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Alkaline Phosphatase Activity: New Assay for the Reflotron® System. Results of the Evaluation in Eight Clinical Laboratories

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Published/Copyright: June 1, 2005
Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Volume 39 Issue 1

Abstract

A new reagent carrier, Reflotron® ALP, has been developed for the Reflotron® system, allowing easy and rapid measurement (in less than 3 minutes) of alkaline phosphatase (ALP) activity in capillary blood, venous blood, heparinized plasma or serum. The evaluation of the analytical performance of the assay was carried out at eight clinical laboratories. The study of the imprecision using the measurements in human samples resulted in coefficients of variation ranging from 1.3% to 4.6% (within-run) and from 3.2% to 4.0% (day-to-day). The analytical specificity of the Reflotron® ALP assay agrees well with ALP methods using a N-methyl-D-glucamine buffer solution. The calibration of the Reflotron® ALP assay, however, is related to the reference intervals for ALP methods using a diethanolamine buffer solution.

Method comparisons were performed with the ALP method on Hitachi instruments using diethanolamine buffer. Reflotron® ALP measurements in blood and plasma in 157 randomly selected split samples showed excellent agreement (slope: 0.99; intercept: 0.7 U/l; median bias: 2.3%; median difference from the comparison method: −0.3%). Specimens from pregnant women and adolescents were excluded from this study. Differing values were obtained in a method comparison using 48 samples containing predominantly the ALP bone isoform (slope: 0.81; intercept: 31.5 U/l; median bias: 5.7%; median difference from the comparison method: −12.2%). Regression analysis of the results from 21 sera with prevailing placental ALP gave a slope of 1.51, and an intercept of −41.1 U/l (median bias: 8.6%; median difference from the comparison method: 35.6%). Reflotron® ALP was compared with three different wet chemistry procedures using different buffer compounds: N-methyl-D-glucamine or diethanolamine or 2-amino-2-methyl-1-propanol. In samples containing predominantly ALP isoforms not of liver origin, the measurements with N-methyl-D-glucamine buffer gave the best fit with respect to Reflotron®.

In an interference study with 18 drugs, no effect on the test results could be detected. Total bilirubin up to 750 μmol/l and hemolysis up to 1.7 g/l free hemoglobin did not influence the test.

Reflotron® ALP proved to be an easy and rapid method with excellent precision. The accuracy related to an ALP method using diethanolamine buffer was good. The systematic differences for ALP in samples from pregnant women and adolescents have to be taken into account. The assay is well suited for differential diagnosis of hepatic diseases in decentralized testing.

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Published Online: 2005-06-01
Published in Print: 2001-02-21

Copyright © 2001 by Walter de Gruyter GmbH & Co. KG

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  3. Further Characterization of Serum Amyloid A4 as a Minor Acute Phase Reactant and a Possible Nutritional Marker
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  13. Analysis of Large and Small Samples of Biochemical and Clinical Data.
  14. Evaluation of Five Commercial Enzyme Immunoassays for the Detection of Human Cytomegalovirus-Specific IgM Antibodies in the Absence of a Commercially Available Gold Standard
  15. Alkaline Phosphatase Activity: New Assay for the Reflotron® System. Results of the Evaluation in Eight Clinical Laboratories
  16. Report on the 4th Estonian Summer School of Laboratory Medicine
  17. Laboratory-Related Measures of Patient Outcomes: An Introduction. Edited by Michael G. Bissell
  18. Report from the 50th Anniversary Congress of the Hungarian Society of Clinical Pathology and from the Executive Board Meeting of FESCC in Debrecen (Hungary)
  19. Report from the 8th Meeting of the Balkan Clinical Laboratory Federation
https://doi.org/10.1515/CCLM.2001.015

Articles in the same Issue

  1. Editorial
  2. Polymorphisms in the Apolipoprotein E Gene Regulatory Region in Relation to Coronary Heart Disease and Their Effect on Plasma Apolipoprotein E
  3. Further Characterization of Serum Amyloid A4 as a Minor Acute Phase Reactant and a Possible Nutritional Marker
  4. Determination of Human Angiotensin Converting Enzyme (ACE) Gene Polymorphisms in Erectile Dysfunction: Frequency Differences of ACE Gene Polymorphisms according to the Method of Analysis
  5. Simple Gas Chromatography Analysis of Faecal Butyrate: Application to Patients at Risk of Pouchitis
  6. Determination of Glycerol in Plasma by an Automated Enzymatic Spectrophotometric Procedure
  7. Clinical Applications of the 2nd Generation Assay for Anti-TSH Receptor Antibodies in Graves' Disease. Evaluation in Patients with Negative 1st Generation Test
  8. The Clinical Value of Microtransferrinuria and Microalbuminuria in the Prediction of Pre-eclampsia
  9. A Non-Icteric Cholecystectomized Patient with Recurrent Attacks of Right Epigastric Pain and Dilated Common Bile Duct – Do Liver Function Tests Predict Bile Duct Stones?
  10. Serum Lactate Dehydrogenase Isoenzyme 1 and Prediction of Death in Patients with Metastatic Testicular Germ Cell Tumors
  11. Annual Rhythmic and Non-Rhythmic Biological Variation of Magnesium and Ionized Calcium Concentrations
  12. Unit-Independent Reporting of Laboratory Test Results
  13. Analysis of Large and Small Samples of Biochemical and Clinical Data.
  14. Evaluation of Five Commercial Enzyme Immunoassays for the Detection of Human Cytomegalovirus-Specific IgM Antibodies in the Absence of a Commercially Available Gold Standard
  15. Alkaline Phosphatase Activity: New Assay for the Reflotron® System. Results of the Evaluation in Eight Clinical Laboratories
  16. Report on the 4th Estonian Summer School of Laboratory Medicine
  17. Laboratory-Related Measures of Patient Outcomes: An Introduction. Edited by Michael G. Bissell
  18. Report from the 50th Anniversary Congress of the Hungarian Society of Clinical Pathology and from the Executive Board Meeting of FESCC in Debrecen (Hungary)
  19. Report from the 8th Meeting of the Balkan Clinical Laboratory Federation
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