Evaluation of NT-proBNP assay Using Dimension RxL

Song, Sang Hoon; Park, Chul Min; Chun, Sun Hee; Park, Kyoung Un; Kim, Jin Q; Song, Junghan

Abstract

BACKGROUND: We evaluated the analytical performance of the recently introduced Dimension RxL NT-proBNP method (Dade Behring, Deerfield, IL).
METHODS
Within-run precision and total precision were assessed according to CLSI guideline EP5-A2 with control material of low and high level. Linearity was evaluated in the range of 30-32,420 pg/mL made by patient samples. Correlation with E170 (Roche Diagnositics, Mannheim, Germany) was evaluated using 49 patient samples in the range of 8.4-20754.5 pg/mL. Plasma concentrations in 241 healthy persons were measured and the distributions according to age and sex were obtained.
RESULTS
The CV of within-run precision was 3.3-4.8% and the CV of total precision was 4.4-8.1%. The linearity was R2=0.988. The correlation with E170 was excellent (R=0.996). NT-proBNP values measured by Dimension RxL were higher than those by E170 (mean 282.0 pg/mL, 95% CI 130.6-433.4 pg/mL) in the range of 8.4-20,754.5 pg/mL. The 97.5% value from 241 healthy persons was 134.7 pg/mL, and 117.4 pg/mL in male and 156.4 pg/mL in female. It was higher in persons > or =50 years old than those <50 years old (180.3 vs. 117.3 pg/mL).
CONCLUSIONS
Dimension RxL NT-proBNP assay showed acceptable analytical performance. This assay may be used for early detection and follow up of patients with congestive heart failure.