J Clin Pathol Qual Control.  2000 Dec;22(2):259-261.

Comparative Evaluation between VARIANT(TM) II Hb A(1C) Analyzer and IMx Glycated Hemoglobin Assay

• Shin KS
• Hwang SY
• Son BR

Abstract

BACKGROUND: Measurement of hemoglobin A(1C) is used as an objective measure of long-term blood glucose control in diabetic patients. We evaluated recently improved hemoglobin A1C autoanalyzer (VARIANT(TM) II Hb A(1C) 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(TM) 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(TM) II and IMx showed good correlation with a slope of 1.164, an intercept at -0.41415, and coefficient of correlation was 0.9574. The throughput of VARIANT(TM) II was 15.9 samples per hour and the reference range was 5.1-6.5%.
CONCLUSIONS
The VARIANT(TM) II Hb A(1C) analyzer provides improved precision, accuracy and adequate throughput, and the instrument is suitable for use of clinical laboratory.

MeSH Terms

Blood Glucose
Chromatography, Liquid
Hemoglobin A, Glycosylated*
Humans
Reference Values
Blood Glucose