ГЭТ 220-2024 (НИО 244)

The state primary standard GET 220-2024 consists of a set of technical means and auxiliary equipment:

1. A complex for reproducing and transmitting units of DNA sequence copy number, DNA sequence copy concentration, and DNA sequence copy number ratio:

   • A setup based on optical (light) microscopy for measuring the linear dimensions of droplets.
   • A digital polymerase chain reaction (dPCR)-based assay for measuring DNA copy number, DNA copy concentration, and DNA copy ratio;
   • A directed sequencing (Sanger) assay for determining nucleotide sequences in DNA using capillary electrophoresis in a linear polymer;
2. Auxiliary equipment ensuring the operation and reliability of the primary standard

Ensuring the uniformity of measurements of the content of copies of a DNA sequence:

• Testing of reference materials, including for type approval purposes;
• Certification of secondary standards;

• Ensuring metrological traceability of measurement results performed:

  • In laboratory medicine;
  • In monitoring the composition and quality of food raw materials and food products;
  • In sanitary control;
  • In veterinary control;
  • In biotechnology laboratories;
  • In medical genetic research in forensic medicine.

The development of the standard is consistent with the Russian Federation's scientific and technological development strategy in terms of responding to biological threats to national security, using genetic data and technologies, and transitioning to personalized, predictive, and preventive medicine. The relevance of developing the GET 220 standard is driven by the growing need for metrological support for DNA content measurements performed in laboratory medicine for medical genetic, virological, and bacteriological research, in forensic medicine, nature-based technologies, veterinary medicine, the food industry, and scientific research.

Not specified