelmann E., Groneberg D.A., and Kulus M. Parental tobacco smoking is associated with augmented IL-13 secretion in children with allergic asthma. J. Allergy Clin. Immunol. 117 (2006) 97
6. Foster P.S., Martinez-Moczygemba M., Huston D.P., and Corry D.B. Interleukins-4, -5, and -13: emerging therapeutic targets in allergic disease. Pharmacol. Ther. 94 (2002) 253
7. Grünig G., Warnock M., Wakil A.E., Venkayya R., Brombacher F., Rennick D.M., Sheppard D., Mohrs M., Donaldson D.D., Locksley R.M., et al. Requirement for IL-13 independently of IL-4 in experimental asthma. Science 282 (1998) 2261
8. Hartl D., Latzin P., Zissel G., Krane M., Krauss-Etschmann S., and Griese M. Chemokines indicate allergic bronchopulmonary aspergillosis in patients with cystic fibrosis. Am. J. Respir. Crit. Care Med. 173 (2006) 1370
9. Juniper E.F., O'Byrne P.M., and Guyatt G.H. Development and validation of a questionnaire to measure asthma control. Eur. Resp. J. 14 (1999) 902
10. Karaman O., Arli O., Uzuner N., Islekel H., Babayigit A., Olmez D., Kose S., and Tezcan D. The effectiveness of asthma therapy alternatives and evaluating the effectivity of asthma therapy by interleukin-13 and interferon gamma levels in children. Allergy Asthma Proc. 28 (2007) 204
11. Kasaian M.T., and Miller D.K. IL-13 as a therapeutic target for respiratory disease. Biochem. Pharmacol. 76 (2008) 147
12. Kasaian M.T., Donaldson D.D., Tchistiakova L., Marquette K., Tan X.Y., Ahmed A., Jacobson B.A., Widom A., Cook T.A., Xu X., Barry A.B., Goldman S.J., Kasaian A., MT D., Tchistiakova L., Marquette K., Tan X.Y., Ahmed A., Jacobson B.A., Widom A., Cook T.A., Xu X., et al. Efficacy of IL-13 neutralization in a sheep model of experimental asthma. Am. J. Respir. Cell Mol. Biol. 36 (2007) 368
13. Kasaian M.T., Tan X.Y., Jin M., Fitz L., Marquette K., Wood N., Cook T.A., Lee J., Widom A., Agostinelli R., Bree A., Schlerman F.J., Olland S., Wadanoli M., Sypek J., Gill D., Goldman S.J., and Tchistiakova L. IL-13 neutralization by two distinct receptor blocking mechanisms reduces IgE responses and lung inflammation in cynomolgus monkeys. J. Pharmacol. Exp. Ther. 325 3 (2008 Jun) 882
14. LaPorte S.L., Juo Z.S., Vaclavikova J., Colf L.A., Qi X., Heller N.M., Keegan A.D., and Garcia K.C. Molecular and structural basis of cytokine receptor pleiotropy in the interleukin-4/13 system. Cell 132 (2008) 259
15. Lee Y.C., Lee K.H., Lee H.B., and Rhee Y.K. Serum levels of interleukins (IL)-4, IL-5, IL-13, and interferon-gamma in acute asthma. J. Asthma 38 (2001) 665
16. Lim C.T., and Zhang Y. Bead-based microfluidic immunoassays: the next generation. Biosens. Bioelectron. 22 (2007) 1197
17. Lu A, Agee SJ, Held D, Rieckenberg C, Freese B, Sheets D, Livingston R, Puskas R, Todd J. Use of single-molecule counting technology to determine the concentration of cytokines IL-6, IL-8, IL-17, and IL-1B in plasma from healthy subjects. In: American Association of Clinical Chemistry, Oak Ridge Conference; 2008; San Jose, CA.
