Improvement and validation of d-xylose determination in urine and serum as a new tool for the noninvasive evaluation of lactase activity in humans

J Clin Lab Anal. 2014 Nov;28(6):478-86. doi: 10.1002/jcla.21713. Epub 2014 Mar 22.

Abstract

Background: The phloroglucinol assay is the current method for d-xylose determination in urine/plasma/serum. However, its sensitivity is limited when low amounts of d-xylose are to be measured, such as in the noninvasive evaluation of intestinal lactase with 4-galactosylxylose (gaxilose). An improved assay was therefore needed.

Methods: We developed and validated a modified version of the phloroglucinol-based assay for quantification of d-xylose in urine/serum samples. A method for gaxilose determination by gas chromatography (GC) was also optimized.

Results: Linearity ranged from 0.125 to 5.0 mg/l (5-200 mg/l in original sample). Accuracy at LOQ (0.125 mg/l) was 0.97/2.49% in spiked urine/serum; for other quality controls (QC), it was <1.27%. Intra- and interassay precision at LOQ were 6.02% and 6.45% for urine, and 8.86% and 10.00%, respectively, for serum; for other QC, precision was <2.15%. Linearity of gaxilose determination by GC was 3.90-195.17 for urine and 9.75-195.17 mg/l for serum with acceptable sensitivity and reproducibility. The method proved adequate for the d-xylose determination in healthy and hypolactasic subjects after oral administration of gaxilose.

Conclusions: The modified method provides high sensitivity and robustness for d-xylose quantification in urine/serum for routine clinical use especially in the noninvasive diagnosis of intestinal lactase deficiency with the gaxilose test.

Keywords: 4-galactosylxylose; analytical validation; d-xylose; gaxilose; hypolactasia; intestinal lactase; phloroglucinol.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't
  • Validation Study

MeSH terms

  • Chromatography, Gas / methods
  • Colorimetry / methods*
  • Disaccharides / blood
  • Disaccharides / chemistry
  • Disaccharides / metabolism*
  • Disaccharides / urine
  • Humans
  • Lactase / metabolism*
  • Phloroglucinol / chemistry
  • Reproducibility of Results
  • Sensitivity and Specificity
  • Xylose / blood
  • Xylose / chemistry
  • Xylose / metabolism*
  • Xylose / urine

Substances

  • Disaccharides
  • 4-O-galactopyranosylxylose
  • Xylose
  • Phloroglucinol
  • Lactase