ClinReact ITA® Enzymatic Creatinine Test Reagent kit
(Enzymatic Method)
INSTRUCTION FOR USE
animals.
•Contains materials of microbial origin.
30201345 R1 1x60mL; R2 1x20mL; Std 1x3mL •For detailed information refer Material Safety Data
Sheet
2-8°C REAGENTS PREPARATION, STORAGE AND STABILITY
• Supplied reagent is stable at a temperature between
2°C - 8°C until expiry date. Stability claims are based on
INTENDED USE
real time studies.
For in vitro diagnostic use only. ClinReact ITA® Enzymatic
• Onboard: Stable for 15 days at 2 -8°C
Creatinine Test Reagent kit (Enzymatic Method) is intended
for the quantitative determination of Creatinine in human WORKING REAGENT
serum or urine by spectrophotometry.
Mix 3 Volumes of Enzymatic Creatinine R1 & 1 Volume
TEST SUMMARY Enzymatic CreatinineR2 to prepare single working reagent.
Creatinine is formed in muscles from phosphocreatine. It is
an important form of energy by being store of high energy
phosphate. Creatinine determination have one advantage SPECIMEN COLLECTION & PREPARATION
over urea determination that it is not affected by high • Collect blood specimens using Standard laboratory
protein diet. Serum creatinine is more specific and sensitive procedures.
indicator of renal function. Simultaneous estimation of • Urine: Collect with no preservative. Random
serum urea and creatinine provides better information. specimens or specimens timed over intervals
Serum urea nitrogen and creatinine ratio is >15 in pre renal shorter than 24 hours are acceptable for analysis.
failure and <10 in renal failure. Decreased levels are found For exact measurement of analyte in urine it is
in muscle dystrophy. important to dilute in distilled water in 1:19 ratio
and multiply the results with 20.
TEST PRINCIPLE
Creatinine is determined by the following PATIENT PREPARATION
reaction: No special patient preparation is necessary.
Creatininase
Creatinine + H2O Creatine SPECIMEN HANDLING AND STORAGE
Creatinase
Creatine + H2O Sarcosine + Urea
Fresh serum. Stable 1 day at 2-8ºC
Urine for 24 hours collection is preferred.
Sarcosine oxidase
Sarcosine + O2 + H2O Glycine + HCHO MATERIALS REQUIRED BUT NOT PROVIDED
+ H2O2 • spectrophotometry.
Peroxidase • Common laboratory equipment.
H2O2 + TOOS + 4-AA Quinone dye + 4 H2O
• Quality Control materials.
• Isotonic saline for sample dilution.
The absorbance of the produced red dye at 545 nm is
proportional to the creatinine concentration in the sample.
OPERATING RECOMMENDATIONS FOR ANALYZER
CALIBRATIONS
KIT CONTENTS It is essential to calibrate the Analyzer on which ClinReact
R1 R2 Standard ITA® Enzymatic Creatinine Test Reagent kit (Enzymatic
reagent Reagent Method) is used at a recommended frequency of once in 7
Manual/ Semi- 1x 60 mL 1x20 mL 1x3 mL days. In addition, calibration of instruments has to be
automated performed every time any of the following changes are
Analyzer made:
WARNINGS & PRECAUTIONS FOR USE • When the Lot number of the kit changes
• This reagent is for in vitro diagnostic use only. • When critical system parts of the instruments are
• Not for internal or external use in humans or replaced due to service or maintenance.
Trivitron Healthcare Pvt. Ltd. Doc.No. THPL/BC/IFU/ECRE Feedback and Customer Queries Contact:
Plot No. A2 & A3, SIPCOT Industrial park, 24 Hours Helpline No. +91 98400 80008
Version No.: 03 Effective Date: 05/05/2023 Email: [email protected]
Irungattukottai, Sriperumbudur Taluk,
Kanchipuram, Tamil Nadu, (India) – 602105
ClinReact ITA® Enzymatic Creatinine Test Reagent kit
(Enzymatic Method)
INSTRUCTION FOR USE
CALIBRATION PROCEDURE
• Calibration of analyzer can be done using suitable
Reagent System : Two Reagents
Multicalibrator of known Enzymatic Creatinine
concentration.
• Refer to user manual of analyzer and IFU of respective Test Parameters
Calibrator/Standard that is used for recommendations
on reconstitution, handling & storage. Reaction Endpoint Units mg/dL
• For semi-automated analyzers run the
calibrator/standard on standard mode to get the K-
Factor. 10 µl
Reaction Sample
• For fully automated analyzers run the Direction
Increasing
Volume
(Urine), 50
calibrator/standard on calibration mode to get the K- µl (serum)
factor.
Reagent 0.6ml
QUALITY CONTROL Wavelength 546nm
Volume: (600µl)
• Analyze control materials at regular intervals to verify
system performance. Flow cell
37°C Standard conc 2 mg/dL
• Analyze Quality control materials after the specified Temperature
service and maintenance procedures have been
performed on the instruments. Zero Setting Reagent Linearity 40mg/dL
• Choose controls that check the clinically relevant
range. incubation Time 10 min Reading Time 10 Secs.
• Analyze controls in the same manner as patient
samples, before or during patient sample processing.
