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

Studies & Validation

When it comes to validating assays, each company operates its own strategy. Use us as an external study site or let us organize complete external studies for you:
From the planning, the selection of suitable study sites, to the provision of validation samples and the complete processing of the validation.

Please tell us what you need. We would be happy to check on availability and send you an individual offer.

Make contact with BIOMEX.