A value or determination collected by measurement or calculation.

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

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

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

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

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 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.

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

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

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

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

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

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

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

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.

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

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

A prepared sample, often using a Blank that has been "spiked" with a measurable analyte.

A broad term that can be used synonymously with Performance Evaluation, Method Validation and/or Method Verification.

The original source of the Sample such as Sample, EQA, or the name of the Manufacturer.

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

The general identification used to identify a specific Sample.

A systematic process to evaluate whether the performance of a medical Test meets quality goals to be used for medical testing.

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

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

A Quality Control material, usually developed by a manufacturer, with a known Expected Result used for monitoring Test performance.

A method developed by the laboratory or a regulator approved/validated method that has been modified.

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

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. $\text{Agreement \%} = \left( \frac{\text{Results in Agreement}}{\text{Total Number of Comparisons}} \right) \times 100$ See: Agreements

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

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. $\text{Agreement \%} = \left( \frac{\text{Results in Agreement}}{\text{Total Number of Comparisons}} \right) \times 100$ See: Agreements

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. $PPV = \frac{TP}{TP + FP}$