ELISA in the multiplex era: Potentials and pitfalls

Proteomics - Clinical Applications

Volumn 9, Issue 3-4, 2015, Pages 406-422

  Tighe, Patrick J ^a   Ryder, Richard R ^a   Todd, Ian ^a   Fairclough, Lucy C ^a  

^a UNIVERSITY OF NOTTINGHAM   (United Kingdom)

Author keywords

ELISA; In vitro diagnostics; Multiplex immunoassay

Indexed keywords

MESSENGER RNA; THYROGLOBULIN ANTIBODY; BIOLOGICAL MARKER;

AUTOIMMUNE THYROIDITIS; AUTOMATION; CHEMOLUMINESCENCE; CROSS REACTION; DNA MICROARRAY; ELECTRONICS; ENZYME LINKED IMMUNOSORBENT ASSAY; HUMAN; IN VITRO STUDY; INFORMATION PROCESSING; LIMIT OF QUANTITATION; MOLECULAR INTERACTION; MULTIPLEX ENZYME LINKED IMMUNOSORBENT ASSAY; POINT OF CARE TESTING; PRIORITY JOURNAL; PROTEIN EXPRESSION; PROTEIN MICROARRAY; QUALITY CONTROL; REVIEW; STANDARDIZATION; VALIDATION PROCESS; IMMUNOASSAY; PROCEDURES;

BIOMARKERS; ENZYME-LINKED IMMUNOSORBENT ASSAY; HUMANS; IMMUNOASSAY;

EID: 84928027704     PISSN: 18628346     EISSN: 18628354     Source Type: Journal    
DOI: 10.1002/prca.201400130     Document Type: Review

References (96)

