Left-over samples
Clinical samples
Matched sets
Seroconversion panels
Mixed titer panels
ZeptoMetrix panels
Tissue samples
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
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)
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.