배경: 이 연구는 전혈을 이용한 현장검사용 새로운 신속 측방유동면역분석법인 SelexOnTM B형 나트륨이뇨펩티드(B-type natriuretic peptide, BNP) 검사(Osang Healthcare, Korea)의 분석적 성능을 평가하기 위해 수행되었다.
방법: SelexOnTM BNP 검사의 비정밀도, 직선성 및 검사법 비교를 평가하였다. 방법 비교를 위해서는 두 가지 상업용 BNP 분석법인 ADVIA Centaur® BNP (Siemens Healthcare diagnostics Inc., USA)와 Triage® BNP (Alere, USA) 검사를 100명의 환자 전혈을 이용하여 실시하였다. 참고구간은 건강검진 참가자 120명의 잔여 검체로 검정하였다.
결과: SelexOn BNP는 BNP 농도가 각각 89.44 pg/mL, 480.71 pg/mL 및 1,201.84 pg/mL인 경우 총 변이계수(CV)가 20.3%, 13.3% 및 10.3%였다. 직선성은 평가된 56 pg/mL-1,544 pg/mL범위에서 관찰되었다. SelexOn BNP (y)의 회귀 방정식은 각각 Centaur BNP (x)와 y=0.9706x-21.68 (r=0.930), Triage BNP (x)와 y=0.7600x+0.0506 (r=0.845)이었다. 임상적 의사결정농도(100 pg/mL)에서 SelexOn BNP의 예측 값은 두 개의 비교 가능한 분석법보다 최대 25% 낮았다. 120 검체 중 114 (95%) 검체에서 SelexOn BNP 수치가 50 pg/mL 미만이었다.
결론: SelexOn BNP가 EDTA 전혈을 사용하여 신속하게 급성 심부전의 감별 진단과 치료 모니터링을 위한 현장검사로 사용되기 위해서는 다른 BNP 분석법과 호환가능한 임상적 의사결정농도를 갖도록 더욱 향상되어야 할 것이다.
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Original Article
현장검사용 SelexOnTM B형 나트륨이뇨펩티드 면역분석기의 성능 평가
Performance Evaluation of a Point of Care SelexOnTM B-Type Natriuretic Peptide Immunoassay
1가톨릭대학교 의과대학 진단검사의학교실
2가톨릭대학교 서울성모병원 진단검사의학과
3가톨릭대학교 인천성모병원 진단검사의학과
4가톨릭대학교 부천성모병원 진단검사의학과
Dong Wook Jekarl, M.D.1,2, Seungok Lee, M.D. 
1,3, Hyunyu Choi, B.S.3, Se Woon Cho, M.T.3, Hae-il Park, M.D.1,4
1,3, Hyunyu Choi, B.S.3, Se Woon Cho, M.T.3, Hae-il Park, M.D.1,41Department 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
Received: July 30, 2019; Revised: January 9, 2020; Accepted: January 13, 2020
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.
Lab Med Online 2020; 10(3): 207-213
Published July 1, 2020 https://doi.org/10.3343/lmo.2020.10.3.207
Copyright © The Korean Society for Laboratory Medicine.
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.
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.
Keywords
Point of care testing, B-type natriuretic peptide, Lateral flow immunoassay
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