Cytokine Controls

(CTK Control)

CATALOGUE NO. KGST5006
LOT NO. 2450 (3081EV, 3004EV, 3005EV) v1
EXPIRY: 2010-04
PRESENTATION: Lyophilised
SIZE: 3 x 3 x 1 ml
LABELLING GUIDE
CTK                Cytokine
CONTROL    Control

INTENDED USE
BGT Cytokine controls are in-vitro diagnostic products intended for use as an assayed quality control in the routine monitoring of accuracy and precision for the analytes listed in this insert.
The BGT Cytokine Controls are multi-analyte. Each control contains all of the analytes listed overleaf. There are 3 levels of control: low, medium and high; Level 1, 2 and 3 respectively.

REAGENT COMPOSITION
Lyophilised human serum, pH 7.5 containing preservatives and a range of cytokines and growth factors as listed overleaf.

STORAGE AND STABILITY
Unopened: Lyophilised cytokine controls are stable up to the expiration date when stored at +2 to +8oC.
Opened: Once reconstituted, the controls are stable for 10 - 12 hours when stored at +2 to +8oC in the original vial, or up to 2 weeks at -20oC. Only the required amount of product should be removed. After use, any residual product should NOT BE RETURNED to the original vial.

SAFETY PRECAUTIONS AND WARNINGS
For in-vitro diagnostic use only. Do not pipette by mouth. Exercise the normal precautions required for handling laboratory reagents.
Human source material from which this product has been derived has been tested at donor level for the Human Immunodeficiency Virus (HIV 1, HIV 2) antibody, Hepatitis B Surface Antigen (HbsAg), and Hepatitis C Virus (HCV) antibody and found to be NON-REACTIVE. FDA approved methods have been used to conduct these tests.
However, since no method can offer complete assurance as to the absence of infectious agents, this material and all patient samples should be handled as though capable of transmitting infectious diseases and disposed of accordingly.

Health and Safety Data Sheets are available on request.

The reagents must be used only for the purpose intended by suitably qualified laboratory personnel, under appropriate laboratory conditions.

MATERIALS PROVIDED
Batch Specific barcodes for use with Evidence and Investigator analysers
Batch Specific control settings for the Evidence and Investigator analysers and Instructions for Use CD
CTK CONTROL 1    3 x 1 ml
CTK CONTROL 2    3 x 1 ml
CTK CONTROL 3    3 x 1 ml

MATERIALS REQUIRED BUT NOT PROVIDED
Volumetric Pipette

FOR EVIDENCE SYSTEMS
Evidence Cytokine Array         EV3508 or EV3544
Investigator Cytokine Array    EV3513
2 ml Sample cups                   EV3574
16 mm Sample tubes             EV3633

PROCEDURAL NOTES

EVIDENCE / INVESTIGATOR CD ROM INSTALLATION
Insert disc into CDROM drive
Double click on MY COMPUTER icon on Windows desktop
Double click on CD drive icon
Double click on UPDATE CONTROLS.EXE
Select the box next to either evidence or evidence investigator™ controls for the relevant array
Click on UPDATE
A progress bar will appear and once complete will say ‘Update Complete'
Click on EXIT
Control information (lot, target, SD, barcode, display name) for this lot of controls has now been updated.

PREPARATION

Procedure

1. Open the vial very carefully, avoiding any loss of material.
2. Reconstitute with 1 ml accurately measured distilled water at +20 to +25°C.
3. Replace the rubber stopper, close vial and leave to stand for 15 minutes out of bright light before use.
4. Make sure all dry material has dissolved then place the vial on a roller for 15 minutes.
5. Do not shake the vial.

The control should only be reconstituted using this procedure.

FOR THE evidence ANALYSER ONLY
Label appropriate sample tubes with the batch specific control barcodes provided. Using a volumetric pipette, transfer the required amount of control to the appropriate barcode labelled tube or sample cup to be used on the evidence analyser.

LIMITATIONS

1. Do not use the product past the expiry date.
2. Control settings are lot specific. Do not mix lots of reagents.
3. Do not use the product if there is evidence of contamination.

VALUE ASSIGNMENT
Controls are assigned using a minimum of 36 replicates over multiple analysers. For each control level, the outliers are removed from the data set using Chauvenet's exclusion principle and the remaining values are averaged to produce a target. The ranges are provided as the target ± 2 standard deviations. The assignment is then validated on three different analysers.

ABBREVIATIONS
IL               Interleukin
VEGF        Vascular Endothelial Growth Factor
TNFα        Tumour Necrosis Factor alpha
IFNγ          Interferon gamma
MCP-1      Monocyte Chemoattractant Protein-1
EGF          Epidermal Growth Factor

Hersteller:

Von-Langen-Weg 10 D-48565 Steinfurt Tel.: 02551/4090  Fax.: 02551/1298 Web: www.biogentechnologies.de