What is CEN/TS 17626 about?
CEN/TS 17626 specifies requirements and gives recommendations for the pre-examination phase of human specimens. This includes stool, saliva, skin and urogenital specimens, intended for microbiome DNA examination. The pre-examination phase includes but is not limited to specimen collection, handling, transport, storage, processing, isolation of DNA, and documentation.
International, national, or regional regulations or requirements can also apply to specific topics covered in CEN/TS 17626.
Note: Different dedicated measures are taken for pre-examination processes for infectious disease examination and for microbiome DNA examination from tissue. These are outside of the scope of CEN/TS 17626.
Who is CEN/TS 17626 for?
CEN/TS 17626 on molecular In vitro diagnostic examinations are applicable to:
- Medical laboratories
- Laboratory customers
- Vitro diagnostics developers and manufacturers
- Biobanks
- Institutions and commercial organizations performing biomedical research
- Regulatory authorities
Why should you use CEN/TS 17626?
The collection of human specimens is a crucial part of in vitro diagnostic examinations. CEN/TS 17626 specifies recommendations for the pre-examination phase of microbiome DNA testing. As a result, the test results of microbiome DNA studies become more reliable and credible.
CEN/TS 17626 provides standard procedures for collecting the human specimen which is important in the prevention and detection of diseases. In vitro diagnostics may also be used in precision medicine to identify patients who are likely to benefit from specific treatments or therapies.