1. Vanmassenhove, J., Vanholder, R., Nagler, E., Van Biesen, W., Urinary and serum biomarkers for the diagnosis of acute kidney injury: an in-depth review of the literature. Nephrol. Dial. Transplant. 2013, 28, 254-273.
2. Trojanowski, J. Q., Vandeerstichele, H., Korecka, M., Clark, C. M. et al., Update on the biomarker core of the Alzheimer's disease neuroimaging initiative subjects. Alzheimers Dement. 2010, 6, 230-238.
3. Brooks, J. D., Translational genomics: the challenge of developing cancer biomarkers. Genome Res. 2012, 22, 183-187.
4. Maisel, A. S., Choudhary, R., Biomarkers in acute heart failure-state of the art. Nat. Rev. Cardiol. 2012, 9, 478-490.
5. Frampton, J. P., White, J. B., Simon, A. B., Tsuei, M. et al., Aqueous two-phase system patterning of detection antibody solutions for cross-reaction-free multiplex ELISA. Sci. Rep. 2014, 4, 4878.
6. Kohler, G., Milstein, C., Continuous cultures of fused cells secreting antibody of predefined specificity. Nature 1975, 256, 495-497.
7. Feinberg, J. G., Wheeler, A. W., Detection of auto-immune antibody and tissue antigens by the 'microspot' technique. J. Clin. Pathol. 1963, 16, 282-284.
8. Ekins, R. P., Multi-analyte immunoassay. J. Pharm. Biomed. Anal. 1989, 7, 155-168.
9. Hansson, M., Mathsson, L., Schlederer, T., Israelsson, L. et al., Validation of a multiplex chip-based assay for the detection of autoantibodies against citrullinated peptides. Arthritis Res. Ther. 2012, 14, R201.
10. Seyfarth, F., Schliemann, S., Wiegand, C., Hipler, U. C., Elsner, P., Diagnostic value of the ISAC((R)) allergy chip in detecting latex sensitizations. Int. Arch. Occup. Environ. Health 2014, 87, 775-781.
11. Onell, A., Hjalle, L., Borres, M. P., Exploring the temporal development of childhood IgE profiles to allergen components. Clin. Transl. Allergy 2012, 2, 24.
12. Rockmann, H., van Geel, M. J., Knulst, A. C., Huiskes, J. et al., Food allergen sensitization pattern in adults in relation to severity of atopic dermatitis. Clin. Transl. Allergy 2014, 4, 9.
13. Prosperi, M. C., Belgrave, D., Buchan, I., Simpson, A., Custovic, A., Challenges in interpreting allergen microarrays in relation to clinical symptoms: a machine learning approach. Pediatr. Allergy Immunol. 2014, 25, 71-79.
14. King, E. M., Filep, S., Smith, B., Platts-Mills, T. et al., A multi-center ring trial of allergen analysis using fluorescent multiplex array technology. J. Immunol. Methods 2013, 387, 89-95.
15. Sander, I., Zahradnik, E., Kraus, G., Mayer, S. et al., Domestic mite antigens in floor and airborne dust at workplaces in comparison to living areas: a new immunoassay to assess personal airborne allergen exposure. PLoS One 2012, 7, e52981.
16. Earle, C. D., King, E. M., Tsay, A., Pittman, K. et al., High-throughput fluorescent multiplex array for indoor allergen exposure assessment. J. Allergy Clin. Immunol. 2007, 119, 428-433.
17. Fu, Q., Zhu, J., Van Eyk, J. E., Comparison of multiplex immunoassay platforms. Clin. Chem. 2010, 56, 314-318.
18. Salmona, M., Delarue, S., Delaugerre, C., Simon, F., Maylin, S., Clinical evaluation of BioPlex 2200 HIV Ag-Ab, an automated screening method providing discrete detection of HIV-1 p24 antigen, HIV-1 antibody, and HIV-2 antibody. J. Clin. Microbiol. 2014, 52, 103-107.
19. Holding, S., Wilson, F., Spradbery, D., Clinical evaluation of the BioPlex 2200 Celiac IgA and IgG Kits-a novel multiplex screen incorporating an integral check for IgA deficiency. J. Immunol. Methods 2014, 405, 29-34.
20. Guigue, N., Menotti, J., Hamane, S., Derouin, F., Garin, Y. J., Performance of the BioPlex 2200 flow immunoassay in critical cases of serodiagnosis of toxoplasmosis. Clin. Vaccine Immunol. 2014, 21, 496-500.
