An Approval Status for an MV where work is in progress. In this state the MV can be edited.

An Approval Status for an MV where the work is prepared and ready for evaluation by another laboratory member.

An Approval Status for an MV that has been approved by the lab and ready for audit by a regulatory assessor.

A 5 Day Test is a standardized procedure used for method validation/verification and experiments in clinical and medical laboratories. It involves performing 5 replicates/results in each of the 5 runs conducted over a course of 5 days to ensure precision and accuracy of the method.

In Semi-Quantitative testing, Acceptable Result Range represents Results that can be considered in Agreement with the Expected Result even if it is not a complete match. In Cualia you can set the Test Definition to adjust Acceptable Result Ranges for your Semi-Quantitative Tests.

Minimum requirements needed for a statistical representation to be considered valid.

Closeness of the Actual measured results to the Actual true value. This reflect the absence of systematic error.

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

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

The name of the Cualia member that performed the analytical testing

Substance or chemical constituent being measured or analyzed.

An instrument/kit from a Testing System that is used to perform Tests

The shorter human readable designation given to an analyzer used to distinguish it in common workplace discourse (eg Blue CBC)

This is primarily how your analyzer will be displayed while navigating in Cualia. Oftentimes in a laboratory setting, instrumentation will often go by a more casual name such as “Blue CBC” or “Chem 01” as opposed to a serial or model number.

A unique identifier for the analyzer. Usually the Serial Number provided by the manufacturer.

The name of the analyzer, usually the model's name provided by the manufacturer.

The status of an Experiment or MV. Either Drafting, Under Review or Approved.

The Mean of the Error Index's within a collection.

Comparison of Run replicate measurement(s) that occur on different runs/days. Other Names → Inter-Assay

The difference in Results when comparing laboratory Quantitative methods with established methods.

A sample of similar matrix to method's expected sample with none of the analyte present. Oftentimes this can be a zero standard from a calibrator.

Process of testing and adjusting an instrument or test system to establish a correlation between the measurement response and the concentration or amount of the substance that is being measured by the test procedure.

The assaying of materials of known concentration in the same manner as patient samples to substantiate the instrument or test system’s calibration throughout the reportable range for patient test results.

The effect of high concentration measurements on subsequent low concentration samples.

Measure of how much a high concentration sample influences the result of a subsequent low concentration sample. $\text{Carryover (\%)} = \frac{\text{Low Diff}}{\overline{\text{High}} - \overline{\text{ Low-Low}}} \times 100$ ${\overline{\text{High}}}$: Average of High results ${\overline{\text{Low-Low}}}$: Average of Low-Low results

An MV experiment used to evaluate the effect of high concentration testing on subsequent low concentration samples.

A result from a low sample tested directly after testing a high sample

The subtracted difference between the first and last Low Concentration samples. $\text{Low Diff} = \text{Low Rep 1} - \text{Low Rep 3}$

A result from a low sample tested directly after testing a low sample

Results where the difference is clinically insignificant and within allowable error ranges.

Range of analyte values that a method can measure, allowing for specimen dilution, concentration, or other pretreatment used to extend the direct analytical measurement range. The distinction between CRR and RR is that CRR may be up to the medical director's discretion of what range of results to report.

Ratio of the Standard Deviation of the Mean, often expressed as a percentage. See: CV%. It provides a relative comparison of the Standard Deviation independent of the size of the value. $\text{CV} = \frac{\sigma}{\mu}$ $\sigma$ = Standard Seviation ${\mu}$ = Mean

Coefficient of variation expressed as a percent

Cohen's Kappa is a statistical measurement of interrater reliability. It represents the statistical extent that collected data represents the variables measured, ie not chance.

Bias of the same amount that is seen throughout the range of a test

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

Cualia includes a library of analyzers, tests, analytes and TEas to include in your organization to get started quickly. General profiles of Laboratory Developed Analyzers can also be used as a template.

Days refers to the number of distinct days on which a test is repeated to assess the consistency of results over time.

Quantifies the agreement between two measurement methods, considering measurement errors. A maximum allowable difference from 1 is standard. $VR = \frac{Var(X) + Var(Y)}{Var(X - Y)}$ $Var(X)$ = Variance of X $Var(Y)$ = Variance of Y

A specialized division within a lab that focuses on particular types of tests or medical disciplines.

Statistically generated summary data used to represent the collection

When two values, based testing requirements and Error Allowance are outside of acceptable agreement.

directional change in Results obtained from a Test over a period of time/usage

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.

An indicator representing the relationship between values.

The type of error (TEa, SEa or REa) that will be used for calculating Error Index agreement between two results.

The proportion of the Bias to the Error Allowance. An Error Index must be between -1 and 1 to be considered in agreement.

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.

A process has already been through a recognized Validation process.

Test to measure the equality of two datasets

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.

This name will be used for report signing and will be the same across all organizations you are a member.

An MV experiment used to evaluate the effect of interfering substances on sample concentration measurements.

An Interfering Substance (IF) is an external or endogenous compounds that can alter the outcome of a laboratory test by affecting the test's reagents, analytes, or measurement process.

