Sesmed Medikal

Biosystems Biyokimya Kitleri

Biosystems Urea Reagent

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.

CLINICAL SIGNIFICANCE

  • 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

  • A. 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.
  • B. 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).

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.

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.

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