Albumin in Human Serum with Roche c502

Detection of Alkaline Phosphatase in Human Serum with Roche c502

Test Name: In vitro test for the quantitative determination of alkaline phosphatase in human serum and plasma on Roche/Hitachi cobas c systems.
Method Name: Colorimetric assay that measures the increase in absorbance caused by the catalytic activity of alkaline phosphatase on p-nitrophenyl. It is determined by measuring the increase in absorbance.
Results: Technical Range: 5-1200 U/L
Reportable Range: 5-957 U/L
Reference Ranges: Age Range Female (U/L) Male (U/L)
0-14 days 82-249 82-249
15 days-1 year 122-473 122-473
1-9 years 142-336 142-336
10-12 years 128-420 128-420
13-14 years 55-255 115-471
15-16 years 49-116 81-333
17-18 years 43-86 53-149
≥ 19 years 45-117 45-117
Clinical Significance: Alkaline phosphatase in serum consists of four structural genotypes: the liver bone kidney type, the intestinal type, the placental type and the variant from the germ cells. It occurs in osteoblasts, hepatocytes, leukocytes, the kidneys, spleen, placenta, prostate and the small intestine. The liver bone kidney type is particularly important.

A rise in the alkaline phosphatase occurs with all forms of cholestasis, particularly with obstructive jaundice. It is also elevated in diseases of the skeletal system, such as Paget’s disease, hyperparathyroidism, rickets and osteomalacia, as well as with fractures and malignant tumors. A considerable rise in the alkaline phosphatase activity is sometimes seen in children and juveniles. It is caused by increased osteoblast activity following accelerated bone growth.

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

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. Centrifuge samples containing precipitates before performing the assay.   Storage and Stability:    60 days at -20 °C 7 days at 2-8 °C 7 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