title: Ð Ð°Ð·ÑÐ°Ð±Ð¾ÑÐºÐ° Ð¼ÐµÑÑÐ¾Ð»Ð¾Ð³Ð¸ÑÐµÑÐºÐ¾Ð³Ð¾ Ð¾Ð±ÐµÑÐ¿ÐµÑÐµÐ½Ð¸Ñ Ð¸Ð·Ð¼ÐµÑÐµÐ½Ð¸Ð¹ ÐºÐ¾Ð¿Ð¸Ð¹Ð½Ð¾ÑÑÐ¸ Ð³ÐµÐ½Ð° HER2
title: Ð²ÑÐ¿ÑÑÐºÐ½Ð°Ñ ÐºÐ²Ð°Ð»Ð¸ÑÐ¸ÐºÐ°ÑÐ¸Ð¾Ð½Ð½Ð°Ñ ÑÐ°Ð±Ð¾ÑÐ° Ð±Ð°ÐºÐ°Ð»Ð°Ð²ÑÐ°
titleType: Subtitle
title: Development of metrological support for the measuring copy number variation of the HER2 gene
Creators: name: Ð¡ÑÐµÐ¿Ð°Ð½Ð¾Ð²Ð°, ÐÐ½Ð°ÑÑÐ°ÑÐ¸Ñ
Publisher: name: Ð¡Ð°Ð½ÐºÑ-ÐÐµÑÐµÑÐ±ÑÑÐ³ÑÐºÐ¸Ð¹ Ð¿Ð¾Ð»Ð¸ÑÐµÑÐ½Ð¸ÑÐµÑÐºÐ¸Ð¹ ÑÐ½Ð¸Ð²ÐµÑÑÐ¸ÑÐµÑ ÐÐµÑÑÐ° ÐÐµÐ»Ð¸ÐºÐ¾Ð³Ð¾
Year: 2023
Subjects: Ð³ÐµÐ½ HER2
Ð¸Ð·Ð¼ÐµÑÐµÐ½Ð¸Ðµ ÐºÐ¾Ð¿Ð¸Ð¹Ð½Ð¾ÑÑÐ¸
ÑÑÐ°Ð½Ð´Ð°ÑÑÐ½ÑÐ¹ Ð¾Ð±ÑÐ°Ð·ÐµÑ
Ð¿Ð¾Ð»Ð¸Ð¼ÐµÑÐ°Ð·Ð½Ð°Ñ ÑÐµÐ¿Ð½Ð°Ñ ÑÐµÐ°ÐºÑÐ¸Ñ Ð² ÑÐµÐ°Ð»ÑÐ½Ð¾Ð¼ Ð²ÑÐµÐ¼ÐµÐ½Ð¸
ÑÐ¸ÑÑÐ¾Ð²Ð°Ñ ÐºÐ°Ð¿ÐµÐ»ÑÐ½Ð°Ñ Ð¿Ð¾Ð»Ð¸Ð¼ÐµÑÐ°Ð·Ð½Ð°Ñ ÑÐµÐ¿Ð½Ð°Ñ ÑÐµÐ°ÐºÑÐ¸Ñ
ÑÐ¸ÑÐ»Ð¾ ÐºÐ¾Ð¿Ð¸Ð¹ Ð¿Ð¾ÑÐ»ÐµÐ´Ð¾Ð²Ð°ÑÐµÐ»ÑÐ½Ð¾ÑÑÐ¸
Ð¾ÑÐ½Ð¾ÑÐµÐ½Ð¸Ðµ ÑÐ¸ÑÐ»Ð° ÐºÐ¾Ð¿Ð¸Ð¹ Ð¿Ð¾ÑÐ»ÐµÐ´Ð¾Ð²Ð°ÑÐµÐ»ÑÐ½Ð¾ÑÑÐ¸
the HER2 gene
measuring copy number variation
standart reference mateerial
real-time polymerase chain reaction
digital droplet polymerase chain reaction
sequence copy number
sequence copy number ratio

description: Ð Ð°Ð±Ð¾ÑÐ° Ð¿Ð¾ÑÐ²ÑÑÐµÐ½Ð° ÑÐ°Ð·ÑÐ°Ð±Ð¾ÑÐºÐµ Ð¼ÐµÑÑÐ¾Ð»Ð¾Ð³Ð¸ÑÐµÑÐºÐ¾Ð³Ð¾ Ð¾Ð±ÐµÑÐ¿ÐµÑÐµÐ½Ð¸Ñ Ð¸Ð·Ð¼ÐµÑÐµÐ½Ð¸Ð¹ ÑÐ¸ÑÐ»Ð° ÐºÐ¾Ð¿Ð¸Ð¹ Ð³ÐµÐ½Ð° HER2, ÐºÐ¾ÑÐ¾ÑÐ¾Ðµ Ð¼Ð¾Ð¶ÐµÑ Ð±ÑÑÑ Ð¾Ð±ÐµÑÐ¿ÐµÑÐµÐ½Ð° Ð·Ð° ÑÑÐµÑ Ð¿ÑÐ¸Ð¼ÐµÐ½ÐµÐ½Ð¸Ñ ÑÑÐ°Ð½Ð´Ð°ÑÑÐ½Ð¾Ð³Ð¾ Ð¾Ð±ÑÐ°Ð·ÑÐ° (Ð¡Ð) ÑÐ¸ÑÐ»Ð° ÐºÐ¾Ð¿Ð¸Ð¹ Ð¿Ð¾ÑÐ»ÐµÐ´Ð¾Ð²Ð°ÑÐµÐ»ÑÐ½Ð¾ÑÑÐ¸ Ð³ÐµÐ½Ð° HER2. ÐÑÐ½Ð¾ÑÐµÐ½Ð¸Ñ ÑÐ¸ÑÐµÐ» ÐºÐ¾Ð¿Ð¸Ð¹ Ð¿Ð¾ÑÐ»ÐµÐ´Ð¾Ð²Ð°ÑÐµÐ»ÑÐ½Ð¾ÑÑÐµÐ¹ Ð³ÐµÐ½Ð¾Ð² HER2 Ð¸ RPPH1, Ð° ÑÐ°ÐºÐ¶Ðµ HER2 Ð¸ CEP17 ÑÐ²Ð»ÑÑÑÑÑ Ð´Ð¸Ð°Ð³Ð½Ð¾ÑÑÐ¸ÑÐµÑÐºÐ¸Ð¼Ð¸ Ð¼Ð°ÑÐºÐµÑÐ°Ð¼Ð¸ Ð°Ð³ÑÐµÑÑÐ¸Ð²Ð½Ð¾ÑÑÐ¸ ÑÐ°ÐºÐ° Ð¼Ð¾Ð»Ð¾ÑÐ½Ð¾Ð¹ Ð¶ÐµÐ»ÐµÐ·Ñ, ÑÐ²ÑÐ·Ð°Ð½Ð½Ð¾Ð³Ð¾ Ñ Ð³Ð¸Ð¿ÐµÑÑÐºÑÐ¿ÑÐµÑÑÐ¸ÐµÐ¹ HER2. ÐÐ´Ð½Ð¸Ð¼ Ð¸Ð· Ð¼ÐµÑÐ¾Ð´Ð¾Ð², Ð¿Ð¾Ð·Ð²Ð¾Ð»ÑÑÑÐ¸Ñ Ð¸Ð·Ð¼ÐµÑÐ¸ÑÑ ÑÐ¸ÑÐ»Ð¾ ÐºÐ¾Ð¿Ð¸Ð¹ Ð³ÐµÐ½Ð°, ÑÐ²Ð»ÑÐµÑÑÑ Ð¼ÐµÑÐ¾Ð´ Ð¿Ð¾Ð»Ð¸Ð¼ÐµÑÐ°Ð·Ð½Ð¾Ð¹ ÑÐµÐ¿Ð½Ð¾Ð¹ ÑÐµÐ°ÐºÑÐ¸Ð¸ Ð² ÑÐµÐ°Ð»ÑÐ½Ð¾Ð¼ Ð²ÑÐµÐ¼ÐµÐ½Ð¸ (ÐÐ¦Ð -Ð Ð), Ð¿ÑÐ¸Ð¼ÐµÐ½ÐµÐ½Ð¸Ðµ ÐºÐ¾ÑÐ¾ÑÐ¾Ð³Ð¾ ÑÑÐµÐ±ÑÐµÑ ÐºÐ°Ð»Ð¸Ð±ÑÐ°ÑÐ¾ÑÐ°. ÐÑÐ»Ð¸ Ð¿ÑÐ¾Ð²ÐµÐ´ÐµÐ½Ñ Ð¸ÑÑÐ»ÐµÐ´Ð¾Ð²Ð°Ð½Ð¸Ñ ÐºÐ»ÐµÑÐ¾ÑÐ½ÑÑ Ð»Ð¸Ð½Ð¸Ð¹ ÐºÐ°Ðº Ð²Ð¾Ð·Ð¼Ð¾Ð¶Ð½ÑÑ Ð¸ÑÑÐ¾ÑÐ½Ð¸ÐºÐ¾Ð² Ð³ÐµÐ½ÐµÑÐ¸ÑÐµÑÐºÐ¾Ð³Ð¾ Ð¼Ð°ÑÐµÑÐ¸Ð°Ð»Ð° Ð´Ð»Ñ ÑÐ¾Ð·Ð´Ð°Ð½Ð¸Ñ Ð¿ÑÐ¾ÑÐ¾ÑÐ¸Ð¿Ð° Ð¡Ð ÑÐ¸ÑÐ»Ð° ÐºÐ¾Ð¿Ð¸Ð¹ Ð¿Ð¾ÑÐ»ÐµÐ´Ð¾Ð²Ð°ÑÐµÐ»ÑÐ½Ð¾ÑÑÐ¸ Ð³ÐµÐ½Ð° HER2. ÐÐ¾ÑÐ»Ðµ Ð½Ð°ÑÐ°ÑÐ¸Ð²Ð°Ð½Ð¸Ñ ÐºÐ»ÐµÑÐ¾Ðº Ð¾ÑÐ¾Ð±ÑÐ°Ð½Ð½Ð¾Ð¹ Ð»Ð¸Ð½Ð¸Ð¸ HeLa S3 Ð±ÑÐ»Ð° Ð²ÑÐ´ÐµÐ»ÐµÐ½Ð° Ð¸ Ð¾ÑÐ¸ÑÐµÐ½Ð° Ð³ÐµÐ½Ð¾Ð¼Ð½Ð°Ñ ÐÐÐ. ÐÐµÑÐ¾Ð´Ð¾Ð¼ ÐÐ¦Ð -Ð Ð Ð±ÑÐ»Ð¸ Ð¿Ð¾Ð´Ð¾Ð±ÑÐ°Ð½Ñ Ð¾Ð¿ÑÐ¸Ð¼Ð°Ð»ÑÐ½ÑÐµ ÑÑÐ»Ð¾Ð²Ð¸Ñ Ð¿ÑÐ¾Ð²ÐµÐ´ÐµÐ½Ð¸Ñ Ð°Ð¼Ð¿Ð»Ð¸ÑÐ¸ÐºÐ°ÑÐ¸Ð¸, Ñ Ð¸ÑÐ¿Ð¾Ð»ÑÐ·Ð¾Ð²Ð°Ð½Ð¸ÐµÐ¼ ÑÐ¸ÑÑÐ¾Ð²Ð¾Ð¹ ÐºÐ°Ð¿ÐµÐ»ÑÐ½Ð¾Ð¹ ÐÐ¦Ð  (ÑÐºÐÐ¦Ð ) Ð¿ÑÐ¾ÑÐ¾ÑÐ¸Ð¿Ñ Ð¡Ð