In order to strengthen the specification and guidance of the second-generation sequencing technology detection reagents, and further ensure and improve the quality of related products, the China Food and Drug Administration Research Institute (the Central Inspection Institute) has organized the "General Technical Guidance for the Quality Assessment of Second Generation Sequencing Technology Detection Reagents". The Principles are now published.
This document is the first quality evaluation technical guideline issued by the Central Procuratorate. It aims to standardize the key aspects of product design, R&D and verification, thus effectively ensuring product quality. The general technical guidelines issued this time provide guidance for the quality control of related products, and are widely applicable to various second-generation sequencing technology detection reagents, which is conducive to the development of the industry.
The guiding principles are mainly for the quality requirements of the second generation sequencing (NGS) technology detection reagent (hereinafter referred to as "NGS detection reagent"), covering basic principles, main raw materials, testing procedures and performance evaluation.
The guidelines apply to the quality assessment of detection reagents based on NGS technology. The intended use of NGS detection reagents includes, but is not limited to, the following: clinically relevant applications such as tumor-related gene abnormalities, genetic disease-related gene abnormalities, pre-implantation chromosome aneuploidy, fetal chromosome aneuploidy, and pathogenic microorganisms. The NGS technologies involved in such detection reagents include targeted sequencing and non-targeted sequencing: targeted sequencing refers to partial sequencing of the genome in the sample, such as target gene sequencing , exon (group) sequencing, etc.; Non-targeted sequencing refers to the sequencing of the genome of a potential organism in a sample. In principle, enterprises are not recommended to use whole-genome sequencing for detection. If enterprises apply whole-genome sequencing technology, sufficient technical applicability should be verified and submitted for reporting.
The sample to be tested may be a human sample (such as body fluid, tissue, excretion, etc.) or a pathogenic microorganism isolated culture (such as a blood culture, a sputum culture, etc.), and the test object may be deoxyribonucleic acid (DNA) or ribonucleic acid ( RNA) or a mixture of the two.
Attachment : General technical guidelines for quality evaluation of second-generation sequencing technology detection reagents
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