Набор реагентов Leccurate для определения иммунохроматографи... Инструкция
Показания к применению
Набор предназначен для качественного обнаружения методом иммунохроматографии антигена коронавируса SARS-CoV-2 в биологическом материале человека (мазок из носоглотки).
Инструкция
Состав
тест-кассета - 1 шт.,
зонд для взятия образца (пробы) - 1 шт.,
буферный раствор для разведения образца (пробы) - 1 шт.,
инструкция по использованию - 1 шт.
Описание
Набор реагентов Leccurate для определения иммунохроматографическим методом антигена коронавируса SARS-CoV-2 с применением коллоидного золота по мазку из носоглотки.
Коронавирус относится к большому семейству вирусов и представляет собой одноцепочечный РНК-содержащий вирус с оболочкой (envelope). Известно, что вирус вызывает простуду, ближневосточный респираторный синдром (БВРС), тяжелый острый респираторный синдром (ТОРС) и другие серьезные заболевания. Структурным белком SARS-CoV-2 является нуклеокапсид N (Nucleocapsid), это белковый компонент вируса. Он относительно консервативен среди коронавирусов и часто используется в качестве инструмента для диагностики коронавируса. ACE2, который является ключевым рецептором для проникновения SARS-CoV-2 в клетку, имеет большое значение для изучения механизма развития вирусной инфекции.
Данный набор работает по принципу реакции "антиген-антитело" и методу иммуноанализа. Тест-кассета содержит моноклональные антитела нуклеокапсида N коронавируса, меченные коллоидным золотом и предварительно нанесенные на мембрану, а также моноклональные антитела нуклеокапсида N коронавируса, иммобилизированные в области тестирования (Т), и соответствующие антитела в области контроля качества (C).
Во время тестирования нуклеокапсид N, содержащийся в образце, связывается с антителами нуклеокапсида N коронавируса, которые мечены коллоидным золотом и предварительно нанесены на мембрану. Затем конъюганты под действием капилляров движутся вверх, где связываются с моноклональными антителами нуклеокапсида N, иммобилизированным в области тестирования (Т). Чем выше содержание нуклеокапсида N в образце, тем больше антител было связано, и тем темнее становится красный цвет тестовой области (Т). Если в образце не содержится коронавирус, или содержание вируса ниже предела обнаружения, то цвет тестовой области Т не изменится.
Показания к применению
Набор предназначен для качественного обнаружения методом иммунохроматографии антигена коронавируса SARS-CoV-2 в биологическом материале человека (мазок из носоглотки).
Способ применения и дозы
Набор предназначен для качественного обнаружения методом иммунохроматографии антигена коронавируса SARS-CoV-2 в биологическом материале человека (мазок из носо- и ротоглотки).
Забор образцов: при отборе образцов соблюдайте общие меры предосторожности. Обращайтесь со всеми образцами как с потенциально инфицированными.
При работе с отобранными образцами должны учитываться требования СП 1.3.3118-13 "Безопасность работы с микроорганизмами I-II групп патогенности (опасности)".
Данный набор реагентов применяется для тестирования образцов - мазков из носо- и ротоглотки.
Следует принять необходимые меры защиты, чтобы избежать прямого контакта с образцами. В случае случайного контакта необходимо своевременно провести дезинфекционную обработку и принять соответствующие меры.
Взятие мазка: основным видом биоматериала для исследования является материал, полученный при заборе мазка из носоглотки и двух носовых ходов для большей потенциальной концентрации вируса.
Хранение образцов: необходимо провести тестирование в течение 1 часа после забора образцов.
Перед тестированием образцы должны быть доведены до комнатной температуры.
Внимательно ознакомьтесь с инструкцией по применению перед проведением теста. Перед тестированием доведите реактивы и образцы до комнатной температуры.
1. Для отбора проб необходимо вскрыть индивидуальную упаковку зонда, взять его в руку и последовательно вставить этот же зонд в оба носовых прохода на всю длину ватного тампона и осторожно повернуть зонд в каждом из них по пять раз.
