Services

Biomex is available as a partner to provide comprehensive advice to suppliers of in-vitro diagnostics and to accompany them from blood collection to certified tests. Our service expertise includes project definition, establishment of test series, quality control support, evaluation and validation of IvD products in serological tests and according to the new IVDR. Based on our decades of experience in in vitro diagnostics as well as accreditation, we can also offer the performance of studies such as external studies, external quality assessment, methodological comparison studies, broad range analyses or monitoring. Please contact us!

 

Performance evaluation studies

Performance evaluation studies

  • Cutoff determination
  • Analytical and diagnostic sensitivity/specificity
  • Feasibility studies (within-run precision, limit of blank, dilution linearity, %recovery, sample carryover)
  • Studies in accordance with "MPG-DIN ISO 14155" (Ethics committee, patient consent, site selection and contracting)

Validation

  • Freshly drawn blood samples
  • Precision
  • Detection limit, LoB
  • Method comparison
  • Linearity
  • Sensitivity
  • Calibration stability, Onboard stability
  • Cross-reactons, interference
  • Internal lab precision (day-to-day precision)
  • Module and analyzer precision
  • Reproducibility (lab, user)
  • Stability testing after freeze thaw-cycles
Clinical performance studies

Clinical performance studies

  • to assist in obtaining CE mark acc. to CTS for Annex II, list A products
  • To assist in scientific validation
  • Analytical and clinical performance evaluation studies
  • Provision, supervision, support or implementation of reference tests
  • Creation and evaluation of anamnesis data
IVDR und CTS

IVDR und CTS

  • Scientific validity reports
  • Analytical performance evaluation studies
  • Clinical performance evaluation studies
  • Support in generating the Technical Dossier
  • Implementation of PMS plans and reports (Post-Market Surveillance) 
  • Consulting and support in the introduction of the UDI (Unique Device Identification)
  • Support for the approval of IVDR compliant products
  • Communication with the Notified Bodies
Prospective sample collection

Prospective sample collection

  • Provision of precisely defined samples for prospective studies
  • Quantitative and qualitative documentation of prospective samples according to the analytical and serological requirements of the tests
  • Delivery of bulk material is possible
  • Human samples with different stages of infection available for antibody detection (seroconversion samples)