Lab Contact is the primary contact method of reaching a laboratory. This can be an email, phone number or name.

The general identification used to identify a specific Sample.

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

A specific location within the organization where laboratory tests and analyses are conducted.

A statistical technique for Method Comparison for measuring the correlation two paired Result sets.

A reference Level within a range to determine performance around that value.

An is the highest concentration of analyte detected for a blank sample. This can be determined through the LoB MV Experiment. $LoB=μ+1.645×σ$ $μ$: Mean of the results $σ$: Standar Deviation of results

An MV Experiment used to determine the lowest "reliable" value measured from a test

An MV Experiment used to determine the lowest amount of analyte that can be reliably determined.

A statistically calculated line in the notation of Y = mx + b that represents the linear relationship between two datasets

Linearity is an MV experiment to establish the correlation between Reference and Actual Results

LoQ Allowable Error (k) sets the LoQ precision by scaling the LoQ Reference Value. With a general standard of 10%, a higher value increases statistical confidence.

A calculated value from the LoQ Allowable Error % (k) and the LoQ Reference Value which returns the maximum TE result acceptable from an LoQ Experiment. $LoQ\ Allowable\ Error\ \% = Reference\ LoQ\ Value \times \frac{k}{100}$ Reference LoQ Value: The validated LoQ concentration determined during validation k: LoQ Allowable Error

The manufacturer stated LoQ determined through validation.

A specific identifier for a batch of Materials from a manufacturer

The name of the Testing System manufacturer that produced the instrument.

A performance metric for a test determined by the Manufacturer through Validation

A document from the Manufacturer of a Test providing details on Manufacturer Claims, Procedures, warnings and any other considerations for testing.

A material, such as a reagent, control, or calibrator used to execute a procedure or process

Average value amongst a sample group

Mean of all the Error Indexes calculated from a group of samples. A large distance from 0 can indicate a shift or Systematic error between the Actual and Reference result values.

Limiting values that are used to exclude or confirm membership in a particular clinical class or to warn of significant physiologic effects that are likely to occur when a particular analyze, (which is usually held in homeostatic control) reaches that value.

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 to be used for medical testing.

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 principle mechanism or technology utilized by a system such as Radio Immunoassay or RT-PCR.

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.

The minimum number of eligible samples required in order for the Reference Interval to be set. For a verification we recommend minimum 20 samples.

The lowest concentration of an analyte that can be reliably detected by a test, distinguishing it from zero or background noise.

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

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. $\text{NPV} = \frac{\text{TN}}{\text{TN} + \text{FN}} \times 100\%$

The initiation process to set up your user profile and organization’s lab details.

The top-level entity representing the overall institution, such as a hospital, clinic, or laboratory network.

Measures the strength and direction of the linear relationship between two measurement methods using Passing Bablok regression. A minimum absolute value of 0.95 is standard for strong correlation. $r = \frac{Cov(X, Y)}{Var(X) + Var(Y)}$ $Cov(X, Y)$ = Covariance of X and Y $Var(X)$ = Variance of X $Var(Y)$ = Variance of Y

Mathematical value expressing the linear correlation between paired Result sets (Actual Expected). Mathematically, it is defined as the quality of least squares fitting to the original data. Inputs: Two sets of of paired Results: Actual and Expected Outputs: Pearson Correlation Coefficient

Measures the strength and direction of a linear relationship between two variables. A minimum absolute value of 0.95 is standard for strong correlation. $r = \frac{Cov(X, Y)}{\sigma_X \sigma_Y}$ $Cov(X, Y)$ = Covariance of X and Y $σ_X$ = Standard Deviation of X $σ_Y$ = Standard Deviation of Y $Cov(X, Y) = \frac{1}{n-1} \sum_{i=1}^{n} (x_i - \bar{x})(y_i - \bar{y})$ $n$ = Number of data points $x_i$ = Individual data point of variable $Xy_i$ = Individual data point of variable Y $\bar{x}$ = Mean of variable X $\bar{y}$ = Mean of variable Y

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

The member’s role within an organization or laboratory such as Department Head or Lab Personnel

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

An experiment that evaluates Random Error through replicate measurements across concentration levels.

Bias that can be increased or decreased in different amounts but in consistent proportion depending on the concentration

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 systematic process and documentation of efforts to reach or maintain Quality Standards.

Defined Quality objective/target/goal/criteria for the laboratory to meet.

A Test Result Type that produces Results as a numerical value within a Range.

Quantitative Agreement uses Error Allowance as TEa or its counterparts REa, SEa, or a Custom Error rate. Actual and Expected are in Agreement when the Bias between the Results is less than the Error Allowance and the Error Index is less than 1.0

R-squared is a statistical measure that represents the proportion of the variance in the dependent variable that is explained by the independent variables in a regression model. It ranges from 0 to 1, with higher values indicating a better fit. Usually >0.95 is considered statistical correlation. $R^2 = 1 - \frac{\sum_{i=1}^{n} (y_i - \hat{y}i)^2}{\sum{i=1}^{n} (y_i - \bar{y})^2}$ $R^2$ = Coefficient of determination $y_i$ = Observed value $\hat{y}_i$= Predicted value $\bar{y}$ = Mean of observed values $n$ = Sample size

The maximum amount of Random Error allowed for two results to be in agreement

An error in measurement caused by factors which vary from one measurement to another.

