Skip to main content
SpringerLink
Log in

Bioanalytical Parameters in Immunoassays and Their Determination

  • Chapter
  • First Online:
Point-of-Care Technologies Enabling Next-Generation Healthcare Monitoring and Management

  • 775 Accesses

Abstract

Immunoassays (IAs) play a prominent role in in vitro diagnostics (IVD) of single or multiple analytes in patient samples, a prerequisite for the monitoring and management of health. Stringent bioanalytical testing in parallel with robust statistical analysis stems from the growing concerns for public health and safety. In addition, the prominent role of statistical analysis should adhere to the recent guidelines provided by the regulatory authorities. The guidelines are regularly updated as reflected by continuously evolving technologies and recent trends in IVD and point-of-care testing (POCT). The IA must provide precision, accuracy, high sensitivity, specificity, reproducibility, and robustness. This chapter provides an overview of the critical bioanalytical parameters and their determination, as desired by the regulatory guidelines.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Log in via an institution
Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 129.00
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Hardcover Book
USD 169.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

References

  1. Trullols E, Ruisanchez I, Rius FX. Validation of qualitative analytical methods. Trends Anal Chem. 2004;23(2):137–45.

    Article  Google Scholar 

  2. Ellison SLR, Fearn T. Characterising the performance of qualitative analytical methods: statistics and terminology. Trends Anal Chem. 2005;24(6):468–76.

    Article  Google Scholar 

  3. Stenman UH. Immunoassay standardization: is it possible, who is responsible, who is capable? Clin Chem. 2001;47(5):815–20.

    MathSciNet  Google Scholar 

  4. Valentin MA, 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(5):869–77.

    Article  Google Scholar 

  5. Guidance for industry – bioanalytical method validation. 2013. https://www.fda.gov/downloads/Drugs/Guidances/ucm368107.pdf

  6. Guideline on bioanalytical method validation. 2011. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500109686.pdf

  7. Marquette CA, Blum LJ. State of the art and recent advances in immunoanalytical systems. Biosens Bioelectron. 2006;21(8):1424–33.

    Article  Google Scholar 

  8. Vashist SK, Luppa PB, Yeo LY, Ozcan A, Luong JHT. Emerging technologies for next-generation point-of-care testing. Trends Biotechnol. 2015;33(11):692–705.

    Article  Google Scholar 

  9. Strandberg-Larsen M, Krasnik A. Measurement of integrated healthcare delivery: a systematic review of methods and future research directions. Int J Integr Care. 2009;9(1):e01.

    Article  Google Scholar 

  10. Varkey P, Reller MK, Resar RK. Basics of quality improvement in health care. Mayo Clin Proc. 2007;82:735–9.

    Article  Google Scholar 

  11. Armbruster DA, Pry T. Limit of blank, limit of detection and limit of quantitation. Clin Biochem Rev. 2008;29(Suppl 1):S49–52.

    Google Scholar 

  12. Armbruster DA, Alexander DB. Sample to sample carryover: a source of analytical laboratory error and its relevance to integrated clinical chemistry/immunoassay systems. Clin Chim Acta. 2006;373(1–2):37–43.

    Article  Google Scholar 

  13. Krouwer JS. Setting performance goals and evaluating total analytical error for diagnostic assays. Clin Chem. 2002;48(6.1):919–27.

    Google Scholar 

  14. Kricka LJ. Interferences in immunoassay—still a threat. Clin Chem. 2000;46(8):1037–8.

    Google Scholar 

  15. Tate J, Ward G. Interferences in immunoassay. Clin Biochem Rev. 2004;25(2):105–20.

    Google Scholar 

  16. Ismail AAA. A radical approach is needed to eliminate interference from endogenous antibodies in immunoassays. Clin Chem. 2005;51(1):25–6.

    Article  MathSciNet  Google Scholar 

  17. Bjerner J, Nustad K, Norum LF, Olsen KH, Bormer OP. Immunometric assay interference: incidence and prevention. Clin Chem. 2002;48(4):613–21.

    Google Scholar 

  18. Niu H, Klem T, Yang J, Qiu Y, Pan L. A biotin-drug extraction and acid dissociation (BEAD) procedure to eliminate matrix and drug interference in a protein complex anti-drug antibody (ADA) isotype specific assay. J Immunol Methods. 2017;446:30–6.

