Development of a novel screening test to detect galactosuria
Research type
Research Study
Full title
Development of a simple first-line screening test to detect galactose in urine, utilising glucose dehydrogenase reagent strips.
IRAS ID
172199
Contact name
Michelle Young
Contact email
Duration of Study in the UK
0 years, 3 months, 31 days
Research summary
Neonates presenting with symptoms including vomiting, diarrhoea and jaundice shortly after starting milk feeds which contain lactose, may be suffering from a galactose metabolism disorder, galactosaemia, resulting in lactose intolerance. Lactose-free infant formula may be life-saving, followed by lactose-free and a galactose restricted diet throughout life.
The first-line screening test employed at the Basingstoke and North Hampshire (BNHH)for the diagnosis of galactosaemia in the neonate is a Benedict's reagent screening method which detects reducing substances (including galactose)in urine. Urine samples which appear positive on this screening test will then undergo sugar chromatography to identify which sugars, if any, are present. Like other laboratories, BNHH reverted to using this more traditional screening method since "Clinitest" tablets became unavailable. However, this method requires the use of caustic, corrosive reagents at high temperature.
It is known that glucose dehydrogenase (GDH), unlike glucose oxidase, is not highly specific for glucose. Furthermore, it is acknowledged that pyrrolo quinolone (PQQ)-dependent GDH reacts with galactose, maltose and xylose. Various hand-held devices designed for the purpose of diabetic monitoring of glucose levels use GDH test strips, including the Roche Accu-Chek glucose meter, which uses the PQQ-dependent GDH system. The known limitation of the PQQ-dependent GDH system could potentially be exploited for the purpose of first-line screening for the detection of galactose in urine. This study aims to develp such a screening test, assessing the suitability of the Roche Accu-Chek glucose meter as a potential alternative to the Benedict's reagent method. Standards of known concentrations of galactose, glucose, maltose and xylose will be prepared and used to construct standard curves. Sensitivity, specificity, precision will be assessed, as well as possible interferences. Having carried out these investigations, a comparison study will be carried out using excess patient urine sample; comparing results obtained using the PQQ-dependent GDH reagent strips against those which were obtained using the current Benedict's reagent screening method.REC name
HSC REC B
REC reference
15/NI/0185
Date of REC Opinion
30 Sep 2015
REC opinion
Further Information Favourable Opinion