Официальная позиция Росздравнадзора по поводу экспресс-тестов на антитела к COVID-19
26 мая 2020
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№196, май 2020
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Официальная позиция Росздравнадзора по поводу экспресс-тестов на антитела к COVID-19
В связи с большим количеством информации, касающейся экспресс-тестов для выявления антител к коронавирусной инфекции COVID-19, Федеральная служба по надзору в сфере здравоохранения 25 мая на своем сайте опубликовала рекомендации по их применению.
Ведомство отмечает, что результаты тестирования на антитела не должны использоваться как единственное основание, подтверждающее наличие вируса, или для информирования о статусе инфекции. Если результаты тестирования отрицательны, но у человека сохраняются клинические симптомы заболевания, то ему необходимо провести дополнительное тестирование с использованием других методов.
Отрицательный результат экспресс-тестов не исключает возможности заражения COVID-19.
Кроме этого, положительные результаты такого тестирования могут быть связаны как с текущим штаммом коронавируса, так и с другими ранее выявленными видами вируса, например, HKU1, NL63, OC43, 229E.
Росздравнадзор напоминает, что экспресс-тесты являются скрининговыми и не рекомендованы для лабораторной диагностики нового коронавируса. Такие тесты предназначены только для диагностики in vitro и не применимы в бытовых (домашних) условиях. Экспресс-тесты следует использовать для выявления антител IgG и IgM к COVID-19 в образцах цельной крови, сыворотки или плазмы. С помощью таких тестов нельзя определять ни количественное значение, ни скорость увеличения концентрации антител IgG или IgM к COVID-19.
Также ведомство обращает внимание, что экспресс-тесты рекомендуется использовать не ранее 3‑го дня после появления клинических симптомов. Для пациентов, не имеющих симптомов заболевания, рекомендуется проведение дополнительных клинических и лабораторных исследований.
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