The CTS (Common Technical Specifications) and the CS (Common Specifications) provide IVD manufacturers with defined criteria and procedures for assessing the conformity of their products.
In-vitro diagnostics from List A or Class D, C, and possibly also B are tested for the following parameters as part of the clinical performance assessment before market launch (pre-market), taking into account the CTS / CS and the CLSI Guideline EP24-A2 and EP28-A3c:
- Diagnostic sensitivity:
This describes the probability that the product will produce a positive result if the target marker is present.
- Diagnostic specificity:
This describes the probability that the product will produce a negative result if the target marker is absent.
- Positive/negative predictive value:
This describes the ability of a product to separate true positive/negative results from false positive / negative results for a certain attribute in a certain population.
- Likelihood ratio (LR):
The LR indicates how the result of a diagnostic test affects the probability of a disease being present.
- Expected values in affected and unaffected population groups.
Biomex GmbH has many years of experience in validating IVDs in accordance with the current CTS / CS and supports manufacturers, for example, by providing the necessary reference samples and analysis data. As an option, we can also carry out the entire implementation of a clinical performance evaluation study, from planning and project planning, defining the study design, to monitoring the results, so that the prescribed evidence level of the study can be guaranteed right from the start.