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Validating a new assay

Validating a new assay


The results of the analytical validation or verification determine whether, and how, the test will be implemented and set the requirements for performance monitoring ongoing validation of the test. Check if you have access through your login credentials or your institution. Before introducing any new test into the clinical laboratory, the performance characteristics of the assay must be "verified," if it is a US Food and Drug Administration FDA -approved or FDA-cleared test, or "validated," if it is a laboratory-developed test. The key components of the process, as detailed by the ACCE framework, are analytical validation, clinical validation, clinical utility and consideration of the ethical, legal and social implications of the test. In the age of point-of-care instrumentation, issues of quality control and test validation are no longer restricted to clinical laboratories, but now fall upon the responsible clinician. Many laboratories, especially those introducing new types of molecular assays, would welcome additional guidance, especially in the form of specific examples, on the process of preparing a new molecular assay for clinical use. We describe implementation processes, types of tests and their key validation components, and suggest some relevant statistical approaches that can be used by individual laboratories to ensure that tests are conducted to defined standards. This paper outlines the principles of validation and verification in the context of clinical human molecular genetic testing. The final stage of the laboratory process is to determine whether the performance of the test, in terms of accuracy, meets the required diagnostic standards. Consultation between a clinical laboratory and clinicians is often necessary to determine the acceptability of the data generated; successful test validation produces a reference interval, test sensitivity and specificity, or receiver operating characteristic curve that is medically useful.

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Validating a new assay. A standardized framework for the validation and verification of clinical molecular genetic tests.

Validating a new assay


The results of the analytical validation or verification determine whether, and how, the test will be implemented and set the requirements for performance monitoring ongoing validation of the test. Check if you have access through your login credentials or your institution. Before introducing any new test into the clinical laboratory, the performance characteristics of the assay must be "verified," if it is a US Food and Drug Administration FDA -approved or FDA-cleared test, or "validated," if it is a laboratory-developed test. The key components of the process, as detailed by the ACCE framework, are analytical validation, clinical validation, clinical utility and consideration of the ethical, legal and social implications of the test. In the age of point-of-care instrumentation, issues of quality control and test validation are no longer restricted to clinical laboratories, but now fall upon the responsible clinician. Many laboratories, especially those introducing new types of molecular assays, would welcome additional guidance, especially in the form of specific examples, on the process of preparing a new molecular assay for clinical use. We describe implementation processes, types of tests and their key validation components, and suggest some relevant statistical approaches that can be used by individual laboratories to ensure that tests are conducted to defined standards. This paper outlines the principles of validation and verification in the context of clinical human molecular genetic testing. The final stage of the laboratory process is to determine whether the performance of the test, in terms of accuracy, meets the required diagnostic standards. Consultation between a clinical laboratory and clinicians is often necessary to determine the acceptability of the data generated; successful test validation produces a reference interval, test sensitivity and specificity, or receiver operating characteristic curve that is medically useful.

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    The key components of the process, as detailed by the ACCE framework, are analytical validation, clinical validation, clinical utility and consideration of the ethical, legal and social implications of the test. Many laboratories, especially those introducing new types of molecular assays, would welcome additional guidance, especially in the form of specific examples, on the process of preparing a new molecular assay for clinical use.

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