COD 11802 COD 11502 COD 11542 CREATININE

2 x 50 mL 4 x 50 mL 1x1L
STORE AT 2-30ºC
Reagents for measurement of creatinine concentration
Only for in vitro use in the clinical laboratory
CREATININE
JAFFÉ

PRINCIPLE OF THE METHOD REFERENCE VALUES

Creatinine in the sample reacts with picrate in alkaline medium forming a coloured complex (Jaffé Serum and plasma4:
method). The complex formation rate is measured in a short period to avoid interferences 1,2. Serum and
Method Jaffé non compensated Jaffé compensated
plasma samples contain proteins that react in a non specific way; nevertheless, the results can be
corrected subtracting a fixed value. The use of this correction is known as the Jaffé method Men 0.9 - 1.3 mg/dL = 80 - 115 mol/L 0.7 - 1.2 mg/dL = 62 - 106 mol/L
compensated6,7. Women 0.6 - 1.1 mg/dL = 53 - 97 mol/L 0.5 - 0.9 mg/dL = 44 - 80 mol/L

CONTENTS Urine5:
COD 11802 COD 11502 COD 11542 Men: 14 - 26 mg/kg/24-h = 124 - 230 mol/kg/24-h
A. Reagent 1 x 50 mL 2 x 50 mL 1 x 500 mL Women: 11 - 20 mg/kg/24-h = 97 - 177 mol/kg/24-h
B. Reagent 1 x 50 mL 2 x 50 mL 1 x 500 mL These ranges are given for orientation only; each laboratory should establish its own reference ranges.
S. Standard 1 x 5 mL 1 x 5 mL 1 x 5 mL
QUALITY CONTROL
COMPOSITION It is recommended to use the Biochemistry Control Serum level I (cod. 18005, cod. 18009 and cod.
A. Reagent. Sodium hydroxide 0.4 mol/L, detergent. 18042) and II (cod. 18007, cod. 18010 and cod. 18043) and the Biochemistry Control Urine (cod. 18054
WARNING: H315: Causes skin irritation. H319: Causes serious eye irritation. P280: Wear protective and cod. 18066) to verify the performance of the measurement procedure.
gloves/protective clothing/eye protection/face protection. P305+P351+P338: IF IN EYES: Rinse cautiously
with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
Each laboratory should establish its own internal Quality Control scheme and procedures for corrective
P332+P313: If skin irritation occurs: Get medical advice/attention. action if controls do not recover within the acceptable tolerances.
B. Reagent. Picric acid 25 mmol/L. METROLOGICAL CHARACTERISTICS
S. Glucose/Urea/Creatinine Standard. Glucose 100 mg/dL, urea 50 mg/dL, creatinine 2 mg/dL (177 mol/L).
Aqueous primary standard. − Detection limit: 0.1 mg/dL creatinine = 8.84 mol/L creatinine
For further warnings and precautions, see the product safety data sheet (SDS). − Linearity limit: 20 mg/dL = 1768 mol/L creatinine. For higher values dilute sample 1/2 with distilled
water and repeat measurement.
STORAGE
− Precision:
Store at 2-30ºC.
Reagents and Standard are stable until the expiry date shown on the label when stored tightly closed and if Serum. Mean (mg/dL) / (mol/L) Repeatability (CV)% Reproducibility (CV)%
contaminations are prevented during their use. 1.09 mg/dL = 96.6 mol/L 3.0 % 4.4 %
Indications of deterioration:
3.32 mg/dL = 294 mol/L 1.3 % 1.9 %
− Reagents: Reagents: RA is a NaOH solution with high concentration. In some storage conditions (i.e.
storage at a lower temperature than indicated) a precipitate may appear in the vial that will not affect the 15.5 mg/dL = 1371 mol/L 0.8 % 1.7 %
reagent performance and will disappear with a slight rotation of the vial before carrying out the analysis. RB,
Urine. Mean (mg/dL) / (mol/L) Repeatability (CV)% Reproducibility (CV)%
presence of particulate material, turbidity. Absorbance of the blank over 0.350 at 500 nm (1 cm cuvette).
− Standard: Presence of particulate material, turbidity. 73 mg/dL = 6463 mol/L 1.0 % 5.7 %
176 mg/dL = 15576 mol/L 0.5 % 5.4 %
AUXILIARY REAGENTS
748 mg/dL = 66208 mol/L 0.9 % 5.2 %
Biochemistry Calibrator (BioSystems cod. 18011) or Biochemistry Calibrator Human (BioSystems cod. 18044).
For repeatability and reproducibility studies, samples were measured on three different analyzers
REAGENT PREPARATION during five days, one run per day and five replicates per run.
Standard (S) is provided ready to use.
− Trueness: Results obtained with this reagent did not show systematic differences when compared
Working Reagent: Mix equal volumes of Reagent A and Reagent B. Mix thoroughly. Stable for 1 month with reference reagents (Note 2). Details of the comparison experiments are available on request.
at 2-8ºC.
− Interferences: Bilirubin (up to 3 mg/dL), hemolysis (hemoglobin up to 500 mg/dL), lipemia
ADDITIONAL EQUIPMENT (triglycerides up to 600 mg/dL) and protein and ketonic bodies do not interfere. High concentration
− Thermostatic water bath at 37ºC of reducing compounds may interfere. Other drugs and substances may interfere 8.
− Analyzer, spectrophotometer or photometer able to read at 500  20 nm. These metrological characteristics have been obtained using an analyzer. Results may vary if a
SAMPLES different instrument or a manual procedure are used.
Serum, plasma or urine collected by standard procedures. Heparin, EDTA, oxalate and fluoride may be DIAGNOSTIC CHARACTERISTICS
used as anticoagulants.
Creatinine is a catabolic end product of creatine (or phosphocreatine). The amount produced each day
Creatinine in serum/plasma is stable up to 7 days at 20-25 ºC, 7 days at 2-8 ºC or 3 months at -20 ºC.
is related to the muscle mass. Creatinine is freely filtered by the glomerulus (small amounts are
Creatinine in urine is stable up to 2 days at 20-25 ºC, 6 days at 2-8 ºC or 6 months at -20 ºC3.
reabsorbed and are also secreted by the renal tubules).
PROCEDURE Creatinine measurement is used almost exclusively in the assessment of kidney function (impaired
1. Bring the Working Reagent and the photometer to 37ºC. renal perfusion, loss of functioning nephrons) and in the monitoring renal dialysis 5,9.
2. Pipette into a cuvette: (Note 1) Clinical diagnosis should not be made on the findings of a single test result, but should integrate both
clinical and laboratory data.
Working Reagent 1.0 mL
Standard (S) or Sample 0.1 mL NOTES
3. Mix and insert cuvette into the photometer. Start stopwatch. 1. These reagents may be used in several automatic analysers. Instructions for many of them are
available on request.
4. Record the absorbance at 500 nm after 30 seconds (A 1) and after 90 seconds (A2).
2. For measurement in serum or plasma with the Jaffé method compensated, introduce the corrective
CALCULATIONS value for the reaction of nonspecific proteins as a constant factor subtracted from the concentration
The creatinine concentration in the sample is calculated using the following general formula (Note 2): value obtained6,7.
(A2 – A1) Sample BIBLIOGRAPHY
x C Standard x Sample dilution factor – Corrective Factor5,6,7 = C Sample
(A2 – A1) Standard 1. Bartels H, Böhmer M. Eine mikromethode zur kreatininbestimmung. Clin Chim Acta 1971; 32: 81-85.
If the Creatinine Standard provided has been used to calibrate: 2. Fabiny DL, Ertingshausen G. Automated reaction-rate method for determination of serum creatinine with
CentrifiChem. Clin Chem 1971; 17: 696-700.
Serum and plasma
Urine 3. World HealthOrganization (WHO). Use of anticoagulants in diagnostic laboratory investigations. Document
Jaffé non compensated Jaffé compensated WHO/DIL/LAB/99.1, Rev.2; 2002.
x 2] = mg/dL x 2] - 0.2373 = mg/dL x 100] = mg/dL 4. Mazzachi BC, Peake MJ, Ehrhardt V. Reference range and method comparison studies for enzymatic and
 (A2 – A1) Sample Jaffé creatinine assays in plasma and serum and early morning urine. Clin Lab 2000;46:53-55.

