Performance Characteristics of Quality Control Material KKU-Hb for Thalassemia Diagnosis (คุณสมบัติของวัสดุควบคุมคุณภาพ KKU-Hb ในการตรวจวินิจฉัยโรคธาลัสซีเมีย)

The accurate and reliable measurement of hemoglobin separation and determination is essentialfor thalassemia diagnosis. The validation of quality control material KKU-Hb by characterizationof their homogeneity and their stability in storage during April-June 2004, was described. HighPerformance Liquid Chromatography (HPLC) and Low Pressure Liquid Chromatography (LPLC)instruments were used for hemoglobin separation and Hb A2 determination. Results of homogeneitystudy showed that KKU-Hb had small coefficient of variation ranging between 1.43-4.58percent and 4.27-5.56 percent for intralaboratory study and interlaboratory study, respectively. Thesematerials could be stored at -6oC for 2 months without significant decrease in Hb A2 level (p>0.05).In conclusion, the validation, homogeneity and stability of KKU-Hb support their use as qualitycontrol material for measurement of hemoglobin separation and determination by HPLC and LPLCinstruments.Key words: quality control material, hemoglobin separation and determination