Sesmed Medikal

Biosystems Biyokimya Kitleri

Biosystems Calibrator of Proteins Reagent

Protein Control Serum. For 1 mL. Lyophilized human serum containing component concentrations

Biosystems Calibrator of Proteins Reagent

INTENDED USE
The Protein Control Serum is intended for quality control purposes only
and is supplied with suggested intervals of acceptable values.
COMPOSITION
Protein Control Serum. For 1 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 the vial very carefully, avoiding any loss of the lyophilized
material.
2. Pipette exactly 1.00 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 Protein Control Serum is stable until the expiration date
given in the label.
The components of the reconstituted material are stable for at least
10 days at 2-8ºC. For longer periods, keep frozen. Avoid repeated freezethaw 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.

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