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

Hyunjin Kim; Jinsook Lim; Sun Hoe Koo; Jimyung Kim; Seon Young Kim; Gye Cheol Kwon

doi:10.3343/lmo.2019.9.1.6

Journal List > Lab Med Online > v.9(1) > 1120078

Go to TopGo to Top Go to BottomGo to Bottom

TOOLS

Kim, Lim, Koo, Kim, Kim, and Kwon: Performance Evaluation of the CRE2 Reagent from Siemens for Serum Creatinine Measurement

Original Article

Lab Med Online 2019;9(1):6-11.

Published online: 19 January 2019

DOI: https://doi.org/10.3343/lmo.2019.9.1.6

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

Hyunjin Kim, M.D., Jinsook Lim, M.D., Sun Hoe Koo, M.D., Jimyung Kim, M.D., Seon Young Kim, M.D., Gye Cheol Kwon, M.D.

Department of Laboratory Medicine, Chungnam National University Hospital, Daejeon, Korea

Corresponding author: Gye Cheol Kwon https://orcid.org/0000-0002-4886-0590 Department of Laboratory Medicine, Chungnam National University Hospital, 282 Moonhwa-ro, Joong-gu, Daejeon 35015, Korea Tel: +82-42-280-7799, Fax: +82-42-257-5365, E-mail: kckwon@cnu.ac.kr

Received 29 August 2017 Revised 2 April 2018 Accepted 16 April 2018

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

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.

Keywords: CRE2, Precision, Linearity, Comparison, Accuracy

REFERENCES

1.Chung HJ., Chun SI., Min WK. Creatinine determination with minimized interference. J Lab Med Qual Assur. 2008. 30:229–31.

2.Burtis CA., Ashwood ER, et al. eds. Tietz textbook of clinical chemistry and molecular diagnostics. 4th ed.St. Louis, MO: Elsevier Inc.;2006. p. 797–801.

3.O'Leary N., Pembroke A., Duggan PF. A simplifed procedure for eliminating the negative interference of bilirubin in the Jaffe reaction for creatinine. Clin Chem. 1992. 38:1749–51.

4.Myers GL., Miller WG., Coresh J., Fleming J., Greenberg N., Greene T, et al. Recommendations for improving serum creatinine measurement: a report from the Laboratory Working Group of the National Kidney Disease Education Program. Clin Chem. 2006. 52:5–18.

5.Siemens Dimension Vista^® system Creatinine (CRE2) Flex^® reagent cartridge. https://www.accessdata.fda.gov/cdrh_docs/pdf13/K133728.pdf.

6.Clinical and Laboratory Standards Institute. Method comparison and bias estimation using patient samples; approved guideline. 2nd ed.EP09-A2. Wayne, PA: Clinical and Laboratory Standard Institute;2002.

7.Clinical and Laboratory Standards Institute. Evaluation of precision of quantitative measurement procedures; approved guideline. 3rd ed.EP05-A3. Wayne, PA: Clinical and Laboratory Standard Institute;2014.

8.Clinical and Laboratory Standards Institute. Evaluation of the linearity of quantitative measurement procedures; a statistical approach; approved guideline. EP06-A. Wayne, PA: Clinical and Laboratory Standards Institute. 2003.

9.Clinical and Laboratory Standards Institute. Preliminary evaluation of quantitative clinical laboratory measurement procedures; approved guideline. 3rd ed.EP10-A3.Wayne, PA: Clinical and Laboratory Standards Institute;2006.

10.Robert L. National Institute of Standards and Technology certifcate of analysis, standard reference material. 665:2014. 1–3.

11.Nah H., Lee SG., Lee KS., Won JH., Kim HO., Kim JH. Evaluation of bilirubin interference and accuracy of six creatinine assays compared with isotope dilution-liquid chromatography mass spectrometry. Clin Bio-chem. 2016. 49:274–81.

12.Ricos C., Alvarez V., Cava F., Garcia-Lario JV., Hernandez A., Jimenez CV, et al. Desirable specifcations for total error, imprecision, and bias, derived from intra- and inter-individual biological variation. https://www.westgard.com/biodatabase1.htm. (updated on 2014).