Ð±ÑÐ»Ð° Ð¿ÑÐ¸ÑÐ²Ð¾ÐµÐ½Ð° ÑÐ°ÑÐ°ÐºÑÐµÑÐ¸ÑÑÐ¸ÐºÐ° Ð¾ÑÐ½Ð¾ÑÐµÐ½Ð¸Ñ ÑÐ¸ÑÐ»Ð° ÐºÐ¾Ð¿Ð¸Ð¹ Ð¿Ð¾ÑÐ»ÐµÐ´Ð¾Ð²Ð°ÑÐµÐ»ÑÐ½Ð¾ÑÑÐ¸ Ð³ÐµÐ½Ð° HER2 Ðº ÑÐ¸ÑÐ»Ñ ÐºÐ¾Ð¿Ð¸Ð¹ Ð¿Ð¾ÑÐ»ÐµÐ´Ð¾Ð²Ð°ÑÐµÐ»ÑÐ½Ð¾ÑÑÐ¸ Ð³ÐµÐ½Ð° CEP17. Ð¢Ð°ÐºÐ¶Ðµ ÑÐ¾ÑÑÐ°Ð²Ð»ÐµÐ½ Ð±ÑÐ´Ð¶ÐµÑ Ð½ÐµÐ¾Ð¿ÑÐµÐ´ÐµÐ»ÐµÐ½Ð½Ð¾ÑÑÐ¸ Ð²ÑÐ±ÑÐ°Ð½Ð½Ð¾Ð¹ Ð¼Ð¾Ð´ÐµÐ»Ð¸ Ð¸Ð·Ð¼ÐµÑÐµÐ½Ð¸Ð¹. ÐÐ¾Ð»ÑÑÐµÐ½Ð½ÑÐµ ÑÐµÐ·ÑÐ»ÑÑÐ°ÑÑ Ð¼Ð¾Ð³ÑÑ Ð±ÑÑÑ Ð¸ÑÐ¿Ð¾Ð»ÑÐ·Ð¾Ð²Ð°Ð½Ñ Ð´Ð»Ñ Ð¼ÐµÑÑÐ¾Ð»Ð¾Ð³Ð¸ÑÐµÑÐºÐ¾Ð³Ð¾ Ð¾Ð±ÐµÑÐ¿ÐµÑÐµÐ½Ð¸Ñ Ð´Ð¸Ð°Ð³Ð½Ð¾ÑÑÐ¸ÐºÐ¸ HER2+ ÑÐ¾ÑÐ¼Ñ ÑÐ°ÐºÐ° Ð¼Ð¾Ð»Ð¾ÑÐ½Ð¾Ð¹ Ð¶ÐµÐ»ÐµÐ·Ñ Ñ Ð¸ÑÐ¿Ð¾Ð»ÑÐ·Ð¾Ð²Ð°Ð½Ð¸ÐµÐ¼ Ð¼ÐµÑÐ¾Ð´Ð° ÐÐ¦Ð -Ð Ð. ÐÐ°Ð½Ð½ÑÐ¹ Ð¼ÐµÑÐ¾Ð´, Ð² Ð¾ÑÐ»Ð¸ÑÐ¸Ðµ Ð¾Ñ ÑÐ°ÑÐ¿ÑÐ¾ÑÑÑÐ°Ð½ÐµÐ½Ð½ÑÑ Ð¿Ð¾Ð»ÑÐºÐ¾Ð»Ð¸ÑÐµÑÑÐ²ÐµÐ½Ð½ÑÑ Ð¼ÐµÑÐ¾Ð´Ð¾Ð², Ð¿ÑÐµÐ´Ð¿Ð¾Ð»Ð°Ð³Ð°ÐµÑ Ð¸Ð·Ð¼ÐµÑÐµÐ½Ð¸Ðµ ÑÐ¸ÑÐ»Ð° ÐºÐ¾Ð¿Ð¸Ð¹ Ð¿Ð¾ÑÐ»ÐµÐ´Ð¾Ð²Ð°ÑÐµÐ»ÑÐ½Ð¾ÑÑÐ¸ Ð³ÐµÐ½Ð° HER2. ÐÐ½ÐµÐ´ÑÐµÐ½Ð¸Ðµ ÑÐ°Ð·ÑÐ°Ð±Ð¾ÑÐ°Ð½Ð½Ð¾Ð³Ð¾ Ð¿Ð¾Ð´ÑÐ¾Ð´Ð° Ð² ÐºÐ»Ð¸Ð½Ð¸ÑÐµÑÐºÑÑ Ð¿ÑÐ°ÐºÑÐ¸ÐºÑ Ð¿Ð¾Ð²ÑÑÐ¸Ñ Ð´Ð¾ÑÑÐ¾Ð²ÐµÑÐ½Ð¾ÑÑÑ Ð´Ð¸Ð°Ð³Ð½Ð¾ÑÑÐ¸ÐºÐ¸ Ð¸ ÑÐ´ÐµÐ»Ð°ÐµÑ Ð¿Ð¾Ð´Ð±Ð¾Ñ ÑÐ¾Ð¾ÑÐ²ÐµÑÑÑÐ²ÑÑÑÐµÐ³Ð¾ Ð»ÐµÑÐµÐ½Ð¸Ñ Ð±Ð¾Ð»ÐµÐµ ÑÐ¾ÑÐ½ÑÐ¼.
description: The given work is devoted to the development of metrological support for measuring the copy number of the HER2 gene, which can be provided using a standard reference material (SRM) of the number of copies of the HER2 gene sequence. The ratio of the copy number of the HER2 and RPPH1 gene sequences, as well as HER2 and CEP17, are diagnostic markers of the aggressiveness of breast cancer associated with HER2 overexpression. One of the methods to measure the gene copy number is the real-time polymerase chain reaction (PCR-RT) method, which requires a calibrator for using. Studies of cell lines as possible sources of genetic material for the creation of a prototype with the HER2 gene copy number sequence were carried out. After the cells of the selected HeLa S3 line were enlarged, genomic DNA was isolated and purified. Optimal amplification conditions were selected by PCR-RT and using digital droplet PCR (ddPCR) the SRM prototype was assigned a characteristic of the ratio of the copy number of the HER2 gene sequence to the number of copies of the CEP17 gene sequence. The uncertainty budget of the selected measurement model has also been compiled. The obtained results can be used for metrological support of the diagnosis of HER2+ forms of breast cancer using the PCR-RT method. This method, unlike common semi-quantitative methods, involves measuring the number of copies of the HER2 gene sequence. The introduction of the developed approach into clinical practice will increase the reliability of diagnosis and make the selection of appropriate treatment more accurate.