Variability in the measurement of lipoprotein(a) in the British Isles

This version was published on 1 July 2009

Ann Clin Biochem 2009;46:311-315
doi:10.1258/acb.2009.08166
© 2009 Association for Clinical Biochemistry

 

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Original Articles


Mike Mackness1 and
Elizabeth Hughes2


1 Division of Cardiovascular Sciences, University of Manchester, Manchester;
2 Department of Clinical Biochemistry, Sandwell General Hospital, West Bromwich, UK


Corresponding author: Mike Mackness, Division of Cardiovascular Sciences, University of Manchester, Department of Medicine, Manchester Royal Infirmary, Oxford Road, Manchester M13 9WL, UK. Email: mike.mackness{at}manchester.ac.uk


Background: Elevated Lipoprotein(a) concentrations are a risk factor forcoronary heart disease; however, methodological problems haveprevented its introduction to routine clinical practice.

Methods: Thirty-six laboratories each assayed 20 samples (the same 20in each laboratory) using two different Lp(a) kits per laboratory,randomly assigned from the total of 12 used in the study.

Results: The duplicate error, i.e. the error between-duplicate analysesfor each sample, for all kits was small, indicating all kitshad a good precision for all the assays. However, there wasa very large variation between the kits in the Lp(a) concentrationassigned to a sample that could be over 100%. All methods showeda negative or positive bias as the concentration of Lp(a) increased.Most worryingly, as used in this study, several Lp(a) kits detectedLp(a) in a solution of 5% bovine serum albumin in phosphate-bufferedsaline. The between-laboratory variation in Lp(a) concentrationmeasured using the same kit was very large, e.g. for a samplewith a mean concentration of 78.8 mg/dL Lp(a) the between-laboratoryvariation was 29.7 mg/dL (37.7%). Even with samples with a relativelylow Lp(a) concentration of 16.0 mg/dL had a between-laboratoryvariation of 12.3 mg/dL (76.8%).

Conclusion: There is wide variability in reported Lp(a) concentrations,assayed in the same sample, using different Lp(a) assays. Atthe present time these differences prevent the use of Lp(a)as a routine diagnostic tool.


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