Produkte/Klinische Chemie/Kontrollen/Kontrollseren/Immunoassay Premium Plus

Immunoassay Premium Plus

controls for immunoassays

available in 3 levels

LevelSizeCat. No.
112 x 5 mlKG3109
212 x 5 mlKG3110
312 x 5 mlKG3111
Tri-Level12 x 5 mlKG3112

INTENDED USE
This product is intended for in vitro diagnostic use in the quality control of the accuracy of Immunoassays on clinical chemistry systems. This material can be used to monitor the control of accuracy or the control of reproducibility of Immunoassays.

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 to 8°C). Reconstituted serum is stable for 7 days at 2 to 8°C if kept capped in original container and free from contamination or 4 weeks frozen once at -20°C. 25-OH Vitamin D and 1,25(OH)2 Vitamin D are stable for 5 days at 2-8ºC. C-Peptide is stable for 1 day at 2-8ºC. Parathyroid hormone (PTH) and Thyroglobulin should be tested within 4 hours of reconstitution, when stored at 2 to 8°C or within 2 weeks when stored below -20°C. No frozen stability claim is made for ACTH, Aldosterone and C-Peptide. Only the required amount of product should be removed. After use, any residual product should NOT BE RETURNED to the original vial.
UNOPENED: Store refrigerated (2 to 8°C). Stable to expiration date printed on individual vials.
Bacterial contamination of the reconstituted serum will cause reductions in the stability of many components. If bacterial contamination is suspected, the vial should be discarded and a fresh vial reconstituted.

PREPARATION
Immunoassay Premium Plus is supplied lyophilised.

  1. Carefully reconstitute each vial of lyophilised serum with exactly 5ml of distilled water at +20 to 25°C. Close 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
Immunoassay Premium Plus - Level 1: 12 x 5ml 
Immunoassay Premium Plus - Level 2: 12 x 5ml
Immunoassay Premium Plus - Level 3: 12 x 5ml
Immunoassay Premium Plus - Tri-Level: 12 x 5ml

MATERIAL REQUIRED BUT NOT PROVIDED
Volumetric Pipette

VALUE ASSIGNMENT
Each batch of Immunoassay Premium Plus is submitted to a number of reference laboratories and values are assigned from a consensus of results obtained by these laboratories using a unique statistical analysis. With each batch a control range is provided for individual parameters and each parameter method. The control range is equivalent to the assigned mean ±2 S.D. This results in extremely accurate values, which may be confidently used by laboratories to ensure the accuracy of their methods. Aldosterone and Estriol are present in the control but values are not provided.
If a method is unavailable, contact BGT BioGenTechnologies GmbH, Tel: 02551/4090 or email info@biogentechnologies.de.


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

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



 
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