URICA
Research type
Research Study
Full title
Evaluating urinary carbonic anhydrase II (CAII) excretion as a fast, simple and economical means of diagnosing haemolysis in newborns under minimal-laboratory conditions
IRAS ID
170697
Contact name
Hammad Khan
Contact email
Sponsor organisation
Guy’s and St Thomas’ NHS Foundation Trust
Duration of Study in the UK
1 years, 1 months, 0 days
Research summary
Haemolysis is the rupturing of red blood cells that can be triggered by sepsis, blood group incompatibility (haemolytic disease of newborn), protozoan infection (malaria) and genetic traits (G6PD deficiency, sickle cell). Haemolysis is relevant to newborns and children in the UK and globally, with incidence related to ethnicity. Since haemolysis can cause severe anaemia, routine and accurate monitoring of red cells is required for diagnosis and management. The tests used at present require adequate resources in the form of staff and apparatus as well as hygiene. As a complicating factor, newborns normally show a degree of haemolysis (physiological jaundice) because of red cell turnover. Thus, tests for haemolysis should be adequately quantitative. Objective: Red blood cells contain the soluble protein carbonic anhydrase II (CAII) which is released into plasma upon haemolysis. Due to the protein’s small size, it is filtered by the kidney. Thus, CAII is expected to be found in the urine of haemolysing patients. We are able to detect CAII even after 1:10,000 dilution in urine using antibodies against the protein. Urine samples from neonates will be collected for CAII measurements. These read-outs will be compared against clinical information that evaluates haemolysis (blood haemoglobin, plasma bilirubin, skin jaundice). Subject to validating the diagnostic value of urinary CAII excretion, we will optimise the CAII assay for use in point-of-care detection devices. Clinical benefits: A urine-based test for haemolysis would provide a means of measuring and monitoring haemolysis rapidly, routinely and with minimal demands on resources, thereby addressing the limitations of presently used tests. The technology would be particularly relevant to field work and in economically-deprived regions where haemolysis tends to be more prevalent.
REC name
North of Scotland Research Ethics Committee 2
REC reference
15/NS/0042
Date of REC Opinion
12 May 2015
REC opinion
Further Information Favourable Opinion