Analytical evaluation of the CK-MB mass assay on the Technicon Immuno 1 system.
OBJECTIVE
To evaluate the performance of the Technicon Immuno 1 CK-MB mass assay.


METHODS
The precision was measured using the BioRad Liquichek CK-MB controls and the Technicon Immuno 1 SETpoint CK-MB calibrators. The linearity was verified by diluting 9 patient serum samples containing high CK-MB concentrations, and the minimum detectable concentration determined by repetitive analysis of the zero calibrator. The assay was compared with the Johnson & Johnson Vitros CK-MB activity assay using 111 patient serum samples. The reference range was determined using serum samples from 100 healthy adult volunteers.


RESULTS
The assay shows within-run CVs varying from 1.5 to 7.5% and between-day CVs from 1.5 to 4.8% for CK-MB concentrations ranging from 3.9 to 99.0 micrograms/L. The linearity study gave correlation coefficients greater than 0.9961. There was a very good correlation between mass and activity assays (r = 0.985). The reference values were estimated at 0.0-4.2 micrograms/L and the minimum detectable concentration at 0.5 micrograms/L.


CONCLUSIONS
The evaluation shows that the Technicon Immuno 1 CK-MB mass assay has the analytical characteristics suitable for its inclusion in the modern clinical repertoire.
Lévesque
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Department of Clinical Biochemistry, Centre Universitaire de Santé de l'Estrie, Sherbrooke, Québec, Canada.
Letellier
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Grant
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D003402:Creatine Kinase / Q000097:blood* / Q000592:standards; D006801:Humans; D007118:Immunoassay / Q000379:methods* / Q000592:standards / Q000706:statistics & numerical data; D018189:Immunomagnetic Separation / Q000379:methods* / Q000592:standards / Q000706:statistics & numerical data; D007527:Isoenzymes; D012016:Reference Values; D012044:Regression Analysis; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
D007527:Isoenzymes; D003402:Creatine Kinase