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KMID : 0375320000220020259
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Journal of Clinical Pathology and Quality Control
2000 Volume.22 No. 2 p.259 ~ p.262
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Comparative Evaluation between VARIANVM II Hb A1 Analyzer and IMx Glycated Hemoglobin Assay
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Shin Kyeong-Seob
Son Bo-Ra
Hwang Seock-Yeon
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Abstract
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Background : Measurement of hemoglobin A, is used as an objective measure of long-term blood glucose control in diabetic patients. We evaluated recently improved hemoglobin A,c autoanalyzer (VARIANTTM II Hb A,c analyzer, Bio-Rad, CA, USA) using ion-exchange high performance liquid chromatography (HPLC) method.
Methods : Linearity, precision, comparison with IMx glycated hemoglobin assay (Abott Laboratories, IL, USA) and throughput were evaluated. The reference range was determined from 144 healthy subjects.
Results : The VARIANT" II was founded to be linear in a range of 5.6% to 14.0% (r2=0.997). The within-run and between-day precision were 1.09% and 3.72% for low level (7.9%), 0.39% and 2.5% for middle level (9.2%), 0.7% and 1.86% for high level (14.1%), respectively. Comparison study between VARIANT" II and IMx showed good correlation with a slope of 1.164, an intercept at -0.41413, and coefficient of correlation was 0.9574. The throughput of VARIANTTM 11 was 15.9 samples per hour and the reference range was 5.1-6.5%.
Conclusions : The VARIANT" 1 Hb A,c analyzer provides improved precision, accuracy and adequate throughput, and the instrument is suitable for use of clinical laboratory.
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KEYWORD
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Hemoglobin (Hb) A, c, Ion-exchange HPLC, IMx glycated hemoglobin
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