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Methodology

Reduction of Dilution Error in Elisas Using an Internal Standard

, &
Pages 1451-1464 | Received 04 Mar 2016, Accepted 23 May 2016, Published online: 17 Jun 2016

References

  • Wild D . The Immunoassay Handbook. Elsevier, Oxford, UK (2013).
  • Bults P , van de MerbelNC, BischoffR. Quantification of biopharmaceuticals and biomarkers in complex biological matrices: a comparison of liquid chromatography coupled to tandem mass spectrometry and ligand binding assays. Expert Rev. Proteomics12 (4), 355–374 (2015).
  • Bracewell DG , FrancisR, SmalesCM. The future of host cell protein (HCP) identification during process development and manufacturing linked to a risk-based management for their control. Biotechnol. Bioeng. 112 (9), 1727–1737 (2015).
  • Tighe PJ , RyderRR, ToddI, FaircloughLC. ELISA in the multiplex era: potentials and pitfalls. Proteomics Clin. Appl. 9 (3–4), 406–422 (2015).
  • DeSilva B , SmithW, WeinerRet al. Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. Pharm. Res. 20 (11), 1885–1900 (2003).
  • FDA . Bioanalytical Method Validation (Draft Guidance for Industry) (2013). www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm368107.pdf
  • Nencini F , PratesiS, PetroniG, MatucciA, MaggiE, VultaggioA. Assays and strategies for immunogenicity assessment of biological agents. Drug Dev. Res. 75 (Suppl. 1), S4–S6 (2014).
  • USP Chapter 1033. Biological Assay Validation. USP Pharmacopeial Convention (2013).
  • Berkow L . Factors affecting hemoglobin measurement. J. Clin. Monit. Comput. 27 (5), 499–508 (2013).
  • Favaloro EJ , VerbruggenB, MillerCH. Laboratory testing for factor inhibitors. Haemophilia20 (Suppl. 4), 94–98 (2014).
  • Rustamov O , SmithA, RobertsSAet al. The measurement of anti-Mullerian hormone: a critical appraisal. J. Clin. Endocrinol. Metab. 99 (3), 723–732 (2014).
  • Kricka LJ , CarterTJ, BurtSMet al. Variability in the adsorption properties of microtitre plates used as solid supports in enzyme immunoassay. Clin. Chem. 26 (6), 741–744 (1980).
  • Harrison RO , HammockBD. Location dependent biases in automatic 96-well microplate readers. J. Assoc. 71 (5), 981–987 (1988).
  • Liang Y , WoodleSA, ShibekoAM, LeeTK, OvanesovMV. Correction of microplate location effects improves performance of the thrombin generation test. Thromb. J. 11 (1), 12–21 (2013).
  • Oliver DG , SandersAH, HoggRD, HellmanJW. Thermal gradients in microtitration plates. Effects on enzyme-linked immunoassay. J. Immunol. Methods42 (2), 195–201 (1981).
  • Verch T . Application of quality by design and statistical quality control concepts in immunoassays. Bioanalysis6 (23), 3251–3260 (2014).
  • Hooton JW , PaetkauV. Random assignment of treatments in a 96-well (8 × 12) microtiter plate. A practical method. J. Immunol. Methods94 (1–2), 81–89 (1986).
  • Hentz NG , KnaideTR. Effect of liquid-handling accuracy on assay performance. J. Lab Autom. 19 (2), 153–162 (2014).
  • Joelsson D , MoravecP, TroutmanM, PigeonJ, DePhillipsP. Optimizing ELISAs for precision and robustness using laboratory automation and statistical design of experiments. J. Immunol. Methods337 (1), 35–41 (2008).
  • Pandya K , RayCA, BrunnerL, WangJ, LeeJW, DeSilvaB. Strategies to minimize variability and bias associated with manual pipetting in ligand binding assays to assure data quality of protein therapeutic quantification. J. Pharm. Biomed. Anal. 53 (3), 623–630 (2010).
  • Tsoi J , PatelV, ShihJ. A practical approach to automate randomized design of experiments for ligand-binding assays. Bioanalysis6 (5), 705–713 (2014).
  • Noble JE , WangL, CerasoliEet al. An international comparability study to determine the sources of uncertainty associated with a non-competitive sandwich fluorescent ELISA. Clin. Chem. Lab. Med. 46 (7), 1033–1045 (2008).
  • Panicker G , RajbhandariI, GurbaxaniBM, QuerecTD, UngerER. Development and evaluation of multiplexed immunoassay for detection of antibodies to HPV vaccine types. J. Immunol. Methods417, 107–114 (2015).
  • Lippi G , GuidiGC, MattiuzziC, PlebaniM. Preanalytical variability: the dark side of the moon in laboratory testing. Clin. Chem. Lab. Med. 44 (4), 358–365 (2006).
  • Plebani M . Errors in clinical laboratories or errors in laboratory medicine?Clin. Chem. Lab. Med. 44 (6), 750–759 (2006).
  • Makarenkov V , ZentilliP, KevorkovD, GagarinA, MaloN, NadonR. An efficient method for the detection and elimination of systematic error in high-throughput screening. Bioinformatics23 (13), 1648–1657 (2007).
  • Shapiro AB , WalkupGK, KeatingTA. Correction for interference by test samples in high-throughput assays. J. Biomol. Screen. 14 (8), 1008–1016 (2009).
  • Watzig H , Oltmann-NordenI, SteinickeFet al. Data quality in drug discovery: the role of analytical performance in ligand binding assays. J. Comput. Aided Mol. Des. 29 (9), 847–865 (2015).
  • Jani D , AllinsonJ, BerishaFet al. Recommendations for use and fit-for-purpose validation of biomarker multiplex ligand binding assays in drug development. AAPS J. 18 (1), 1–14 (2016).
  • Spriggs FP , DurigaN, RathiA, QuQ. Resolution of matrix interference: quantitative and quasi-quantitative ligand-binding assays case studies. Bioanalysis6 (8), 1093–1101 (2014).
  • Cox KL , DevanarayanV, KriauciunasA, ManettaJ, MontroseC, SittampalamS. Immunoassay methods. Assay Guidance Manual. Eli Lilly & Company and the National Center for Advancing Translational Sciences, Bethesda, MD, USA (2004).
  • Das SK , StanleyER, GuilbertLJ, FormanLW. Discrimination of a colony stimulating factor subclass by a specific receptor on a macrophage cell line. J. Cell Physiol104 (3), 359–366 (1980).
  • Higgins KM , DavidianM, ChewG, BurgeH. The effect of serial dilution error on calibration inference in immunoassay. Biometrics54 (1), 19–32 (1998).
  • Hutcheon JA , ChioleroA, HanleyJA. Random measurement error and regression dilution bias. BMJ340, c2289 (2010).
  • Ponnayyan SS , SharmaK, MullangiR, SukumaranSK. Review of the validated HPLC and LC-MS/MS methods for determination of drugs used in clinical practice for Alzheimer’s disease. Biomed. Chromatogr. 28 (11), 1431–1490 (2014).
  • Syed M , SrinivasNR. A comprehensive review of the published assays for the quantitation of the immunosuppressant drug mycophenolic acid and its glucuronidated metabolites in biological fluids. Biomed. Chromatogr. 30 (5), 721–748 (2016).
  • Roselle C , VerchT, Shank-RetzlaffM. Mitigation of microtiter plate positioning effects using a block randomization scheme. Anal. Bioanal. Chem. 408 (15), 3969–3079 (2016).

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