• If control values fall outside your acceptable range, PROCEDURE FOR Serum in SEMI-AUTO ANALYZER
investigate the cause before deciding the reporting of Pipette into a clean dry test tube labeled as Standard
patient result. (S)and Test (T):
The following corrective actions are recommended in such
situations: - Addition Sequence B S T
• Repeat the same controls. Regent R1 450 µl 450 µl 450 µl
• If repeated control results are outside the limits,
Standard 50 µl -
prepare fresh control serum and repeat the test.
• If results on fresh control material still remain outside Sample - 50 µl
the limits, then repeat the test with fresh reagent. Mix & Incubate for 5 min at 37°C then add
• If results are still out of control, contact Technical Regent R2 150 µl 150 µl 150 µl
Services or your local distributor.
Mix well and incubate for 5 min at 37°C. Measure the
TESTING absorbance of Test and Standard against the reagent
1. Check reagent inventories at least daily to ensure that blank.
quantities are sufficient for the planned work load.
2. Bring all reagents, Calibrator and samples to room CALCULATIONS
temperature 18 - 28⁰C, prior to analysis. Δ Abs of sample
3. Test parameters are as follows: Creatinine Conc (mg/dl) = x Standard Conc.
Δ Abs of standard
PROCEDURE FOR URINE:
Trivitron Healthcare Pvt. Ltd. Doc.No. THPL/BC/IFU/ECRE Feedback and Customer Queries Contact:
Plot No. A2 & A3, SIPCOT Industrial park, 24 Hours Helpline No. +91 98400 80008
Version No.: 03 Effective Date: 05/05/2023 Email: [email protected]
Irungattukottai, Sriperumbudur Taluk,
Kanchipuram, Tamil Nadu, (India) – 602105
ClinReact ITA® Enzymatic Creatinine Test Reagent kit
(Enzymatic Method)
INSTRUCTION FOR USE
Pipette into a clean dry test tube labeled as Standard ANALYTICAL SPECIFICITY
(S)and Test (T): Cross contamination studies have not been performed on
automated instruments. Certain reagent/ instrument
Addition Sequence B S T combinations used in sequence with this assay may
Regent R1 450 µl 450 µl 450 µl interfere with reagent performance and test results.
INTERFERENCES
Standard 10 µl -
Following substances do not interfere:
Sample - 10 µl Hemoglobin upto 5 g/l, bilirubin up to 30 mg/dl, Lipemia
Mix & Incubate for 5 min at 37°C then add upto 1000 mg/dl
Regent R2 150 µl 150 µl 150 µl REFERENCES
1. Kaplan,L.A., Pesce,A.J. :Clinical Chemistry, Mosby
Mix well and incubate for 5 min at 37°C. Measure the Ed.(1996)
absorbance of Test and Standard against the reagent blank. 2. Jakobs, D. S., Kasten, Jr., B. L., DeMott, W. R. Wolfson,
W. L.: Laboratory Test Handbook, Lexi-Compand
CALCULATIONS Wiliams & Wilkins Ed.(2ndEdition–1990)
Δ Abs of sample 3. Myers, G. L. et. al.: Recommendations for Improving
Creatinine Conc (mg/dl)= x Standard Conc. Serum Creatinine Measurement: A report from
Δ Abs of standard laboratory working group of the National kidney
REFERENCE INTERVALS disease education program, Clinical Chemistry52,1,5–
Serum: 18(2006)
Male: 0.6 - 1.1mg /dl, 4. Börner, U., Szaz, G. et. Al.: A specific fully enzymatic
Female: 0.5 - 0 .8mg/dl method for creatinine reference values in serum, J.
Clin. Chem. Clin. Biochem17:679-882(1979)
Urine: 5. Searcy,R.L. “Diagnostic Biochemistry” McGraw-Hill,
Male: 1070 - 2150 mg/dl (24 hrs accumulated urine) NewYork,NY.199
Female: 769 - 1200 mg/dl (24 hrs accumulated urine) PRODUCT LABEL SYMBOLS REFERENCE
PERFORMANCE CHARECTERISTICS Lot/Batch
REPORTABLE LINEARITY RANGE Catalog Number
Number
The reportable linearity range of the kit is determined to be
0.1mg/dL - 40 mg/dL Manufacturing
REPRODUCIBILITY Expiry Date
Date
WITHIN RUN
Mean CV Number In Vitro
Sample Manufacturer
Concentration % of Runs Diagnostic
Contains
Level 1 1.94 1.02 10 Temperature
sufficient for ‘n’
Limit
tests
Level 2 5.17 0.30 10
Keep away from Do Not use, if
sunlight box damaged
RUN TO RUN CE Mark –
Mean CV Number Device complies
Sample Instruction For
Concentration % of Runs with the
Use
Directive
Level 1 1.96 0.49 10 98/79/EC
EU
Level 2 5.17 0.43 10 Representative
ANALYTICAL PROCEDURE
Trivitron Healthcare Pvt. Ltd. Doc.No. THPL/BC/IFU/ECRE Feedback and Customer Queries Contact:
Plot No. A2 & A3, SIPCOT Industrial park, 24 Hours Helpline No. +91 98400 80008
Version No.: 03 Effective Date: 05/05/2023 Email: [email protected]
Irungattukottai, Sriperumbudur Taluk,
Kanchipuram, Tamil Nadu, (India) – 602105
