Research Article

Analytical Validation of a New Enzymatic and Automatable Method for d-Xylose Measurement in Human Urine Samples

Table 1

Parameters obtained in the analytical validation of the enzymatic D-xylose quantification method.

ParametersCobas c502 
(Roche)
ILab 600 
(Werfen)
Dimension Vista 
1500 (Siemens)

Range of linearity (mg/dL)0.25 to 150.02 to 150.25 to 15
Linearity:
0.99980.99960.9999
a (AU⋅dL/mg)0.0610 ± 0.00040.088 ± 0.0020.0285 ± 0.0002
(mg/dL)0.0006 ± 0.0030.01 ± 0.010.003 ± 0.001
 CV0.00380.01440.0012
Limits
 LoB (mg/dL)0.0460.0720.011
 LoD (mg/dL)0.1860.4900.130
 LoQ (mg/dL)0.6231.6400.420
 LLoQ (mg/dL)0.8500.5500.550
CV
 Within-run CV (%)<3.7<7.1<13.6
 Between-run CV (%)<11.5<3.0ND
 Total CV (%)<11.8<7.7ND
Inaccuracy
 Within-run inaccuracy (%)≤12.0<9.0<9.7
 Between-run inaccuracy (%)<5.9<3.9ND
Carry-over (%)3.34.0ND

LLoQ: lower limit of quantification; LoB: limit of blank; LoD: limit of detection; LoQ: limit of quantification; ND: not determined.