Albumin in Human Serum with Roche c502

Detection of Albumin in Human Serum with Roche c502

Test Name: In vitro test for the quantitative determination of albumin in human serum and plasma on Roche/Hitachi cobas c systems.
Method Name: Photometrical measurement of the blue-green complex formed when albumin binds to bromcresol green.
Results: Technical Range: 0.2-6 g/dL
Reportable Range: 0.31-5.61 g/dL
Reference Ranges: Age Range Male (g/dL) Female (g/dL)
0-7 days 2.4-3.9 1.9-4.0
8-180 days 2.1-4.9 1.9-4.4
181 days-1 year 2.2-4.7 2.3-4.7
1 year-6 year 3.6-5.2 3.6-5.2
6-17 years 3.8-5.6 3.8-5.6
18-150 years 3.4-5.0 3.4-5.0
    Clinical Significance: Albumin is a carbohydrate-free protein, which constitutes 55-65 % of total plasma protein. It maintains plasma oncotic pressure and is also involved in the transport and storage of a wide variety of ligands and is a source of endogenous amino acids. Albumin binds and solubilizes various compounds, e.g., bilirubin, calcium, and long-chain fatty acids. Furthermore, albumin is capable of binding toxic heavy metal ions as well as numerous pharmaceuticals, which is the reason why lower albumin concentrations in blood have a significant effect on pharmacokinetics.

Hyperalbuminemia is of little diagnostic significance except in the case of dehydration. Hypoalbuminemia occurs during many illnesses and is caused by several factors: compromised synthesis due either to liver disease or as a consequence of reduced protein uptake; elevated catabolism due to tissue damage (severe burns) or inflammation; malabsorption of amino acids (Crohn’s disease); proteinuria as a consequence of nephrotic syndrome; protein loss via the stool (neoplastic disease). In severe cases of hypoalbuminemia, the maximum albumin concentration of plasma is 2.5 g/dL (380 µmol/L). Due to the low osmotic pressure of the plasma, water permeates through blood capillaries into tissue (edema). The determination of albumin allows monitoring of a controlled patient dietary supplementation and serves also as an excellent test of liver function.

Submission Criteria: For specimen collection and preparation, only use suitable tubes or collection containers.
Only the specimens listed below were tested and found acceptable.
Plasma: Li-heparin and K2-EDTA plasma
Do not use fluoride plasma

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, therefore not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases.  When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.
Storage and Stability:    120 days at -20°C (4 months)
150 days at 2-8°C (5 months)
75 days at 20-25°C (2.5 months)

Rejection Criteria: Rejection criteria include but are not limited to:
1. Specimens containing fibrin or clots.
2. Excessive platelet clumping
3. Leaking specimens
4. Substandard mixing or collection
5. Expired or improperly stored collection tubes.
6. Improperly filled tubes based on collection tube manufacturer’s guidelines.
7. Contaminated specimens (IV fluid, foreign particles, etc.)
8. Specimens not analyzed within the appropriate time frame.
9. Samples not shipped at appropriate temperature.
10. Samples without 2 proper identifiers or samples having identifiers that do not
match the electronic or paper lab requisition.
Authorization: Diagnostic testing can only be performed with approval from an authorized provider/agency.
Turn Around Time: