lmo Laboratory Medicine Online Lab Med Online 2093-6338 The Korean Society for Laboratory Medicine 10.3343/lmo.2017.7.3.135 lmo-7-135 Original Article Performance Evaluation of a Point-of-care Test, ‘Samsung LABGEO PA CHF Test’, for the Amino-terminal Pro-brain Natriuretic Peptide KimMan JinM.D. 1 2 LeeKyunghoonM.D. 1 3 JunSun-HeeM.T. 3 SongSang HoonM.D. 1 2 SongWoon HeungPh.D. 4 SongJunghanM.D. 1 3 Department of Laboratory Medicine, Seoul National University College of Medicine, Seoul, Korea Department of Laboratory Medicine, Seoul National University Hospital, Seoul, Korea Department of Laboratory Medicine, Seoul National University Bundang Hospital, Seongnam, Korea Department of Biomedical Laboratory Science, Shinhan University, Uijeongbu, Korea Corresponding author: Junghan Song Department of Laboratory Medicine, Seoul National University Bundang Hospital, 82 Gumi-ro 173beon-gil, Bundang-gu, Seongnam 13620, Korea Tel: +82-31-787-7691, Fax: +82-31-787-4015, E-mail: songjhcp@snu.ac.kr 72017 1772017 73 135140 05102016 27102016 28102016 Copyright © 2017 The Korean Society for Laboratory Medicine 2017 This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. 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.

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Linearity curves of measured values vs. expected values for NT-proBNP.Abbreviation: NT-proBNP, amino-terminal pro-brain natriuretic peptide

Comparison between results from E170 and Samsung LABGEO PA CHF Test. (A) Passing and Bablok regression, y=6.5653+0.9196x (r=0.96), (B) Bland-Altman plots for the two methods.

Bland-Altman plots for whole blood and plasma specimens. (A) Passing and Bablok regression, y=-3.5451+1.0770x (r=0.99), (B) Bland-Altman plots for whole blood and plasma specimens.

Coefficients of variation (CVs) for NT-proBNP

Imprecision (CV %) Low level (153 pg/mL) High level (1,500 pg/mL)
Repeatability 5.55 6.61
Within-laboratory 6.68 6.73

Abbreviations: NT-proBNP, N-terminal pro-brain natriuretic peptide.