farmaecFARMAKOEKONOMIKA. Modern Pharmacoeconomics and PharmacoepidemiologyФАРМАКОЭКОНОМИКА. Современная фармакоэкономика и фармакоэпидемиология2070-49092070-4933IRBIS LLC10.17749/2070-4909.2020.13.1.52-63farmaec-342Research ArticleOriginal ArticleОригинальные статьиReal-time RT-PCR diagnostics of virus causing COVID-19Диагностика вируса, вызывающего COVID-19, методом ПЦР в реальном времениГончароваЕ. В.GoncharovaE. V.

Гончарова Елена Васильевна – к.б.н., в.н.с. 

 

Elena V. Goncharova – PhD, Senior Researcher

ДонниковА. Е.DonnikovA. E.

Донников Андрей Евгеньевич – к.м.н., заведующий лабораторией молекулярно-генетических методов 

 

Andrei E. Donnikov – MD, PhD, Head of the Laboratory of Molecular Genetic Methods

КадочниковаВ. В.KadochnikovaV. V.

Кадочникова Владислава Викторовна – к.б.н., с.н.с. 

ул. Гурьянова, д. 83, стр. 1, Москва 109388

Vladislava V. Kadochnikova – PhD, Senior Researcher

МорозоваС. А.MorozovaS. A.

Морозова Светлана Андреевна – руководитель отдела регистрации 

 

Svetlana A. Morozova – Head of Registration

https://orcid.org/0000-0003-2641-3471БолдыреваМ. Н.BoldyrevaM. N.

Болдырева Маргарита Николаевна – д.м.н., медицинский директор 

 

Margarita N. Boldyreva – MD, Dr Sci Med, Medical Director

https://orcid.org/0000-0001-7279-4362ГалкинаИ. С.GalkinaI. S.

Галкина Ирина Сергеевна – к.х.н., директор по маркетингу 

 

Irina S. Galkina – PhD, Marketing Director

Galkina@dna-technology.ruhttps://orcid.org/0000-0002-3367-9844БлиновД. В.BlinovD. V.

Блинов Дмитрий Владиславович – к.м.н., руководитель по медицинским и научным вопросам; врач-невролог

Researcher ID: E-8906-2017

1-е Успенское шоссе, д. 111, Московская область, Одинцовский район, Лапино

Dmitry V. Blinov – MD, PhD, MBA, Head of Medical and Scientific Affairs, ; Neurologist

Researcher ID: E-8906-2017

ООО «НПФ ДНК-Технология»РоссияLLC “NPF DNA-Technology”.Russian FederationФедеральное государственное бюджетное учреждение «Национальный медицинский исследовательский центр акушерства, гинекологии и перинатологии имени академика В.И. Кулакова» Министерства Здравоохранения РФРоссияFSBI “National Medical Research Center for Obstetrics, Gynecology and Perinatology n.а. Academician V.I. Kulakov” Ministry of Healthcare of the Russian FederationRussian FederationООО «НПФ ДНК-Технология»РоссияLLC “NPF DNA-Technology”Russian FederationООО «ДНК-Технология»РоссияLLC “NPF DNA-Technology”Russian FederationИнститут Превентивной и Социальной Медицины ; Клинический госпиталь Лапино, ГК «Мать и Дитя»РоссияInstitute for Preventive and Social Medicine; Lapino Clinic Hospital, MD Medical Group.Russian Federation2020240420201315263Copyright © Goncharova E.V., Donnikov A.E., Kadochnikova V.V., Morozova S.A., Boldyreva M.N., Galkina I.S., Blinov D.V., 20202020Гончарова Е.В., Донников А.Е., Кадочникова В.В., Морозова С.А., Болдырева М.Н., Галкина И.С., Блинов Д.В.Goncharova E.V., Donnikov A.E., Kadochnikova V.V., Morozova S.A., Boldyreva M.N., Galkina I.S., Blinov D.V.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.pharmacoeconomics.ru/jour/article/view/342Aim

Aim: the study was aimed to develop a reagent kit for the real-time RT-PCR diagnostics of virus causing COVID-19.

Materials and Methods

Materials and Methods. Three target sites were chosen in the genome SARS-CoV-2. The testing included 220 samples, 48 artificially created positive samples (made from patients’ biomaterial) and 172 clinical samples (scrapes from nasal and pharyngeal cavities, bronchoalveolar lavage, expectoration, endotracheal/nasopharyngeal aspirate, feces, post-mortem material), obtained from two medical centers. Preliminary, the obtained biomaterial was analyzed with a reagent kit of comparison. The evaluation was performed with a confidential interval CI 95%. The calculation of CI for the sensitivity and specificity was made based on the distribution of χ2.

Results

Results. The authors developed a technology of novel coronavirus infection (COVID-19) real-time RT-PCR diagnostics for the application in practical healthcare and proposed the variants of testing at all the stages (preanalytical, analytical, and post-analytical, including automated results processing). The proposed reagent kit meets the requirements of the World Health Organization and the Ministry of Healthcare of the Russian Federation. The study results demonstrated high sensitivity and specificity. The sensitivity was 100% (95% CI) 95.6–100%; the specificity was 100% (95% CI) 96.7–100%.

Conclusion

Conclusion. The proposed reagent kit was registered in the RF as a medical product; the registration certificate No. RZN 2020/9948 dated 01.04.2020. The application of the reagent kit in network laboratories will provide patients with access to testing for the virus causing COVID-19 and contribute to quick differential diagnostics, improvement of pandemic control, and accurate statistics on the spread of the virus. 

Цель – разработка набора реагентов для диагностики вируса, вызывающего COVID-19, методом ПЦР в реальном времени.

Материалы и методы

Материалы и методы. В качестве мишеней были выбраны три участка генома SARS-CoV-2. Тестирование выполнено на 220 образцах – 48 положительных образцах, искусственно созданных из биоматериала пациентов, и 172 клинических образцах (соскобы из полости носа и зева, бронхоальвеолярный лаваж, мокрота, эндотрахеальный/назофарингеальный аспират, фекалии, аутопсийный материал) из двух медицинских центров. Предварительно биоматериал был проанализирован с использованием набора сравнения. Оценка проводилась с доверительным интервалом 95%. Расчет доверительных интервалов для чувствительности и специфичности осуществлялся на основании распределения χ2.

Результаты

Результаты. Для использования в практическом здравоохранении разработана технология диагностики новой коронавирусной инфекции (COVID-19) методом ПЦР в реальном времени, предложены конкретные варианты проведения всех этапов тестирования – преаналитического, аналитического и постаналитического, включая автоматизированную обработку результата. Исследуемый набор реагентов соответствует рекомендациям ВОЗ и МЗ РФ. Испытания продемонстрировали высокую чувствительность и специфичность: чувствительность составила 100% (95%-й доверительный интервал) 95,6–100%; специфичность составила 100% (95%-й доверительный интервал) 96,7–100%.

Заключение

Заключение. Набор реагентов зарегистрирован в РФ как медицинское изделие, регистрационное удостоверение № РЗН 2020/9948 от 01.04.2020. Использование его сетевыми лабораториями позволит обеспечить массовый доступ пациентов к тестированию на вирус, вызывающий COVID-19, способствуя быстрому получению результата дифференциальной диагностики, улучшению контроля над пандемией, получению корректной статистики распространения вируса. 

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The authors declare that there are no conflicts of interest present.