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)

Clincal performance studies

The Clinical Performance Study is a very extensive and complex data collection and evaluation and can be divided into the areas of scientific validity and analytical and clinical performance evaluation. To conduct such an extensive study, a very high number of existing samples is required, whose clinical condition can be accurately described using reference tests, anamnesis data and test algorithms. Both positive samples from sick patients and negative samples from healthy patients are required. Biomex GmbH supports you by providing the necessary reference samples and analysis data, so that you can draw on our comprehensive stock of precisely defined human samples including disease markers for the necessary test series of the performance evaluation study.Wir unterstützen auch bei der Planung und Projektierung, dem Festlegen des Studiendesigns und dem Monitoring der Ergebnisse, so dass die notwendige Evidenz der Studie von Anfang an gewährleistet ist.

Are you planning a clinical performance evaluation study or looking for support in implementing a compliant performance evaluation?

Get in touch with us and benefit from our many years of experience.