Prostate-specific antigen: bias and molarity of commercial assays for PSA in use in England

Ann Clin Biochem 2006;43:35-48
doi:10.1258/000456306775141731
© 2006 Association for Clinical Biochemistry

 

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What’s this?

Original Articles


Andrew W Roddam,
Janet Rimmer,
Claire Nickerson,
Anthony Milford Ward and
The NHS Prostate Cancer Risk Management Programme


Cancer Research UK Epidemiology Unit, University of Oxford, Oxford, UK;
NHS Cancer Screening Programmes, Sheffield, UK


Background: The UK Prostate Cancer Risk Management Programmehas recommended that all assays for prostate-specific antigen(PSA) should be both equimolar in their response to free andcomplexed PSA and calibrated to the World Health Organization(WHO) First International Standard for PSA (90:10). To determinewhich assays currently being used by diagnostic laboratoriesin England fulfil these criteria, a PSA recovery experimentwas performed.

Methods: In all, 15 samples containing varying mixtures andconcentrations of the WHO International Standards for PSA andfree PSA were sent to 223 laboratories in England who participatein the UK National External Quality Assessment Service (UK NEQAS)scheme for analysis. Analytical platforms were assigned to oneof 11 methods, and the results were converted into recoverypercentages and analysed by means of a linear random interceptmodel.

Results: No method was both unbiased and equimolar; estimatesof bias ranged from -5% to 22% and estimates of non-equimolarity(change in bias per percent increase in free PSA) ranged from-0.18% to 0.28%.

Conclusions: Analytical methods currently in use for PSA inEngland have inter-method differences; some methods have estimatedbiases over 10% which can result in unacceptable clinical performancecharacteristics. Methods for PSA should be equimolar and calibratedto the international standard to minimize the likelihood ofclinical errors.


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