Biosystems Rheumatoid Control Serum Level 1-2 INTENDED USE
The Rheumatoid Control Serum is intended for quality control purposes
only and is supplied with suggested intervals of acceptable values.
Rheumatoid 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 withthe 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
PREPARATION AND USE
1. Open a vial very carefully, avoiding any loss of the lyophilized
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
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 Rheumatoid 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
Biosystems Rheumatoid Control Serum Level 1-2 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
Biosystems Coagulation reagents include the main diagnostic tests and they are characterized by high stability and a good performance using low volume consumption.
These reagents can be performed in semiautomatic and automatic coagulation instruments, independently of the kind of clot detection method (optical and mechanic).