Clinical Laboratory Tests – Evaluation of analytical and preanalytical performance

Accurate, Reliable, Comprehensive: Evaluation of the analytical and preanalytical performance of clinical laboratory tests

Before the clinical utility of a medical laboratory test can be evaluated, it is first necessary to evaluate the analytical and preanalytical performance and characterize the test with regard to trueness, precision, sensitivity, and selectivity.

When the stakes are high, and there is a need for superior reliability in the data generated by measurements in the laboratory, QuoData helps you to regain confidence in your methods. 

What we provide

We provide comprehensive services for evaluation of the analytical and preanalytical performance of clinical laboratory tests.

Analytical and preanalytical performance is evaluated according to CLSI guidelines (Clinical and Laboratory Standards Institute) and modern experimental designs.

Due to our considerable experience and our role in international standardization, QuoData can offer valuable guidance regarding experimental design, the statistical model for the estimation of performance characteristics, and the application of assessment criteria. In particular, the use of highly efficient designs can considerably reduce the workload. 

Our services include 

• Design and statsitical evaluation of studies for evaluation of preanalytic conditions on test results.
• Design of method validation studies for laboratory tests. The design takes into account typical routine conditions in the lab and matrix-effects of the analyzed samples. 
• Statistical evaluation of results including calculation of method performance parameters such as
  • Trueness 
  • Precision: intra- and inter- assay
  • Limit of detection (LoD) 
  • Limit of quantification (LoQ) 
  • Measurement range (e.g. linear range)
  • Specificity / selectivity 
  • Robustness
• Interpretation of results and conclusions
• Reporting

Target audience

• Medical laboratories and clinical research laboratories
• Companies that develop laboratory tests/assays (e.g., in vitro diagnostics)