bloodjourГематология и трансфузиологияRussian journal of hematology and transfusiology0234-57302411-3042ООО Издательский дом «Практика»10.35754/0234-5730-2022-67-4-525-534bloodjour-408Research ArticleОРИГИНАЛЬНЫЕ СТАТЬИORIGINAL ARTICLESВнедрение лабораторного исследования на анти-HBcore у доноров кровиThe introduction of Laboratory testing for anti-HBcore in blood donorshttps://orcid.org/0000-0001-6158-233XФаенкоА. П.FaenkoA. P.

Фаенко Александр Павлович, кандидат медицинских наук, трансфузиолог отделения комплектования донорских кадров

123182, Москва

Aleksandr P. Faenko, Cand. Sci. (Med.), Transfusiologist at the Donor Recruitment Department

123182, Moscow

alexfaenko@mail.ruhttps://orcid.org/0000-0002-7371-8545ФилипповаА. А.FilippovaA. A.

Филиппова Анна Александровна, кандидат медицинских наук, заведующая отделом обеспечения безопасности донорской крови и еекомпонентов, эпидемиолог

123182, Москва

Anna A. Filippova, Cand. Sci. (Med.), Head of the Department for Ensuring the Safety of Donor Blood and its Components, Epidemiologist

123182, Moscow

fa852007@yanndex.ruhttps://orcid.org/0000-0001-5405-1282ГолосоваС. А.GolosovaS. A.

Голосова София Александровна, директор

123182, Москва

Sofi ya A. Golosova, Director

123182, Moscow

golosova@bloodfmba.ruhttps://orcid.org/0000-0001-7761-8093ГлазовЯ. Н.GlazovYa. N.

Глазов Ярослав Николаевич, заместитель директора по медицинской части, трансфузиолог

123182, Москва

Yaroslav N. Glazov, Deputy Director for Medical Affairs, Transfusiologist

123182, Moscow

yglazov@bloodfmba.ruhttps://orcid.org/0000-0003-4491-8123ИвановаИ. В.IvanovaI. V.

Иванова Ирина Викторовна, заведующая отделом лабораторной диагностики

123182, Москва

Irina V. Ivanova, Head of the Laboratory Diagnostics Department

123182, Moscow

iivanova@bloodfmba.ruhttps://orcid.org/0000-0002-7581-0740КлюеваЕ. А.KlyuevaE. A.

Клюева Елена Александровна, кандидат медицинских наук, заведующая отделом организации оказания медицинской помощи по профилю «Трансфузиология», врач-методист

123182, Москва

Elena A. Klyueva, Cand. Sci. (Med.), Head of the Department of Organization of Medical Care in the Field of Transfusiology, Methodist

123182, Moscow

iospkdir@bk.ruhttps://orcid.org/0000-0002-9324-0702КасаткинМ. А.KasatkinM. A.

Касаткин Михаил Анатольевич, заведующий отделом заготовки донорской крови и ее компонентов, трансфузиолог

123182, Москва

Mikhail А. Kasatkin, Head of Department of Procurement of Donor Blood and its Components

123182, Moscow

mkasatkin@bloodfmba.ruФГБУЗ «Центр крови Федерального медико-биологического агентства»РоссияBlood Center of the Federal Medical-Biological AgencyRussian Federation202227122022674525534Copyright © Фаенко А.П., Филиппова А.А., Голосова С.А., Глазов Я.Н., Иванова И.В., Клюева Е.А., Касаткин М.А., 20222022Фаенко А.П., Филиппова А.А., Голосова С.А., Глазов Я.Н., Иванова И.В., Клюева Е.А., Касаткин М.А.Faenko A.P., Filippova A.A., Golosova S.A., Glazov Y.N., Ivanova I.V., Klyueva E.A., Kasatkin M.A.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.htjournal.ru/jour/article/view/408Введение

Введение. Внедрение скринингового тестирования на антитела к ядерному антигену вируса гепатита В (анти-HBcore) призвано предотвратить заготовку донорской крови от лиц, имеющих скрытую форму вирусного гепатита В, при которой не идентифицируется поверхностный HBsAg.

Цель – оценить частоту встречаемости маркеров анти-HBcore у доноров в условиях действующего нормативно-правового поля.

