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Quantitative Tests
Qualitative TestsMVs
MV Overview and Details
Experiment Design
Working with ExperimentsQualitative Experiments
QL Precision
QL Limit of Detection
QL Method Comparison
QL TruenessQuantitative Experiments
QNT Precision
QNT Limit of Blank
QNT Limit of Quantitation
QNT Linearity
QNT Method Comparison
QNT Reference Interval
QNT Carryover
QNT TruenessSettings
General SettingsQualitative Tests
A qualitative test determines the presence or absence of a substance or condition, providing results as positive, negative, or a category.
Overview
This section will cover:
- Quantitative Tests and information on their details.
- How to manage your quantitative tests.
Lab Juice
A Qualitative Test is a type of laboratory test used to determine the presence or absence of a substance or condition, rather than measuring its exact quantity. The results of qualitative tests are typically expressed in binary terms (e.g., positive/negative) or categorical terms (e.g., present/absent, type of microorganism identified).
These tests are essential in various medical and clinical settings for diagnostic purposes, such as detecting infections, identifying specific genetic markers, or determining the presence of drugs or toxins in a sample. Qualitative tests are often used for initial screening and diagnostic decision-making, providing crucial information that guides further quantitative testing and treatment.
Definitions
Name | Definition |
|---|---|
Actual | Actual represents the real-world value measured by the instrument being evaluated. |
Agreement | Whether two values, usually the actual and reference values acceptably agreeable, based on testing requirements and/or Error Allowance. |
Agreements | The total number of measurements between actual and reference value in agreement. |
Analyte | Substance or chemical constituent being measured or analyzed. |
Analyzer Display Name | 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. |
Disagreement | When two values, based testing requirements and Error Allowance are outside of acceptable agreement. |
Laboratory Developed Test (LDT) | A method developed by the laboratory or a regulator approved/validated method that has been modified. |
Manufacturer Claim | A performance metric for a test determined by the Manufacturer through Validation |
Manufacturer Insert | A document from the Manufacturer of a Test providing details on Manufacturer Claims, Procedures, warnings and any other considerations for testing. |
Method Validation | A systematic process to evaluate whether the performance of a medical Test meets quality goals to be used for medical testing. |
Method Verification | 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. |
Neg Label | A label used in a Qualitative test to express a that a sample does not have detectable levels of substrate |
Negative | Value from Qualitative or Semi-Quantitative set in Tests that expresses non-detection of the measured substrate. |
Pos Label | A label used in a Qualitative test to express a that a sample has detectable levels of substrate |
Qualitative Agreement | In Qualitative testing a matching pair of Actual and Reference Results are considered in Agreement |
Reference Value | The value/result that represents the true value from a trusted reference source such as a verified instrument, EQA, or a commercial product. |
Result(s) | A value or determination collected by measurement or calculation. |
Sample(s) | Individual specimens collected for testing representing the source. In MV experiments with Runs, this can refer to to the number of concentration levels used. |
Test | A Test is a process used to determine the presence or concentration of a substrate. |
Test Abbreviation | A concise, 12-character maximum shorthand for a test, such as ALT for Alanine Aminotransferase. |
Test Details | Information about a test relevant to the description, background and performance metrics. |
Test Systems | 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 |
Units | The standardized measurements used to express the quantity of a substance or the outcome of a test. |
Analyte
An Analyte is the substance or chemical constituent being measured or analyzed. This can include molecules like glucose, cholesterol, or more complex entities such as viral RNA or specific antigens, like those for COVID-19.
The term "analyte" is used broadly and does not differentiate based on the testing methodology, encompassing any target substance regardless of the specific analytical technique employed. There is subjectivity involved as the targets can be specific but refer to a larger group. For example, COVID as a test analyte may actually measure specific antigens or sequences.
Subscription Plans
Free Plan Limited to 1 location, department and analyzer
Core Lab Plan Can have 1 lab, unlimited departments and analyzers
Organization Plan -Coming Soon- Unlimited labs, departments, and analyzers
Add a Qualitative Test to an Analyzer
- Navigate to the Analyzer
- Select the Quantitative Tests Tab
- Select “Add a Test” which will direct your browser to the test adding form
- Fill out the required fields submit the form
Edit Test Information
To edit Test Information, navigate to the analyzer’s test list and select the test. An edit button will appear on the test information sidebar which will direct to the test editing form.
Test Information
To view Test Information, navigate to the analyzer’s test list and select it. A sidebar with the test information will appear with the details and performance characteristics.
The fields for test represent various details, performance characteristics and general information about the test needed for MV experiments and quality control.
Analyte
The Analyte field allows your test to be linked to an analyte. This means that you can search your tests for what analyte they measure even if they may have different test names or specific antigens. Typing in the Analyte field will search through the analyte libraries to select the correct match or add a new analyte.
Test Abbreviation
The Test Abbreviation is a required field and often used throughout Cualia as a shorthand for the test.
Neg and Pos Labels
The Neg and Pos Labels are used in your test when another terminology is more appropriate such as False/True or Not Detected/Detected.
Units
The test’s Units field shows what standardized measurement system the test uses. While it won’t affect the outcomes of MVs, it’s important to keep these set properly for clinical management of your lab.
In Quantitative Tests the field is required. In Qualitative tests the units field is optional, and part of Limit based MV experiments.
Externally Validated
The Externally Validated checkmark allows for entry about the validation that the test has already gone through. It is common for medical labs to acquire instrumentation that have already been validated by authoritative bodies such as the FDA or CE. Information on validation status will usually be offered by the manufacturer.
Minimum Detectable Concentration
Minimum Detectable Concentration (MDC) is the lowest concentration of an analyte that can be reliably detected by a test, distinguishing it from zero or background noise. It is a critical parameter in assessing the sensitivity of a test.
In Limit of Detection (LoD) MV experiments, MDC is verified to establish the test's ability to identify low levels of an analyte accurately.
Description
The test Description is an optional field to enter any general information about the test.
Delete a Test
To delete a test, enter the edit form for the test and select Delete Test. A confirmation modal will appear. After confirmation the test will be deleted and will redirect back to the analyzer.
FAQs
How many tests can my analyzer have?
An analyzer can have unlimited tests.
How will editing test fields affect MVs?
Cualia is designed to be robust and fulfill the requirements of a high throughput laboratory. Any changes made to a test will not affect any MVs regardless of approval status.
MV’s in progress will be able to import changes made to the analyzer’s test. Any test fields that do not match the state of the analyzer will show a purple border that allows you to sync the changes automatically.
