What are clinically validated biomarkers and how they make research data robust

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.

Being clinically validated means:

• Our values match clinical lab results: When measuring a particular sample, our NMR platform gives corresponding values for clinical biomarkers (like glucose) to any other clinical methods (photometric or enzymatic methods). So, if you take two aliquots from the same sample and send one to a regular hospital laboratory and one to us, you’ll get matching values from both the labs.
  
• Batch effect free: No matter how many samples you analyse using our platform, you’ll get uniform results for all your samples.

How clinically validated biomarkers support your research?

• No systemic bias, well-suited for big cohorts: In big projects, which typically use more than one clinical laboratory to analyse their samples, you often see variations in the results delivered by the different labs. So, say, you are interested in routine clinical measurements like glucose and cholesterol, and to save time, you are using 3 different labs to get your samples analysed. When the data finally arrives, you realise that Lab 1 has a systematic bias in cholesterol compared to Lab 2 and 3, while Lab 3 has systematically lower glucose values. Such variations can be extremely infuriating and problematic. However, with our clinically validated biomarkers, such a bias would not arise. You’ll get uniform data for all your samples no matter how big or small the cohort size is.
  
• Saves time, cost and sample material: NMR is a fast and cost-effective technology that provides high-throughput broad-spectrum analysis. So, you can send all your samples to us at once and receive data on our full panel for each sample, including routine clinical biomarkers. Since our measurements are optimised to match clinical chemistry values, you can also skip clinical chemistry analysis and save more costs and time as well as sample material.

Quality certified and controlled like clinical labs 

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. 

How our biomarkers are validated: 

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:  

• bias when compared to the standard reference material, and metrological traceability of calibration; 
• method comparison to at least one external accredited laboratory;  
• repeatability and stability;  
• functional sensitivity (Limit of Quantification);  
• linearity and measuring range. 

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.

How the data quality is monitored by the authorities:

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:

• monitor the performance of each device, between devices and between laboratory sites,
• assess performance with respect to external laboratories, and
• monitor performance over short and longer time periods.

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?