21. Gomez, E., Jespersen, D. J., Harring, J. A., Binnicker, M. J., Evaluation of the Bio-Rad BioPlex 2200 syphilis multiplex flow immunoassay for the detection of IgM- and IgG-class antitreponemal antibodies. Clin. Vaccine Immunol. 2010, 17, 966-968.
22. Lash, G. E., Scaife, P. J., Innes, B. A., Otun, H. A. et al., Comparison of three multiplex cytokine analysis systems: Luminex, SearchLight and FAST Quant. J. Immunol. Methods 2006, 309, 205-208.
23. Lash, G. E., Naruse, K., Robson, A., Innes, B. A. et al., Interaction between uterine natural killer cells and extravillous trophoblast cells: effect on cytokine and angiogenic growth factor production. Hum. Reprod. 2011, 26, 2289-2295.
24. Welsh, B. T., Mapes, J., An overview of assay quality systems at Myriad, RMB, Inc., https://rbm.myriad.com/scientific-literature/white-papers/quality-control-white-paper/.
25. Wakisaka, Y., Ago, T., Kamouchi, M., Kuroda, J. et al., Plasma S100A12 is associated with functional outcome after ischemic stroke: research for biomarkers in ischemic stroke. J. Neurol. Sci. 2014, 340, 75-79.
26. Harari, O., Cruchaga, C., Kauwe, J. S., Ainscough, B. J. et al., Phosphorylated tau-Abeta42 ratio as a continuous trait for biomarker discovery for early-stage Alzheimer's disease in multiplex immunoassay panels of cerebrospinal fluid. Biol. Psychiatry 2014, 75, 723-731.
27. Kiddle, S. J., Thambisetty, M., Simmons, A., Riddoch-Contreras, J. et al., Plasma based markers of [11C] PiB-PET brain amyloid burden. PLoS One 2012, 7, e44260.
28. Phillips, R. O., Sarfo, F. S., Landier, J., Oldenburg, R. et al., Combined inflammatory and metabolic defects reflected by reduced serum protein levels in patients with Buruli ulcer disease. PLoS Negl. Trop. Dis. 2014, 8, e2786.
29. Straface, A. L., Myers, J. H., Kirchick, H. J., Blick, K. E., A rapid point-of-care cardiac marker testing strategy facilitates the rapid diagnosis and management of chest pain patients in the emergency department. Am. J. Clin. Pathol. 2008, 129, 788-795.
30. Apple, F. S., Christenson, R. H., Valdes, R., Jr., Andriak, A. J. et al., Simultaneous rapid measurement of whole blood myoglobin, creatine kinase MB, and cardiac troponin I by the triage cardiac panel for detection of myocardial infarction. Clin. Chem. 1999, 45, 199-205.
31. Darkoh, C., Comer, L., Zewdie, G., Harold, S. et al., Chemotactic chemokines are important in the pathogenesis of irritable bowel syndrome. PLoS One 2014, 9, e93144.
32. Stommel, J. M., Kimmelman, A. C., Ying, H., Nabioullin, R. et al., Coactivation of receptor tyrosine kinases affects the response of tumor cells to targeted therapies. Science 2007, 318, 287-290.
33. Engelman, J. A., Zejnullahu, K., Mitsudomi, T., Song, Y. et al., MET amplification leads to gefitinib resistance in lung cancer by activating ERBB3 signaling. Science 2007, 316, 1039-1043.
34. Eckstein, N., Servan, K., Girard, L., Cai, D. et al., Epidermal growth factor receptor pathway analysis identifies amphiregulin as a key factor for cisplatin resistance of human breast cancer cells. J. Biol. Chem. 2008, 283, 739-750.
35. Trune, D. R., Larrain, B. E., Hausman, F. A., Kempton, J. B., MacArthur, C. J., Simultaneous measurement of multiple ear proteins with multiplex ELISA assays. Hear. Res. 2011, 275, 1-7.
36. Gomez-Puerta, J. A., Celis, R., Hernandez, M. V., Ruiz-Esquide, V. et al., Differences in synovial fluid cytokine levels but not in synovial tissue cell infiltrate between anti-citrullinated peptide/protein antibody-positive and -negative rheumatoid arthritis patients. Arthritis Res. Ther. 2013, 15, R182.