The Range between the lowest and highest value

Range of values from lowest to highest that was measured within a group of samples.

The range of values that includes the central 95% of a healthy population's test results. It is derived from a large sample of healthy individuals to ensure accuracy and reliability. It is often considered the normal range of results for a healthy person.

An experiment used to determine the normal ranges for a test within populations measured by the laboratory

Classifications used to segment reference intervals based on specific characteristics of the population such as age or gender.

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.

An organization or government agency responsible for offering accreditation or qualifications for medical laboratory testing.

Multiple tests on the same sample to assess precision and repeatability, conducted within a run or across multiple runs.

An MV report documents analyzer details, tests, and results for submission to accreditation bodies.

Analytical range at which a method's results is verified. A Linearity experiment is used to determine this range. Reportable range means the span of test result values over which the laboratory can establish or verify the accuracy of the instrument or test system measurements response.

The type of result, either Qualitative, Semi-Quantitative, or Quantitative that Test Result can offer.

A value or determination collected by measurement or calculation.

In MV experiments, the Results Per Day is the number of replicate measurements that will be taken per day.

The percent of the population results that must be within the Reference Interval for it to be confirmed. We recommend a 95% to match with statistical confidence intervals for populations.

The ability of a test to maintain performance standards when in non-optimal measurement conditions.

A sequence of measurements on a set of samples under the same conditions, performed within a defined time period.

The sample correlation coefficient (R) quantifies the strength and direction of the linear relationship between two variables based on sample data. A min value of 0.95 is standard. $R = \sqrt{r^2}$ $r^2$ = Coefficient of Determination

The size/count of the collection.

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

Can describe the specific Sample Type, source and/or medium that is used to collect and/or store the sample.

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

An XY plot of two corresponding datasets where point are plotted as individual points on their XY scale. The Scatter Plot may also include lines as guide markers.

A Result Type that can be definable as a set of possible options.

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

A statistically calculated line in the notation of Y = mx + b that represents the linear relationship between two datasets. $y = mx + b$ $m = \frac{n(\sum xy) - (\sum x)(\sum y)}{n(\sum x^2) - (\sum x)^2}$ $b = \frac{\sum y - m \sum x}{n}$ m: The slope of the line, which indicates how much y changes for a unit change in x. b: The y-intercept of the line, which is the value of y when x=0. n: The number of data points or observations in the dataset. x: The independent variable values in the dataset. y: The dependent variable values in the dataset.

Measures the strength and direction of a monotonic relationship between two variables. A minimum absolute value of 0.95 is standard for strong correlation. $p = 1 - \frac{6 \sum d_i^2}{n(n^2 - 1)}$ $d_i$= Difference between ranks of X and Y $n$ = Number of pairs

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

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

Statistical measure of the amount of variation from the mean. $\sigma = \sqrt{\frac{1}{n-1} \sum_{i=1}^{n} (x_i - \bar{x})^2}$ σ = Standard Deviation n = Sample Size $x_i$ = Individual data point $\bar{x}$ = Mean

Difference between two methods are random, and can exceed TEas, but are considered statistically the same.

A set of experiments performed to validate/verify a test procedure.

The total of a collection with all values added together

A consistent, predictable error that skews results in a specific direction. Systematic errors affect the accuracy of the test results, leading to a consistent deviation from the true value.

Acceptable shift across the detectable range of a test in a single direction.

A Test is a process used to determine the presence or concentration of a substrate.

A concise, 12-character maximum shorthand for a test, such as ALT for Alanine Aminotransferase.

Information about a test relevant to the description, background and performance metrics.

A Testing System is a product, model, system or a developed process/method used in the medical laboratory setting for performing analysis of clinical samples. This can represent a system offered a Manufacturer or an LDT

Range between the lowest and highest concentrations of an analyte that a test can accurately measure without dilution or concentration.

The set limit of combined REa and SEa tolerable for a single result. It represents the error range around an Expected result that can be considered in Agreement to an Actual result. TEa = REa + SEa

Total Error for LoQ represents the calculated error at the low concentration. $TE=σ+2×Bias$ σ: Standard Deviation of the results Bias: Difference between mean of samples and reference value

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.

Trueness is an MV Experiment that evaluates the performance of a test by comparing sample test results with true values. Usually an EQA.

The standardized measurements used to express the quantity of a substance or the outcome of a test.

A statistical technique for Method Comparison for calculating a line of best fit Line of Best Fit fit between to two paired Result sets.

Combined Results across Runs of the same Level on the same run, day or time period. Oftentimes a run load volume can be instrument specific and “Within Day” is commonly used. Other Names → Intra-Assay

Number of Standard Deviation's a value is from the Expected Means.