Dr. Karl Lewin Günther

Head of in.vent Clinical Services +49330255199550 E-MAIL SENDEN

Analytical Performance Studies

in.vent Clinical Services

An Analytical Performance Study assesses the ability of a device to correctly measure the corresponding analyte. Using state-of-the-art approaches and following the corresponding guidelines (e.g. CLSI) we will take care of all necessary steps: - Procurement of samples - Assessment of all parameters described in IVDR, annex I, Section 9.1, point (a) - Detection and quantification limits - Intererences and cross-reactivity - Trueness (Bias) - Precision (Repeatability and reproducibility) - Measuring range - Linearity - Cut-off - Specimen collection and handling criteria - Generation of the Analytical Performance Study Report according to IVDR, annex XIII, part A. For Analytical Performance Studies we cooperate with our trusted partner Future Diagnostics!

Vorteile des Produkts

  • ICS and Future Diagnostics - Synergistic cooperation leads to highest efficiency
  • +40 years of accumulated experience
  • Reliable data thanks to internationally accepted guidelines