Evaluation of Analytical Performance of Variant II Turbo HbA1c Analyzer According to Sigma Metrics.

BACKGROUND

Hemoglobin A1c, (HbA1c) which is the major constituent of glycated hemoglobin, has been used in the follow-up of retrospective glycemia for years and in the diagnosis of diabetes mellitus nowadays. Since the analytical performance of HbA1c should be high likewise all laboratory tests, various quality control measures are used. Sigma metrics is one of these measures and it is the combination of bias, precision and total allowable error that ensures a general evaluation of analytical quality. The aim of our study was to evaluate the analytical performance of Bio-Rad's Variant Turbo II HbA1c analyzer according to sigma metrics.

METHODS

Sigma levels were calculated using the data obtained from two levels of internal and 12 external quality control materials (Bio-Rad) of Variant II Turbo HbA1c analyzer according to σ = (TEa% - Bias%) / CV% formula.

RESULTS

The mean sigma levels for low and high quality control materials were found to be 3.0 and 4.1, respectively.

CONCLUSIONS

The annual mean analytical performance of Variant II Turbo HbA1c analyzer was found to be acceptable according to sigma metrics. In order to be sure of the difference in HbA1c results indicating the success or failure in treatment but not arise from analytical variation, it is thought that more stringent quality control measures should be applied to reach higher sigma levels.