    Article  Google Scholar 

  19. Fernando SA, Wilson GS. Studies of the ‘hook’ effect in the one-step sandwich immunoassay. J Immunol Methods. 1992;151(1–2):47–66.

    Article  Google Scholar 

  20. Class 2 Device Recall CoatACount Direct Androstenedione. 2014. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=128287

  21. Class 2 Device Recall IMMULITE/IMMULITE 1000 Systems Androstenedione. 2014. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=124991

  22. Carey G, Lewis SC. Method of handling reagents in a random access protocol. United States Patent, US6498037B1.

    Google Scholar 

  23. Gebrian PL, Evers TP. Random access reagent delivery system for use in an automatic clinical analyzer. United States Patent, US7169356B2.

    Google Scholar 

  24. Ismail AAA, Walker PL, Cawood ML, Barth JH. Interference in immunoassay is an underestimated problem. Ann Clin Biochem. 2002;39(4):366–73.

    Article  Google Scholar 

  25. Carraro P, Plebani M. Errors in a stat laboratory: types and frequencies 10 years later. Clin Chem. 2007;53(7):1338–42.

    Article  Google Scholar 

  26. Ismail Y, Ismail AA, Ismail AAA. Erroneous laboratory results: what clinicians need to know. Clin Med. 2007;7(4):357–61.

    Article  Google Scholar 

  27. Plebani M. The detection and prevention of errors in laboratory medicine. Ann Clin Biochem. 2010;47(Pt 2):101–10.

    Article  Google Scholar 

  28. Ceriotti F. The role of external quality assessment schemes in monitoring and improving the standardization process. Clin Chim Acta. 2014;432:77–81.

    Article  Google Scholar 

  29. Perich C, Ricós C, Alvarez V, Biosca C, Boned B, Cava F, et al. External quality assurance programs as a tool for verifying standardization of measurement procedures: pilot collaboration in Europe. Clin Chim Acta. 2014;432:82–9.

    Article  Google Scholar 

  30. Taverniers I, De Loose M, Van Bockstaele E. Trends in quality in the analytical laboratory. II. Analytical method validation and quality assurance. Trends Anal Chem. 2004;23(8):535–52.

    Article  Google Scholar 

  31. Findlay JW, Smith WC, Lee JW, Nordblom GD, Das I, DeSilva BS, et al. Validation of immunoassays for bioanalysis: a pharmaceutical industry perspective. J Pharm Biomed Anal. 2000;21(6):1249–73.

    Article  Google Scholar 

  32. Thaler M, Muller C, Schlichtiger A, Grundler K, Moore M, Luppa PB. Steroid binding properties of the 2nd WHO international standard for sex hormone-binding globulin. Clin Chem Lab Med. 2011;49(5):869–72.

    Article  Google Scholar 

  33. Jin M, Wener MH, Bankson DD. Evaluation of automated sex hormone binding globulin immunoassays. Clin Biochem. 2006;39(1):91–4.

    Article  Google Scholar 

  34. http://www.bernardmgross.com/sites/default/files/cases/2014/05/filed-complt-122.pdf (2010).

Download references

Author information

Authors and Affiliations

  1. Labsystems Diagnostics Oy, Vantaa, Finland

    Sandeep Kumar Vashist

  2. Innovative Chromatography Group, Irish Separation Science Cluster (ISSC), School of Chemistry and Analytical, Biological Chemistry Research Facility (ABCRF), University College Cork, Cork, Ireland

    John H. T. Luong

Authors
  1. Sandeep Kumar Vashist
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. John H. T. Luong
    View author publications

    You can also search for this author in PubMed Google Scholar

Rights and permissions

Reprints and permissions

Copyright information

© 2019 Springer Nature Switzerland AG

About this chapter

Check for updates. Verify currency and authenticity via CrossMark

Cite this chapter

Vashist, S.K., Luong, J.H.T. (2019). Bioanalytical Parameters in Immunoassays and Their Determination. In: Point-of-Care Technologies Enabling Next-Generation Healthcare Monitoring and Management. Springer, Cham. https://doi.org/10.1007/978-3-030-11416-9_8

Download citation

  • DOI: https://doi.org/10.1007/978-3-030-11416-9_8

  • Published:

  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-030-11415-2

  • Online ISBN: 978-3-030-11416-9

  • eBook Packages: EngineeringEngineering (R0)

Publish with us

Policies and ethics

Search

Navigation