Alkaline Phosphatase 100

Alkaline Phosphatase 100

Product Details:

  • Supply Ability : 10000 Kit Per Day
2702 INR/Kit
X

Price And Quantity

  • 1 Kit
  • 2702 INR/Kit

Trade Information

  • EXW ABPL
  • Cash Against Delivery (CAD), Cash in Advance (CID), Cheque, Letter of Credit (L/C), Letter of Credit at Sight (Sight L/C)
  • 10000 Kit Per Day
  • 2 Days
  • Yes
  • packaging : Empity
  • Asia, Australia, Central America, North America, South America, Eastern Europe, Western Europe, Middle East, Africa
  • All India
  • certification : iso

Product Description

Introduction

  • AutoPure Alkaline Phosphatase is a reagent kit for direct quantitative determination of Alkaline Phosphatase  in human serum and plasma on automated clinical chemistry analyzers.
  •  AutoPure Alkaline Phosphatase is a singal reagent system.
  •  AutoPure Alkaline Phosphatase  has a singal step reconstitution . It involves reconstitution of substrate tablet with the diluent.
  • With  AutoPure Alkaline Phosphatase , the assay is linear upto 2000IU/I(33.4ukat/I)

Principle

 Alkaline Phosphatase cleaves p-nitrophenyl phosphate (p-NPP) in the presence of magnesium ions, to form p-nitrophenol and phosphate.

p-nitrophenyl phosphate+ h20 p-nitrophenol+phosphate

The intensity of the yellow colour formed is directly proportional to the  Alkaline Phosphatase activity in the specimen and is measured kinetically.

Preparation Of Working Solution

 Reconstitute the substrate tablet with diluent as per the instruction indicated on the diluent bottle. Swirl gently.

Reagent Storage, Stability & Handling 

 AutoPure Alkaline Phosphatase is a singal reagent system.

Shelf life 

Stable till the expiry date indicated on the label, when stored at 2 8 C

On- Board Reagent Stability 

21 days 2- 8 C after opening Protect the reagent from light and contamination.

Do not freeze the reagent

Components & Concentration Of  Working Solution

Component                                                                               Concentration 

  • Diethanolamine buffer, ph9.8                                           1mol/I
  • p-nitrophenyl phosphate                                                  >10mmol/1
  • Magnesium Chloride                                                         >0.5 mmol/1
  • Stabilizers, excipients & surface active agents.                 

Specimen Collection & Preservation

Collect sample using standard sampling tube. Haemolyzed specimen should be avoided as it may falsely elevate results. Serum or heparinized plasma can be used. Anticogulants suc as EDTA oxalate or citrate inhibit the Alkaline Phosphatase activity and hence cannot be used. Alkaline Phosphatase  activity in serum/ plasma is stable for 4 days at 2- 8 C and 28 days at -20 C . Centrifuge samples containing precipitate before performing assay.

Calculations

Fully automated system automatically calculate the Alkaline Phosphatase activity of each sample.

Result in ukat/l= Result in IU/Ix 0.0167

Application Sheet 

Refer to application sheet for details. For additional system application, contact our local Accurex representative.

Calibration

For calibration , it is recommended to use C.f,a,s or any other suitable calibrator material.

Calibration frequency 

Re- calibration is recommended

  • Whenever a fresh reconstituted reagent is used.
  • Whenever the reagent lot is changed.
  • As per the requirement of quality control procedures.

Absorption of atmospheric CO2 by the opened reagent bottle leads to impaired calibration stability. 

Quality Control

Each batch of AutoPure   Alkaline Phosphatase is assayed with alteast six quality control sera Precinorm, Precipath, Biorad l, Accutrol Normal and Accutrol Abnormal prior to release.

To ensure adequate control, it is recommended that the labortory should use a normal and abnormal commercial reference control the reagent and instrument functions together.

If the control values fall outside the specified limits, each of the below criteria should be crosee checked and corrected:

  • Proper instrument function wavelength setting, light source and temperature control.
  • Cleanliness of probes and cuvettes.
  • Bacterial contamination of wash water used by the instrument.
  • Expiry date of the reagent kill

Expected Values

Serum/Plasma 

  • Serum/Plasma
  • 37 C
  • Adult (More than 15 years)
  • 108-306 IU/I
  • 1.8- 5.1 ukat/I
  • Child (Less than 15 years)
  • 210-810IU/I
  • 3.5-13.5ukat/l

 Note

Expected range varies from population to population. It is therefore recommended that each laboratory should establish its own normal range. For diagnostic purposes, the alkaline phosphatase results should always be assessed in conjuction with the patients medical history, clinical examinations and other findings.

Performance Characteristics

Linearity

 With AutoPure Alkaline Phosphatase, the assay is linear upto 2000IU/I(33.4ukat/l). Determine samples with higher concentrations via the rerun function. On instruments without rerun function , manually dilute the samples with higher concentration using 0.9%NaCl or distilled/ deionized water  Multiply the result with the appropriate dilution factor

Interference

There is no significant interference in samples containing upto 25 mg/dl of bilirubin and 400mg/dl of haemoglobin.

Precision

Reproducibilty was determined using quality control sera as shown below

 

Within run

Between run

Quality control material

Mean IU/I

SD IU/I

%CV

Mean IU/I

SD IU/I

%CV

low control serum

160

1.91

1.2

158

1.99

1.3

High control serum

394

2.85

0.7

363

2.05

0.6

 
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