EAGLE GLYCOHEMOGLOBIN CONTROLS

CAT. NO. GH-50 (Normal Control)

Intended for use as Human Glycohemoglobin Control

SUMMARY AND EXPLANATION

The Eagle GLYCOHEMOGLOBIN CONTROLS is a whole blood hemolysate prepared from human erythrocytes. The controls provide three levels of glycohemoglobin in the normal, mid(contolled diabetic) and elevated range. Stabilizers added to maintain hemoglobin in the reduced state providing complete control for the glycohemoglobin procedure.

PRINCIPLE

The Eagle GLYCOHEMOGLOBIN CONTROLS should be assayed in the same manner as unknown specimens. The EXPECTED RANGE gives the acceptable limits for assay values. The lot number on the control vial should agree with lot number of the accompanying package insert.

REACTIVE INGREDIENTS:

Glycohemoglobin prepared from human erythrocytes. Preservatives added. Consult MEAN VALUE and EXPECTED RANGE for acceptable results.

PRECAUTIONS:

For In Vitro Diagnostic Use: Handle with same precautions used for human blood samples. The erythrocytes used in this product have been tested non-reactive for Hepatitis B Surface Antigen, Hepatitis B Core Antigen, and HIV Antibody.

STORAGE AND STABILITY:

The reconstituted controls are stable for at least one month if stored at 2-8ºC and sealed tightly. For extended stability, the reconstituted controls may be aliquoted and frozen for up to six months if tightly sealed. Do not refreeze after thawing. PROTECT FROM LIGHT AND HEAT. Do Not Allow Controls to remain at room temperature after reconstitution for any extended period of time. If not used immediately place in refrigerator. They may be taken direct from refrigerator, used immediately and returned. Do Not Warm To Room Temperature.

RECONSTITUTION:

Add 1.0 mL deionized water. Gently mix for 10 minutes. Observe for undissolved material.

DETERIORATION:

A dark brown coloration and clumping after reconstitution would indicate deterioration. Failure to achieve indicated values after reconstitution could also indicate deterioration.

PROCEDURE

The Eagle GLYCOHEMOGLOBIN CONTROLS should be assayed in the same manner as unknown blood specimens. Follow the directions which accompany the reagent kit used in the assay.

MATERIALS PROVIDED:

Eagle GLYCOHEMOGLOBIN CONTROL (Cat. No. GH-50)

MATERIALS REQUIRED BUT NOT PROVIDED:

GLYCOHEMOGLOBIN TEST KIT.

LIMITATIONS

Among factors which might cause inaccurate results are improper pipetting, inadequate mixing and poorly calibrated instruments. The lot number on the control vial should agree with lot number of the accompanying package insert.

DEFINITIONS:

Mean Value: The average value obtained by assaying representative samples of the entire lot.

EXPECTED RANGE:

The acceptable limits to be used as a guide in determining the accuracy of the assay procedure. The assay results for the controls should fall within the stated EXPECTED RANGE.