Korean J Clin Pathol.  1999 Feb;19(1):36-39.

Performance Evaluation of TOSOH Automated Glycohemoglobin Analyzer HLC-723GHb V A1c 2.2TM

• Jeong GY
• Lee MK
• Kim JW

Abstract

BACKGROUND
We evaluated the performance of the TOSOH glycohemoglobin analyzer HLC-723GHb V A1c 2.2TM (TOSOH Corp. Kyoto, Japan), a recently introduced automated hemoglobin A1c (HbA1c) analyzer using high performance liquid chromatography (HPLC) method without sample pretreatment.
METHODS
The performance characteristics evaluated were precision, linearity, comparison with VARIANTTM (Bio-Rad, Germany) and throughput following NCCLS evaluation protocols (EP5-T2, EP6-P, and EP9-T).
RESULTS
The within-run and between-day CV's were 0.910 and 1.328 for low level (6.2%), 1.214 and 1.460 for middle level (8.5%), and 0.789 and 1.449 for high level (10.7%), respectively. We found the perfect linearity of HbA1c (%) from 6.5 to 10.2 (r2=0.9995). Comparison studies between A1c 2.2 and VARIANTTM yielded the following correlation equations; A1c 2.2TM = 0.9915 (VARIANTTM) + 0.1198 %HbA1c (r=0.9936, P < 0.0001). Throughput was 28.0 tests per hour for A1c 2.2TM compared with 15.2 tests for VARIANTTM, which were determined including red blood cell lysis time before sample loading for VARIANTTM. A1c 2.2TM did not need sample pretreatment.
CONCLUSIONS
With the above results, A1c 2.2TM shows acceptable performance and is suitable for routine use in the clinical laboratory.

Keyword

Hemoglobin A1c (HbA1c); HPLC; Instrument evaluation

MeSH Terms

Chromatography, High Pressure Liquid
Chromatography, Liquid
Erythrocytes