Potential benefits of implementing the technology «endpoint» to detect RNA virus SARS-COV-2 in field conditions: prospective study

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Abstract

OBJECTIVE: the assessment of potential benefits of implementing hardware technologies, available for supply in the Russian Armed Forces to hold mass rapid screening test of servicemen for RNA virus SARS-CoV-2 by PCR on «endpoint» in field conditions.

MATERIALS AND METHODS: PCR on «endpoint» was applied according to the protocol of RNA virus detection by the set of test system PCR-RV «PolivirSARS-CoV-2» with extraction reagent «RNA-express», joint production of LLC NPF «Litech» and the Federal Research and Clinical Centre of Physical-Chemical Medicine FMBA. The biomaterial for the research was 157 samples of nasal-pharyngeal smears, taken from patients with clinical symptoms of respiratory disease who had contacts with COVID-19. Statistics. The data received from pilot studies had standard statistical processing in the program «Statistica 6,0». Non-parametric Pearson’s chi-square (c2) criteria was used to assess the significance of different observation frequencies of the studied feature in independent groups. Probability p≤0,05 and higher was considered sufficient to conclude statistical importance of the differences received.

RESULTS: It is stated that out of 157 biomaterial samples, assessed for the content of SARS-CoV-2 virus’s genetic markers by PCR on «endpoint» and PCR «Realtime», 141 and 146 samples, respectively, turned out to be positive. In addition, there were no statistically important differences between the received data in these methods (c2=1,013, р=0,31).

DISCUSSION: It is shown that comparative characteristics of the studied methods in laboratory SARS-Соv-2 virus diagnostics suggested the possibility of detecting specific segment of the virus genome by PCR «endpoint» technology, using expendable reagents, made for PCR «Realtime».

About the authors

D. Yu. Pishchugin

637 center for state sanitary and epidemiological surveillance

Author for correspondence.
Email: 97583421@mail.ru

Dmitry Yu. Pishchugin — Head of the; Chief State Sanitary
Doctor

299028, Sevastopol, 40 Drevnaya str

Russian Federation

R. A. Tarumov

State Scientific-research Test Institute of the Military Medicine

Email: tarumov_ra@mail.ru

Roman A. Tarumov — Senior Researcher, Candidate of Medical Sciences;

195043, St. Petersburg, st. Lesoparkovaya 4

Russian Federation

S. G. Shubenkin

637 center for state sanitary and epidemiological surveillance

Email: 97583421@mail.ru

Sergey G. Shubenkin — Head of the Department (Microbiological) 

299028, Sevastopol, 40 Drevnaya str

Russian Federation

A. N. Shemeneva

637 center for state sanitary and epidemiological surveillance

Email: 97583421@mail.ru

Anna N. Shemeneva — Senior medical expert of the Department (State Sanitary and Epidemiological supervision of the area of
responsibility) 

299028, Sevastopol, 40 Drevnaya str.

Russian Federation

O. G. Tsintsadze

637 center for state sanitary and epidemiological surveillance

Email: 97583421@mail.ru

Otari G. Tsintsadze — Cand. of Sci. (Med.), Head of the Department of Especially Dangerous Infections of the Department (Microbiological)

299028, Sevastopol, 40 Drevnaya str.

Russian Federation

L. L. Ohotskaya

637 center for state sanitary and epidemiological surveillance

Email: 97583421@mail.ru

Lyudmila L. Okhotskaya — bacteriologist of the Department (Microbiological) 

299028, Sevastopol, 40 Drevnaya str.

Russian Federation

References

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  2. Ravi N. Cortade D., Ng E., Wang Sh. Diagnostics for SARS-CoV-2 detection: A comprehensive review of the FDA-EUA COVID-19 testing landscape // Biosensors and bioelectronics. 2020. Vol. 165. P. 24–54. doi: 10.1016/j.bios.2020.112454.
  3. Платонов А.Е. Статистический анализ в медицине и биологии: задачи, терминология, логика, компьютерные методы. М.: Изд-во РАМН, 2000. 52 с.

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