현장검사 분석 기기인 ABL90 FLEX PLUS의 크레아티닌 분석능 평가
Performance Evaluation of the ABL90 FLEX PLUS Point-of-Care Analyzer in Measuring Creatinine Levels
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배경: 크레아티닌은 신기능 평가를 위한 중요한 도구이며 조영제 유발 신부전과 같은 급성 신기능 저하를 진단하기 위해 전혈을 이용하여 크레아티닌을 현장검사 방법으로 측정하는 방법이 활발히 사용되고 있다. 본 연구는 현장검사 장비인 ABL90 FLEX PLUS (Radiometer, Denmark)의 크레아티닌의 측정 성능을 평가하여 임상적 유용성을 알아보고자 시행되었다. 방법: ABL90 FLEX PLUS의 크레아티닌 측정 성능 평가를 위해 CLSI 지침에 따라 정밀도, 직선성, 상관성을 평가하였다. 상관성 평가는 혈청을 이용하여 측정한 Beckman Coulter AU5800 (Beckman Coulter, USA)의 결과와, 동일한 환자의 전혈을 이용하여 측정한 ABL90 FLEX PLUS의 결과를 비교하였다. 결과: 정밀도 평가 결과 총 정밀도 변이계수는 두 정도관리 물질에서 각각 0.0%, 0.8%였다. 직선성 평가 결과(측정범위 0.4-8.4 mg/dL) 회귀식을 이용하여 도출 한 결정계수(R2)가 0.9993이었다. Beckman Coulter AU5800와 상관성 비교 평가 결과, 상관계수(r)가 0.989로 도출되어 95% CI 범위 이내에 포함되었으며, 95% 일치한계 경계값은 -0.649 mg/dL (-18.8%)와 0.643 mg/dL (17.8%)였다. 결론: 현장검사 장비인 ABL90 FLEX PLUS의 크레아티닌 측정값에 대한 평가결과 정밀도, 직선성, 상관성 모두 우수하였다. 이를 바탕으로 고려할 때 ABL90 FLEX PLUS는 임상적으로 유용할 것으로 판단된다.
Abstract
Background: To diagnose acute renal failure, creatinine levels in whole blood are typically assessed using point-of-care testing (POCT) methods. The present study aimed to evaluate the performance of a newly developed POCT blood gas analyzer, the ABL90 FLEX PLUS (Radiometer, Denmark), which can measure creatinine in blood. Methods: Precision and linearity of the ABL90 FLEX PLUS were evaluated and compared with those of the Beckman Coulter AU5800 (Beckman Coulter, USA), according to the CLSI guidelines for creatinine measurement performance. Results: For the ABL90 FLEX PLUS, the total imprecision (%CV) levels of two control materials were measured to be 0.0% and 0.8%, while linearity was evaluated, with the R2 value measured to be 0.9993 (0.4-8.4 mg/dL). Compared to the AU5800, the ABL90 FLEX PLUS correlation coefficient (r) was found to be 0.989. The 95% limits of agreement were determined to be -0.649 and 0.643 mg/dL (-18.8% and 17.8%). Conclusions: The ABL90 FLEX PLUS exhibited good performance for creatinine test. This indicates that the ABL90 FLEX PLUS can be potentially useful in clinical laboratories.
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