Creatinine Jaffe Clinical Chemistry reagent, Elitech

Description

Generic [800 Tests]

INTENDED USE

ELITech Clinical Systems CREATININE JAFFE is an in vitro diagnostic reagent intended for the quantitative determination of creatinine in human serum samples on analyzers or semi-automatic analyzers.

The standard is intended for the calibration of the reagent.

These in vitro diagnostic devices are for professional use only.

CLINICAL SIGNIFICANCE 

Creatinine is the waste product of creatine, a com- pound present mainly in muscle tissues. It is usually produced a relatively constant rate and is freely filtered by the glomerulus, which makes it an excellent marker of renal function, with serum creatinine concentration increasing in case of acute or chronic renal insufficiency.

In practice, creatinine measurement in blood performed to help diagnose kidney diseases, to screen for early kidney failure for patients at risk, to monitor treatments against these pathologies or to monitor renal function during treatments that may impair this function.

LIMITATION OF USE

The quantitative assay of creatinine alone can not be used to diagnose a disease or a specific pathology.

The results must be interpreted in conjunction with other diagnostic test results, clinical findings and the patient’s medical history.

METHOD & PRINCIPLE 

Jaffe – Kinetic.

In alkaline medium, creatinine reacts with picrate to form a red complex. The rate of increase of absorbance measured at 505 nm is proportional to creatinine concentration.

COMPOSITION

Reagent 1: R1

Sodium hydroxide 0.31   mol/L Also contains phosphate

Reagent 2: R2

Picric acid 8.7 mmol/L

Standard: Std

Creatinine 2  mg/dL

177 μmol/L

MATERIALS REQUIRED BUT NOT PROVIDED

• CALI-0550 ELICAL 2
• CONT-0060 ELITROL I
• CONT-0160 ELITROL II
• Normal saline solution (NaCl 9 g/L).
• Analyzers or semi-automatic analyzers.
• General Laboratory equipment (e.g. pipette).
• Do not use materials that are not required as indicated above.

PRECAUTIONS FOR USE AND WARNINGS

• The reagent R1 is classified as hazardous :