HemoCue HbA1c 501, Operating Manual

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1. INTENDED USE
The Hemocue® HbA1c 501Test Cartridge, together with the Hemocue® HbA1c
501 Analyzer, which are parts of the Hemocue® HbA1c 501 system provides a
convenient method for measuring the percentage of hemoglobin A1c (HbA1c %) in
both capillary and anticoagulated venous whole blood samples. The test is for point
of care use to monitor glycemic control in patients with diabetes mellitus.
The Hemocue® HbA1c 501 system uses a boronate affinity assay to separate the
glycated hemoglobin fraction from the nonglycated fraction. The Hemocue®
HbA1c 501 system is intended to be used by professionals in laboratories, clinics
and hospitals.
IMPORTANT: Please read through and familiarize yourself with the contents of
thi s operating ma nual before using the system for the first time.
2. GENERAL INFORMATION
The HemoCue® HbA1c 501 system is a small, portable, and fully automated point-
of-care system for all healthcare environments. The system delivers rapid results
with laboratory equivalent accuracy and precision across all test parameters.
The HemoCue® HbA1c 501 system may be used as a basic test system where the
user manually records the results, or as an advanced system where accessories
enable automatic printing of results, input of patient and operator identification
numbers, and full connectivity to a PC. This makes the system highly versatile as it
can be tailored to specific user needs.
This manual contains all the information needed to operate and maintain the
HemoCue® HbA1c 501 system.
3. PRINCIPLES OF OPERATION
The HemoCue® HbA1c 501 system is a fully automated boronate affinity assay for
determination of the Hemoglobin A1c percentage (HbA1c %) in whole blood.
The Test Cartridge consists of a cartridge and a reagent pack containing the
reagents necessary for the determination of hemoglobin A1c, with a sampling area
for blood collection.
The reagent pack is pre-filled with reagent solution and rinsing solution. The reagent
solution contains agents that hemolyse erythrocytes and bind hemoglobin specifically
as well as a boronate resin that binds to the cis-diols of glycated hemoglobin.