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Establishment of control ranges and target values

The routine analysis of controls with known concentrations is a valuable tool for the acceptance of test runs and to validate that analyzed sample concentrations are in fact repeatable and reproducible at your laboratory. Mercodia can assist you to establish a control program, with target values and acceptance ranges for your control material.

  1. Pool samples (serum or plasma) with low, intermediate and high analyte levels. 
  2. Aliquot each control level and store in -20°C. 
  3. Run each control level at 12-20 separate occasions: 
    • Preferably by different operators and with different batches of the method for all error factors to be included. 
    • Run in as many replicates (for example duplicates or triplicates) as you intend to run your samples. 
  4. Determine the mean (target) value and intra, inter and total assay variations (SD) for example by a one-way ANOVA. 
  5. Establish the range from the total variation (mean +/- SD): 
    • SD (total variation) is usually multiplied with a factor 2 (for 95% confidence interval) or 3 (for 99% confidence interval). 
When monitoring controls, these ranges are used to verify if a run is accurate.If your controls are within these established acceptance ranges your test run is considered accurate. 

You may also send your results from your control measurements to us and we will help you with establishing control range and target values. Excel sheet for reporting of your measurement results will be provided by Mercodia. Contact us here.