Method Validation or Correlation The Mislabeled Specimen Laboratory Calculators Statistics
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Method Validation (Correlation)

Determine the validity or correlation of recovered values of an analyte with a new method in comparison to the reference method.

CLIA Recommendation: Must be done to determine the correlation factor between two methodologies.

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Method A (New Method):
Analyzer:  

Method B (Comparison Method):
Analyzer:  


Enter up to 30 values below:

Method A































Method B



















































Number of Samples:
Range of Observation
Correlation Coefficient(r):
New Method Mean:
Comparison Method Mean:
Average Difference:
Slope:
Y-intercept:
Interpretation:


Correlation Graph

%Difference Plot

Definition of Terms:

Method validation is the process used to confirm that the analytical procedure employed for a specific test is suitable for its intended use. Results from method validation can be used to judge the quality, reliability and consistency of analytical results; it is an integral part of any good analytical practice.

Formula:

n = Number of points or dilutions
x-axis = Comparison or reference method
y-axis = New method
sumxy = sum of the products of the target & recovered values of a certain dilution
sumx = sum of all target values
sumy = sum of all recovered values
sumx2 = sum of all the squares of target values
sumy2 = sum of all the squares of recovered values
slope = ((n * sumxy) – (sumx * sumy))/((n * sumx2) – (sumx 2))
intercept = sumy – (slope * sumx)/n
correlation coefficient = ((n * sumxy) – (sumx * sumy)) / (((n * sumx2) – sumx2 * ((n * sumy2) – sumy2)0.5

Passing Criteria:

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  • Slope should be greater than 0.5
  • Slope should be less than 1.5
  • Correlation Coefficient should be equal or greater than 0.7

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