Performance Evaluation of a Point of Care SelexOnTM B-Type Natriuretic Peptide Immunoassay
10.3343/lmo.2020.10.3.207
- Author:
Dong Wook JEKARL
1
;
Seungok LEE
;
Hyunyu CHOI
;
Se Woon CHO
;
Hae-il PARK
Author Information
1. Department of Laboratory Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea
- Publication Type:Original Article
- From:Laboratory Medicine Online
2020;10(3):207-213
- CountryRepublic of Korea
-
Abstract:
Background:This study was conducted to evaluate the analytical performance of the SelexOnTM B-type natriuretic peptide (BNP) assay (Osang Healthcare Inc., Korea), a new rapid lateral flow immunoassay for point of care (POC) testing using whole blood.
Methods:The imprecision, linearity, and method comparison of SelexOnTM BNP assay were evaluated. Two commercial BNP assays, the ADVIA Centaur® BNP (Siemens Health Care diagnostics Inc., USA) and the Triage® BNP assays (Alere, USA), were included for method comparison using 100 whole blood samples from patients. The reference interval was verified using 120 residual samples from health examination participants.
Results:The SelexOn BNP had total CVs of 20.3%, 13.3%, and 10.3% in BNP concentrations of 89.44 pg/mL, 480.71 pg/mL, and 1,201.84 pg/mL of control materials, respectively. Linearity was observed from 56 pg/mL to 1544 pg/mL. The SelexOn BNP (y) regression equation was y=0.9706x-21.68 with Centaur BNP (x) (r=0.930) and y=0.7600x+0.0506 with Triage BNP (x) (r=0.845), respectively. The predicted mean difference (%) of the SelexOn BNP at the clinical decision levels (100 pg/mL) was up to 25% lower than the two comparative methods. The SelexOn BNP levels were below 50 pg/mL in 114 (95%) of the 120 samples.
Conclusions:The SelexOn BNP using EDTA was developed as a POC test for differential diagnosis or treatment monitoring for acute heart failure. However, clinical decision values must be improved to be compatible with other BNP methods.
