Analysis of HBA1C by TINIA and HPLC in diabetic patients attending a tertiary care Hospital
Objective: To compare the analytical performance of reference & alternative method to measure glycated hemoglobin.
Material & Methods: This cross-sectional study was conducted at Fauji Foundation Hospital Rawalpindi from 1st March 2019 to 1st April 2019. Blood samples of 150 diabetic female patients were collected in potassium ethylene diamine tetra acetic (EDTA) vacutainers & measured for Glycated Haemoglobin (HbA1c) levels on Bio-Rad Variant II Turbo system by high-performance liquid chromatography (HPLC) and turbidimetric inhibitory immunoassay (TINIA) using Dimensions RXL Auto Analyzers. Mean ± standard deviation (SD) were calculated for quantitative variables. Correlation analysis and method comparison of the results obtained was done.
Results: The mean ± SD HbA1c values from TINIA and HPLC were 7.789% ± 2.106% and 7.797% ± 2.552%, respectively. The within-run coefficients of variation for TINIA and HPLC were 0.57% and 0.54% and for between-run were 0.87% and 0.83 respectively. Both methods showed good correlation (TINIA, r=.986, r2 = .972, P <0 .001 and HPLC, r = .986, r2= .972, P < 0.001).
Conclusion: Both methods showed accuracy and the results were comparable. A strong correlation existed between the two methods, which means these methods can be used equally and interchangeably. A developing country with limited resources requires an efficient and cost-effective solution to overcome the growing burden of diabetes. The turbimetric immunoassay is a more convenient and simple technique due to low cost, quick turnaround time of results compared to HPLC, sensitivity and specificity.
Key Words: Glycated hemoglobin, Diabetes Mellitus, Chromatography and immunoassay.