Creatinine Enzymatic 120

Creatinine Enzymatic 120

Product Details:

  • Taste Other
  • Shape other
  • Other Names Biochemistry Reagent
  • Appearance Biochemistry Reagent
  • Shelf Life 18 Months
  • Physical Form Liquid
  • Smell Other
  • Supply Ability : 10000 Kit Per Day
5991 INR/Kit
X

Price And Quantity

  • 1 Kit
  • 5991 INR/Kit

Product Specifications

  • Reagents
  • Biochemistry Reagent
  • Creatinine is a chemical waste molecule that is generated from muscle metabolism. Creatinine is produced from creatine, a molecule of major importance for energy production in muscles. Approximately 2% of the bodys creatine is converted to creatinine every day. Creatinine is transported through the bloodstream to the kidneys. The kidneys filter out most of the creatinine and dispose it of in the urine. The kidneys maintain the blood creatinine in a normal range.
  • Other
  • Liquid
  • 100
  • 18 Months
  • Other
  • other
  • Other
  • ACC90688
  • Biochemistry Reagent
  • Biochemistry Reagent

Trade Information

  • EXW ABPL
  • Paypal, Cash Against Delivery (CAD), Cash in Advance (CID), Cheque, Letter of Credit (L/C), Letter of Credit at Sight (Sight L/C)
  • 10000 Kit Per Day
  • 2 Days
  • Yes
  • packaging : Empity
  • Asia, Australia, Central America, North America, South America, Eastern Europe, Western Europe, Middle East, Africa
  • All India
  • brand name : ACCUREX BIOMEDICAL

Product Description

Introduction
  • Autopure Creatinine (Enzymatic) is a reagent kit for quantitative determination of creatinine concentration in human serum and urine based on enzymatic method.
  • Autopure Creatinine (Enzymatic) is a ready to use, two liquid reagent system.
  • With Autopure Creatinine (Enzymatic), the assay is linear upto 200 mg/dL.

Clinical Significance

  • Creatinine is a chemical waste molecule that is generated from muscle metabolism. Creatinine is produced from creatine, a molecule of major importance for energy production in muscles. Approximately 2% of the bodys creatine is converted to creatinine every day.
  • Creatinine is transported through the bloodstream to the kidneys. The kidneys filter out most of the creatinine and dispose it of in the urine. The kidneys maintain the blood creatinine in a normal range.
  • Creatinine has been found to be a fairly reliable indicator of kidney function. As the kidneys become impaired the creatinine level in the blood will rise. Abnormally high levels of creatinine thus warn of possible malfunction or failure of the kidneys.

 Principle

Through a series of enzymatic reactions, creatinine is converted to glycine. Endogenous components such as creatine and sarcosine are eliminated in the first step of the reaction.The hydrogen peroxide formed reacts with TOOS in the presence of peroxidase (POD), to form a quinone dye.

The intensity of the colour is directly proportional to the concentration of creatinine in the specimen and is measured photometrically at 546 nm.

  • Creatinine + H2O - Creatine  Creatinase 
  •  Creatine + H2O - Sarcosine + Urea
  • Sarcosine + 02+ H2O - Glycine + HCHO + H202 
  • 2H202 + 4-AAP + TOOS - POD Quinone dye + 4H20
  • TOOS : N ethyl N (2 hydroxy-3-sulfopropyl) m toluidine 4 AAP : 4-Aminoantipyrine

Reagent Storage, Stability & Handling

Autopure Creatinine (Enzymatic) is a ready-to-use, two liquid reagent system.

Shelf life

  • Stable till the expiry date indicated on the label, when stored at 2 - 8C.
  • On-Board Reagent Stability
  • R1:28 days at 2-8C after opening 
  • R2:28 daysat 2-8C after opening
  • Protect the reagents from direct light and contamination. Do not freeze the reagent.

Specimen Collection & Preservation

Collect sample using standard sampling tube. Serum is the specimen of choice. Urine samples (24 hrs) should be diluted appropriately before use. Creatinine in samples is stable for 24 hours if stored at 2 -8 C.

Calculations

Fully automated system automatically calculates the Creatinine concentration of each sample.

Calibration

For calibration, it is recommended to use C.f.a.s.* or any other suitable calibrator material.

Calibration frequency

Re-calibration is recommended

  • Whenever the reagent lot is changed.
  • As per the requirement of quality control procedures.

 Quality Control

Each batch of Autopure Creatinine (Enzymatic) is assayed with atleast six controls sera - Precinorm , Precipath, Biorad l  Biorad Accutrol normal and Accutrol Abnormal prior to releaseA.

To ensure adequate quality control, it is recommended that the laboratory should use a normal and an abnormal commercial reference control material. It should be realized that the use of quality control material checks both reagent and instrument functions together.

If the control values fall outside the specified limits, each of the below criteria should cross-checked and corrected:

  • Proper instrument function wavelength setting, light source and temperature control
  • Cleanliness of probes and cuvettes.
  • Bacterial contamination of wash water used by the instrument
  • Expiry date of the reagent kit

Expected Values

 

Serum

Urine

Men

0.7-1.2 mg/Dl

40-278 mg/Dl

Women

0.5- 1.0 mg/dl

29-226 MG/Dl

 Expected range varies from population to population. It is therefore recommended that each laboratory should establish its own reference range. For diagnostic purposes, creatinine results should always be assessed in conjunction with the patient's medical history, clinical examination and other findings.

Performance Characteristics

Linearity

With Autopure Creatinine (Enzymatic), the assay is linear upto 200 mg/dL. Determine samples with higher concentration via the rerun function. On instruments without rerun function, manually dilute the samples with higher concentration using normal saline (0.9% NaCI) or distilled/deionized water and repeat the assay. The result obtained should be then multiplied with dilution factor to obtain correct creatinine concentration.

Interferences

There is no significance interference in samples containing upto 1000 mg/dL Triglyceride and 40 mg/dL Bilirubin.

Precision Studies

Reproducibility was determined using three levels of serum specimen as shown below:

 

Within run ( n=80)

Between run ( n=80)

Serum

Mean ( mg/Dl)

SD (mg/Dl)

CV

Mean ( mg/Dl)

SD (mg/Dl)

CV

Sample 1

0.74

0.015

2.1

0.74

0.022

3

Sample 2

1.38

0.015

1.1

1.38

0.026

1.9

Sample 3

4.04

0.029

0.7

4.04

0.058

1.4

 Co-Relation Studies

A comparison of Creatinine determination using Autopure Creatinine (Enzymatic) and reference competitor's product gave the following co-relation(mg/dL):

Linear Regression (Serum):

  • y = 0.9467x + 0.0643
  • r2 = 0.9981

No. of samples measured: 55

References

  • Tietz, N. W. (Ed): Fundamentals of Clinical Chemistry, W. B. Saunders Co., Philadelphia, 865(1982).
  • Artiss, J.D., Mc Enroe, R.J., Zak, B.; Clin. Chem, 30 (1984)1389.
  • Mazzachi BC, Peake MJ, Ehrhardt V. Reference Range and Method Comparison Studies for Enzymatic and Jaffe Creatinine Assays in Plasma and Serum and Early Morning Urine. Clin. Lab 2000;46;53-55.
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