Development and Evaluation of a New Creatine Kinase MB Mass Determination Assay Using a Latex Agglutination Turbidimetric Immunoassay with an Automated Analyzer

作者：Hoshino Tadashi; Hanai Kazuma^*; Tanimoto Kazuhito; Nakayama Tomohiro

来源：Clinical Laboratory, 2016, 62(5): 877-885.

DOI：10.7754/Clin.Lab.2015.150910

Background: The diagnosis of myocardial infraction (MI) in patients presenting to the emergency department represents a clinical challenge. It is known that creatine kinase-MB isoenzyme (CK-MB) is present in soluble cell fractions of cardiac muscle, and injury to those cells results in an increase of CK-MB in the blood. Therefore, CK-MB is a suitable clinical biomarker of myocardial infraction.
Methods: To measure CK-MB mass rapidly and easily, we developed the new reagent 'L-type Wako CK-MB mass' (L-CK-MB mass) for the latex agglutination turbidimetric immunoassay method. Using a Hitachi LABOSPECT 008, we evaluated the performance of this assay as a method for quantifying CK-MB mass, and we compared the measurement of the serum CK-MB mass concentration with this assay to that obtained using an electrochemiluminescence immunoassay (ECLIA).
Results: A dilution test showed linearity from 5 mu g/L to 190 mu g/L, and the limit of quantification of the L-CK-MB mass assay was 3.0 mu g/L. The within-run CV and between-day CV were 1.0 - 4.5% and 1.8 - 4.4%, respectively. Serum CK-MB mass concentration determined using the L-CK-MB mass assay was reliably and strongly correlated with that determined using ECLIA (n = 163, r = 0.999, y = 0.977x + 0.307).
Conclusions: The L-CK-MB mass assay is able to specifically determine CK-MB mass and is a very useful method for the accurate measurement of CK-MB mass for routine clinical analyses.

• 出版日期2016