INTERFERENCE IN IMMUNOASSAYS
Year 2023,
Volume: 8 Issue: 1, 22 - 31, 24.03.2023
Eugene Gıtongorı Mogaka
,
Resul Karakuş
E. Ümit Bağrıaçık
Abstract
Immunoassays are simple, efficient and reliable means for testing patient samples in the modern hospital. Their specificity and sensitivity have provided robust means by which detection of analytes can be achieved with ease. The underlying principle of antigen-antibody reactions forming a measurable complex exposes immunoassays to possible interference from proteins and other reactants with structural similarities to antibodies and or the analytes. Accounting for the sensitivity of the test and its reliability, the impact of interferents both endogenous like autoantibodies and exogenous factors like drugs, involved in the assay is worth investigating since the alternative would be producing unreliable results. Insights for developing tests for assessing discordant results following troubleshooting of immunoassays as possible remedial measures have been provided.
References
- 1. Wu AHB. A selected history and future of immunoassay development and applications in clinical chemistry. Clin Chim Acta [Internet] 2006 [cited 2021 Dec 15];369(2):119–24. Available from: https://pubmed.ncbi.nlm.nih.gov/16701599/
- 2. Ruibal Morell A. Remembering our history: 60 years ago radioimmunoanalysis was discovered. Rev Española Med Nucl e Imagen Mol (English Ed 2020;39(6):337–9.
- 3. Luo YR, Chakraborty I, Lazar-Molnar E, Wu AHB, Lynch KL. Development of Label-Free Immunoassays as Novel Solutions for the Measurement of Monoclonal Antibody Drugs and Antidrug Antibodies. Clin Chem [Internet] 2020 [cited 2022 Jan 14];66(10):1319–28. Available from: https://academic.oup.com/clinchem/article/66/10/1319/5904419
- 4. Ahsan H. Monoplex and multiplex immunoassays: approval, advancements, and alternatives. Comp Clin Path [Internet] 2021 [cited 2022 Jan 14];1–13. Available from: https://link.springer.com/article/10.1007/s00580-021-03302-4
- 5. Chigaev A, Sklar LA. Aspects of VLA-4 and LFA-1 regulation that may contribute to rolling and firm adhesion. Front Immunol [Internet] 2012 [cited 2020 Mar 3];3(AUG):242. Available from: http://journal.frontiersin.org/article/10.3389/fimmu.2012.00242/abstract
- 6. Pan R, Li G, Liu S, Zhang X, Liu J, Su Z, et al. Emerging nanolabels-based immunoassays: Principle and applications in food safety. TrAC Trends Anal Chem 2021;145:116462.
- 7. Clinical and Laboratory Standards Institute. Interference Testing in Clinical Chemistry; Approved Guideline—Second Edition. [Internet]. Pennsylvania 19087-1898 USA, 2005: 2005 [cited 2021 Dec 20]. Available from: https://demo.nextlab.ir/Organization/Documents/CLSI-Standards/CLSI-EP7-A2.aspx
- 8. Ward G, Simpson A, Boscato L, Hickman PE. The investigation of interferences in immunoassay. Clin Biochem 2017;50(18):1306–11.
- 9. 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(1):29–37.
- 10. Ghazal K, Brabant S, Prie D, Piketty ML. Hormone Immunoassay Interference: A 2021 Update. Ann Lab Med [Internet] 2022 [cited 2022 Jan 13];42(1):3–23. Available from: https://synapse.koreamed.org/articles/1147379
- 11. Chagoya Rodrigo C, Ruben Alejandro CP, Romero Javier H, Oviedo Cristobal L, Gutierrez Rosa Isela C, Medina Andrea V, et al. Hypersensivity Reactions to Steroids: Review. Glob Vaccines Immunol 2018;3(1).
