What is ISO 21474-1 about?
ISO 21474 discusses In vitro diagnostic medical devices on multiplex molecular testing for nucleic acids. ISO 21474-1 outlines provide the terms and general requirements for the evaluation of the quality of nucleic acids as the analytes for multiplex molecular tests, which simultaneously identify two or more nucleic acid target sequences of interest.
ISO 21474-1 is applicable to all multiplex molecular methods used for examination using in vitro diagnostic (IVD) medical devices and laboratory-developed tests (LDTs). It provides information for both qualitative and quantitative detection of nucleic acid target sequences.
ISO 21474-1 is also intended as guidance for multiplex molecular assays that detect and/or quantify human nucleic acid target sequences or microbial pathogen nucleic acid target sequences from human clinical specimens. ISO 21474-1 is applicable to any molecular in vitro diagnostic examination performed by medical laboratories.
Who is ISO 21474-1 for?
ISO 21474-1 on terminology and general requirements for nucleic acid quality evaluation is useful for:
- Manufacturers of medical devices
- Test laboratories and customers for medical devices
- Regulatory authorities
- In vitro diagnostics developers, biobanks, institutions, and commercial organizations performing biomedical research.
Why should you use ISO 21474-1?
The first generation of in vitro diagnostics (IVD) medical devices for nucleic acid-based molecular tests have been focused on the detection or quantitation of a single nucleic acid sequence (e.g., viral RNA, mRNA, or genomic DNA) within a clinical specimen. By comparison, a multiplex molecular test simultaneously measures multiple nucleic acid sequences of interest in a single reaction.
ISO 21474-1 guideline provides pre-analytical phase considerations, specimen quality considerations, nucleic acid quality considerations, nucleic acid quality for multiplex molecular tests, nucleic acid quantity, nucleic acid extraction, purification, and quality evaluation methods for terminology and general requirements for nucleic acid quality evaluation. This helps in improving the quality and safety for evaluating nucleic acid.
