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1 Departments of Clinical Biochemistry and Medicine at Pinderfields General Hospital, Mid Yorkshire Hospitals NHS Trust, Wakefield, West Yorkshire WF1 4DG, United Kingdom.
2 Leeds Teaching Hospitals NHS Trust, The General Infirmary at Leeds, Leeds LS1 3EX, United Kingdom.
aAddress correspondence to this author at: Pathology Laboratory, Pinderfields General Hospital, Wakefield, West Yorkshire WF1 4DG, United Kingdom. E-mail dr.ismail{at}panp-tr.northy.nhs.uk.
Background: Immunoassays are used in almost all medical and surgical specialties, but they suffer from interference from proteins such as antibodies in some patients’ sera. Such interferences are usually reported in the literature only as case reports after the introduction of a new assay.
Methods: We undertook a prospective observational study on 5310 patients for whom the common immunoassay tests for thyroid-stimulating hormone (TSH) and/or gonadotropins were requested. All TSH and gonadotropin results were critically assessed for a mismatch between the clinical details and analytical results to identify samples suspected of analytical unreliability. These were tested further by three approaches to screen for interference.
Results: From the 5310 sets of results, 59 patients’ samples were identified as suspect and were tested further. Analytically incorrect results were found in 28 (0.53% of the total studied). The magnitude of interference varied, but in 23 of 28 patients (82%), it was considered large enough to have a potentially adverse effect on cost and/or the clinical care of these patients. Two cases, described in detail, illustrate the adverse effect of error on patient care and cost, and the second highlights the difficulties and limitations of current approaches for identifying interference and inaccuracy in immunoassays.
Conclusions: Because millions of TSH/gonadotropin tests are carried out in UK hospital laboratories alone, our data suggest that thousands of patients could be adversely affected by errors from interferences. Early identification of interference in cases with unusual results could be valuable.
The following articles in journals at HighWire Press have cited this article:
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  A. A A Ismail Thyroid stimulating hormone cut-off to define subclinical hypothyroidism Ann Clin Biochem, September 1, 2009; 46(5): 426 - 426. [Full Text] [PDF]
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 A A A Ismail Interference from endogenous antibodies in automated immunoassays: what laboratorians need to know J. Clin. Pathol., August 1, 2009; 62(8): 673 - 678. [Abstract] [Full Text] [PDF]
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P M Clark Laboratory services for thyroglobulin and implications for monitoring of differentiated thyroid cancer J. Clin. Pathol., May 1, 2009; 62(5): 402 - 406. [Abstract] [Full Text] [PDF]
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H A Ross, P P C A Menheere, (on behalf of the Endocrinology Section of SKML [D, C M G Thomas, A H Mudde, M Kouwenberg, and B H R Wolffenbuttel Interference from heterophilic antibodies in seven current TSH assays Ann Clin Biochem, November 1, 2008; 45(6): 616 - 616. [Full Text] [PDF]
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 J. H Barth Analytical problems associated with HCG assay BMJ, October 13, 2008; 337(oct13_2): a2076 - a2076. [Full Text]
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M. Fahie-Wilson and D. Halsall Polyethylene glycol precipitation: proceed with care Ann Clin Biochem, May 1, 2008; 45(3): 233 - 235. [Full Text] [PDF]
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 C. L Buckner, L. Wilson, and C. N. Papadea An Unusual Cause of Elevated Serum Total {beta}hCG Ann. Clin. Lab. Sci., January 1, 2007; 37(2): 186 - 191. [Abstract] [Full Text] [PDF]
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 J. D. Newman, P. B. Bergman, J. C.G. Doery, and N. D.H. Balazs Factitious increase in thyrotropin in a neonate caused by a maternally transmitted interfering substance. Clin. Chem., March 1, 2006; 52(3): 541 - 542. [Full Text] [PDF]
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D. J. Warren, J. Bjerner, E. Paus, O. P. Bormer, and K. Nustad Use of an In Vivo Biotinylated Single-Chain Antibody as Capture Reagent in an Immunometric Assay to Decrease the Incidence of Interference from Heterophilic Antibodies Clin. Chem., May 1, 2005; 51(5): 830 - 838. [Abstract] [Full Text] [PDF]
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M. J. Ellis and J. H. Livesey Techniques for Identifying Heterophile Antibody Interference Are Assay Specific: Study of Seven Analytes on Two Automated Immunoassay Analyzers Clin. Chem., March 1, 2005; 51(3): 639 - 641. [Full Text] [PDF]
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A. A.A. Ismail A Radical Approach Is Needed to Eliminate Interference from Endogenous Antibodies in Immunoassays Clin. Chem., January 1, 2005; 51(1): 25 - 26. [Full Text] [PDF]
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R. Sapin, A. Agin, and F. Gasser Misleading High Thyrotropin Results Obtained with a Two-Site Immunometric Assay Involving a Chimeric Antibody Clin. Chem., May 1, 2004; 50(5): 946 - 948. [Full Text] [PDF]
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J. Kristiansen The Guide to Expression of Uncertainty in Measurement Approach for Estimating Uncertainty: An Appraisal Clin. Chem., November 1, 2003; 49(11): 1822 - 1829. [Abstract] [Full Text]
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L. L. Leape Striving for Perfection Clin. Chem., November 1, 2002; 48(11): 1871 - 1872. [Full Text] [PDF]
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