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Institute for Transfusion Medicine and Gene Therapy

Quality Control

Department head: Dr. Marie-Christin Pauly

The quality control department is responsible for blood product testing in accordance with the German Medicines Act and includes the quality control laboratory and the blood donation laboratory.

Quality Control Laboratory
Head of Diagnostics: Isabella Klink

For routine quality control, regular checks are carried out randomly on all manufactured units in order to demonstrate compliance with the product specification. In addition, stability analyses are carried out at the end of the shelf life to provide evidence for the correct storage of the products. Furthermore, data on critical quality parameters is collected and submitted to the federal authority within the scope of evaluating change requests to the marketing authorization dossier. A list of diagnostic services provided by the Quality Control Laboratory can be found below.

Blood Donation Laboratory
Head of Diagnostics: Doreen Grundke

In the blood donation laboratory, samples of the donated blood are analysed for infectious diseases using serological detection methods and virus genome analyses. In the case of samples with atypical screening test results, the confirmatory tests are carried out in an external laboratory. Follow-up samples are also made from all blood donations, archived and re-examined if necessary.

Diagnostic Services of the Quality Control Laboratory

  • Complete blood cell count
  • Chemical analyses (potassium, lactate, total protein, citrate, ATP)
  • Clotting factor analyses (clotting factor VIII, V, XI)
  • Flow Cytometry
  • Microbiological controls
  • Free (plasma) haemoglobin
  • pH
  • Platelet function (aggregometry)

Diagnostic Services of the Blood Donation Laboratory

Serology testing

  • HIV-1 p24 antigen
  • Antibodies against HIV-1 and HIV-2
  • HBV-surface antigen
  • Antibodies against HBV-core
  • Antibodies against HBV-surface antigen (quantitative)
  • Antibodies against HCV
  • Antibodies against Treponema pallidum
  • Antibodies against CMV (IgG)

Virus genome testing

  • HIV genome (dual target)
  • HCV genome
  • HBV genome
  • HEV genome
  • HAV genome
  • PVB19 genome
  • WNV genome
Contact

Dr. Marie-Christin Pauly
Head of Quality Control

MEDICAL CENTER - UNIVERSITY OF FREIBURG
Institute for Transfusion Medicine and Gene Therapy
Hugstetter Straße 55
79106 Freiburg  

Telephone +49 761 270 34730
Fax +49 761 270 37900

qualitaetskontrolle@uniklinik-freiburg.de

Isabella Klink
Head of Diagnostics
Quality Control Laboratory  

MEDICAL CENTER - UNIVERSITY OF FREIBURG
Institute for Transfusion Medicine and Gene Therapy
Hugstetter Straße 55
79106 Freiburg  

Telephone +49 761 270 3479 0

qualitaetskontrolle@uniklinik-freiburg.de

Doreen Grundke
Head of Diagnostics
Blood Donation Laboratory  

MEDICAL CENTER - UNIVERSITY OF FREIBURG
Institute for Transfusion Medicine and Gene Therapy
Hugstetter Straße 55
79106 Freiburg  

Telephone +49 761 270 34880
immunhaematologie@uniklinik-freiburg.de