Creatinine Jaffè kin.
fluid(5+1)
Colorimetric test for the kinetic determination without deproteinization, Jaffe method
REAGENT PACKAGE INFORMATION TESTING PROCEDURE
Configuration Material provided
Product FURUNO
Product No. - Workingsolutions as described above
Name Analyzer R1 R2 Additional materials required
CF05917084-F 6 x 67mL 6 x 17mL - Calibrators and controls as indicated below
- “Saline Diluent” is used as diluent:
CF05917084-F3 Creatinine CA-270 3 x 67mL 3 x 17mL Product No. Product name Configuration
Jaffè CA-400 FSD917070 Saline Diluent 5 x 67mL
CF05917084-F4 kin.fluid(5+1) CA-800 4 x 20mL 4 x 7mL
CF05917084-F8 8 x 20mL 8 x 7mL MESUREMENT RANGE
0.04 – 29 mg/dL in CA series
INTENDED USE CONVERSION FACTOR
In vitro test for the quantitative determination of Creatinine in human serum, mg/dL μmol/L Factor: 88.4
plasma and urine. μmol/L mg/dL Factor: 0.0113
SUMMARY EXPECTED VALUES
In muscle metabolism, creatinine is synthesized endogenously from creatine Reference: Mazzachi, Schlebusch, Junge, et. al.:
and creatine phosphate. Under conditions of normal renal function, creatinine is Serum, plasma
excreted by glomerular filtration. Creatinine determinations are performed for
mg/dL μmol/L
the diagnosis and monitoring of acute and chronic renal disease as well as for
Adult Males 0.67-1.17 59-104
the monitoring of renal dialysis. Creatinine concentrations in urine can be used
as reference values for the excretion of certain analytes (albumin, a-amylase). Females 0.51-0.95 45-84
Children Neonates (Premature) 0.33-0.98 29-87
MEASUREMENT PRINCIPLE Neonates (full term) 0.31-0.88 27-77
In an alkaline solution creatinine forms a color complex with picrate 2-12 month 0.16-0.39 14-34
(“Jaffe” method without deproteinization). 1 - less than 3 years 0.18-0.35 15-31
3 – less than 5 years 0.26-0.42 23-37
Creatinine + Picric acid Creatinine-Picric acid Complex 5 – less than 7 years 0.29-0.47 25-42
7 – less than 9 years 0.34-0.53 30-47
CONCENTRATION OF WORKING SOLUTION 9 – less than 11 years 0.33-0.64 29-56
Reagent 1 11 – less than 13 years 0.44-0.68 39-60
NaOH 187.8 mmol/L 13 – less than 15 years 0.46-0.77 40-68
Phosphate 7.5 mmol/L Urine, 1 morning urine
st
Reagent 2 mg/dL mmol/L
Picric acid 8.73 mmol/L Males 40-278 3.54-24.6
Females 29-226 2.55-20.0
REAGENT PREPARATIN, STORAGE AND STABILITY Urine, 24 hours
R1: Ready to use mg/day mmol/day
R2: Ready to use Males 980-2200 9-19
The sealed reagents are stable up to the indicated expiry date if stored at +18° Females 720-1510 6-13
- +22°C. Creatinine clearance
After opening the bottle, it is stable for 28 days when kept onboard in the 66-143 mL/min
analyzer, if contamination is avoided. Each laboratory should investigate the transferability of the expected values to
its own patient population and if necessary determine its own reference range.
SAMPLE MATERIAL For diagnostic purposes the creatinine results should always be assayed in
Serum, heparinized plasma, EDTA plasma conjunction with the patient's medical history, clinical examinations and other
Stability: 7days at +20℃ to +25℃ findings.
