Analytical error and interference in immunoassay: Minimizing risk

Annals of Clinical Biochemistry

Volumn 48, Issue 5, 2011, Pages 418-432

  Sturgeon, Catharine M ^a   Viljoen, Adie ^b  

^a Royal Inrmary of Edinburgh ^*  (United Kingdom)

^b LISTER HOSPITAL   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

CARCINOEMBRYONIC ANTIGEN; CHORIONIC GONADOTROPIN; CHORIONIC GONADOTROPIN BETA SUBUNIT; DIGOXIN; GROWTH HORMONE; HEMOGLOBIN; HETEROPHILE ANTIBODY; IMMUNOGLOBULIN G; IMMUNOGLOBULIN M; INSULIN; LIPID; LUTEINIZING HORMONE; LYMPHOCYTE ANTIBODY; MACROGOL; PARATHYROID HORMONE; PROSTATE SPECIFIC ANTIGEN; REAGENT; RECOMBINANT HUMAN INSULIN; RHEUMATOID FACTOR; TESTOSTERONE; THYROGLOBULIN; THYROID HORMONE; THYROTROPIN; TROPONIN; VITAMIN D; ANTIBODY;

ACCURACY; ANALYTICAL ERROR; AUTOIMMUNE DISEASE; CLINICAL LABORATORY; CROSS REACTION; DIFFERENTIATED THYROID CANCER; DILUTION; FALSE POSITIVE RESULT; FAMILIAL DYSALBUMINEMIC HYPERTHYROXINEMIA; GEL FILTRATION CHROMATOGRAPHY; HEALTH CARE PERSONNEL; HUMAN; IMMUNOADSORPTION; IMMUNOASSAY; IN VIVO STUDY; INTERPERSONAL COMMUNICATION; LABORATORY PERSONNEL; MASS SPECTROMETRY; MEDICAL DOCUMENTATION; PRECIPITATION; PRIORITY JOURNAL; PROLACTINOMA; REVIEW; RISK MANAGEMENT; STANDARDIZATION; THYROID FUNCTION TEST; ANIMAL; CHEMISTRY; DIAGNOSTIC ERROR; METHODOLOGY; PROTEIN BINDING; REPRODUCIBILITY; SERUM; STANDARD;

ANIMALS; ANTIBODIES; DIAGNOSTIC ERRORS; DISCLOSURE; HUMANS; IMMUNOASSAY; PROTEIN BINDING; REPRODUCIBILITY OF RESULTS; RISK MANAGEMENT; SERUM;

EID: 84855176252     PISSN: 00045632     EISSN: 17581001     Source Type: Journal    
DOI: 10.1258/acb.2011.011073     Document Type: Review

References (80)

