Lab Med Online.  2017 Jul;7(3):135-140. 10.3343/lmo.2017.7.3.135.

Performance Evaluation of a Point-of-care Test, ‘Samsung LABGEO PA CHF Test’, for the Amino-terminal Pro-brain Natriuretic Peptide

Affiliations
  • 1Department of Laboratory Medicine, Seoul National University College of Medicine, Seoul, Korea. songjhcp@snu.ac.kr
  • 2Department of Laboratory Medicine, Seoul National University Hospital, Seoul, Korea.
  • 3Department of Laboratory Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
  • 4Department of Biomedical Laboratory Science, Shinhan University, Uijeongbu, Korea.

Abstract

BACKGROUND
The amino-terminal pro-brain natriuretic peptide (NT-proBNP) is a useful biomarker for the diagnosis of acute congestive heart failure. A point-of-care test (POCT) could rapidly detect the presence of NT-proBNP during emergencies. We evaluated the analytical performance of the new Samsung LABGEO PA CHF Test (Samsung Electronics, Korea).
METHODS
Based on the guidelines of the Clinical and Laboratory Standards Institute (CLSI), we compared the precision, linearity, and method with those of the E170 (Roche Diagnostics, Switzerland). Matrix comparison between the NT-proBNP values in whole blood and plasma was also performed, and the reference interval was determined using residual samples from healthy adults selected based on the evaluation criteria.
RESULTS
The Samsung LABGEO PA CHF Test provided results in approximately 18 min. The coefficient of variation (CV) of within-laboratory precision was below 6.8%. A desirable linearity was observed in the range of 0–10,000 pg/mL, with R²=0.99. The correlation with E170 was also excellent (N=108, r=0.96). NT-proBNP values in the whole blood were correlated with those in the plasma (N=36, r=0.99). The reference interval for the circulating NT-proBNP concentration was determined in 118 plasma samples from healthy subjects (26-75 yr of age). The 97.5th percentile was found to be 58.3 pg/mL.
CONCLUSIONS
The Samsung LABGEO PA CHF Test demonstrated a good analytical performance. It could be a powerful tool as a POCT for clinical practice, particularly during emergencies.

Keyword

NT-proBNP; Point-of-care testing; Performance evaluation
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