Alkaline Phosphatase (ALP) Reagent For Use In The Clinical Laboratory
Introduction
Elevated levels of Alkaline Phosphatase (ALP) activity in serum are of interest in the detection and diagnosis of several general disease conditions, most notably hepatobiliary disease and bone disease associated with increased osteoblastic activity. ALP activity in serum may also be seen elevated in obstructive jaundice, occlusion of the common bile or hepatic duct, and cirrhosis.
Test Principle
The DCL ALP-SL method is based on a modification of the International Federation of Clinical Chemistry (IFCC) procedure for ALP measurement in serum. In the test reaction, ALP hydrolyzes the substrate p-nitrophenyl phosphate (p-NPP) to form the yellow chromogen p-nitrophenol. The rate of increase in absorbance of the reaction mixture at 415 nm, due to the formation of p-nitrophenol, is proportional to the ALP activity.
Key Features & Benefits
Liquid Stable Format – Liquid stable technology eliminates the need for reagent reconstitution procedures, saving time and labor, while reducing preparation errors and reagent waste.
Extended Linear Range – Able to accurately measure concentrations of ALP in serum samples up to 2,000 U/L, which reduces the need for repeat testing.
Negligible Interference Effects – No significant interference displayed from samples with elevated levels of lipemia or icterus.
Minimal Sample Requirements – Each test requires only micro-liters of sample, making it ideal for a wide range of applications including geriatric, pediatric and veterinary testing.
Fast Test Turnaround Time – Generate accurate and reliable test results quickly – the reaction takes only five (5) minutes.
Test Flexibility – Perform testing using fully automated testing procedures, with an extensive listing of instrument applications readily available.
Extended Shelf Life – With a shelf life claim of twenty (20) months from date of manufacture, any concerns involving inventory management and ordering frequency are greatly minimized.
Supporting Products Available – Quality control, calibration and linearity/reference materials are readily available for the utmost confidence in test reporting.
Reliable Test Results – A history of performance in reference, hospital and physician office laboratories alike.
Choice of Packaging Options – The assay is offered in a choice of two (2) convenient packaging formats, which are ideally suited for any laboratory, regardless of workflow demands.
Specific Performance Characteristics
Reportable Range (NCCLS EP6-P) – The reportable range of the assay, using automated procedures, will depend on a number of factors. However, for the majority of automated procedures, the assay provides a reportable range from 4.3 to 2,000 U/L.
Accuracy (NCCLS EP9-P) – The performance of this method (y) was compared with the performance of another commercially available ALP method (x) on a Roche/Hitachi 717™ analyzer. Forty (40) patient serum samples, with ALP values ranging from 16 – 1,895 U/L, were tested resulting in a correlation coefficient of 1.000, with a linear regression equation of y = 1.0276 x – 1.0 U/L.
Precision (NCCLS EP5-T2) – Estimates for performance were obtained on two (2) separate levels of commercially available serum control materials with concentrations of 47 U/L and 214 U/L, analyzed in forty (40) runs conducted over twenty (20) days on a Roche/Hitachi 717™ analyzer. The resulting SD’s for within-run precision testing were 1.1 U/L and 2.1 U/L respectively, generating CV’s of 2.4% and 1.0%. The resulting SD’s for total precision performance testing were 2.1 U/L and 7.4 U/L respectively, generating CV’s of 4.6% and 3.5%.
Ordering Information
| |
Product
|
Catalogue
Number
|
Packaging
Configuration
|
ALP-SL |
328-10 |
1 x 100 mL (R1); 1 x 25 mL (R2) |
ALP-SL |
328-30 |
3 x 100 mL (R1); 1 x 75 mL (R2) |
Supporting Products
|
DC-Cal Calibrator |
SE-035 |
5 x 3 mL |
DC-Trol Level 1
Control |
SM-052 |
10 x 5 mL |
DC-Trol Level 2
Control |
SM-056 |
10 x 5 mL |
|
REFER TO PACKAGE INSERT AND/OR MSDS FOR ADDITIONAL TECHNICAL INFORMATION
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Revision No. 328.1S-04-18-07
© Diagnostic Chemicals Limited 2007. All rights reserved.