1. Seth J, Sturgeon C. Pitfalls in immunoassays in endocrinology. Endocrinology and Metabolism In-service Training and Continuing Education [AACC] 1993;11:89-99
2. Ismail AA. Interference from endogenous antibodies in automated immunoassays: what laboratorians need to know. J Clin Pathol 2009;62:673-8
3. Klee GG. Interferences in hormone immunoassays. Clin Lab Med 2004;24:1-18
4. Sturgeon CM. Limitations of assay techniques for tumor markers. Chapter 4. In: Diamandis EP, Fritsche HA, Lilja H, Chan DW, Schwartz MK, eds. Tumor Markers: Physiology, Pathobiology, Technology and Clinical Applications. Chicago: AACC Press, 2002
5. Howanitz JH, Bjerner J, Chace NM, et al. Clinical and Laboratory Standards Institute (CLSI). Immunoassay Interference by Endogenous Antibodies; Approved Guideline. Document I/LA30-A. Wayne, PA: CLSI, 2009;28
6. Jones AM, Honour JW. Unusual results from immunoassays and the role of the clinical endocrinologist. Clin Endocrinol (Oxf) 2006;64:234-44
7. Bjerner J, Nustad K, Norum LF, et al. Immunometric assay interference: incidence and prevention. Clin Chem 2002;48:613-21
8. Ismail AA, Walker PL, Barth JH, et al. Wrong biochemistry results: two case reports and observational study in 5310 patients on potentially misleading thyroid-stimulating hormone and gonadotropin immunoassay results. Clin Chem 2002;48:2023-9
9. Sturgeon CM, Duffy MJ, Stenman UH, et al. National Academy of Clinical Biochemistry laboratory medicine practice guidelines for use of tumor markers in testicular, prostate, colorectal, breast, and ovarian cancers. Clin Chem 2008;54:e11-79
10. Preissner CM, Dodge LA, O'Kane DJ, et al. Prevalence of heterophilic antibody interference in eight automated tumor marker immunoassays. Clin Chem 2005;51:208-10
11. Giovanella L, Ghelfo A. Undetectable serum thyroglobulin due to negative interference of heterophile antibodies in relapsing thyroid carcinoma. Clin Chem 2007;53:1871-2
12. Wu A, Collinson P, Jaffe A, et al. High-sensitivity cardiac troponin assays: what analytical and clinical issues need to be addressed before introduction into clinical practice? Interview by Fred S. Apple. Clin Chem 2010;56:886-91
13. British Thyroid Association. UK Guidelines for the use of thyroid function tests. 2006. See http://www.british-thyroid-association.org/info-for-patients/Docs/TFT_guideline_nal_version_July_2006.pdf (last checked 16 May 2011)
14. Surks MI, DeFesi CR. Normal serum free thyroid hormone concentrations in patients treated with phenytoin or carbamazepine. A paradox resolved. JAMA 1996;275:1495-8
15. Dasgupta A. The effects of adulterants and selected ingested compounds on drugs-of-abuse testing in urine. Am J Clin Pathol 2007;128:491-503
16. O'Kane M. The reporting, classication and grading of quality failures in the medical laboratory. Clin Chim Acta 2009;404:28-31
17. Plebani M. The detection and prevention of errors in laboratory medicine. Ann Clin Biochem 2010;47:101-10
18. Westgard JO, Westgard QC. Madison, Wisconsin, 2009. See http://www. westgard.com/ (last checked 16 May 2011)
19. Ungerer JP, Pretorius CJ, Dimeski G, et al. Falsely elevated troponin I results due to outliers indicate a lack of analytical robustness. Ann Clin Biochem 2010;47:242-7
20. Wild DG. The Immunoassay Handbook. 3rd edn. Oxford: Elsevier Ltd, 2005
21. Klee GG. Harmonization and standardization of thyroid function tests. Clin Chem 2010;56:879-80
22. Sturgeon CM, Berger P, Bidart JM, et al. Differences in recognition of the 1st WHO international reference reagents for hCG-related isoforms by diagnostic immunoassays for human chorionic gonadotropin. Clin Chem 2009;55:1484-91
23. Berger P, Sturgeon C, Bidart JM, et al. The ISOBM TD-7 Workshop on hCG and related molecules. Towards user-oriented standardization of pregnancy and tumor diagnosis: assignment of epitopes to the three-dimensional structure of diagnostically and commercially relevant monoclonal antibodies directed against human chorionic gonadotropin and derivatives. Tumour Biol 2002;23:1-38
24. Lopez MF, Rezai T, Sarracino DA, et al. Selected reaction monitoring-mass spectrometric immunoassay responsive to parathyroid hormone and related variants. Clin Chem 2010;56:281-90
25. Heald AH, Bhattacharya B, Cooper H, et al. Most commercial insulin assays fail to detect recombinant insulin analogues. Ann Clin Biochem 2006;43:306-8
26. Sturgeon CM, Ellis AR. Improving the comparability of immunoassays for prostate-specic antigen (PSA): progress and problems. Clin Chim Acta 2007;381:85-92
