Sentence examples for analytically validated from inspiring English sources
Such analytically validated assays require only validation against clinical data to be approved as IVDs, and are termed IVD candidates.
As a part of the clinical qualification effort, the study here is aimed to provide justification for prospective validation of the upgraded and analytically validated automated BSI as a first quantitative imaging biomarker that can add clinical value to the treatment management of the mCRPC patients.
have an analytically validated assay for its measurement, have undergone validation for addressing a specific clinical problem, have been shown to have clinical utility such as improving patient outcome, enhancing quality of life, or reducing cost of care, have a cost-effective assay, and be a target for therapy.
The 12 RT-qPCR assays and associated processes were therefore analytically validated using pre-defined performance criteria prior to clinical validation of the RS.
At the time the Onco type DX Breast Cancer Assay was analytically validated there was no widely accepted standard for multi-analyte RT-PCR tests.
Indeed, successful clinical validation may be challenging unless the biomarker is based on a robust, analytically validated platform.
The multi-step approach for analytically validating the performance of this system is presented.
To analytically validate the proposed performance index, a six story three-dimensional structure is considered as an example with a fully active tendon controller system implemented in one direction of the building.
The aim of this study was to analytically validate the applicability of I-FISH in assessing 9p deletion in ccRCC and to clinically assess its long-term prognostic impact following surgical excision of ccRCC.
The experimental design for analytically validating the precision of the assay from RNA was based on Clinical Laboratory and Standards Institute (CLSI) guidelines for the evaluation of precision of in vitro diagnostic devices outlined in EP05-A2 [ 25].
The experimental design for analytically validating the reproducibility from tissue was based on CLSI guidelines for the evaluation of precision of in vitro diagnostic devices outlined in CLSI EP05-A2.
