A common question we get about our biomarker panel data is regarding the 37 clinically validated CE-marked biomarkers. Here’s a quick note on what "clinically validated biomarkers" means and how it increases the reliability and validity of your research results.
One of the core tenets of all scientific research is reproducibility. So, if the same samples generate different results every time when they are measured by a different lab, then the biological signals will remain obscure, or worse, get lost.
Even though the NMR technology is inherently free from batch effects, there are strict quality control measures in place to ensure there is no variation in results.
In fact, our methods and measurements are validated and controlled in the same way as any other clinical laboratory.
Our method is validated by evaluating the analytical performance of the measurement procedure for each validated biomarker.
1. The performance characteristics for each validated biomarker include:
2. The individual validation protocols follow the CLSI (Clinical and Laboratory Standards Institute) guidelines, as well as fulfil the requirements of BS EN 13612 that applies to the performance evaluation of In vitro diagnostic medical devices (IVD).
3. Biomarkers that fulfil these pre-set criteria and present acceptable performance are then considered successfully validated.
1. We are regularly evaluated under various External Quality Assurance (EQA) programmes, where they send us blind samples. The EQA then evaluates our measurements and verifies that they are comparable to other clinical laboratories.
2. Nightingale’s quality management system is based on compliance with EN ISO 13485:2016, SFS-EN ISO/IEC 17025:2017, and SFS-EN ISO 15189 (2013) –– all of which have set requirements for quality assurance.
3. Nightingale's quality assurance is designed to fulfil the following requirements:
4. Compliance is verified in audits performed by external parties, for instance like Dekra for certification of our quality management system according to EN ISO 13485:2016, and FINAS for accreditation of Nightingale according to SFS-EN ISO/IEC 17025:2017.
Interested in knowing more about our biomarker panels for research?