|
KMID : 1011220150020020024
|
|
Clinical & Experimental Thrombosis and Hemostasis
2015 Volume.2 No. 2 p.24 ~ p.28
|
|
|
Performance Evaluation of an Immunoturbidimetric Heart-Type Fatty Acid-Binding Protein Assay and the Establishment of Reference Limits in the Korean Population
|
|
Bang Hae-In
Park Ro-Jin
|
|
|
Abstract
|
|
|
Purpose: Currently, cardiac troponins T and I remain the best biomarkers in acute coronary syndromefor both diagnosis and risk assessment. Heart-type fatty acid-binding protein (H-FABP) has been recentlydeveloped as an early cardiac biomarker. The aim of this study was to evaluate the performance of anH-FABP reagent (Randox Laboratories, Crumlin, United Kingdom), which is an automated immunoturbidimetryassay for the quantitative determination of H-FABP, and establish reference limits in the generalKorean population.
Methods: The H-FABP reagent was evaluated for its precision, linearity, limits, carryover and interferencefollowing the Clinical and Laboratory Standards Institute guidelines. In addition, the reference limitsof H-FABP were established in 130 men and 129 women.
Results: The within-run, between-run, between-day and total coefficient of variation for H-FABP assaywere 5.74%, 3.30%, 5.08%, and 8.35% at the low level, respectively, and 2.07%, 2.39%, 2.98%, and 4.35%at the high level. Linearity was achieved in the range of 1.03-139.06 ng/mL with the high coefficient of determination(R2) of 0.9969. No specific interferences were observed in a high concentration sample. Theupper limits of the reference ranges were 8.42 ng/mL and 10.48 ng/mL in men and women, respectively.
Conclusion: The H-FABP immune-turbidimetric assay for the measurement of H-FABP in serum showedexcellent precision and linearity. Using this assay with an automated chemistry analyzer and the referencelimits established in the Korean population were considered useful for the carrying out of this assayin Korea.
|
|
|
KEYWORD
|
|
|
Acute coronary syndrome, Cardiac biomarker, Heart-type fatty acid-binding protein
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|
|
|