Proceedings of the Conference on Health and Wellbeing in Modern Society (CHW 2021)

Testing of a Reagent Kit “TEST-NRAS-TISSUE” to Determine Indications for Targeted Therapy in Patients

Authors
Andrey Toropovskiy1, Olga Pavlova1, 2, 3, *, Denis Viktorov1, Alexey Nikitin1, Olga Gulenko2
1TestGen LLC, Ulyanovsk, 432072, Russia
2Samara State Transport University, Samara, 443066, Russia
3Samara State Medical University, Samara, Russia
*Corresponding author. Email: casiopeya13@mail.ru
Corresponding Author
Olga Pavlova
Available Online 17 January 2022.
DOI
10.2991/ahsr.k.220103.054How to use a DOI?
Keywords
reagent kit; TEST-NRAS-TISSUE; targeted therapy; DNA; diagnostic sensitivity; diagnostic specificity
Abstract

The aim of the work was to determine the functional properties and efficiency of a reagent kit for determining the mutation status of the NRAS gene by allele-specific real-time PCR in human genomic DNA samples. These samples were taken from paraffin-fixed tissue samples (Test-NRAS-tissue) according to TU 21. 20.23-008-97638376-2016. It was introduced into clinical and laboratory practice to determine indications for target therapy with anti-EGFR monoclonal antibody-based drugs in patients diagnosed with colorectal cancer with the wild-type NRAS gene. In vitro, the diagnostic medical product “Reagent kit, used for determination of the NRAS gene mutation status by PCR-RV in the human genomic DNA sample from paraffin-fixed tissue samples (Test-NRAS-tissue), was tested. During the clinical trials, 44 paraffin-fixed tissue samples (FFPE blocks) were analyzed in two series of experiments. That is, 88 clinical-laboratory experiments were performed, of which 46 experiments were made with genomic DNA samples with an established negative status of NRAS gene mutations and 42 experiments – with genomic DNA samples having an established positive status of NRAS gene mutations. The determination of the NRAS mutation status in the studied samples was performed using direct Sengler sequencing. Analysis and evaluation of the results of the clinical and laboratory tests of the Test-NRAS-tissue medical device confirmed that it allowed a qualitative determination of the mutation status of the twelfth codon (Gly12Asp, Gly12Cys, Gly12Ser), thirteenth codon (Gly13Asp, Gly13Arg) and sixty-first codon (Gln61Lys, Gln61Leu, Gln61Arg) of the NRAS gene. This was specified by allele-specific real-time PCR in human genomic DNA samples from paraffin-embedded tissue samples with high diagnostic sensitivity (94.1 %) and diagnostic specificity (89.1 %) at a 90 % confidence level.

Copyright
© 2022 The Authors. Published by Atlantis Press International B.V.
Open Access
This is an open access article under the CC BY-NC license.

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Volume Title
Proceedings of the Conference on Health and Wellbeing in Modern Society (CHW 2021)
Series
Advances in Health Sciences Research
Publication Date
17 January 2022
ISBN
978-94-6239-513-8
ISSN
2468-5739
DOI
10.2991/ahsr.k.220103.054How to use a DOI?
Copyright
© 2022 The Authors. Published by Atlantis Press International B.V.
Open Access
This is an open access article under the CC BY-NC license.

Cite this article

TY  - CONF
AU  - Andrey Toropovskiy
AU  - Olga Pavlova
AU  - Denis Viktorov
AU  - Alexey Nikitin
AU  - Olga Gulenko
PY  - 2022
DA  - 2022/01/17
TI  - Testing of a Reagent Kit “TEST-NRAS-TISSUE” to Determine Indications for Targeted Therapy in Patients
BT  - Proceedings of the Conference on Health and Wellbeing in Modern Society (CHW 2021)
PB  - Atlantis Press
SP  - 273
EP  - 280
SN  - 2468-5739
UR  - https://doi.org/10.2991/ahsr.k.220103.054
DO  - 10.2991/ahsr.k.220103.054
ID  - Toropovskiy2022
ER  -