Mean
In TEa mode, agreement is determined through calculation between the Actual and Reference result based on the experiment setting (TEa, SEa or REa).
The bias and %bias are calculated and used with the TEa to determine the Error Index value. If the Error Index value between -1 and 1, the Actual and Reference result are considered in agreement.
There are two TEa values, one in units and one in a percent. Both TEas will have the Error Index calculation performed and the lowest one will be used for determining experiment agreement.
Let’s say we are calculating the agreement for Glucose test result, which has a TEa from CLIA of:
CLIA TEa for Glucose: ±6 mg/dL or ±8%
For this glucose test we use a control with a reported value of 120 mg/dL. This is the reference value. Running the test, we get an actual result of 129 mg/dL.Before calculating agreement, the Bias must first be calculated to determine the difference between actual and expected.
In this case our Bias is 9 mg/dL and our %Bias is 7.5%. Even though Bias of 9 mg/dL exceeds the ±6 mg/dL TEa, the %Bias of 7.5% < 8%, so actual and reference are in agreement.
Use an error allowance to determine the agreement between measured and reference values. This is useful for evaluating an instrument with the same expected measurements as the reference. You may set the following minimum values for passing.