 (A2 – A1) Standard x 177] = mol/L x 177] - 21 = mol/L x 8840] = mol/L 5. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics, 6th ed. Rifai N, Horvath AR,Wittwer CT.WB
Saunders Co, 2018.
If the Biochemistry Calibrator (BioSystems cod. 18011 or 18044) (not provided) has been used to 6. Weber JA, Van Zanten AP. Interferences in current methods for measurements of creatinine. Clin Chem
calibrate. 1991; 37: 695-700.
Serum and plasma 7. Peake M, Whiting M. Measurement of serum creatinine-current status and future goals. Clin Biochem
Urine 2006;27:173-184.
Jaffé non compensated Jaffé compensated
8. Young DS. Effects of drugs on clinical laboratory tests, 5th ed. AACC Press, 2000.
 (A2 – A1) Sample x C Calibrator x C Calibrator x C Calibrator
9. Friedman and Young. Effects of disease on clinical laboratory tests, 4th ed. AACC Press, 2001.
 (non compensated)] = (compensated) x 0.9] (compensated)
 (A2 – A1) Calibrator mg/dL or mol/L – 0.2373 = mg/dL x 0.9 x 50] = mg/dL
or mol/L
x C Calibrator
(compensated) x 0.9]
– 21 = mol/L

M11502i-23 04/2025
The lateral lines mark the modifications in the current version.