13.Burtis CA., Ashwood ER, et al. eds. Tietz textbook of clinical chemistry and molecular diagnostics. 5th ed.St. Louis, Mo: Elsevier Inc;2006. p. 196–8.

14.Hermida FJ., Lorenzo MJ., Pérez A., Fernández M., Sagastagoia O., Maga-dán C. Comparison between ADVIA Chemistry systems Enzymatic Creatinine_2 method and ADVIA Chemistry systems Creatinine method (kinetic Jaffe method) for determining creatinine. Scand J Clin Lab Invest. 2014. 74:629–36.

15.Schmidt RL., Straseski JA., Raphael KL., Adams AH., Lehman CM. A risk assessment of the Jaffe vs enzymatic method for creatinine measurement in an outpatient population. PLoS ONE. 2015. 10:e0143205.

16.Panteghini M and IFCC Scientifc Division. Enzymatic assays for creatinine: time for action. Clin Chem Lab Med. 2008. 46:567–72.

Fig. 1.

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

Fig. 2.

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

Table 1.

Precision of CRE2 reagent for serum creatinine measurement using Dimension VISTA 500 instrument

Level	Mean	Within-run		Between-run		Between-day		Total		Desirable precision criteria (%)∗
Level	Mean	SD	CV (%)	SD	CV (%)	SD	CV (%)	SD	CV (%)	Desirable precision criteria (%)∗
Low (0.538–0.801 mg/dL)	0.629	0.015	2.4	0.011	1.7	0.006	0.9	0.020	3.1	2.98
Medium (1.67–2.17 mg/dL)	1.889	0.019	1.0	0.019	1.0	0.013	0.7	0.003	1.6
High (7.38–9.1 mg/dL)	8.210	0.060	0.7	0.034	0.4	0.078	0.9	0.104	1.3

^∗ Obtained from the biological variation database specification on Westgard's website (http://www.westgard.com/biodatabase1.htm) [12].

Table 2.

Linearity of CRE2 reagent for serum creatinine measuremen using Dimension VISTA 500 instrument

Test range (mg/dL)	Observed linear range (mg/dL)	Linear range (mg/dL) claimed by the manufacturer∗	Slope	Intercept	R²
0.297–19.00	0.297–19.00	0.150–20.0	1.005	0.031	0.999

^∗ Manufacturer's claimed linear range is indicated in reagent information [5].

Table 3.

Comparison of CRE2 and ECREA reagents using Dimension VISTA 500 instrument with L-CRE reagent using Toshiba 2000FR Neo instru ment at the medical decision levels of serum creatinine using Passing-Bablok regression

Reagent	Slope (95% CI)	Intercept (95% CI)	Decision level (mg/dL)	Expected value (mg/dL)	Expected bias (%)	Minimum bias goal (%)∗
CRE2	1.003 (0.996–1.010)	0.054 (0.036–0.085)	0.6	0.656	9.3	5.1
			1.6	1.659	3.7
			3.5	3.565	1.9
ECREA	0.958 (0.951–0.966)	-0.003 (-0.025–0.012)	0.6	0.572	4.7	5.1
			1.6	1.530	4.4
			3.5	3.350	4.3

^∗ Minimum bias goal based on biological variability, as proposed by Myers et al. [4]. Abbreviation: CI, confidence interval.

Table 4.

Accuracy of serum creatinine measurements using CRE2 and ECREA reagents on Dimension VISTA 500 instrument, and L-CRE reagent on Toshiba 2000FR Neo instrument

Level [Certified con-centration value∗ (mg/dL)]	Low level (0.847_±0.018)			High level (3.877_±0.082)
Level [Certified con-centration value∗ (mg/dL)]	CRE2	ECREA	L-CRE	CRE2	ECREA	L-CRE
Reagent
Mean (mg/dL)	0.910	0.792	0.818	4.03	3.82	3.91
Bias (mg/dL)	0.063	-0.055	-0.029	0.15	-0.06	0.03
Percent bias (%)	7.4	-6.4	-3.4	3.9	-1.5	0.7

^∗ National Institute of Standards and Technology certificate of analysis, standard reference material 967a [10].

TOOLS

Similar articles