Performance evaluation of SD A1cCare as a HbA1c analyzer for point-of-care testing.

OBJECTIVES: Some studies have shown that a rapid feedback of HbA1c results is helpful for controlling plasma glucose levels. Point-of-care (POC) instruments that are fast, portable, and easy to use are suitable for rapid determination of HbA1c levels. Here, we evaluated the analytical performance of a newly developed POC HbA1c analyzer, SD A1cCare (SD Biosensor, Inc.). DESIGN AND METHODS: The precision, linearity, and correlation with the Variant II Turbo instrument (Bio-Rad Laboratories, Inc.) were evaluated according to CLSI guidelines for SD A1cCare. All tests were performed according to the manufacturer instructions, and statistical analyses, including linear regression and Passing-Bablok regression, were performed. Bias from the IFCC reference targets was also evaluated with 12 duplicate specimens (n=24 in total). RESULTS: The coefficients of variation based on EP9-A2 protocol were 2.6% in SI unit and 1.8% in NGSP unit. The calibration curve was linear, with R(2)=0.9911 in the range of 23.5 to 125.1 mmol/mol in SI units (4.3% to 13.6% in NGSP units). The results of the SD A1cCare correlated with those of the Variant II Turbo (r=0.986). Deviations from IFCC targets at 30, 60, and 90 mmol/mol IFCC levels were -1.95, -1.85, and -1.74 mmol/mol, respectively. CONCLUSIONS: The SD A1cCare analyzer showed excellent precision, linearity, correlation with the Variant II Turbo analyzer, and accuracy with IFCC targets. Therefore, it may be suitable for HbA1c assays in the POC setting and in small laboratories.