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)

Prospective Sampling

After establishing a hypothesis, many manufacturers want to test the effectiveness of a treatment or an assay, for example. Biomex GmbH supports its customers in the realization of prospective studies, both in the procurement of suitable sample material and in the planning and implementation of the study.

Contact us!

Prospective sample collection

The prospective study is the collection of samples that a client needs to obtain scientifically proven findings. The prospective sample collection is therefore designed to meet the needs of the client and his question (customized) and is the basis for a legally compliant and evidence-based application and marketing of diagnostic and medical devices. In general, a specific human sample (blood, plasma, tissue, body fluids) with a precisely defined characteristics profile is specified. The requirements for the samples can range from simple negative samples to very specific and rare disease patterns and disease progressions, depending on the study question.

Due to our worldwide good networking and cooperation with laboratories, hospitals and research institutions as well as our own plasma centers, we can also procure market-tight raw materials for prospective sample collection.

Please ask us. We will be pleased to support you.