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Standards Development
This document gives general requirements for interpretation and reports of multiplex molecular tests using IVD medical devices and laboratory developed tests (LDTs), including qualitative/quantitative detection of nucleic acid targets.
This document is applicable to all the methods that are used for IVD medical devices and LDTs that measure two or more nucleic acid targets of interest. This document is intended for multiplex assays that evaluate human nucleic acid targets, and detection of microbial pathogens in the background of human genome directly from clinical specimens.
The first generation of in vitro diagnostics (IVD) medical devices for nucleic acid-based molecular tests has been focused on detection or quantitation of a single biomarker of a given class (e.g., viral RNA, mRNA and genomic DNA) within a sample. Recently, devices are emerging based on a multiplex molecular test that simultaneously measures multiple nucleic acid sequences in a single reaction, and the development and clinical use of such IVD medical devices are rapidly expanding with the elucidation of clinical significance of the relevant biomarkers and technological advances. These assays use a variety of platforms and technologies, and measure both DNA and RNA targets. While the different technologies applied to multiplex molecular test may be different in the chemistry, basic principles for sample treatment, control strategy, data assessment, and reporting of the results are essentially the same, independent of any set of reagents in use. Laboratories can develop assays in-house (“home-brew, laboratory-developed”) or use commercially available multiplex assays involving a variety of technologies and instrument platforms. With the increase in the availability and use of multiplex assays, a guideline for the development, verification, validation, control, data analysis, interpretation and reports, and implementation of multiplex assays is needed to assist laboratories and manufacturers. For a multiplex nucleic acid test to reliably achieve its intended use, there must be control of the process from the acquisition of the sample and preparation of the nucleic acid for testing to the evaluation of the data and the reporting of the results. Multiplex molecular testing provides significant challenges to the laboratory with regards to appropriate verification and validation, acquisition of appropriate control materials, data analysis, interpretation and reporting. The complexity of data analysis, interpretation and reporting of results is increased relative to uniplex assays. The competition among reactions in multiplex assays may impose more stringent requirements for sample purity, sample input, reagents, and platforms to avoid nonspecific reactions and background signal. In comparison to single analyte assays, multiplex assays require an increased number of controls, more complex performance evaluation/data analysis algorithms, and more complex reporting of results. Implementation of multiplex molecular testing identifies large numbers of genetic variations, which are crucial for optimal patient care. Therefore, the international consensus about the method and the process of interpretation and reporting of results for the multiplex molecular testing is impedingly needed as a critical issue in the growing global market. It is imperative to standardize the interpretation and reporting of molecular results among laboratories performing these tests. This document provides recommendations for various aspects of interpretation and reporting of multiplex molecular testing, which can be applied to various technologies currently in use for multiplex molecular testing. This document is designed to assist medical laboratories in interpretation and reporting of results of multiplex molecular nucleic acid tests for diagnostic use. The interpretation and reporting of results that determines the decision-making and quality practice in patient care will therefore be defined for the multiplex molecular testing.
This international standard addresses improving reliability and authenticity of reports for multiplex molecular testing, and enables the uptake of emerging technologies in the growing market to improve the laboratory requirements and thus accurate patient diagnostic results.
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