Sesmed Medikal

Biosystems Biyokimya Kitleri

Biosystems Control Serum Biochemistry level 1- 2

The lyophilized Biochemistry Control Serum is stable until the expiration date given in the label.

Biosystems Control Serum Biochemistry level 1- 2

INTENDED USE
The Biochemistry Control Serum is intended for quality control purposes
only and is supplied with suggested intervals of acceptable values.
COMPOSITION
Biochemistry Control Serum. For 5 mL. Lyophilized human serum
containing component concentrations suitable for the quality control of the
clinical laboratories, and without preservatives which might interfere with
the tests.
Components from human origin have been tested and found to be
negative for the presence of antibodies anti-HIV and anti-HCV, as well as
for HBs antigen. However, they should be handled cautiously as potentially
infectious.
PREPARATION AND USE
1. Open a vial very carefully, avoiding any loss of the lyophilized material.
2. Pipette exactly 5.00 mL of distilled water into the vial. The component
values depend on the accuracy of this reconstitution step.
3. Close the vial with the stopper and let stand for 20 minutes at room
temperature.
4. Swirl gently, avoiding the formation of foam, to ensure complete
dissolution of contents.
5. The reconstituted control serum is to be treated like the patient serum.
STORAGE AND STABILITY
Store at 2-8ºC.
The lyophilized Biochemistry Control Serum is stable until the expiration
date given in the label.
The components of the reconstituted material are stable for at least 7 days
at 2-8ºC, for most components, excepting:
 AST is stable 8 hours at 2-8ºC.
 Alkaline phosphatase values rise about 10-20% during the first 2 hours
after reconstitution.
For longer periods, keep frozen. Avoid repeated freeze-thaw cycles.
SPECIFIED VALUES
The assigned concentration values for components and their traceability
are shown in the enclosed value sheets. Traceability of the results can be
assured only if the BioSystems reagents and recommended measurement
procedures are used.
The suggested intervals of acceptable values have been calculated from
previous experience in interlaboratory variability and are given for
orientation only. Each laboratory should establish its own precision
parameters.