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 Diagnostika nach allgemeinen technischen Spezifikationen (CTS serology and NAT, 2009/10

  • 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 (Serum und Plasma)

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

Andere Panel

  • Seroconversion
  • Standardization
Produktion

Bulk Material (Serum und Plasma)

  • 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 trial (for external quality assessment)
Zeitschiene Service
R&D

Performance Studien

  • Cut-off determination
  • Analytical and Diagnostic
    Sensitivity/Specificity
  • ROC analysis of selected cases versus normal controls
  • Feasibility studies (within-run precision, limit of blank, dilution linearity, %recovery, sample carryover)
  • Studies according to “MPG-DIN ISO 14155” (Ethics committee, patient consent, site selection and contracting)
    IVD-R
  • Scientific validity report
  • Analytical performance study
  • Clinical performance study
Validierung/Implementierung

 Validierung

  • Precision (within run)
  • Limit of detection, Limit of blank
  • Method comparison
  • Linearity
  • Sensitivity
  • Calibration stability, Onboard stability
  • Cross-reacting, interference
  • Intermediate precision (inter-day)
  • Inter-module/device
  • Reproducibility (inter-lab, inter-user)
  • Stability testing/Freeze thaw
    Clinical performance studies (to assist in obtaining CE mark acc. to CTS for Annex II, list A products)
Qualitätskontrolle

Launch (für Chargenfreigabe):

    • Precision testing
    • Stability testing
    • Lot-Lot testing
    After Sales

    Externe Qualitätskontrolle (Ringversuche)

    •    Biochemistry
    •    Immunology
    •    Microbiology
    •    Hematology