COVID-19 support resources Useful resources for customers developing diagnostic tests for COVID-19

We are receiving a lot of questions about relevant statistical analyses in the Analyse-it Method Validation edition to help in evaluating new diagnostic tests for COVID-19. Below are some quick links to documentation about these tests, with links to examples showing how Analyse-it can help with the statistical analysis.

If you want to use our software you can download a free trial at Analyse-it Method Validation edition free trial.

• Diagnostic accuracy (CLSI EP12-A2)
  See Sensitivity/Specificity, Predictive values, Estimating the sensitivity and specificity of a binary test and Comparing the accuracy of two binary diagnostic test.
  
  EP12-A2 Example: Sensitivity specificity of 2 diagnostic tests
  
• Detection capability of molecular methods (CLSI EP17-A2)
  See detection capability of molecular methods using Probit analysis, see: Estimating the detection limit using a Probit fit and may be useful for determining the cutoff of a method with an internal continuous response see: Estimating the detection limit of a measurement system and Estimating the detection limit of a measurement system using a precision profile.
  
  EP17-A2 Example 1:
  LoB and LoD EP17-A2 Example 2:
  LoD from precision profile EP17-A2 Example 4:
  Probit detection limit
  

Recent relevant blog posts

• Sensitivity/Specificity and The Importance of Predictive Values for a COVID-19 test
• Why the diagnostic test 'accuracy' statistic is useless
• COVID-19: Establishing the diagnostic accuracy (sensitivity/specificity) of a test using Analyse-it
• Diagnostic accuracy (Sensitivity/Specificity) versus Agreement (PPA/NPA) statistics
• COVID-19: Calculating PPA/NPA agreement measures using Analyse-it
• COVID-19: Calculating the detection limit for a SARS-CoV-2 RT-PCR assay using Analyse-it

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