37. Ramirez, J., Ruiz-Esquide, V., Pomes, I., Celis, R. et al., Patients with rheumatoid arthritis in clinical remission and ultrasound-defined active synovitis exhibit higher disease activity and increased serum levels of angiogenic biomarkers. Arthritis Res. Ther. 2014, 16, R5.
38. Yang, C. C., Lin, C. Y., Wang, H. S., Lyu, S. R., Matrix metalloproteases and tissue inhibitors of metalloproteinases in medial plica and pannus-like tissue contribute to knee osteoarthritis progression. PLoS One 2013, 8, e79662.
39. Kim, Y. H., Park, C. S., Jang, T. Y., Immunologic properties and clinical features of local allergic rhinitis. J. Otolaryngol. Head Neck Surg. 2012, 41, 51-57.
40. Rajkumar, T., Vijayalakshmi, N., Gopal, G., Sabitha, K. et al., Identification and validation of genes involved in gastric tumorigenesis. Cancer Cell Int. 2010, 10, 45.
41. Green, V. L., Michno, A., Greenman, J., Stafford, N. D., Effect of treatment on systemic cytokines in head and neck squamous cell carcinoma patients. Results Immunol. 2011, 2, 1-6.
42. Nishida, Y., Higaki, Y., Taguchi, N., Hara, M. et al., Objectively measured physical activity and inflammatory cytokine levels in middle-aged Japanese people. Prev. Med. 2014, 64, 81-87.
43. Rosser, C. J., Dai, Y., Miyake, M., Zhang, G., Goodison, S., Simultaneous multi-analyte urinary protein assay for bladder cancer detection. BMC Biotechnol. 2014, 14, 24.
44. Kolokythas, A., Karas, M., Sarna, T., Flick, W., Miloro, M., Does cytokine profiling of aspirate from jaw cysts and tumors have a role in diagnosis? J. Oral Maxillofac. Surg. 2012, 70, 1070-1080.
45. Tighe, P., Negm, O., Todd, I., Fairclough, L., Utility, reliability and reproducibility of immunoassay multiplex kits. Methods 2013, 61, 23-29.
46. Chowdhury, F., Williams, A., Johnson, P., Validation and comparison of two multiplex technologies, Luminex and Mesoscale Discovery, for human cytokine profiling. J. Immunol. Methods 2009, 340, 55-64.
47. Chaturvedi, S., Dell, E., Siegel, D., Brittingham, G., Seetharam, S., Development of a rapid streptavidin capture-based assay for the tyrosine phosphorylated CSF-1R in peripheral blood mononuclear cells. Int. J. Biol. Sci. 2013, 9, 1099-1107.
48. Smith, T. G., Ellison, J. A., Ma, X., Kuzmina, N. et al., An electrochemiluminescence assay for analysis of rabies virus glycoprotein content in rabies vaccines. Vaccine 2013, 31, 3333-3338.
49. Hoofring, S. A., Lopez, R., Hock, M. B., Kaliyaperumal, A. et al., Immunogenicity testing strategy and bioanalytical assays for antibody-drug conjugates. Bioanalysis 2013, 5, 1041-1055.
50. Banerji, U., van Doorn, L., Papadatos-Pastos, D., Kristeleit, R. et al., A phase I pharmacokinetic and pharmacodynamic study of CHR-3996, an oral class I selective histone deacetylase inhibitor in refractory solid tumors. Clin. Cancer Res. 2012, 18, 2687-2694.
51. Moncunill, G., Aponte, J. J., Nhabomba, A. J., Dobano, C., Performance of multiplex commercial kits to quantify cytokine and chemokine responses in culture supernatants from Plasmodium falciparum stimulations. PLoS One 2013, 8, e52587.
52. Cai, Y. J., Huang, L., Leung, T. Y., Burd, A., A study of the immune properties of human umbilical cord lining epithelial cells. Cytotherapy 2014, 16, 631-639.
53. Chen, Y. C., Yang, X., Miao, L., Liu, Z. G. et al., Serum level of interleukin-6 in Chinese patients with multiple sclerosis. J. Neuroimmunol. 2012, 249, 109-111.
54. Chou, C. S., Lin, L. Y., Chen, K. M., Lai, S. C., FlowCytomix analysis for Toxoplasma gondii infection in pregnant women in central Taiwan. J. Obstet. Gynaecol. 2011, 31, 375-379.
55. Mustafa, A. S., Al-Saidi, F., El-Shamy, A. S., Al-Attiyah, R., Cytokines in response to proteins predicted in genomic regions of difference of Mycobacterium tuberculosis. Microbiol. Immunol. 2011, 55, 267-278.
