Quantitative determination of glycated hemoglobin (HbA1c)
IVD
Store 2 - 8ºC.
INTENDED USE
This product is for the purpose of calibrating results in the quantitative
determination of human hemoglobin A1c (HbA1c) in blood by automated
immunoassay
PRODUCT CHARACTERISTICS
The lyophilized hemoglobin A1c calibrators are a hemolysate prepared
from packed human erythrocytes. Stabilizers are added to maintain
hemoglobin in the reduced state for the accurate calibration of the
hemoglobin A1c procedure.
PREPARATION
Reconstitute vials with 0.5mL deionized water. Gently mix for 10
minutes, or until all material has dissolved.
The calibrators should be treated in the same manner as
patient specimens regarding 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.
CALIBRATION
The setpoint value of the calibrators was obtained by calibrating with
materials referenced to IFCC values using the Spinreact HbA1c Reagent
Set.
MATERIAL REQUIRED AND NOT PROVIDED
Hemoglobin A1c Reagent kit, from Spinreact Ref: 43100 or 43101
Hemoglobin A1c Control kit, from Spinreact Ref:43106
STORAGE AND STABILITY
1. Store calibrators at 2-8°C. Stable until expiration date if sealed
tightly. PROTECT FROM LIGHT AND HEAT.
2. The reconstituted calibrators should be stored refrigerated (2-
8°C) and sealed tightly. The calibrator retains it assigned value
for at least for 3 weeks at 2-8°C.
PROCEDURE
To be used in turbidimetric assays.
The lyophilized hemoglobin A1c calibrator kit will produce a calibration
curve that will be stable for at least 7 days on most analyzers.
