2.1 E Background

Background to the author

The author has validated and installed 20 NDIR systems modified in the period 2000 to 2002 at universities (University of Berlin (Benjamin Franklin and Virchow Clinic, University of Marburg, University of Halle, Ludwig-Maximilians-University of Munich, Goethe-University of Frankfurt (here replacement of a mass spectrometer by a NDIR system), University of Kiel, Second Hospital Shihazuang China, Leiden University Hospital as well as at various hospitals and medical laboratories in Germany, Switzerland, Austria, Denmark, France and Poland. Some NDIR systems are used for quantitative monitoring of metabolic processes by means of isotope-labelled compounds online in rat models or e.g. for calorimetry in animal models (Veterinär med. Institut Braunschweig, Veterinärmed. Institut Rostock).

Validation experience

The author has participated in the following system validations, among others:

• 2002/2003 Multicentre equivalence study Focalpoint (Automated Histopathological Screening Procedure for Early Detection of Human Papillomavirus HPV) on 5000 patients (Düsseldorf, Einbeck, Bad Münder).

• 2010 Ultrasound-assisted decalcification of bone marrow biopsies using ultrasound decalcifier and special decalcification reagents (developed on behalf of the author) for rapid and reliable diagnosis of bone marrow changes using classical histopathological staining techniques and IHC (immunohistochemical reactions).