Services

Biomex can act as a partner to provide comprehensive advice to providers of in-vitro diagnostics and to support them from blood collection to certified tests. Our service expertise include the definition of projects, the creation of measurement series, support with quality control, as well as the evaluation and validation of IVD products in serological tests in accordance with the new IVDR regulation. Because of our decades-long experience with in vitro diagnostics and accreditation, we can also offer the implementation of studies such as external studies, round robin tests, methodological comparative studies, bandwidth analyses and monitoring. Please contact us!

Performance Evaluation

1. Scientific validity
1.1 Pre-Market

  • Scientific literature (peer reviewed)
  •  Consensual expert appraisals/expert statements from relevant specialist organizations
  • Results of proof of concept studies
  • Results from clinical performance studies

1.2 Post-Market-Surveillance (PMS)

  • Proactive data collection
  • Evaluation of performance data
  • Latest technology - state-of-the-art

2. Analytical performance
2.1 Analytical sensitivity

  • Detection and quantification limits (LoD, LoB, LoQ)
  • Linearity
  • Measuring range (defined by LoQ and linearity)

2.2 Analytical specificity

  • Cross-reactions (analytes with similar structures, such as precursors, metabolites, related organisms)
  • Interferences (hemoglobin, icteric, lipemic, RF +, HAMA, ...) 

2.3 Stability studies for assays and samples

  • Sample type, matrices, sample stability, storage conditions, freeze-thaw process
  • Calibration stability, onboard stability
  • Module and device precision

2.4 Trueness (distortion)

2.5 Precision

  • Repeatability (day-to-day measurement)
  • Reproducibility (laboratory and user)

2.6 Accuracy (as a result of trueness and precision)

3. Clinical Performance Evaluation
3.1 CTS/CS

  • Diagnostic sensitivity
  • Diagnostic specificity
  • Positive predictive value
  • Negative predictive value
  • Likelihood ratio
  • Expected values ​​in affected and unaffected population groups

3.2 Near-Patient Testing (NPT)

  • Conformity assessment according to Annexes IX to XI IVDR
  • Evaluation of the technical documentation

3.3 Lay studies
To apply for special approval for an in-vitro diagnostic test for self-use by laypeople

Customer Specific Solutions

1. Operation of COVID-19 rapid test centers

  • Planning and implementation
  • In accordance with the requirements of the Covid Occupational Safety and Health Ordinance (current version)
  • on their company premises within Germany

2. External study site

  • Implementation of clinical performance evaluation studies
IVDR Conformity / CTS

Implementation of the IVDR requirements

  • Classification of the product
  • Definition of certification tasks
  • Support during the conformity assessment procedure
  • Unique Device Identification (UDI)
  • GAP analysis
  • Technical documentation
  • Post-Market-Surveillance (PMS)
  • Communication with notified bodies
Prospective Sampling

Prospective sample collection

  • Provision of precisely defined samples for conducting prospective studies
  • Quantitative and qualitative documentation of the prospective samples in compliance with the analytical and serological requirements of the tests
  • Supply of bulk material
  • Human samples at various stages of infection available for antibody detection (seroconversion panels)