Zeitschiene Produkte
R&D

Patientenproben (Serum und Plasma)

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

Proben oder Panel (Serum und Plasma)

Validierung von HIV, HBV, HCV in vitro Diagnostica according to common technical specifications (CTS serology and NAT, 2009/108/EC):

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

Validierung anderer Parameter (i.e. Hematology, Clin. Chemistry Endocrinology, Autoimmunity)

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

QC Release Panel von üblichen Analyten

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

Andere Panel

  • Seroconversion
Produktion

Bulkmaterial - Plasma und Serum

Plasma is available as either native or processed (recalcified/delipidized/diafiltrated/ultrafiltrated)
Human serum is derived from clotted whole blood

  • Positive (low, medium, high range)
  • Negative (no virus, no analyte)
  • Samples for ring trial (for external quality assessment)

Andere Rohstoffe

  • ELISA consumables (substrate, conjugated antibodies, buffers)
  • Rheumatoid factor adsorbent
  • Bovine serum albumin
  • Native & recombinant antigens
Zeitschiene Service
R&D

Performance Studien

  • Cut-off determination
  • Analytical and Diagnostic
    Sensitivity/Specificity
  • ROC analysis of selected cases versus normal controls
Validierung/Implementierung
  • Precision (within run)
  • Intermediate precision (inter-day)
  • Inter-module/device
  • Reproducibility (inter-lab, inter-user)
  • Stability testing/Freeze thaw
  • Method comparison
  • Site selection and contracting
  • Ethics committee & patient consent
  • Familiarization
  • Ring trial
  • Main trial (method comparison, cut-off, clinical decision point, disease biomarkers, therapeutic monitoring)
Qualitätskontrolle

Launch (für Chargenfreigabe):

    • Precision testing
    • Stability testing
    • Lot-Lot testing

    Post-launch:

    • FDA warning
    • CAPA response
    • Risk mitigation