56. Szczypka, M., Ploch, S., Obminska-Mrukowicz, B., Modulation of Th1/Th2 cytokine production by selective and nonselective phosphodiesterase inhibitors administered to mice. Pharmacol. Rep. 2012, 64, 179-184.
57. Pardo Morales, R. V., Zúñiga Torres, M. G., Martínez Carrillo, B. E., Gómez Martínez, S. et al., Inflammatory mediators and immune response in Mexican adolescents. Nutr. Hosp. 2011, 26, 1115-1119.
58. Berthoud, T. K., Manaca, M. N., Quelhas, D., Aguilar, R. et al., Comparison of commercial kits to measure cytokine responses to Plasmodium falciparum by multiplex microsphere suspension array technology. Malaria J. 2011, 10, 115.
59. Ostendorff, H. P., Awad, A., Braunschweiger, K. I., Liu, Z. et al., Multiplexed VeraCode bead-based serological immunoassay for colorectal cancer. J. Immunol. Methods 2013, 400-401, 58-69.
60. Backen, A. C., Cummings, J., Mitchell, C., Jayson, G. et al., 'Fit-for-purpose' validation of SearchLight multiplex ELISAs of angiogenesis for clinical trial use. J. Immunol. Methods 2009, 342, 106-114.
61. Brookes, K., Cummings, J., Backen, A., Greystoke, A. et al., Issues on fit-for-purpose validation of a panel of ELISAs for application as biomarkers in clinical trials of anti-angiogenic drugs. Br. J. Cancer 2010, 102, 1524-1532.
62. Bastarache, J. A., Koyama, T., Wickersham, N. E., Ware, L. B., Validation of a multiplex electrochemiluminescent immunoassay platform in human and mouse samples. J. Immunol. Methods 2014, 408, 13-23.
63. Hartmann, M., Roeraade, J., Stoll, D., Templin, M. F., Joos, T. O., Protein microarrays for diagnostic assays. Anal. Bioanal. Chem. 2009, 393, 1407-1416.
64. Horan, P. K., Wheeless, L. L., Jr., Quantitative single cell analysis and sorting. Science 1977, 198, 149-157.
65. Nolan, J. P., Mandy, F., Multiplexed and microparticle-based analyses: quantitative tools for the large-scale analysis of biological systems. Cytometry A 2006, 69, 318-325.
66. Ellington, A. A., Kullo, I. J., Bailey, K. R., Klee, G. G., Antibody-based protein multiplex platforms: technical and operational challenges. Clin. Chem. 2010, 56, 186-193.
67. Houser, B., Bio-Rad's Bio-Plex(R) suspension array system, xMAP technology overview. Arch. Physiol. Biochem. 2012, 118, 192-196.
68. Pla-Roca, M., Leulmi, R. F., Tourekhanova, S., Bergeron, S. et al., Antibody colocalization microarray: a scalable technology for multiplex protein analysis in complex samples. Mol. Cell. Proteomics 2012, 11, M111 011460.
69. Boja, E. S., Jortani, S. A., Ritchie, J., Hoofnagle, A. N. et al., The journey to regulation of protein-based multiplex quantitative assays. Clin. Chem. 2011, 57, 560-567.
70. Boja, E. S., Rodriguez, H., The path to clinical proteomics research: integration of proteomics, genomics, clinical laboratory and regulatory science. Korean J. Lab. Med. 2011, 31, 61-71.
71. Chau, C. H., Rixe, O., McLeod, H., Figg, W. D., Validation of analytic methods for biomarkers used in drug development. Clin. Cancer Res. 2008, 14, 5967-5976.
72. Ellington, A. A., Kullo, I. J., Bailey, K. R., Klee, G. G., Measurement and quality control issues in multiplex protein assays: a case study. Clin. Chem. 2009, 55, 1092-1099.
73. Valentin, M. A., Ma, S., Zhao, A., Legay, F., Avrameas, A., Validation of immunoassay for protein biomarkers: bioanalytical study plan implementation to support pre-clinical and clinical studies. J. Pharm. Biomed. Anal. 2011, 55, 869-877.
74. Bastarache, J. A., Koyama, T., Wickersham, N. E., Mitchell, D. B. et al., Accuracy and reproducibility of a multiplex immunoassay platform: a validation study. J. Immunol. Methods 2011, 367, 33-39.
