Lab Med Online.  2019 Jan;9(1):6-11. 10.3343/lmo.2019.9.1.6.

Performance Evaluation of the CRE2 Reagent from Siemens for Serum Creatinine Measurement

• Kim H
• Lim J
• Koo SH
• Kim J
• Kim SY
• Kwon GC

• KMID: 2430203
• DOI: http://doi.org/10.3343/lmo.2019.9.1.6

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.

Keyword

CRE2; Precision; Linearity; Comparison; Accuracy

MeSH Terms

Bias (Epidemiology)
Creatinine*
Delivery of Health Care
Diagnosis
Indicators and Reagents
Kidney Diseases
Methods
Quality Control
Risk Assessment
Creatinine
Indicators and Reagents

Figure

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  Fig. 1. Comparison of creatinine values measured by L-CRE and CRE2 reagents.

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  Fig. 2. Comparison of creatinine values measured by L-CRE and ECREA reagents.

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