Principle of The Method Quality Control: Alkaline Picrate

COD 11802 COD 11502 COD 11542 CREATININE
2 x 50 mL 4 x 50 mL 1x1L
STORE AT 15-30ºC
Reagents for measurement of creatinine concentration CREATININE
Only for in vitro use in the clinical laboratory
ALKALINE PICRATE
PRINCIPLE OF THE METHOD QUALITY CONTROL

Creatinine in the sample reacts with picrate in alkaline medium forming a coloured complex. The It is recommended to use the Biochemistry Control Serum level I (cod. 18005, 18009 and 18042)
complex formation rate is measured in a short period to avoid interferences1,2. and II (cod. 18007, 18010 and 18043) to verify the performance of the measurement procedure.
Each laboratory should establish its own internal Quality Control scheme and procedures for
CONTENTS
COD 11802 COD 11502 COD 11542
corrective action if controls do not recover within the acceptable tolerances.
A. Reagent 1 x 50 mL 2 x 50 mL 1 x 500 mL METROLOGICAL CHARACTERISTICS

B. Reagent 1 x 50 mL 2 x 50 mL 1 x 500 mL
S. Standard 1 x 5 mL 1 x 5 mL 1 x 5 mL
− Detection limit: 0.03 mg/dL creatinine = 2.65 µmol/L creatinine
− Linearity limit: 20 mg/dL = 1768 µmol/L creatinine. For higher values dilute sample 1/2 with
COMPOSITION distilled water and repeat measurement.
A. Reagent. Sodium hydroxide 0.4 mol/L, detergent. − Repeatibility (within run):
Irritant (Xi): R36/38: Irritating to eyes and skin. S26: In case of contact with eyes, rinse Mean concentration CV n
immediately with plenty of water and seek medical advice. S37/39: Wear suitable gloves and 2.9 % 20
1.7 mg/dL = 150 µmol/L
eye/face protection.
5.3 mg/dL = 468 µmol/L 1.3 % 20
B. Reagent. Picric acid 25 mmol/L.
S. Glucose/Urea/Creatinine Standard. Glucose 100 mg/dL, urea 50 mg/dL, creatinine 2 mg/dL − Reproducibility (run to run):
(177 µmol/L). Aqueous primary standard. Mean concentration CV n
STORAGE 1.7 mg/dL = 150 µmol/L 3.9 % 25

5.3 mg/dL = 468 µmol/L 2.9 % 25
Store at 15-30ºC.
Reagents and Standard are stable until the expiry date shown on the label when stored tightly − Sensitivity: 31 mA⋅dL/mg = 0.351 mA⋅L/µmol
closed and if contaminations are prevented during their use.
− Trueness: Results obtained with this reagent did not show systematic differences when
Indications of deterioration: compared with reference reagents (Note 2). Details of the comparison experiments are
− Reagents: Presence of particulate material, turbidity, absorbance of the blank over 0.350 at available on request.
500 nm (1 cm cuvette).
− Interferences: Hemoglobin (10 g/L), bilirubin (10 mg/dL), protein and ketonic bodies do not
− Standard: Presence of particulate material, turbidity.
interfere. Lipemia (triglycerides > 2 g/L) may interfere. High concentration of reducing
REAGENT PREPARATION compounds may interfere. Other drugs and substances may interfere4.
Standard (S) is provided ready to use. These metrological characteristics have been obtained using an analyzer. Results may vary if a
different instrument or a manual procedure are used.
Working Reagent: Mix equal volumes of Reagent A and Reagent B. Mix thoroughly. Stable for 1
month at 2-8ºC. DIAGNOSTIC CHARACTERISTICS
ADDITIONAL EQUIPMENT Creatinine is a catabolic end product of creatine (or phosphocreatine). The amount produced
each day is related to the muscle mass. Creatinine is freely filtered by the glomerulus (small
− Thermostatic water bath at 37ºC amounts are reabsorbed and are also secreted by the renal tubules).
− Analyzer, spectrophotometer or photometer able to read at 500 ± 20 nm. Creatinine measurement is used almost exclusively in the assessment of kidney function
(impaired renal perfusion, loss of functioning nephrons) and in the monitoring renal dialysis3,5.
SAMPLES Clinical diagnosis should not be made on the findings of a single test result, but should integrate
Serum, plasma or urine collected by standard procedures. Dilute fresh urine 1/50 with distilled both clinical and laboratory data.
water before measurement. Heparin, EDTA, oxalate and fluoride may be used as anticoagulants.
NOTES
Creatinine in samples is stable for 24 hours at 2-8ºC.
1. These reagents may be used in several automatic analysers. Instructions for many of them
PROCEDURE are available on request.
1. Bring the Working Reagent and the photometer to 37ºC. 2. Calibration with the provided aqueous standard may cause a matrix related bias, specially in
some analyzers. In these cases, it is recommended to calibrate using a serum based standard
2. Pipette into a cuvette: (Note 1) (Biochemistry Calibrator, cod. 18011 and 18044).
Working Reagent 1.0 mL BIBLIOGRAPHY
Standard (S) or Sample 0.1 mL
1. Bartels H, Böhmer M. Eine mikromethode zur kreatininbestimmung. Clin Chim Acta 1971; 32:
3. Mix and insert cuvette into the photometer. Start stopwatch. 81-85.
4. Record the absorbance at 500 nm after 30 seconds (A1) and after 90 seconds (A2). 2. Fabiny DL, Ertingshausen G. Automated reaction-rate method for determination of serum
creatinine with CentrifiChem. Clin Chem 1971; 17: 696-700.
CALCULATIONS
3. Tietz Textbook of Clinical Chemistry, 3rd edition. Burtis CA, Ashwood ER. WB Saunders Co.,
The creatinine concentration in the sample is calculated using the following general formula: 1999.
(A2 – A1) Sample 4. Young DS. Effects of drugs on clinical laboratory tests, 3th ed. AACC Press, 1997.
x C Standard x Sample dilution factor = C Sample
(A2 – A1) Standard 5. Friedman and Young. Effects of disease on clinical laboratory tests, 3th ed. AACC Press,
1997.
If the Creatinine Standard provided has been used to calibrate (Note 2):
Serum and plasma Urine
(A2 – A1) Sample x 2 = mg/dL creatinine x 100 = mg/dL creatinine

(A2 – A1) Standard x 177 = µmol/L creatinine x 8840 = µmol/L creatinine
REFERENCE VALUES
Serum and plasma3:
Men: 0.9-1.3 mg/dL = 80-115 µmol/L
Women: 0.6-1.1 mg/dL = 53-97 µmol/L
Urine3:
Men: 14-26 mg/kg/24-h = 124-230 µmol/kg/24-h
Women: 11-20 mg/kg/24-h = 97-177 µmol/kg/24-h
These ranges are given for orientation only; each laboratory should establish its own reference
ranges.
M11502i-0615 BioSystems S.A. Costa Brava 30, Barcelona (Spain) 09/2006

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EN ISO 13485 and EN ISO 9001 standards

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COD 11802 COD 11502 COD 11542 CREATININE

PRINCIPLE OF THE METHOD QUALITY CONTROL

A. Reagent 1 x 50 mL 2 x 50 mL 1 x 500 mL METROLOGICAL CHARACTERISTICS

STORAGE 1.7 mg/dL = 150 µmol/L 3.9 % 25

Serum and plasma Urine

(A2 – A1) Sample x 2 = mg/dL creatinine x 100 = mg/dL creatinine

M11502i-0615 BioSystems S.A. Costa Brava 30, Barcelona (Spain) 09/2006

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