Материалы и методы

Материалы и методы. Проведено ретроспективное обсервационное исследование среди доноров крови ФГБУЗ «Центра крови ФМБА России» (ЦК) в условиях действующего нормативно-правового поля. Период наблюдения составил один год. Скрининговое исследование на анти-HBcore у доноров крови и ее компонентов носило избирательный характер согласно требованиям к приложению № 4 приказа МЗ РФ № 1166н от 28.10.2020.

Результаты

Результаты. В период исследования ЦК посетили 17 180 доноров, сдавших 35 840 раз донорскую кровь и ее компоненты. Было проведено 181 исследование на анти-HBcore (0,5 % от всех образцов крови) у 178 уникальных доноров крови и ее компонентов (1,03 % от всех доноров). Получено 14 положительных, 2 сомнительных и 166 отрицательных результатов на анти-HBcore. Вероятность обнаружения положительного результата, в зависимости от условий, составила 9 % (7,3–14,7 %). Не получено значимых различий по обнаружению анти-HBcore у первичных доноров в сравнении с регулярными (отношение шансов (ОШ) = 2,539; 95%-ный доверительный интервал (95% ДИ): 0,7321–8; p = 0,13), так же как и у дон оров мужчин в сравнении с женщинами (ОШ = 2,448; 95% ДИ: 0,7141–11,11; p = 0,17). У 86,7 % доноров с положительным анализом на анти-HBcore ранее не было признаков заболевания вирусным гепатитом В, не выявлялось наличие сомнительного HBsAg, т. е. данные случаи могут быть связаны с оккультной формой. У доноров, не имевших ранее в период донорской карьеры сомнительных результатов по различным гемотрансмиссивным инфекциям, отмечалась незначительно большая вероятность обнаружения положительного результата на анти-HBcore в сравнении с донорами, ранее имевшими сомнительные результаты (OШ = 1,24; 95% ДИ: 0,42–3,69; p = 0,69). За период донорской карьеры донорами с положительным результатом на анти-HBcore было совершено 233 донации крови и ее компонентов, получено 468 единиц донорских компонентов, из которых 365 единиц были выданы в лечебные учреждения.

Заключение

Заключение. Вероятность получения положительного анализа на анти-HBcore в условиях действующего нормативного поля случайна и не зависит от результатов исследования на другие инфекционные маркеры. Рекомендуется проводить анализ на анти-HBcore при каждой донации крови и ее компонентов.

Introduction

Introduction. The introduction of screening testing for antibodies to the hepatitis B virus nuclear antigen (anti-HBcore) is designed to prevent the procurement of donated blood from individuals with the latent (occult) form of viral hepatitis B, in which surface HBsAg is not identified.

Aim – to evaluate the frequency of anti-HBcore markers’ occurrence in donors under the current regulatory and legal framework.

Materials and methods

Materials and methods. This retrospective observational study was conducted with a follow-up period of one year among blood donors of the Blood Center (BC) of the Federal Medical-Biological Agency. The screening study for anti-HBcore in blood donors and its components was selective in accordance with the requirements of Appendix № 4 of Order № 1166n of October 28, 2020 of the Ministry of Health of Russia.

Results

Results. During the study period, the BC was visited by 17,180 donors who donated blood and its components 35,840 times. There were 181 anti-HBcore tests (0.5 % of all blood samples) in 178 unique donors of blood and blood components (1.03 % of all donors). There were 14 positive, 2 questionable and 166 negative results on anti-HBcore tests. The probability of finding a positive result depending on the conditions was 9 % (7.3–14.7 %). There were no statistically significant differences in the detection of anti-HBcore in primary versus regular donors (OR = 2.539; 95% CI: 0.7321–8; p = 0.13), as well as for male donors compared with female donors (OR = 2.448; 95% CI: 0.7141–11.11; p = 0.17). 86.7 % of donors with a positive test for anti-HBcore previously had no signs of viral hepatitis B disease, the presence of questionable HBsAg was not detected, i. e. these cases may be associated with an occult form. Donors who did not previously have questionable results for various bloodborne infections during their donor career had a slightly higher probability of detecting a positive anti-HBcore test compared to donors who previously had these questionable results (OR = 1.24; 95% CI”: 0.42–3.69; p = 0.69). During the period of the donor career, 233 donations of blood and its components were made by donors with a positive result for anti-HBcore, 468 units of donor components were received, of which 365 units were given to medical institutions.

Conclusion

Conclusion. The probability of obtaining a positive test for anti-HBcore in the current regulatory environment is random and does not depend on the results of other infectious markers testing. It is recommended to perform anti-HBcore testing with each donation of blood and blood components.

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