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5CHOLESTECH GDX ANALYZER BASIC OPERATION

Cholestech GDX Analyzer User Manual

4 PRINCIPLES OF THE CHOLESTECH GDX A1C TESTING SYSTEM

Cholestech GDX Analyzer User Manual

Principles of the Cholestech GDX

A1C Testing System

The Cholestech GDX A1C Testing System uses boronate afﬁnity

chromatography to separate the glycated hemoglobin fraction.

The Cholestech GDX Analyzer, which is a single wavelength

spectrophotometer (440 nms), measures both fractions and an

algorithm converts the result into the percentage A1C in the sample.

After a Cholestech GDX Test Cartridge has been placed in the analyzer,

a small sample of blood is added to the ﬁrst sample tube. The blood is

instantly lysed to release the hemoglobin and the boronate afﬁnity resin

binds the glycated hemoglobin. After a short incubation step, the liquid

is poured into the central funnel of the test cartridge and the non-

glycated fraction is collected in an optical chamber, where the

hemoglobin concentration is photometrically measured. A combination

of microswitches is used by the logic of the analyzer to detect the exact

position of a test or control cartridge during operation, and Dynamic

Meniscus Sensing (DMS) is used to detect when liquids enter the

cartridge reading wells.

The glycated hemoglobin remains bound to the boronate afﬁnity

resin, which sits at the bottom of the test cartridge funnel. The

boronate afﬁnity resin is then washed with the contents of the

second buffer tube and the ﬁnal step is the elution of the glycated

hemoglobin off the boronate afﬁnity resin using the third buffer

tube. The glycated hemoglobin concentration is measured and the

A1C concentration in the sample is calculated and reported by the

analyzer. The algorithm for the calculation is:

Where “M” and “C” are slope and intercept factors to correct the

value for DCCT calibration (see

Calibration,

page 8).

Cholestech GDX Analyzer Basic Operation

WARNING: When using the Cholestech GDX

Analyzer, do not operate within an

electromagnetic ﬁeld. Do not operate any

VHF emitting equipment within 1 meter

(39.4 inches).

The Cholestech GDX Analyzer is designed

to be simple and easy to operate. This user

manual describes some basic functions, but

must be used with the package insert in each

pack of Cholestech GDX A1C Test Cartridges.

Please read this user manual carefully

before use.

1. Ensure the Analyzer is placed on a

ﬂat surface. Operate the Analyzer

between 17 and 30ºC (63–86ºF).

2. Remove the power pack. Check that

the input power matches the local

voltage supplied. If the input voltage

does not match the local power supply,

contact Cholestech Technical Service

or your local distributor.

3. Plug the power pack into the main

supply. Connect the jack plug into the

back of the Analyzer indicated by the

following marking.

The analyzer will run through a check

stage. All the red positional indicator lights

on the analyzer will ﬂash, the beep will

sound, and the display will show all icons

and characters momentarily.

A number will appear on the display. This is

the version of software in the analyzer, for

example 2.06.

The Hourglass icon will ﬂash to tell you

to wait.

Note: The Hourglass icon may ﬂash for

some time if the analyzer has been stored

at extreme temperature/humidity. Normally

the time required for warm-up is 10

minutes. If the analyzer has been moved

from a high or low temperature or humid

area just prior to warm-up, the warm-up

period may be extended to up to 40

minutes. If the analyzer fails to warm-up an

error message will appear on the display.

(See

Troubleshooting,

pages 12–13.)

When the analyzer is ready for use, the

Insert and Cartridge icons will ﬂash. The

“left” and “right” arrows will be solid.

You can now use the analyzer to run

an Optics Check Cartridge or an A1C

Test Cartridge.

% A1C= M

+ C

Glycated

X 100

Glycated

+ A

Nonglycated

1 2 3 4 5 6 7 8 9 10 11 12 13 14

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