CREATININE (Jaffe Kinetic)
INTENDED USE observed shift in control values.
Creatinine reagent is used for the quantitative determination of 2. Major preventative maintenance was performed on
creatinine in human serum and urine. the analyzer.
This reagent is for use on fully automatic biochemistry analyzer. 3. A critical part of instrument was replaced like the lamp
or cuvettes etc.
CLINICAL SIGNIFICANCE
REAGENT DETERIORATION
Creatinine, an anhydride of creatine, is a waste product
The reagent should be discarded if:
formed by the spontaneous dehydration of kidneys. Most of
1. Turbidity has occurred; turbidity may be a sign of
the creatinine is found in muscle tissue where it is present as
creatine phosphate and serves as a high energy storage contamination.
2. The reagent fails to meet linearity claims or fails to
reservoir for conversion to ATP. In-dependent of diet, serum
recover control values in the stated range. Samples
creatinine concentrations depend almost entirely upon its
excretion rate by the kidneys. For this reason, its elevation is should be retested using fresh reagent bottle
highly specific for kidney diseases.
SPECIMEN COLLECTION AND STABILITY
METHOD AND PRINCIPLE 1. Serum is recommended.
The assay of creatinine has been based on the reaction of 2. Creatinine in serum is stable for twenty-four (24) hours
creatinine with alkaline picrate as described by Jaffe. Further at refrigerated temperatures (2 - 8°C) and several
modifications have developed the Jaffe reaction into a kinetic months when frozen(-20°C) and protected from
evaporation and contamination.
assay that is fast, simple and avoids interferences.
3. 24-hour urine specimens must be preserved with 15
grams of boric acid.
Alkaline pH
Creatinine + Sodium Picrate Creatinine–Picrate
REAGENTS REQUIRED BUT NOT PROVIDED IN THE KIT
complex
Biochemistry Multicalibrator
(yellow-orange)
INTERFERENCES
Creatinine reacts with picric acid in alkaline conditions to
A number of substances affect the accuracy of creatinine
form a color complex which absorbs at 510 nm. The rate of
determination. See Young et al for a comprehensive list.
formation of color is proportional to the creatinine
concentration in the sample.
CALCULATIONS
Results will be calculated against the factor generated after
REAGENT COMPOSITION
calibration using Biochemistry multi calibrator.
1. Creatinine Picric Acid Reagent: A solution containing 10
We recommend Randox Cal Level 3 for Calibration.
mm picric acid.
2. Creatinine Buffer Reagent: A solution containing 240
WARNING AND PRECAUTIONS
mM, sodium hydroxide and EDTA.
1. This reagent is for "in vitro" diagnostic use only.
2. Creatinine Picric Acid Reagent is a strong oxidizing agent.
REAGENT PREPARATION
Avoid contact with skin. WIPE ANY SPILLAGE, SINCE
Both R1 and R2 Reagent are ready to use. For making working
PICRIC ACID IS EXPLOSIVE.
reagent mix R1 and R2 in 1:1 ratio.
3. Creatinine buffer reagent is an alkali. Avoid ingestion and
contact.
REAGENT STORAGE AND STABILITY
1. Both reagents are stored at room temperature (18 - QUALITYCONTROL
25°C). Reagent kit is stable until the expiry date stated on The integrity of the reaction should be monitored by use of
the lable. normal and abnormal control sera with known creatinine
values.
Onboard stability and calibration frequency:
24 Hrs Onboard: 2 weeks if contamination avoided EXPECTED VALUES
8 Hrs Onboard: 3 weeks if contamination avoided Serum: Male 0.9-1.5mg/dl
The above onboard stability is for BC2000. For other Female 0.7-1.37mg/dl
Analyzers laboratory has to define their own calibration
frequency and Onboard stability according to their LIMITATIONS
workload and laboratory conditions. We recommend every Albumin at a concentration of 10.0 gm/dl contributes 0.2
2 days for result accuracy. mg/dl to the creatinine value, moderate hemolysis (0.2 gm/dl
Recalibration of this test is required when any of these Hgb), grossly icteric and lipemic samples will give elevated
conditions exist: results. Acetoacetate above 10mg/dl will interfere with the
1. A reagent lot number has changed or there is an
CREATININE - Page 1
results.
PERFORMANCECHARACTERISTICS
1. Linearity: 20 mg/dl
2. Comparison: A study performed between this procedure
and a similar kinetic procedure yielded a correlation
coefficient of 0.99 with a regression equation of y = 0.96x
+ 0.06. Serum and control samples used in the study had
creatinine values ranging from 0.9 to 8.3 mg/dl.
3. Precision:
A. Within Run
Mean mg/dl S.D. C.V.%
1.9 0.05 2.6
8.2 0.6 4.3
B. Run to Run
Mean mg/dl S.D. C.V.%
2.0 0.2 10.0
8.2 0.4 4.6
REFERENCES
1. Henry.J.B.,ClinicalDiagnosisandManagementbyLabora
tory
Method. 16th ed.Saunders.Philadelphia. PA.p.263
(1974)
2. Vasilades. J.Clin. Chem. 22:1664 (1976).
3. HeinegardD.andTiderstrom.G.,Clin.Chem.Acta43:305(1
973).
4. Buffer.A.R., Clin. Chem. Acta59:227 (1975).
5. Young.D.S., et al., Clin. Chem. 21 (1975).
6. Tietz.N.W., Fundamentals of Clinical Chemistry. W.B.
Saunders. R.S., Philadelphia p. 1211 (1976).
CREATININE - Page 2