18. Martin K., Viera K., Petr C., Marie N., and Eva T. Simultaneous analysis of cytokines and co-stimulatory molecules concentrations by ELISA technique and of probabilities of measurable concentrations of interleukins IL-2, IL-4, IL-5, IL-6, CXCL8 (IL-8), IL-10, IL-13 occurring in plasma of healthy blood donors. Mediat. Inflamm. 2006 (2006) 65237
19. Mentink-Kane M.M., and Wynn T.A. Opposing roles for IL-13 and IL-13 receptor alpha 2 in health and disease. Immunol. Rev. 202 (2004) 191
20. Miller R., Sadhukhan R., and Wu C. Development of an in vitro potency bioassay for therapeutic IL-13 antagonists: the A-549 cell bioassay. J. Immunol. Methods 334 (2008) 134
21. Minton K. What 'drives' IL-4 versus IL-13 signalling?. Nat. Rev., Immunol. 8 (2008)
22. Morse B., Sypek J.P., Donaldson D.D., Haley K.J., and Lilly C.M. Effects of IL-13 on airway responses in the guinea pig. Am. J. Physiol., Lung Cell. Mol. Physiol. 282 (2002) L44
23. Noah T.L., Tudor G.E., Ivins S.S., Murphy P.C., Peden D.B., and Henderson F.W. Repeated measurement of nasal lavage fluid chemokines in school-age children with asthma. Ann. Allergy Asthma, Immun. 96 (2006) 304
24. Prieto J., Lensmar C., Roquet A., der I.v., Gigliotti D., Eklund A., and Grunewald J. Increased interleukin-13 mRNA expression in bronchoalveolar lavage cells of atopic patients with mild asthma after repeated low-dose allergen provocations. Respir. Med. 94 (2000) 806
25. Puskas R., Held D., Sheets D., Klein B.K., Macy E., Agee S.J., and Todd J. Preliminary validation of two novel immunoassays for detecting VEGF in human and mouse plasma using single molecule counting. ASCO/NCI/EORTC Annual Meeting on Molecular Markers in Cancer; 2008; Hollywood, FL (2008)
26. Schultze A.E., Konrad R.J., Credille K.M., Lu Q.A., and Todd J. Ultrasensitive cross-species measurement of cardiac troponin-I using the Erenna immunoassay system. Toxicol. Pathol. 36 (2008) 777
27. Silvestri M., Bontempelli M., Giacomelli M., Malerba M., Rossi G.A., Stefano A.D., Rossi A., and Ricciardolo M.F.L. High serum levels of tumour necrosis factor-alpha and interleukin-8 in severe asthma: markers of systemic inflammation?. Clin. Exp. Allergy 36 (2006) 1373
28. Stabler T., Piette J.C., Chevalier X., Marini-Portugal A., and Kraus V.B. Serum cytokine profiles in relapsing polychondritis suggest monocyte/macrophage activation. Arthritis Rheum. 50 (2004) 3663
29. Szodoray P., Alex P., Chappell-Woodward C.M., Madland T.M., Knowlton N., Dozmorov I., Zeher M., Jarvis J.N., Nakken B., Brun J.G., et al. Circulating cytokines in Norwegian patients with psoriatic arthritis determined by a multiplex cytokine array system. Rheumatology (Oxford). 46 (2007) 417
30. Tang M.L., and Powell C.V. Childhood asthma as an allergic disease: rationale for the development of future treatment. Eur. J. Pediatr. 160 (2001) 696
31. Todd J., Freese B., Lu A., Held D., Morey J., Livingston R., and Goix P. Ultrasensitive flow-based immunoassays using single-molecule counting. Clin. Chem. 53 (2007) 1990
32. Wills-Karp M. Interleukin-13 in asthma pathogenesis. Immunol. Rev. 202 (2004) 175
33. Wu A.H., Fukushima N., Puskas R., Todd J., and Goix P. Development and preliminary clinical validation of a high sensitivity assay for cardiac troponin using a capillary flow (single molecule) fluorescence detector. Clin. Chem. 52 (2006) 2157
34. Yang G., Volk A., Petley T., Emmell E., Giles-Komar J., Shang X., Li J., Das A.M., Shealy D., Griswold D.E., et al. Anti-IL-13 monoclonal antibody inhibits airway hyperresponsiveness, inflammation and airway remodeling. Cytokine 28 (2004) 224
35. Yang G., Li L., Volk A., Emmell E., Petley T., Giles-Komar J., Rafferty P., Lakshminarayanan M., Griswold D.E., Bugelski P.J., et al. Therapeutic dosing with anti-interleukin-13 monoclonal antibody inhibits asthma progression in mice. J. Pharmacol. Exp. Ther. 313 (2005) 8
36. Yasui T., Uemura H., Yamada M., Matsuzaki T., Tsuchiya N., Noguchi M., Yuzurihara M., Kase Y., and Irahara M. Associations of interleukin-6 with interleukin-1beta, interleukin-8 and macrophage inflammatory protein-1beta in midlife women. Cytokine 41 (2008) 302