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KMID : 1100820190090010006
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Laboratory Medicine Online
2019 Volume.9 No. 1 p.6 ~ p.11
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Performance Evaluation of the CRE2 Reagent from Siemens for Serum Creatinine Measurement
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Kim Hyun-Jin
Lim Jin-Sook
Koo Sun-Hoe
Kim Ji-Myung
Kim Seon-Young
Kwon Kye-Chul
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Abstract
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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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KEYWORD
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CRE2, Precision, Linearity, Comparison, Accuracy
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