- 12. Emerson JF, Lai KKY. Endogenous Antibody Interferences in Immunoassays. Lab Med [Internet] 2013 [cited 2022 Jan 13];44(1):69–73. Available from: https://academic.oup.com/labmed/article/44/1/69/2657820
- 13. Koulouri O, Moran C, Halsall D, Chatterjee K, Gurnell M. Pitfalls in the measurement and interpretation of thyroid function tests. Best Pract Res Clin Endocrinol Metab [Internet] 2013 [cited 2022 Jan 13];27(6):745. Available from: /pmc/articles/PMC3857600/
- 14. Emerson JF, Lai KKY. Endogenous Antibody Interferences in Immunoassays. Lab Med [Internet] 2013 [cited 2022 Jan 20];44(1):69–73. Available from: https://academic.oup.com/labmed/article/44/1/69/2657820
- 15. Dong B, Bergman D, Holst BS. Prevalence of heterophilic antibodies in serum samples from horses in an equine hospital, and elimination of interference using chicken IgY. Acta Vet Scand [Internet] 2021 [cited 2022 Jan 20];63(1):1–6. Available from: https://actavetscand.biomedcentral.com/articles/10.1186/s13028-021-00575-1
- 16. Sturgeon CM, Viljoen A. Analytical error and interference in immunoassay: Minimizing risk. Ann Clin Biochem [Internet] 2011 [cited 2022 Jan 13];48(5):418–32. Available from: https://journals.sagepub.com/doi/full/10.1258/acb.2011.011073
- 17. Gehin JE, Klaasen RA, Norli ES, Warren DJ, Syversen SW, Goll GL, et al. Rheumatoid factor and falsely elevated results in commercial immunoassays: data from an early arthritis cohort. Rheumatol Int [Internet] 2021 [cited 2022 Jan 13];41(9):1657–65. Available from: https://link.springer.com/article/10.1007/s00296-021-04865-9
- 18. Wang H, Bi X, Xu L, Li Y. Negative interference by rheumatoid factor in alpha-fetoprotein chemiluminescent microparticle immunoassay.
- 19. Ross GMS, Filippini D, Nielen MWF, Salentijn GIJ. Unraveling the Hook Effect: A Comprehensive Study of High Antigen Concentration Effects in Sandwich Lateral Flow Immunoassays. Anal Chem [Internet] 2020 [cited 2022 Jan 20];92(23):15587–95. Available from: /pmc/articles/PMC7711776/
- 20. Gauchez AS. Pitfalls and problems in immunoanalysis. Médecine Nucléaire 2015;39(1):71–7.
- 21. Hillebrand JJ, Wickenhagen W V., Heijboer AC. Improving Science by Overcoming Laboratory Pitfalls With Hormone Measurements. J Clin Endocrinol Metab [Internet] 2021 [cited 2022 Jan 20];106(4):e1504–12. Available from: https://academic.oup.com/jcem/article/106/4/e1504/6056612
- 22. Dasgupta A, Wahed A. Biotin interferences with immunoassays. Clin Chem Immunol Lab Qual Control 2021;445–55.
- 23. Li J, Wagar EA, Meng QH. Comprehensive assessment of biotin interference in immunoassays. Clin Chim Acta 2018;487:293–8.
INTERFERENCE IN IMMUNOASSAYS
Year 2023,
Volume: 8 Issue: 1, 22 - 31, 24.03.2023
Eugene Gıtongorı Mogaka
,
Resul Karakuş
E. Ümit Bağrıaçık
Abstract
Immunoassays are simple, efficient and reliable means for testing patient samples in the modern hospital. Their specificity and sensitivity have provided robust means by which detection of analytes can be achieved with ease. The underlying principle of antigen-antibody reactions forming a measurable complex exposes immunoassays to possible interference from proteins and other reactants with structural similarities to antibodies and or the analytes. Accounting for the sensitivity of the test and its reliability, the impact of interferents both endogenous like autoantibodies and exogenous factors like drugs, involved in the assay is worth investigating since the alternative would be producing unreliable results. Insights for developing tests for assessing discordant results following troubleshooting of immunoassays as possible remedial measures have been provided.
References
- 1. Wu AHB. A selected history and future of immunoassay development and applications in clinical chemistry. Clin Chim Acta [Internet] 2006 [cited 2021 Dec 15];369(2):119–24. Available from: https://pubmed.ncbi.nlm.nih.gov/16701599/
- 2. Ruibal Morell A. Remembering our history: 60 years ago radioimmunoanalysis was discovered. Rev Española Med Nucl e Imagen Mol (English Ed 2020;39(6):337–9.
- 3. Luo YR, Chakraborty I, Lazar-Molnar E, Wu AHB, Lynch KL. Development of Label-Free Immunoassays as Novel Solutions for the Measurement of Monoclonal Antibody Drugs and Antidrug Antibodies. Clin Chem [Internet] 2020 [cited 2022 Jan 14];66(10):1319–28. Available from: https://academic.oup.com/clinchem/article/66/10/1319/5904419
- 4. Ahsan H. Monoplex and multiplex immunoassays: approval, advancements, and alternatives. Comp Clin Path [Internet] 2021 [cited 2022 Jan 14];1–13. Available from: https://link.springer.com/article/10.1007/s00580-021-03302-4
- 5. Chigaev A, Sklar LA. Aspects of VLA-4 and LFA-1 regulation that may contribute to rolling and firm adhesion. Front Immunol [Internet] 2012 [cited 2020 Mar 3];3(AUG):242. Available from: http://journal.frontiersin.org/article/10.3389/fimmu.2012.00242/abstract
- 6. Pan R, Li G, Liu S, Zhang X, Liu J, Su Z, et al. Emerging nanolabels-based immunoassays: Principle and applications in food safety. TrAC Trends Anal Chem 2021;145:116462.
