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VETSPEC™REAGENTS - Creatinine

Intended Use

For IN VITRO diagnostic use in the quantitative determination of Creatinine in serum using manual or automated applications.

MethodPrinciple

The substance Creatinine present in the serum sample reacts at 37°C with Picric Acid in alkaline solution to produce a red Tautomer complex which has a maximum absorption at 505 nm. The reaction scheme below illustrates the reaction that occurs in this method.

        37 °C
Creatinine + Picric Acid ────────> Picrate Complex
       OH


Preparation Of Working Reagents

Catachem Creatinine Working Reagent for a single reagent procedure is prepared by mixing equal volumes of Creatinine Diluent and Creatinine Color Reagent. Store the Working Reagent in a closed container at room temperature. Reagents for the two Working Reagent procedure require no
preparation. These reagents are packaged ready for use.

Reagent Storage And Stability

All Catachem Creatinine reagents are stored at room temperature. When stored as directed, these reagents are stable until the expiration date stated on the label. When prepared and stored as directed, the Working Creatinine Reagent (Single reagent method) is stable for 21 days at room temperature.

Method Performance Characteristics

Sensitivity: The sensitivity of this method is 0.023-0.0286  absorbance unit per mg/dL.
Linear Range: There is no significant nonlinearity over the range of 0-20mg/dL.
Precision: Within-run and day-to-day precision is summarized below.

Creatinine

Within-Run Precision

Total Precision

MEAN

SD

CV

SD

CV

mg/dL

mg/dL

%

mg/dL

%

0.65

0.05

8.20

0.05

7.80

9.30

0.09

0.98

0.25

2.60

17.60

0.23

1.30

0.34

1.90


Correlation

A comparison of this method using an automated analyzer and a reference method based upon the Jaffé Reaction resulted in the following regression statistics.

Correlation Data

Parameter

Data Observed

N

193

Range (mg/dL)

0.4 - 8.0

Regression

Y= 1.000x-0.04

Correlation

  r = 0.996

Sy,x

0.16