Research & Development

Patient samples
(Serum, Human Plasma, Tissue)

  • Patient samples
  • Antigens
  • Analytical sensitivity/specificity panels
  • Diagnostic sensitivity/specificity panels
  • Blood-bank marker panel
  • Matrix panels (matched sets)
  • Inhibition (Haemolytic, Lipemic, Icteric)
  • Interference (RF, HAMA, Hyper IgM/IgG, etc.)
  • Parameter specific cross-reactive panels
  • Prospective sample collection
  • Tissue samples
Studies / Validation

Proben oder Panel
(Serum, Plasma and Tissue)

Validation of HIV, HBV, HCV in vitro diagnostics according to common technical specifications (CTS serology and NAT, 2009/108/EC, IVDR)

  • Genotype/Subtype Panels
  • Seroconversion panels
  • Blood-bank marker panel
  • Matrix - matched sets
  • Interference/ Inhibition Panels
  • Cross-reactive panels

Validation of other parameters (i.e. Haematology, Clin. Chemistry Endocrinology, Autoimmunity)

  • Diagnostic sensitivity/specificity panels
  • Clinical specimens for method comparison (left-over or prospective samples)
  • Matrix panels
  • Reference range samples
Quality Control

QC Release Panels 
(Serum, Plasma and Tissue)

  • Positive (low, medium, high range)
  • Negative (no virus, no analyte)
  • Cut-off (values at range of LoD to clinical decision point)

Other panels

  • Seroconversion
  • Standardization
Production

Bulk Materials
(Serum, Plasma and Tissue)

  • Positive Plasma: Disease state (all ranges), Infectious diseases, ToRCH and others
  • Negative Plasma: no virus, no analyte
  • Processed Plasma: Recalcified/delipidized/diafiltrated/ultrafiltrated Human serum is derived from clotted whole blood
  • Samples for ring trials (for external quality assessment)

Studies & Validation

Each company follows its own strategy for validation of assays. Use us as your external study site or let us organize entire external studies for you: From the planning and selection of suitable StudySites to the provision of validation samples and the complete handling of the validation.

Please let us know your needs. We will gladly check availability and you will receive an individual offer

Get in contact with BIOMEX.