Automation of Glycohaemoglobin Measurement and its Application to Renal Patients.

Goraya, Naseem Akhter (2000). Automation of Glycohaemoglobin Measurement and its Application to Renal Patients. MPhil thesis The Open University.



The work for this project was carried out in two parts. The first part of this project describes, evaluates, and compares a new pre-production automated analyser with the manual Pierce affinity method for the measurement of glycohaemoglobin (GHb). The Pierce affinity method has proven reliable for the measurement of GHb, but is very labour intensive requiring several hours for the completion of the test. The alternative new GHb analyser is simple and rapid to use.

The automated method is also more precise (CV < 5%) and is less prone to error than the manual assay. There was a good correlation between the two methods ( n = 50, y = 1.018x -0.1034, r = 0.9806 where y = Drew x = Pierce, p = < 0.0001 using the assigned cahbrant values of BRI = 3.8%, BR2 = 10.0%. As a result of these investigations, we have now replaced our manual method with the automated analyser. Towards the end of this project we came under pressure from our endocrinologist to report our GHb results as DCCT aligned'. To this end we used the Primus DCCT aligned calibrants (intended for their own analyser) with values of Primus 1 = 5.8%, Primus 2 = 13.3%. The results of the correlation study of Biorad versus Primus calibrants was n= 139, y = 0.7585x + 2.0154, r =0.9981 where y = Primus (GHb%) x = Biorad GHb (%), p = < 0.001.

The second part of this project was an evaluation of the effect of continuous ambulatory peritoneal dialysis (CAPD) treatment on GHb results. The peritoneal dialysis solutions used in CAPD contain from 13.6 g to 38.6 g/1 of glucose as an osmotic agent. During CAPD 100-200 g of glucose is absorbed from the glucose-containing dialysate fluids each day. Icodextrin is a starch-derived glucose polymer which also acts as an osmotic agent when administered intraperitoneally for CAPD, but unlike glucose-containing CAPD fluids does not contribute to large amounts of glucose absorption. The GHb measurement for this part of the evaluation was carried out using the Drew Scientific GHb-100 analyser after the first part of the project was successfully completed.

Contrary to what was expected CAPD did not cause a statistically significant difference in the concentration of GHb of non-diabetic patients compared to a non-diabetic group of patients who were not subjected to CAPD.

The research conformed to the ethical standards set out by the Royal Sussex County Hospital for research.

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