27. Burns C, Moore M, Sturgeon C, et al. WHO International Collaborative Study of the Proposed 1st International Standard for Parathyroid Hormone 18-84, Human, Recombinant. Geneva: WHO, 2009. See http://whqlibdoc.who.int/hq/2009/WHO_BS_09.2115_eng.pdf (last checked 16 May 2011)
28. Young DS. Effects of Preanalytical Variables on Clinical Laboratory Tests. 3rd edn. Washington, DC: AACC, 2007
29. Guder WG, Narayanan S, Wisser H, et al. Diagnostic Samples: from the Patient to the Laboratory: the Impact of Preanalytical Variables on the Quality of Laboratory Results. 4th edn. Weinheim: Wiley-Blackwell, 2009
30. Vermeer HJ, Thomassen E, de Jonge N. Automated processing of serum indices used for interference detection by the laboratory information system. Clin Chem 2005;51:244-7
31. Kricka LJ. Human anti-animal antibody interferences in immunological assays. Clin Chem 1999;45:942-56
32. Cartwright D, O'Shea P, Rajanayagam O, et al. Familial dysalbuminemic hyperthyroxinemia: a persistent diagnostic challenge. Clin Chem 2009;55:1044-6
33. Halsall DJ, Fahie-Wilson MN, Hall SK, et al. Macro thyrotropin-IgG complex causes factitious increases in thyroid-stimulating hormone screening tests in a neonate and mother. Clin Chem 2006;52:1968-9
34. Zouwail SA, O'Toole AM, Clark PM, et al. Inuence of thyroid hormone autoantibodies on 7 thyroid hormone assays. Clin Chem 2008;54:927-8
35. Paiva ES, Pereira AE, Lombardi MT, et al. Insulin autoimmune syndrome (Hirata disease) as differential diagnosis in patients with hyperinsulinemic hypoglycemia. Pancreas 2006;32:431-2
36. Fahie-Wilson MN, John R, Ellis AR. Macroprolactin; high molecular mass forms of circulating prolactin. Ann Clin Biochem 2005;42:175-92
37. Jassam NF, Paterson A, Lippiatt C, et al. Macroprolactin on the Advia Centaur: experience with 409 patients over a three-year period. Ann Clin Biochem 2009;46:501-4
38. Bates KJ, Hall EM, Fahie-Wilson MN, et al. Circulating immunoreactive cardiac troponin forms determined by gel ltration chromatography after acute myocardial infarction. Clin Chem 2010;56:952-8
39. Webster R, Fahie-Wilson M, Barker P, et al. Immunoglobulin interference in serum follicle-stimulating hormone assays: autoimmune and heterophilic antibody interference. Ann Clin Biochem 2010;47:386-9
40. Sakai H, Fukuda G, Suzuki N, et al. Falsely elevated thyroid-stimulating hormone (TSH) level due to macro-TSH. Endocr J 2009;56:435-40
41. Jeffery J, Millar H, Mackenzie P, et al. An IgG complexed form of vitamin B12 is a common cause of elevated serum concentrations. Clin Biochem 2010;43:82-8
42. British Thyroid Association. Guidelines for the Management of Thyroid Cancer. 2nd edn. London: Royal College of Physicians, 2007
43. Clark PM. Laboratory services for thyroglobulin and implications for monitoring of differentiated thyroid cancer. J Clin Pathol 2009;62:402-6
44. Hoofnagle AN, Becker JO, Wener MH, et al. Quantication of thyroglobulin, a low-abundance serum protein, by immunoafnity peptide enrichment and tandem mass spectrometry. Clin Chem 2008;54:1796-804
45. Beltran L, Fahie-Wilson MN, McKenna TJ, et al. Serum total prolactin and monomeric prolactin reference intervals determined by precipitation with polyethylene glycol: evaluation and validation on common immunoassay platforms. Clin Chem 2008;54:1673-81
46. Ballieux BE, Weijl NI, Gelderblom H, et al. False-positive serum human chorionic gonadotropin (HCG) in a male patient with a malignant germ cell tumor of the testis: a case report and review of the literature. Oncologist 2008;13:1149-54
47. Scantibodies. Scan-Brief: Scantibodies Heterophilic Blocking Reagent (HBR). Santee, CA: Scantibodies. See http://www.scantibodies.com/ScanBriefV1N1.pdf (last checked 16 May 2011)
48. Koshida S, Asanuma K, Kuribayashi K, et al. Prevalence of human anti-mouse antibodies (HAMAs) in routine examinations. Clin Chim Acta 2010;411:391-4
49. Bjerner J. Human anti-immunoglobulin antibodies interfering in immunometric assays. Scand J Clin Lab Invest 2005;65:349-64
50. Fahie-Wilson M, Halsall D. Polyethylene glycol precipitation: proceed with care. Ann Clin Biochem 2008;45:233-5
51. Ellis MJ, Livesey JH. Techniques for identifying heterophile antibody interference are assay specic: study of seven analytes on two automated immunoassay analyzers. Clin Chem 2005;51:639-41
52. Ram S, Harris B, Fernando JJ, et al. False-positive polyethylene glycol precipitation tests for macroprolactin due to increased serum globulins. Ann Clin Biochem 2008;45:256-9