7days at +2℃ to +8℃
3months at -20℃ REPRODUCIBILITY
Urine Reproducibility in CA-800
Stability: 2days at +20℃ to +25℃
6days at +2℃ to +8℃ Day-to-day run
Within run (n= 20)
6month at -20℃ (Duplicate, 20days)
Collect urine without additives. Mean SD Mean SD
CV% CV%
Centrifuge samples containing precipitate before performing the assay. (mg/dL) (mg/dL) (mg/dL) (mg/dL)
Low 1.42 0.026 1.86 1.40 0.026 1.88
PRECAUTIONS AND WARNINGS High 4.66 0.072 1.55 4.58 0.083 1.81
For in vitro diagnostic use only. Attend to the normal precautions required for
handling all laboratory reagents. TEST COMPARISON
Attention: Reagent 1 contain Sodiumhydroxide. Sodiumhydroxide can cause
Comparison with a test of other manufacturer’s reagent of creatinine
caustic burns. Reagent 2 contain picric acid. Hazardous, toxic. In the case of
enzymatic method in CA-800
contact rinse affected area with plenty of water; get immediate medical attention
Y = 0.906 x + 0.709, R = 0.999, N = 110
after contact with eyes or if ingested.
QUALITY CONTROL
INTERFERENCES Multi QC sample “Centronorm” and ” Centropath” are used.
Free type of Bilirubin:
Product No. Product Name Configuration
Decrease approx. 0.1mg/dL by 10mg/dL of free type of Bilirubin
Conjugate type of Bilirubin: CNORM005 5 x 5 mL
Decrease approx. 0.2mg/dL by 10mg/dL of conjugate type of Bilirubin CNORM010 Centronorm 10 x 5 mL
Hemolytic hemoglobin: No interference less than 500 mg/dL Hb. CNORM020 20 x 5 mL
Chyle: No interference less than 1800 FTU (*) CPATH005 5 x 5 mL
*: FTU: Formazine turbidity unit CPATH010 Centropath 10 x 5 mL
CPATH020 20 x 5 mL
The control intervals and limits must be adapted to the individual laboratory and
country-specific requirements. Values obtained should fall within established
limits. Each laboratory should establish corrective measures to be taken if
values fall out-side the limits.
Centronic GmbH
Am Kleinfeld 11, 85456 Wartenberg/Germany
Phone: 0049-8762724300, Fax: 0049-8762724312
Edition 04/2023, TV-034-CE-001FU
e-mail: info@centronic-gmbh.com
web: www.centronic-gmbh.com
CALIBRATION
Multi-calibrator “Centrocal” is used.
S1: Saline, S2: Centrocal
Recommended calibration interval: every 3 days
Product No. Product Name Configuration
CCAL005 5 x 3mL
CCAL010 Centrocal 10 x 3mL
CCAL020 20 x 3mL
LITERATURE
Piero Fossati, Lorenzo Prencipe und Giovanni Berti. Clin. Chem. 29/8,
1494 (1983).
Börner, U. und Al., J. Clin. Chem. Clin. Biochem. 17 (1979).
K. Tamaoku, et al. anal. clin. acta 136, 121 (1982).
Allen, L. C., Clin. Chem., 28(3), 555, 1982
Haeckel, R. et al., Clin. Chem., 27/1, 179-183, 1981
Tanganeli, E. et al., Clin. Chem., 28/7, 1461-1464, 1982
Mazzachi BC, Peake MJ, Ehrhardt V. Reference Range and Method
Comparison Studies for Enzymatic and Jaffé Creatinine Assays in
Plasma and Serum and Early Morning Urine. Clin Lab 2000;46:53-55.
Schlebusch H, Liappis N, Kalina E, et al. High sensitive CRP and
creatinine: reference intervals from infancy to childhood. J Lab Med
2002;26:341-346.
Junge W, Wilke B, Halabi A, et al. Determination of reference intervals for
serum creatinine, creatinine excretion and creatinine clearance with an
enzymatic and a modified Jaffé method. Clin Chim Acta 2004;344:137-
148.
Centronic GmbH
Am Kleinfeld 11, 85456 Wartenberg/Germany
Phone: 0049-8762724300, Fax: 0049-8762724312
Edition 04/2023, TV-034-CE-001FU
e-mail: info@centronic-gmbh.com
web: www.centronic-gmbh.com
Revision history
Document Name, version Revised Revise content
15. CREA Jaffe TV-034-CE-001FU 2023.04 original
Centronic GmbH
Am Kleinfeld 11, 85456 Wartenberg/Germany
Phone: 0049-8762724300, Fax: 0049-8762724312
Edition 04/2023, TV-034-CE-001FU
e-mail: info@centronic-gmbh.com
web: www.centronic-gmbh.com
