아미노말단 풋뇌나트륨이뇨펩티드 현장 검사 장비 ‘Samsung LABGEO PA CHF Test’의 성능 평가
Performance Evaluation of a Point-of-care Test, ‘Samsung LABGEO PA CHF Test’, for the Amino-terminal Pro-brain Natriuretic Peptide
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배경: 아미노말단 풋뇌나트륨이뇨펩티드(amino-terminal pro-brain natriuretic peptide, NT-proBNP)는 급성 심부전의 치료와 예후 평가에 중요한 생물표지자이다. 현장 장비 검사는 NT-proBNP를 응급실 등에서 빠르게 검출할 수 있다. 우리는 새로운 NT-proBNP 검사 장비인 Samsung LABGEO PA CHF Test의 분석능을 평가하였다. 방법: Clinical and Laboratory Standards Institute (CLSI) 가이드라인에 따라 정밀도, 직선성, 검사 간 비교가 수행되었다. 전혈과 혈장 간의 NT-proBNP 값을 구해 검체 종류별 비교를 시행하였다. 정해진 기준에 따라 선별된 건강한 성인의 잔여 검체로 참고 범위를 설정하였다. 결과: Samsung LABGEO PA CHF Test 검사 결과는 약 18분 이내에 나왔다. 검사실 내 비정밀도는 6.8%보다 작았다. 0–10,000 pg/mL 농도 범위에서 우수한 직선성을 보였으며 결정 계수는 0.99였다. E170 장비와의 상관성은 상관계수 0.96으로 우수하였고 전혈과 혈장으로 시행한 검체 종류별 비교에서도 상관계수 0.99로 좋은 상관성을 보였다. 참고치 설정은 26세에서 75세 사이의 건강인 120명의 검체를 분석하여 97.5 백분위에서 58.3 pg/mL로 정했다. 결론: 본 연구에서, Samsung LABGEO PA CHF Test는 우수한 분석능을 보여주었다. Samsung LABGEO PA CHF Test는 현장 장비 검사로서 특히 응급실에서 임상적으로 유용하게 사용될 것으로 보인다.
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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