analytical validation

analytical validation

The process of determining whether an assay detects the mutation it was designed to detect.
References in periodicals archive ?
The study showed the analytical validation of Epic Sciences' no cell left behind(TM) CTC platform for assay accuracy, linearity, specificity, precision and repeatability across assay runs and multiple operators.
SIVIDON s aim for the overall innovation project is to extend clinical and analytical validation data, to develop ChemoPredict as a CE-marked IVD test according to IVD directive 98/79/EC and to bring this test as a tool for personalized medicine into the European market.
For full analytical validation of a biomarker to be completed for use in Phase II or later, testing needs to occur from preclinical/Phase I exploratory stages.
Analytical validation requires proving that you can detect what you say you can detect.
With those established general guidelines in mind, we describe an approach for analytical validation of clinical sequencing assays.
The analytical validation of a new method should define the detection limits of the test and should also estimate its reproducibility, reliability, accuracy, sensitivity, specificity, and dynamic range.
FDA clearance requires clinical and analytical validation and reporting systems to ensure patient safety issues are addressed.
In brief, one must first validate a method for the detection of a biomarker, analytical validation, before validating the ability of the biomarker to flag the clinical event in question, clinical validation.
His main concepts are data pretreatment to detect outliers of various types and strategies for treating those found; and analytical validation, which assesses results using systematic and extensive comparison.
A secondary purpose is the analytical validation of existing and/or newly developed technologies for their usefulness in cancer detection.
The CE Mark is based on positive results from NanoString's first clinical validation study, as well as a recently completed multi-site analytical validation study.
On July 29, Corgenix will present two posters during the Infectious Disease session: poster B-074 " Analytical validation of the ReEBOV Antigen Rapid Test Kit for the point of care detection of Ebola Virus Disease ;" and poster B-072 " Preliminary validation of saliva samples as clinical matrix on the ReEBOV Antigen Rapid Test Kit for the point of care detection of Ebola Virus Disease.