Total Protein in Human Serum with Roche c502 Detection

Detection of Total Protein in Human Serum with Roche c502

Test Name: In vitro test for the quantitative determination of total protein (TP) in human serum and plasma on Roche/Hitachi cobas c systems.
Method Name: The Roche Diagnostics TP assay is colorimetric-based. In the reaction, divalent copper reacts in alkaline solution with protein peptide bonds in the sample to form the characteristic purple colored biuret complex. Sodium potassium tartrate prevents the precipitation of copper hydroxide and potassium iodide prevents autoreduction of copper. The color intensity is directly proportional to the protein concentration which can be determined photometrically.
Results: Technical Range: 0.2-12 g/dL
Reportable Range: 0.24-11.02 g/dL
Reference Ranges: Age Normal values
0-1 day 4.0 – 7.0 g/dL
1d-1wk 4.0 – 7.6 g/dL
1wk-60y 6.4-8.3 g/dL
60-150y 6.0-8.2 g/dL
    Clinical Significance:   Plasma proteins are synthesized predominantly in the liver, plasma cells, lymph nodes, the spleen and in bone marrow. In the course of disease, the total protein concentration and the percentage represented by individual fractions can significantly deviate from normal values. Hypoproteinemia can be caused by diseases and disorders such as loss of blood, sprue, nephrotic syndrome, severe burns, salt retention syndrome and Kwashiorkor (acute protein deficiency).

Hyperproteinemia can be observed in cases of severe dehydration and illnesses such as multiple myeloma. Changes in the relative percentage of plasma proteins can be due to a change in the percentage of one plasma protein fraction. Often in such cases the amount of total protein does not change. The A/G ratio is commonly used as an index of the distribution of albumin and globulin fractions. Marked changes in this ratio can be observed in cirrhosis of the liver, glomerulonephritis, nephrotic syndrome, acute hepatitis, lupus erythematosus as well as in certain acute and chronic inflammations. Total protein measurements are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow, as well as other metabolic or nutritional disorders.

Submission Criteria: For specimen collection and preparation, only use suitable tubes or collection containers.
Only the specimens listed below were tested and found acceptable.
Serum 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:    1 year at -20°C
28 days at 2-8°C
6 days at 20-25°C

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: 1 day.