Diagnostic Validation
Diagnostic Validation - Related Videos
09:57
Development and Validation of a Quantitative PCR Method for Equid Herpesvirus-2 Diagnostics in Respiratory Fluids
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Cited by 11 •
2016
Here, we present a protocol for the development and validation of a quantitative PCR method used for the detection and quantification of EHV-2 DNA in equine respiratory fluids. The EHV-2 qRT-PCR validation protocol involves a three-part procedure: development, characterization of qRT-PCR assay alone, and characterization of the whole analytical method.
10:42
Design to Implementation Study for Development and Patient Validation of Paper-Based Toehold Switch Diagnostics
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Cited by 7 •
2022
Access to decentralized, low-cost, and high-capacity diagnostics that can be deployed into the community for decentralized testing is critical for combating global health crises. This manuscript describes how to build paper-based diagnostics for viral RNA sequences that can be detected with a portable optical reader.
01:29
Reliability and Validity
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2020
Reliability and validity are two important considerations that must be made with any type of data collection. Reliability refers to the ability to consistently produce a given result. In the context of psychological research, this would mean that any instruments or tools used to collect data do so in consistent, reproducible ways. Unfortunately, being consistent in measurement does not necessarily mean that you have measured something correctly. To illustrate this concept, consider a kitchen...
10:21
Microfluidic Applications for Disposable Diagnostics
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Cited by 1 •
2008
In this interview, Dr. Klapperich discusses the fabrication of thermoplastic microfluidic devices and their application for development of new diagnostics.
21:15
Diagnostic Necropsy and Tissue Harvest
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2016
Source: Kay Stewart, RVT, RLATG, CMAR; Valerie A. Schroeder, RVT, RLATG. University of Notre Dame, IN Many animal experiments rely on final data collection time points that are gathered from the harvesting and testing of organs and tissues. The use of appropriate methods for the collection of organs and tissues can impact the quality of the samples and the analysis of the data that is gleaned for the testing of the tissues. The method of euthanasia of the animal can also impact the quality of...
FAQs
Using a reference method or clinically characterized samples gives the test results a comparison point. Investigators can then determine whether the assay agrees with an established result and identify discrepancies that may reflect analytical limitations or specimen-related problems. This evidence supports judgments about whether the test is suitable for its intended clinical use.
Accuracy, precision, analytical sensitivity, specificity, and reproducibility address different aspects of assay performance. Accuracy concerns agreement with the appropriate comparison, whereas precision concerns consistency of repeated results. Sensitivity and specificity describe detection performance, and reproducibility examines consistency under defined conditions. Considering them together prevents a single favorable metric from determining assay suitability.
Because performance is established under defined conditions, changing specimen type, workflow, instrument, operator, or clinical setting can affect whether results remain consistent. Validation therefore examines potential sources of error in the conditions where the assay will be used. This context helps laboratories judge whether observed performance is transferable to routine testing.
A laboratory first defines intended use and testing conditions, then evaluates assay results against reference methods or clinically characterized samples. It assesses accuracy, precision, analytical sensitivity, specificity, and reproducibility, while reviewing specimen, workflow, instrument, operator, and error considerations. The resulting evidence is used to decide whether the assay performs consistently enough for its planned clinical role.
Validation evidence is especially relevant when selecting an assay, establishing quality assurance, supporting regulatory review, or deciding whether a test is appropriate for patient-related use. The process connects measured analytical performance with the assay’s intended purpose, such as identifying disease, guiding treatment, or monitoring health. It therefore informs decisions beyond instrument-level measurement alone.
Reliable validation findings help laboratories determine whether results can be produced consistently across instruments, operators, and clinical settings. That consistency matters when results are used to identify disease, guide treatment, or monitor health. By exposing performance limitations and possible error sources before routine use, validation contributes to assay selection and safer clinical decision-making.