Research & Development

Left-over samples

Clinical samples

Matched sets

Seroconversion panels

Mixed titer panels

ZeptoMetrix panels

Tissue samples

Studies & Validation

CTS serology and NAT panels
For the validation of HIV, HBV, HCV in-vitro diagnostics according to general technical specifications (CTS) compliant with EC Directive 98/79/EC and the European Regulation 2017/746 (IVDR).
  ▪ Diagnostic sensitivity:
     - Genotype/subtype panels 
     - Seroconversion panels
     - Positive samples
  ▪ Analytical sensitivity
  ▪ Diagnostic specificity

Diagnostic specificity (not CTS)
  ▪ Negative samples
  ▪ Hospitalized patient panels
  ▪ Cross-reaction panels (RF+,
    HAMA, pregnant women,...)
  ▪ Cross-contamination panels
  ▪ Serum/Plasma
    equivalence panels
  ▪ Inhibition panel
    (endogenous factors:
    hemolytic, lipemic,
    icteric)
  ▪ Blood bank marker panels

Quality Control

Release panels for quality control​​​​​
  ▪ Positive 
    (low, medium, high range)
  ▪ Negative 
    (no virus, no analyte)
  ▪ Threshold determination
    (Values in range between
    detection limit and
    clinical decision point)

Linearity panels

Samples for round robin tests (for external quality assessment)

Production

Positively tested bulk material
  ▪ Various degrees of disease
    severity
  ▪ Infectious diseases
  ▪ Autoimmunology,...

Negatively tested bulk material
  ▪ No virus, no analyte
  ▪ For diagnostic controls
    / calibrator

Processed plasma
  ▪ From coagulated whole
    blood
  ▪ Defibrinated, with activated
    charcoal treated,
    delipidated
  ▪ Diafiltered and / or
    ultrafiltered human serum

Purified analytes - Cancer antigens

Serological controls as OEM

Raw materials
  ▪ Human plasma derivatives
  ▪ Albumins of animal
    origins

Quality Control

Quality control is one of the most important steps in the manufacture of in vitro diagnostics. Take advantage of our many years of experience in the procurement of specific plasmas, the processing of negative plasma, and the stabilization of human raw materials. We offer the ideal prerequisites for procurement, processing, and testing. Why? All of our starting materials are tested negative for HIV, HCV and HBsAg.

We would be happy to offer you further tests upon request.