- 7. Clinical and Laboratory Standards Institute. Interference Testing in Clinical Chemistry; Approved Guideline—Second Edition. [Internet]. Pennsylvania 19087-1898 USA, 2005: 2005 [cited 2021 Dec 20]. Available from: https://demo.nextlab.ir/Organization/Documents/CLSI-Standards/CLSI-EP7-A2.aspx
- 8. Ward G, Simpson A, Boscato L, Hickman PE. The investigation of interferences in immunoassay. Clin Biochem 2017;50(18):1306–11.
- 9. 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(1):29–37.
- 10. Ghazal K, Brabant S, Prie D, Piketty ML. Hormone Immunoassay Interference: A 2021 Update. Ann Lab Med [Internet] 2022 [cited 2022 Jan 13];42(1):3–23. Available from: https://synapse.koreamed.org/articles/1147379
- 11. Chagoya Rodrigo C, Ruben Alejandro CP, Romero Javier H, Oviedo Cristobal L, Gutierrez Rosa Isela C, Medina Andrea V, et al. Hypersensivity Reactions to Steroids: Review. Glob Vaccines Immunol 2018;3(1).
- 12. Emerson JF, Lai KKY. Endogenous Antibody Interferences in Immunoassays. Lab Med [Internet] 2013 [cited 2022 Jan 13];44(1):69–73. Available from: https://academic.oup.com/labmed/article/44/1/69/2657820
- 13. Koulouri O, Moran C, Halsall D, Chatterjee K, Gurnell M. Pitfalls in the measurement and interpretation of thyroid function tests. Best Pract Res Clin Endocrinol Metab [Internet] 2013 [cited 2022 Jan 13];27(6):745. Available from: /pmc/articles/PMC3857600/
- 14. Emerson JF, Lai KKY. Endogenous Antibody Interferences in Immunoassays. Lab Med [Internet] 2013 [cited 2022 Jan 20];44(1):69–73. Available from: https://academic.oup.com/labmed/article/44/1/69/2657820
- 15. Dong B, Bergman D, Holst BS. Prevalence of heterophilic antibodies in serum samples from horses in an equine hospital, and elimination of interference using chicken IgY. Acta Vet Scand [Internet] 2021 [cited 2022 Jan 20];63(1):1–6. Available from: https://actavetscand.biomedcentral.com/articles/10.1186/s13028-021-00575-1
- 16. Sturgeon CM, Viljoen A. Analytical error and interference in immunoassay: Minimizing risk. Ann Clin Biochem [Internet] 2011 [cited 2022 Jan 13];48(5):418–32. Available from: https://journals.sagepub.com/doi/full/10.1258/acb.2011.011073
- 17. Gehin JE, Klaasen RA, Norli ES, Warren DJ, Syversen SW, Goll GL, et al. Rheumatoid factor and falsely elevated results in commercial immunoassays: data from an early arthritis cohort. Rheumatol Int [Internet] 2021 [cited 2022 Jan 13];41(9):1657–65. Available from: https://link.springer.com/article/10.1007/s00296-021-04865-9
- 18. Wang H, Bi X, Xu L, Li Y. Negative interference by rheumatoid factor in alpha-fetoprotein chemiluminescent microparticle immunoassay.
- 19. Ross GMS, Filippini D, Nielen MWF, Salentijn GIJ. Unraveling the Hook Effect: A Comprehensive Study of High Antigen Concentration Effects in Sandwich Lateral Flow Immunoassays. Anal Chem [Internet] 2020 [cited 2022 Jan 20];92(23):15587–95. Available from: /pmc/articles/PMC7711776/
- 20. Gauchez AS. Pitfalls and problems in immunoanalysis. Médecine Nucléaire 2015;39(1):71–7.
- 21. Hillebrand JJ, Wickenhagen W V., Heijboer AC. Improving Science by Overcoming Laboratory Pitfalls With Hormone Measurements. J Clin Endocrinol Metab [Internet] 2021 [cited 2022 Jan 20];106(4):e1504–12. Available from: https://academic.oup.com/jcem/article/106/4/e1504/6056612
- 22. Dasgupta A, Wahed A. Biotin interferences with immunoassays. Clin Chem Immunol Lab Qual Control 2021;445–55.
- 23. Li J, Wagar EA, Meng QH. Comprehensive assessment of biotin interference in immunoassays. Clin Chim Acta 2018;487:293–8.