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pISSN 2384-2458 eISSN 2288-7261
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Original Article

J Lab Med Qual Assur 2014; 36(1): 30-38

Published online March 31, 2014

https://doi.org/10.15263/jlmqa.2014.36.1.30

Copyright © Korean Association of External Quality Assessment Service.

Performance Evaluation of the SelexOn Analyser for Seven Biomarkers

Hyun-Young Kim, Soo-Youn Lee, and Hyung-Doo Park

Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea

Correspondence to:Hyung-Doo Park
Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul 135-710, Korea
Tel: +82-2-3410-0290
Fax: +82-2-3410-2719
E-mail: nayadoo@hanmail.net

Received: October 16, 2013; Revised: January 31, 2014; Accepted: February 19, 2014

Abstract

Background: SelexOn (Infopia, Korea) is a novel immunoassay instrument that measures the concentration of α-fetoprotein (AFP), creatine kinase isoenzyme (CK-MB), D-dimer, high-sensitivity C-reactive protein (hs-CRP), myoglobin, prostate-specific antigen (PSA), and thyroid-stimulating hormone (TSH) in whole blood. We evaluated the analytical performance of SelexOn.
Methods: The analytical performance of SelexOn was evaluated for precision and linearity, and compared with the ADVIA Centaur XP Immunoassay System (Siemens, Germany) and the STA-R coagulation analyser (Diagnostica Stago, France).
Results: Within-run CV ranged from 2.9% to 8.9% for all biomarkers. Between-run precision ranged from 1.6% to 11.3% for all biomarkers, except at low levels of D-dimer (16.1%). Observed linearity ranges were AFP, 8.7 to 47.0 ng/mL; CK-MB, 4.7 to 38.7 ng/mL; D-dimer, 393.2 to 2,760.3 ng/mL; hs-CRP, 2.1 to 9.0 mg/L; myoglobin, 67.2 to 441.5 ng/mL; PSA, 2.6 to 23.7 ng/mL; and TSH, 3.3 to 38.9 mIU/L. Upon comparing SelexOn with the Centaur XP and STA-R systems, values of AFP, CK-MB, hs-CRP, and PSA showed good correlation, with correlation coefficients greater than 0.975. The correlation coefficients of TSH, myoglobin, and D-dimer were 0.9723, 0.9649, and 0.8379, respectively. The concordance was excellent for hs-CRP (kappa [κ]=0.958), PSA (κ=0.854), and TSH (κ=0.810); good for AFP (κ=0.655), CK-MB (κ=0.759), and myoglobin (κ=0.783); and moderate for D-dimer (κ=0.561).
Conclusions: SelexOn demonstrated acceptable precision, linearity, and correlation with the Centaur XP and the STA-R for seven biomarkers. Because of its speed and performance, SelexOn may facilitate the rapid screening of patients for cardiovascular disease, thyroid disease, prostate cancer, and hepatocellular carcinoma.
(J Lab Med Qual Assur 2014;36:30-38)

Keywords: Immunoassay, Cardiovascular diseases, Performance, Tumour markers

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