Actual represents the real-world value measured by the instrument being evaluated.

Whether two values, usually the actual and reference values acceptably agreeable, based on testing requirements and/or Error Allowance.

The percentage (%) of paired Results within Agreement amongst the number of Samples measured. $\text{Agreement \%} = \left( \frac{\text{Results in Agreement}}{\text{Total Number of Comparisons}} \right) \times 100$

The total number of measurements between actual and reference value in agreement.

Samples that provide the necessary information for statistical calculations to be performed. Usually this is possessing both an actual and expected result.

A specimen provided by an external quality assessment organization to participating laboratories for testing. The results from these samples are used to evaluate the laboratory's performance and accuracy by comparing it against a benchmark or other participating laboratories.

A sampling of results that are statistically analyzed and interpreted in the evaluation of testing performance.

External Quality Assessment (EQA) evaluates a laboratory's performance by comparing its results with other labs through external sample testing. This ensures accuracy and consistency in diagnostic testing.

The number of false negative results where the test incorrectly missed the presence of the substrate when compared to the reference method.

The number of false positive results where the test incorrectly detected the presence of the substrate when compared to the reference method.

The general identification used to identify a specific Sample.

An MV experiment used to estimate the systematic difference on the basis of the differences observed between the methods. See: QL Method Comparison

A systematic process to evaluate whether the performance of a medical Test meets quality goals set by a validation. Performance evaluations may usually be found in a manufacturer insert.

The minimum percentage of agreement required between the test results and the reference results from the acceptance criteria for the experiment to pass.

An Acceptance Criteria of the minimum number of eligible samples required in order for the evaluation’s requirements to be fulfilled.

A label used in a Qualitative test to express a that a sample does not have detectable levels of substrate

Value from Qualitative or Semi-Quantitative set in Tests that expresses non-detection of the measured substrate.

The proportion of negative test results that are true negatives. $\text{NPV} = \frac{\text{TN}}{\text{TN} + \text{FN}} \times 100\%$

A label used in a Qualitative test to express a that a sample has detectable levels of substrate

Values Qualitative or Semi-Quantitative set in Tests that can express a Result that indicates a Positive Result.

The probability that a Positive Result indicates the Expected analyte Result is a positive. $PPV = \frac{TP}{TP + FP}$

A Result Type for a Test that can only have two possible options

In Qualitative testing a matching pair of Actual and Reference Results are considered in Agreement

Reference methods are well-established, highly accurate, and precise analytical procedures used as standards to evaluate the performance of other methods.

The value/result that represents the true value from a trusted reference source such as a verified instrument, EQA, or a commercial product.

A value or determination collected by measurement or calculation.

Individual specimens collected for testing representing the source. In MV experiments with Runs, this can refer to to the number of concentration levels used.

The ability of the test to correctly identify true positives. $\text{Sensitivity} = \frac{\text{TP}}{\text{TP} + \text{FN}} \times 100\%$

The ability of the test to correctly identify true negatives. $\text{Specificity} = \frac{\text{TN}}{\text{TN} + \text{FP}} \times 100\%$

The number of true negative results where the test correctly identified the absence of the substrate when compared to the reference method.

The number of true positive results where the test correctly detected the presence of the substrate when compared to the reference method.

An Acceptance Criteria of the minimum number of eligible samples required in order for the evaluation’s requirements to be fulfilled.

The minimum percentage of agreement required between the test results and the reference results from the acceptance criteria for the experiment to pass.

Individual specimens collected for testing representing the source. In MV experiments with Runs, this can refer to to the number of concentration levels used.

Whether two values, usually the actual and reference values acceptably agreeable, based on testing requirements and/or Error Allowance.

The total number of measurements between actual and reference value in agreement.

The percentage (%) of paired Results within Agreement amongst the number of Samples measured. $\text{Agreement \%} = \left( \frac{\text{Results in Agreement}}{\text{Total Number of Comparisons}} \right) \times 100$

The number of true positive results where the test correctly detected the presence of the substrate when compared to the reference method.

The number of true negative results where the test correctly identified the absence of the substrate when compared to the reference method.

The number of false positive results where the test incorrectly detected the presence of the substrate when compared to the reference method.

The number of false negative results where the test incorrectly missed the presence of the substrate when compared to the reference method.

The ability of the test to correctly identify true positives. $\text{Sensitivity} = \frac{\text{TP}}{\text{TP} + \text{FN}} \times 100\%$

The ability of the test to correctly identify true negatives. $\text{Specificity} = \frac{\text{TN}}{\text{TN} + \text{FP}} \times 100\%$

The proportion of negative test results that are true negatives. $\text{NPV} = \frac{\text{TN}}{\text{TN} + \text{FN}} \times 100\%$

The probability that a Positive Result indicates the Expected analyte Result is a positive. $PPV = \frac{TP}{TP + FP}$