Description
INTENDED USE
ELITech Clinical Systems ALBUMIN is an in vitro diagnostic reagent intended for the quantitative determination of albumin in human serum and plasma samples on analyzers or semi-automatic analyzers. The standard is intended for the calibration of reagent. These in vitro diagnostic devices are for professional use only.
CLINICAL SIGNIFICANCE
Albumin is mainly synthesized by the liver and represents approximately 50% of plasma proteins. Albumin’s primary function is the maintenance of oncotic pressure and the transport of a large number of compounds. The measurement of serum or plasma albumin is mostly indicated to help in diagnosing and monitoring diseases with protein loss or decreased synthesis (nephrotic syndrome, gastrointestinal loss, hepatic insufficiency), acute and chronic inflammation, and severe malnutrition.
LIMITATION OF USE
The quantitative assay of albumin 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
Bromocresol green (BCG)- End Point
COMPOSITION
Reagent: R
Succinate buffer, pH 4.20 Bromocresol green 0.2 mmol/L Surfactant
Standard: Std (Ref : ALBU-0600/0700) Albumin 3.5 g/dL
35 g/L Sodium azide < 0.1% (w/w)
MATERIALS REQUIRED BUT NOT PROVIDED
- CALI-0550 ELICAL 2
- CONT-0060 ELITROL I
- CONT-0160 ELITROL II
- Analyzers or semi-automatic analyzers.
- General Laboratory equipment (e.g. pipette).
- Do not use materials that are not required as indicated above.
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