Variability in the measurement of lipoprotein(a) in the British Isles.
BACKGROUND
Elevated Lipoprotein(a) concentrations are a risk factor for coronary heart disease; however, methodological problems have prevented its introduction to routine clinical practice.


METHODS
Thirty-six laboratories each assayed 20 samples (the same 20 in 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 analyses for each sample, for all kits was small, indicating all kits had a good precision for all the assays. However, there was a very large variation between the kits in the Lp(a) concentration assigned to a sample that could be over 100%. All methods showed a negative or positive bias as the concentration of Lp(a) increased. Most worryingly, as used in this study, several Lp(a) kits detected Lp(a) in a solution of 5% bovine serum albumin in phosphate-buffered saline. The between-laboratory variation in Lp(a) concentration measured using the same kit was very large, e.g. for a sample with a mean concentration of 78.8 mg/dL Lp(a) the between-laboratory variation was 29.7 mg/dL (37.7%). Even with samples with a relatively low Lp(a) concentration of 16.0 mg/dL had a between-laboratory variation of 12.3 mg/dL (76.8%).


CONCLUSIONS
There is wide variability in reported Lp(a) concentrations, assayed in the same sample, using different Lp(a) assays. At the present time these differences prevent the use of Lp(a) as a routine diagnostic tool.
Mackness
Mike
M
Division of Cardiovascular Sciences, University of Manchester, Department of Medicine, Manchester Royal Infirmary, Manchester M13 9WL, UK. mike.mackness@manchester.ac.uk
Hughes
Elizabeth
E
D001681:Biological Assay / Q000379:methods*; D006801:Humans; D017270:Lipoprotein(a) / Q000097:blood*; D010641:Phenotype; D015203:Reproducibility of Results; D006113:United Kingdom
D017270:Lipoprotein(a)