Lab Med Online.  2020 Jul;10(3):207-213. 10.3343/lmo.2020.10.3.207.

Performance Evaluation of a Point of Care SelexOnTM B-Type Natriuretic Peptide Immunoassay

Affiliations
  • 1Department of Laboratory Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea
  • 2Department of Laboratory Medicine, The Catholic University of Korea, Seoul St. Mary’s Hospital, Seoul, Korea
  • 3Department of Laboratory Medicine, The Catholic University of Korea, Incheon St. Mary’s Hospital, Incheon, Korea
  • 4Department of Laboratory Medicine, The Catholic University of Korea, Bucheon St. Mary’s Hospital, Bucheon, 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.

Keyword

Point of care testing; B-type natriuretic peptide; Lateral flow immunoassay

Figure

  • Fig. 1 The SelexonTM B-type natriuretic peptide (BNP) assay system. (A) The disposable cartridge uses a lateral flow immunoassay to detect BNP. Control and test lines are visible on the nitro-cellulose membrane. The control line indicates that the sample has migrated across the membrane as intended. (B) The camera inside the analyzer detects the signal line intensity. The integrated software converts the signal intensity to a quantitative result and shows it on the display.

  • Fig. 2 Linearity of the SelexOnTM B-type natriuretic peptide assay. The red and green regression lines represent the linear and polynomial fits, respectively. The regression equation between the measured (y) and the assigned values (x) was y=16.38+0.9728x based on a linear fit (R2=0.992).

  • Fig. 3 Scatter plot of method comparison for the SelexOn BNP, the Centaur BNP, and the Triage BNP assays. The red line represents the linear regression equation by the Passing-Bablok fit (left) and difference plots (right). The SelexOn BNP (y) regression equation was (A) y=0.9706x-21.68 with Centaur BNP (x) (r=0.930), and (B) y=0.7600x+0.0506 with Triage BNP (x) (r=0.845).


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