Quantitative determination of glycated hemoglobin (HbA1c)
IVD
Store 2 - 8ºC.
INTENDED USE
This product is for the purpose of monitoring accuracy and precision in
the quantitative determination of human hemoglobin A1c (HbA1c) in
blood by automated immunoassay.
PRODUCT CHARACTERISTICS
The lyophilized HbA1c controls are hemolysates prepared from packed
human erythrocytes. The controls provide two levels of HbA1c, one level
in the normal range and the other level in the elevated range. Stabilizers
are added to maintain hemoglobin in the reduced state providing
complete control of the HbA1c procedure.
REAGENTS
HbA1c Control Level 1 Human blood. Contains preservatives. The
HbA1c concentration is indicated on the vial
HbA1c Control Level 2 label.
PREPARATION
Reconstitute vials with 0.5mL deionized water. Gently mix for 10
minutes. Observe for undissolved material. The reconstituted controls
may be dispensed in 0.1 mL aliquots, sealed tightly and frozen at -20°C,
The lyophilized HbA1c controls should be assayed in the same
manner as blood specimens including the hemolysate
procedure.
PRECAUTIONS
Components from human origin have been tested and found negative for
the presence of HBsAg, HCV and antibody to HIV (1/2). However handle
cautiously as potentially infectious.
Avoid contact with skin and mucous membranes.
MATERIAL REQUIRED AND NOT PROVIDED
Hemoglobin A1c Reagent kit, from Spinreact Ref: 43100 or 43101
Hemoglobin A1c Calibrator kit, from Spinreact Ref:43105
STORAGE AND STABILITY
1. Store controls at 2-8°C. Stable until expiration date if sealed tightly.
PROTECT FROM LIGHT AND HEAT.
2. Reconstituted controls retain their assigned values for at least three
months if frozen. If not frozen, the reconstituted controls are stable
at least one month if stored at 2-8°C and sealed tightly.
3. Do not freeze and thaw more than once.
PROCEDURE
To be used in turbidimetric assays.