53. Smith TP, Fahie-Wilson MN. Reporting of post-PEG prolactin concentrations: time to change. Clin Chem 2010;56:484-5
54. ACOG Committee on Gynecologic Practice. Avoiding inappropriate clinical decisions based on false-positive human chorionic gonadotropin test results. Int J Gynaecol Obstet 2003;80:231-3
55. Heald AH, Butterworth A, Kane JW, et al. Investigation into possible causes of interference in serum testosterone measurement in women. Ann Clin Biochem 2006;43:189-95
56. Wood P. Salivary steroid assays - research or routine? Ann Clin Biochem 2009;46:183-96
57. Cawood ML, Field HP, Ford CG, et al. Testosterone measurement by isotope-dilution liquid chromatography-tandem mass spectrometry: validation of a method for routine clinical practice. Clin Chem 2005;51:1472-9
58. Maunsell Z, Wright DJ, Rainbow SJ. Routine isotope-dilution liquid chromatography-tandem mass spectrometry assay for simultaneous measurement of the 25-hydroxy metabolites of vitamins D2 and D3. Clin Chem 2005;51:1683-90
59. Wong T, Shackleton C, Covey T, et al. Identication of the steroids in neonatal plasma that interfere with 17 alpha-hydroxyprogesterone radioimmunoassays. Clin Chem 1992;38:1830-7
60. Taylor PJ. Matrix effects: the Achilles heel of quantitative high-performance liquid chromatography-electrospray-tandem mass spectrometry. Clin Biochem 2005;38:328-34
61. ThermoScientic. Comparison of Protein A G, A/G and L. Comparison of Protein A, G, A/G and L. See http://www.piercenet.com (last checkedMay 2011)
62. McCutcheon KM, Quarmby V, Song A. Development and optimization of a cell-based neutralizing antibody assay using a sample pre-treatment step to eliminate serum interference. J Immunol Methods 2010;358:35-45
63. Boscato L, Stuart M. Incidence and specicity of interference in two-site immunoassays. Clin Chem 1986;32:1491-5
64. Sturgeon C. Expecting the unexpected - the continued need for vigilance in tumour marker assays. Ann Clin Biochem 2006;43:247-8
65. Al-Mahdili HA, Jones GR. High-dose hook effect in six automated human chorionic gonadotrophin assays. Ann Clin Biochem 2010;47:383-5
66. Sturgeon CM, Hoffman BR, Chan DW, et al. National Academy of Clinical Biochemistry laboratory medicine practice guidelines for use of tumor markers in clinical practice: quality requirements. Clin Chem 2008;54:e1-e10
67. Jassam N, Jones CM, Briscoe T, et al. The hook effect: a need for constant vigilance. Ann Clin Biochem 2006;43:314-7
68. abcNews. Misdiagnosis of cancer. See http://abcnews.go.com/Primetime/story?id=132213&page=1 (last checked 16 May 2011)
69. Gorovits B. Antidrug antibody assay validation: industry survey results. AAPS J 2009;11:133-8
70. Steimer W, Muller C, Eber B. Digoxin assays: frequent, substantial, and potentially dangerous interference by spironolactone, canrenone, and other steroids. Clin Chem 2002;48:507-16
71. Cobo A, Martin-Suarez A, Calvo MV, et al. Clinical repercussions of analytical interferences due to aldosterone antagonists in digoxin immunoassays: an assessment. Ther Drug Monit 2010;32:169-76
72. Bidlingmaier M, Freda PU. Measurement of human growth hormone by immunoassays: current status, unsolved problems and clinical consequences. Growth Horm IGF Res 2010;20:19-25
73. Krull I, Sahli R, Diem P, et al. Variability in cross-reactivity of novel insulin analogues in immunometric insulin assays. Diabet Med 2009;26:1075-6
74. Vivekanandan S, Andrew CE. Cross-reaction of human chorionic gonadotrophin in Immulite 2000 luteinizing hormone assay. Ann Clin Biochem 2002;39:318-9
75. Souberbielle J-C, Cavalier E, Jean G. Interpretation of serum parathyroid hormone concentrations in dialysis patients: what do the KDIGO guidelines change for the clinical laboratory? Clin Chem Lab Med 2010;48:769-74
76. Stephan C, Kopke T, Semjonow A, et al. Discordant total and free prostate-specic antigen (PSA) assays: does calibration with WHO reference materials diminish the problem? Clin Chem Lab Med 2009;47:1325-31
77. Warner MH, Kane JW, Atkin SL, et al. Dehydroepiandrosterone sulphate interferes with the Abbott Architect direct immunoassay for testosterone. Ann Clin Biochem 2006;43:196-9
78. Middle JG. Dehydroepiandrostenedione sulphate interferes in many direct immunoassays for testosterone. Ann Clin Biochem 2007;44:173-7
79. Sigma-Aldrich. Protein A antibody purication kit. Technical bulletin. St Louis, MO: Sigma-Aldrich
80. Boscato L, Stuart M. Heterophilic antibodies: a problem for all immunoassays. Clin Chem 1988;34:27-33