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

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

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Lee, Kyunghoon Jun, Sun-Hee Han, Minje Song, Sang Hoon Park, Kyoung Un Song, Woon Heung Song, Junghan
Description	Author Affiliation: Lee K ( Department of Laboratory Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.); Jun SH ( Department of Laboratory Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.); Han M ( Department of Laboratory Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.); Song SH ( Department of Laboratory Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.); Park KU ( Department of Laboratory Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea); Song WH ( Department of Biomedical Laboratory Science, Shinhan University, Uijeongbu, Republic of Korea.); Song J ( Department of Laboratory Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea)
Abstract	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.
File Format	HTM / HTML
ISSN	00099120
Issue Number	9
Volume Number	48
e-ISSN	18732933
Journal	Clinical Biochemistry
Language	English
Publisher	Elsevier
Publisher Date	2015-06-01
Publisher Place	United States
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Biochemistry Diabetes Mellitus Diagnosis Hemoglobin A, Glycosylated Analysis Point-of-care Testing Humans Immunochromatography Instrumentation Reproducibility Of Results Comparative Study Evaluation Studies Journal Article Research Support, Non-u.s. Gov't
Content Type	Text
Resource Type	Article
Subject	Medicine Clinical Biochemistry

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