75. Eckels, J., Nathe, C., Nelson, E. K., Shoemaker, S. G. et al., Quality control, analysis and secure sharing of Luminex(R) immunoassay data using the open source LabKey Server platform. BMC Bioinformatics 2013, 14, 145.
76. Cretich, M., Damin, F., Chiari, M., Protein microarray technology: how far off is routine diagnostics? Analyst 2014, 139, 528-542.
77. Juncker, D., Bergeron, S., Laforte, V., Li, H., Cross-reactivity in antibody microarrays and multiplexed sandwich assays: shedding light on the dark side of multiplexing. Curr. Opin. Chem. Biol. 2014, 18, 29-37.
78. Guo, A., Zhu, X.-Y., in: Predki, P. (Ed.), Functional Protein Microarrays: Pathways to Discovery, CRC Press, Boca Raton, FL 2006, pp. 60-61.
79. Stoevesandt, O., Taussig, M. J., Affinity reagent resources for human proteome detection: initiatives and perspectives. Proteomics 2007, 7, 2738-2750.
80. Byerly, S., Sundin, K., Raja, R., Stanchfield, J. et al., Effects of ozone exposure during microarray posthybridization washes and scanning. J. Mol. Diagn. 2009, 11, 590-597.
81. de Jager, W., Rijkers, G. T., Solid-phase and bead-based cytokine immunoassay: a comparison. Methods 2006, 38, 294-303.
82. Fernando, S. A., Wilson, G. S., Studies of the 'hook' effect in the one-step sandwich immunoassay. J. Immunol. Methods 1992, 151, 47-66.
83. Bolstad, N., Warren, D. J., Nustad, K., Heterophilic antibody interference in immunometric assays. Best Pract. Res. Clin. Endocrinol. Metab. 2013, 27, 647-661.
84. Hennig, C., Rink, L., Fagin, U., Jabs, W. J., Kirchner, H., The influence of naturally occurring heterophilic anti-immunoglobulin antibodies on direct measurement of serum proteins using sandwich ELISAs. J. immunol. Methods 2000, 235, 71-80.
85. Boscato, L. M., Stuart, M. C., Heterophilic antibodies: a problem for all immunoassays. Clin. Chem. 1988, 34, 27-33.
86. deJager, W., Prakken, B. J., Bijlsma, J. W., Kuis, W., Rijkers, G. T., Improved multiplex immunoassay performance in human plasma and synovial fluid following removal of interfering heterophilic antibodies. J. Immunol. Methods 2005, 300, 124-135.
87. Rhyne, P., http://www.tecan.com/platform/content/element/9550/2-1Rhyne.pdf, Tecan Ltd 2014.
88. Choi, J. S., Roh, J. Y., Lee, J. R., Clinical availability of component-resolved diagnosis using microarray technology in atopic dermatitis. Ann. Dermatol. 2014, 26, 437-446.
89. Martinez-Aranguren, R., Lizaso, M. T., Goikoetxea, M. J., Garcia, B. E. et al., Is the determination of specific IgE against components using ISAC 112 a reproducible technique? PLoS One 2014, 9, e88394.
90. Jenko, K. L., Zhang, Y., Kostenko, Y., Fan, Y. et al., Development of an ELISA microarray assay for the sensitive and simultaneous detection of ten biodefense toxins. Analyst 2014, 139, 5093-5102.
91. FDA, Center for Drug Evaluation and Research (CDER). Guidance for industry: bioanalytical method validation: US Food and Drug Administration, http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070107.pdf, FDA 2001.
92. Master, S. R., Bierl, C., Kricka, L. J., Diagnostic challenges for multiplexed protein microarrays. Drug Discov. Today 2006, 11, 1007-1011.
93. Buchegger, P., Sauer, U., Toth-Szekely, H., Preininger, C., Miniaturized protein microarray with internal calibration as point-of-care device for diagnosis of neonatal sepsis. Sensors 2012, 12, 1494-1508.
94. Augenlicht, L. H., Kobrin, D., Cloning and screening of sequences expressed in a mouse colon tumor. Cancer Res. 1982, 42, 1088-1093.
95. Chang, T. W., Binding of cells to matrixes of distinct antibodies coated on solid surface. J. Immunol. Methods 1983, 65, 217-223.
96. Moody, M. D., Van Arsdell, S. W., Murphy, K. P., Orencole, S. F., Burns, C., Array-based ELISAs for high-throughput analysis of human cytokines. BioTechniques 2001, 31, 186-190, 192-184.