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