Produkte/Klinische Chemie/Kontrollen/Kontrollseren/Chemistry Premium

Chemistry Premium

chemical control

available in two levels

 

LevelSizeCat. No.
25 mlKG5067
35 mlKG5068

 

INTENDED USE
This product is intended for in vitro diagnostic use in the quality control of diagnostic assays. Chemistry Premium is for the control of accuracy.

DEVICE DESCRIPTION
Chemistry Premium is supplied at 2 levels, level 2 and 3. Target values and ranges are supplied for the analytes listed in the value section at both levels.

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.

STORAGE AND STABILITY
OPENED: Store refrigerated (+2°C to +8°C). Reconstituted serum is stable for 8 hours at +25°C or 7 days at +2°C to +8°C and 1 month when frozen once at -20°C (See Limitations).
LIMITATIONS
For Total & Prostatic Acid Phosphatase, the material should be stabilised by adding 1 drop (25 - 30 µl) of 0.7M Acetic acid solution to 1ml of the serum exactly 30 minutes after reconstitution. After stabilisation Total and Prostatic Acid Phosphatase is stable for 2 hours +25°C, 2 days at +2°C to +8°C and 1 month when frozen once at -20°C.
Alkaline Phosphatase levels in the reconstituted serum will rise over the stability period. It is recommended that the reconstituted serum be allowed to stand for 1 hour at +25°C before measurement.
Bilirubin in the serum is light sensitive and it is recommended that the serum be stored in the dark. Stored in the dark it is stable for 4 days at +2°C to +8°C. Do not store at +15°C to +25°C. Do not freeze.
Bacterial contamination of the reconstituted serum will cause reductions in the stability of many components.
Different lot numbers of this control should not be interchanged as the values assigned to the controls vary from lot to lot.
The control should not be used as a calibration material.
UNOPENED: Store refrigerated (+2°C to +8°C). Stable to expiration date printed on individual vials.

PREPARATION FOR USE
Chemistry Premium is supplied lyophilised.

  1. Carefully reconstitute each vial of lyophilised serum with exactly 5 ml of distilled water at +20°C to +25°C. Close the bottle and allow to stand for 30 minutes before use. Ensure contents are completely dissolved by swirling gently. Avoid formation of foam. Do not shake.
  2. Refer to the control section of the individual analyser application.
  3. Refrigerate any unused material. Prior to reuse, mix contents thoroughly.

MATERIALS PROVIDED
Chemistry Premium Level 2 5 ml
Chemistry Premium Level 3 5 ml

MATERIALS REQUIRED BUT NOT PROVIDED
Volumetric Pipette

ASSIGNED VALUES
Each batch of Chemistry Premium is assigned at BGT BioGenTechnologies GmbH with reference to an internal master calibrator which is traceable to international Reference Standards.

NOTES
R All trademarks recognized
(1) DGKC : German Society for Clinical Chemistry
(2) IFCC : International Federation of Clinical Chemistry
(3) SCE : Scandinavian Committee on Enzymes


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img/page/needfull/ce-zeichen.gif Hersteller:

Guenter Keul GmbH
Günter Keul GmbH
Von-Langen-Weg 10
D-48565 Steinfurt
Tel.: 02551/2097  Fax.: 02551/80883
Web: www.keul.de



 
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