ABSTRACT
BACKGROUND: Hemoglobin (Hb)-A1c is routinely used for the management of diabetes. In 2010, HbA1c was included into the diagnostic criteria for diabetes by the American Diabetes Association. A newly developed HbA1c analyzer, ARKRAY ADAMS HA-8180 (ARKRAY KDK, Japan) was introduced. In this study, we evaluated the analytical performance of ARKRAY ADAMS HA-8180 HbA1c analyzer and compared it with the previously used Variant II Turbo (Bio-Rad Laboratories, USA), which is a National Glycohemoglobin Standardization Program (NGSP) certified analyzer. METHODS: According to Clinical Laboratory and Standards Institute (CLSI) evaluation protocol (EP) 5-A, Lyphochek Diabetes Controls (Bio-Rad Laboratories, USA) are used for precision. Two (low and high) levels of quality control materials were analyzed twice a day for 20 days, after which the mean, total standard deviation (SD) and total coefficient of variation (CV), including the between-run CV and between-day CV were calculated. ARKRAY ADAMS HA-8180 HbA1c analyzer and Variant II Turbo were compared with 150 samples according to CLSI EP9-A2. In addition, the linearity and carry over rate were evaluated. RESULTS: Between-run CVs for low and high level quality control materials were 0.0% and 0.3%, respectively, whereas between-day CVs for low and high level quality control materials were 0.3% and 0.2%, respectively. In the linearity test, the coefficient of determination (R2) was 0.99 (range, 3.1-19.3%). Thus, a good correlation was observed between ARKRAY ADAMS HA-8180 HbA1c analyzer and Variant II Turbo (R2=0.994). The carry over rate was 0.0%. CONCLUSIONS: The ARKRAY ADAMS HA-8180 HbA1c analyzer showed excellent precision, linearity, and carryover rate. It also showed excellent correlation with the NGSP certified Variant II Turbo. In conclusion, the ARKRAY ADAMS HA-8180 HbA1c analyzer is a reliable high-performance liquid chromatography (HPLC) analyzer for HbA1c analysis and could be very useful for the diagnosis, treatment, monitoring, and risk assessment of diabetes.
Subject(s)
Chromatography, Liquid , Hemoglobins , Quality Control , Risk AssessmentABSTRACT
BACKGROUND: Hemoglobin (Hb)-A1c is routinely used for the management of diabetes. In 2010, HbA1c was included into the diagnostic criteria for diabetes by the American Diabetes Association. A newly developed HbA1c analyzer, ARKRAY ADAMS HA-8180 (ARKRAY KDK, Japan) was introduced. In this study, we evaluated the analytical performance of ARKRAY ADAMS HA-8180 HbA1c analyzer and compared it with the previously used Variant II Turbo (Bio-Rad Laboratories, USA), which is a National Glycohemoglobin Standardization Program (NGSP) certified analyzer. METHODS: According to Clinical Laboratory and Standards Institute (CLSI) evaluation protocol (EP) 5-A, Lyphochek Diabetes Controls (Bio-Rad Laboratories, USA) are used for precision. Two (low and high) levels of quality control materials were analyzed twice a day for 20 days, after which the mean, total standard deviation (SD) and total coefficient of variation (CV), including the between-run CV and between-day CV were calculated. ARKRAY ADAMS HA-8180 HbA1c analyzer and Variant II Turbo were compared with 150 samples according to CLSI EP9-A2. In addition, the linearity and carry over rate were evaluated. RESULTS: Between-run CVs for low and high level quality control materials were 0.0% and 0.3%, respectively, whereas between-day CVs for low and high level quality control materials were 0.3% and 0.2%, respectively. In the linearity test, the coefficient of determination (R2) was 0.99 (range, 3.1-19.3%). Thus, a good correlation was observed between ARKRAY ADAMS HA-8180 HbA1c analyzer and Variant II Turbo (R2=0.994). The carry over rate was 0.0%. CONCLUSIONS: The ARKRAY ADAMS HA-8180 HbA1c analyzer showed excellent precision, linearity, and carryover rate. It also showed excellent correlation with the NGSP certified Variant II Turbo. In conclusion, the ARKRAY ADAMS HA-8180 HbA1c analyzer is a reliable high-performance liquid chromatography (HPLC) analyzer for HbA1c analysis and could be very useful for the diagnosis, treatment, monitoring, and risk assessment of diabetes.