Sections

Welcome

The Organization

Getting Started

Definitions

App Updates

Analyzers

Quantitative Tests

Qualitative Tests

MVs

MV Overview and Details

Experiment Design

Working with Experiments

Qualitative Experiments

QL Precision

QL Limit of Detection

QL Method Comparison

QL Trueness

Quantitative Experiments

QNT Precision

QNT Limit of Blank

QNT Limit of Quantitation

QNT Linearity

QNT Method Comparison

QNT Reference Interval

QNT Carryover

QNT Trueness

Settings

General Settings

Experiment Design

Experiments are separated in the Qualitative and Quantitative test experiments.

Overview

Experiments are separated in the Qualitative and Quantitative test experiments. This section covers the general principles of how to set up and use Cualia experiments including selecting experiments, acceptance criterias, and data entry.

Lab Juice

MV Experiment are performed in MVs to evaluate the performance of laboratory methods, providing empirical evidence to confirm their accuracy and reliability. These experiments identify systematic and random errors, ensuring the methods meet necessary performance standards. They also facilitate regulatory compliance, as empirical validation is required to confirm adherence to established criteria. Comparative analysis during these experiments benchmarks new methods against reference standards, ensuring their reliability and accuracy.

Controlled experiments in MV are essential for maintaining quality control by ensuring the consistency and reproducibility of results. This process is vital for preserving the integrity of laboratory testing and ensuring high-quality patient care. Thus, MV experiments are fundamental for verifying the efficacy and reliability of laboratory methods, providing confidence in their performance and suitability for clinical use.

Qualitative Experiments

Qualitative Test Experiments, including Method Comparison (MC), Precision (Prec), Limit of Detection (LoD), and Trueness experiments, are essential for confirming the validation information provided in the manufacturer insert.

These experiments verify that the manufacturer's claims about the method's performance—such as accuracy, precision, detection limits, and trueness—are accurate and applicable in the specific laboratory's environment.

Quantitative Experiments

Quantitative Test Experiments confirm the performance characteristics claimed by manufacturers by evaluating precision, accuracy, sensitivity, and linearity. These experiments ensure that the method performs reliably under specific laboratory conditions, maintaining the integrity of test results.

Linearity and Reference Interval experiments assess the method’s accuracy across various concentrations and population groups. Trueness, Carryover, and Interference experiments further validate the method’s reliability in practical clinical scenarios.

By replicating these experiments, laboratories ensure that the method performs as described in the manufacturer insert, providing consistency and reliability. This process ensures regulatory compliance and builds confidence in the method’s suitability for clinical use.

Quantitative MV experiments verify that methods yield accurate and reproducible results, enhancing the quality and effectiveness of laboratory testing. This validation is essential for maintaining high standards of diagnostic accuracy and patient care.

Subscription Plans

Free Plan Each MV is limited to 3 tests and all experiments available.

Core Lab Plan Unlimited tests and experiments

Organization Plan -Coming Soon- Unlimited tests and experiments

Managing MV Tests

After starting the MV, the analyzer tests and all its information will automatically be available in the MV. To view the selected tests in the MV, navigate to the Experiment Design section of the MV and then the Quantitative or Qualitative Tests tab.

Using the Tests Selected dropdown you will be able to toggle whether the test should be included in the MV. The drag on the right side of each test allows the order of tests to be changed.

Deciding Which Experiments Need to be Performed

Deciding which experiments must be performed begins with reviewing the manufacturer's insert which will outline the Oftentimes the manufacturer insert will specifically use the same MV terms such as “LoD.” Focus on confirming these under your lab’s conditions and

It’s also important to consider clinical importance, analytes, and regulatory requirements. For example, the Limit of Blank (LoB) Experiment may not be required for RBC tests as human levels could never reach that low. Prioritize experiments addressing potential variances in your lab, and consult guidelines from bodies like the FDA, CLSI, and EMA to ensure thorough verification.

Managing Experiments

There are 2 ways to Manage Experiments: By test or by experiment.

Managing Experiments by Test

To Manage Experiments by test, navigate to the Experiment Design section of the MV and then to the Quantitative or Qualitative Tests section where the test resides.

In the test’s row, the Experiment Selection dropdown may be used to toggle whether the experiment will be included.

Manage Experiments by Experiment

To Manage Experiments by experiment, navigate to the Experiment Design section of the MV and then to experiments.

The experiment section allows for toggling of tests for each experiment. Each test can be selected individually or toggling the experiment itself will the experiment from all tests.

Overview the Status of Each Experiment

Getting an Overview of the Status of each experiment offers a quick glance method of seeing the whole state of the MV instead of clicking through individual files and PDFs. To access this view navigate to the Experimental Design section and then Experiments.

The toolbar above the sections allows to:

• View all experiment with a specific experiment state
• View all experiments by result type
• Expand/collapse all experiment blocks
• Search by keywords

Experiment States

Experiment States indicate the current condition of the experiment to give clean identifiers to their status. These identifiers may also be found on individual samples with replicates and runs.

Experiment State Descriptions

On this page

• Experiment Design
• Overview
• Lab Juice
• Qualitative Experiments
• Quantitative Experiments
• Subscription Plans
• Managing MV Tests
• Deciding Which Experiments Need to be Performed
• Managing Experiments
• Managing Experiments by Test
• Manage Experiments by Experiment
• Overview the Status of Each Experiment
• Experiment States
• Experiment State Descriptions