Siemens CRE2 시약의 Creatinine 측정 수행능 평가
Performance Evaluation of the CRE2 Reagent from Siemens for Serum Creatinine Measurement
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배경: 크레아티닌 측정에 있어 효소법이 Jaffe 법에 비해 더 정확하다고 알려져 있지만 , Jaffe 법은 여전히 검사실에서 널리 사용되고 있다. 우리는 modifed Jaffe법을 사용하는 Siemens사의 시약인 CRE2 의 수행능을 평가하였다. 방법: 세 농도의 정도관리물질을 사용하여 Siemens사의 Dimension VISTA 500 장비에서 CRE2 의 정밀도 평가를 하였다. 또한 직선성과 검체 간 잔효를 평가하였다 . Siemens CRE2 와 ECREA 로 측정한 68 개 크레아티닌 결과를 기존의 효소법인 L-CRE 결과와 비교하였다. CRE2, ECREA, L-CRE의 정확도는 표준참고물질을 사용하여 평가하였다. 결과: CRE2 의 세 농도에 대한 검사 내 (0.7–2.4%), 검사 간 (0.4–1.7%), 검사일 간 정밀도의 변이계수 (0.7–0.9%), 중간농도와 고농도에 대한 전체 변이계수 ( 각각 1.6%, 1.3%) 는 분석 목표를 만족시켰으며 직선성도 우수하였다(R 2 = 0.999). CRE2 및 ECREA 는 L-CRE와의 상관성 또한 높았다(각각 r = 0.996, r = 0.997). L-CRE 와의 상관성 비교에서는 1 mg/dL 농도 이상의 검체 중에서 CRE2 의 5 개 결과와 ECREA 의 15 개 결과가 minimum bias goal 인 5.1% 를 초과하였다. 검체 간 잔효는 -0.04% 였다. 정확도에 있어서 CRE2, ECREA, L-CRE 의 백분율 바이어스는 저농도에서 7.4, -6.4, -3.4% 이고 고농도에서 3.9, -1.5, 0.7% 였다. 결론: Siemens 사의 크레아티닌 측정 시약인 CRE2 는 우수한 수행능을 보였다. CRE2 는 신뢰할 수 있으며, 신장질환의 진단, 치료경과 관찰과 위험도 평가를 위해 유용하게 사용할 수 있다.
Abstract
Background: For creatinine measurement, the enzymatic method is known to be more accurate than the Jaffe method; however, the latter is still widely used. We evaluated the performance of the CRE2 reagent (Siemens Healthcare Diagnostics Inc., USA), which uses a modified Jaffe method. Methods: Three quality control standards were used for precision evaluations of CRE2 on Dimension VISTA 500 instrument (Siemens). Moreover, the linearity and carryover characteristics were assessed. Sixty-eight creatinine results obtained using the CRE2 and ECREA (enzymatic) reagents (Siemens) were compared with those obtained using the L-CRE (enzymatic) reagent (Shinyang Diagnostics, Korea). The accuracy of CRE2, ECREA, and L-CRE was evaluated using a standard reference material. Results: The CV of within-run (0.7–2.4%), between-run (0.4–1.7%), between-day precision (0.7–0.9%) for three standards, and total CV for medium (1.6%) and high levels (1.3%) satisfied the analytical goal. The linearity for CRE2 was excellent (R2=0.999). Comparisons of CRE2 and ECREA to L-CRE were well correlated (r=0.996 and 0.997, respectively). In comparison with L-CRE, 5 CRE2 results and 15 ECREA results exceeded minimum bias goal (5.1%) in samples with creatinine levels of >1 mg/dL. The carryover rate was −0.04%. In terms of accuracy, the percent bias values of CRE2, ECREA, and L-CRE were 7.4, −6.4, and −3.4, respectively, for low level; and 3.9, −1.5, and 0.7, respectively, for high level. Conclusions: For creatinine measurements, the CRE2 reagent showed good performance. It can be used in the diagnosis, treatment monitoring, and risk assessment of kidney diseases.
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