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Biosystems Urea Reagent

INTENDED USE

Reagent for the measurement of urea concentration in human serum, plasma or urine.

The obtained values are useful as an aid in the diagnosis and treatment of chronic renal failure, and to evaluate the function of renal glomerulus.

This reagent is for use in the BioSystems BA analyzers or in other analyzer with similar performance characteristics.

Biosystems Urea Reagent

Urea is synthesized in the liver as a by-product of the deamination of amino acids. Its elimination in the urine represents the major route for nitrogen excretion.

Elevated urea concentration in plasma is found as a result of a high-protein diet, increased protein catabolism, after a gastrointestinal hemorrhage.

Mild dehydration, shock and heart failure or treatment with glucocorticoids (pre-renal uremia)1,2

Post-renal uremia is caused by conditions that obstruct urine outflow: nephrolithiasis, tumor or prostatic hypertrophy.

The usefulness of urea as an indicator of renal function is limited by the variability of its plasma concentration as a result of nonrenal factors1,2

Clinical diagnosis should not be made on the findings of a single test result, but should integrate both clinical and laboratory data.

PRINCIPLE OF THE METHOD

Urea in the sample consumes, by means of the coupled reactions described below, NADH that can be measured by spectrophotometry3,4

COMPOSITION

5. Reagent: Tris 100 mmol/L, 2-oxoglutarate 5.6 mmol/L, urease > 140 U/mL, glutamate dehydrogenase > 140 U/mL, ethyleneglicol 220 g/L, sodium azide 0.95, pH 8.0.
6. Reagent: NADH 1.5 mmol/L, sodium azide 9.5 g/L.

WARNING: H302: Harmful if swallowed. EUH031: Contact with acids liberates toxic gas. P301+P312: IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.

P330: Rinse mouth. For further warnings and precautions, see the product safety data sheet (SDS).

Biosystems Urea Reagent

STORAGE AND STABILITY

Store at 2-8 ºC.

Components are stable once opened until the expiry date marked in the label if they are stored well closed and care is taken to prevent contamination during their use.

On board stability: Reagents open and kept in the refrigerated compartment of the analyzer are stable 30 days.

Indications of deterioration: Absorbance of the blank below the limit indicated in “Test Parameters”.

ADDITIONAL MATERIALS REQUIRED (NOT PROVIDED)

Biochemistry Calibrator (BioSystems cod. 18011) or Biochemistry Calibrator Human (BioSystemscod. 18044).

REAGENT PREPARATION

Reagents are provided ready to use.

Biosystems Urea Reagent

SAMPLES

Serum, plasma or urine collected by standard procedures.

Urea in serum or plasma is stable for 7 days at 2-8ºC. Heparin is recommended as anticoagulant5

Urea in urine is stable for 2 days at room temperature if microbial growth is prevented5

CALIBRATION

A reagent blank should be done every day and a calibration at least every 30 days, after reagent lot change or as required by quality control procedures.

QUALITY CONTROL

It is recommended to use the Biochemistry Control Serum level I (cod. 18005, cod. 18009 and
cod. 18042) and II (cod. 18007, cod. 18010 and 18043) and the

Biochemistry Control Urine (cod.18054 and cod. 18066) to verify the accuracy of the measurement procedure. Each laboratory should establish its own internal

Quality Control scheme and procedures forcorrective action if control results are not within the acceptable limits.

Biosystems Urea Reagent