J Clin Pathol Qual Control.  1997 Dec;19(2):329-334.

The Evaluation of the OPUS(R) Immunoassay System for the Serum CK-MB Test

• Chun LH
• Sir JU
• Kim HS
• Kim DA
• Park IK

Abstract

BACKGROUND: CK-MB (creatine kinase-MB) is an early marker of acute myocardial infarction and is widely used for the diagnosis of acute myocardial infarction. In this report, we evaluated the OPUS(R) Immunoassay system that we had recently started to use and compared it with IMx(R) system that we had been using.
METHODS
We evaluated the performance of OPUS(R) Immunoassay system in precision, linearity, recovery rate and correlation with IMx(R) system. Control material I (20 ng/mL) and II (120 ng/mL) were used for this study. Within-day precision was estimated by 20 samples for one day and between-day precision was estimated by 1 sample per day for 20 days for both control materials. Linearity was estimated by 6 different concentrations of control II that were serially diluted and the recovery rate was estimated by mixing the same amount of control I and II. Correlation with IMx(R) system was evaluated by measuring 37 patients' samples that reflected values.
RESULTS
The CVs (coefficients of variation) for within-day and between-day precision studies were 7.51%, 10.76% for control I, and 6.08%, 8.26% for control II, respectively. Good results for linearity (r =0.994, P<0.0001) and recovery rate (91.4%) were obtained. Correlation study with IMx(R) system showed y=1.245x + 2.002 (n+37), R2 =0.922 (P<0.0001).
CONCLUSIONS
OPUS(R) Immunoassay system showed good results in within-day and between-day precision, linearity, recovery rate and a good correlation with IMx(R) system

MeSH Terms

Diagnosis
Immunoassay*
Myocardial Infarction
Statistics as Topic