2. Перед тестом следует заранее удалить двусторонний клейкий защитный слой, чтобы не допустить разбрызгивания жидкости. Если двусторонний клейкий защитный слой снят после добавления жидкости для разбавления, это легко может привести к разбрызгиванию жидкости.
3. Раскройте тест-кассету. Вставьте образец в лунку А через отверстие лунки В. Добавьте шесть капель буферного раствора в ячейку А. Не добавляйте буферный раствор в другие ячейки. Аккуратно поверните вставленный зонд, два оборота в каждом направлении.
4. Во время теста тест-кассета должна быть помещена на горизонтальную поверхность стола.
5. Закройте тест-кассету и осторожно нажмите на клейкий слой в соответствующем месте для равномерного крепления сторон, потом начинайте отсчет времени. Ожидайте появления фиолетовой полосы. Результаты теста следует считать в течение 15-20 минут.
Особые указания
Используется для проведения диагностики in vitro, все этапы следует выполнять последовательно в соответствии с инструкцией.
Результаты тестирования могут быть недостоверными в случае, если допущено какое-либо отклонение от указанного в инструкции к данному медицинскому изделию.
Поверхности следует очищать и обеззараживать до и после тестирования.
Продукт содержит тест-кассету, инструкцию по применению, буферный раствор для разведения образца (пробы), зонд для взятия образца.
Тест-кассета состоит из золотой мембраны (с нанесенными моноклональными антителами нуклеокапсида N SARS-CoV-2, меченными колоидным золотом), мембраны для образца, нитроцеллюлозной мембраны (моноклональные антитела нуклеокапсида N SARS-CoV-2, иммобилизированные в области тестирования (Т); антитела козы к иммуноглобулинам мыши, нанесенные на область контроля качества (С)), абсорбционной бумаги, гидрофобной мембраны.
Клиническая диагностика должна быть сделана посредством комплексного анализа специалиста на основе других методов испытаний и клинических симптомов.
- Внимательно прочитайте инструкцию перед началом тестирования и следуйте процедуре правильно.
- Запрещается повторное использование изделий, поскольку они используются только один раз.
- Результат тестирования после истечения срока годности является ненадежным.
- Тест-кассета должна оставаться в герметичной упаковке до использования, поскольку она чувствительна к влаге, необходимо использовать тест-кассету сразу после вскрытия упаковки.
- Не используйте набор, если упаковка повреждена.
- Перед испытанием образцы и тестовое устройство должны находиться при комнатной температуре, не следует замораживать или использовать продукт после истечения срока годности (срок годности указан на упаковке).
- Это диагностический продукт in vitro и риск заражения низок, потому что нет прямого контакта с человеком. Однако, пожалуйста, будьте осторожны при обращении с тестовым набором и клиническими образцами, потенциально содержащими инфекционные источники. Утилизируйте использованные образцы, тест-кассеты, выделения из образцов и пробоотборные мазки согласно соответствующим правилам.
- Запрещается курение и прием пищи на испытательной площадке при передаче образцов или комплектов реагентов.
- Избегайте контакта с кожей и глазами.
- Запрещается проводить тестирование в условиях слишком высокой температуры или влажности, рекомендуемая температура - 15-30 C, влажность - ниже 70%.
- Запрещается употреблять внутрь осушитель, находящийся внутри упаковки.
- При проведении тестирования следует надеть защитную одежду, перчатки и маску.
- Утилизация использованных образцов и наборов реагентов должна осуществляться с установленными в данном регионе законами и правилами.
- Перед тестированием следует заранее удалить двусторонний клейкий защитный слой, чтобы не допустить разбрызгивания буферного раствора; если двусторонний клейкий защитный слой снят после добавления буферного раствора для разбавления, это легко может привести к разбрызгиванию жидкости.
- Не добавляйте капли жидкости для разбавления в другую ячейку.
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шт","dose":"","volume":"","spf":"","size":""},"image":{"isTouch":{"retina":"https://vseapteki.ru/cropping/thumbnails/101/89128/phoneMedium_retina/","default":"https://vseapteki.ru/cropping/thumbnails/101/89128/phoneMedium_default/"},"isFromTablet":{"retina":"https://vseapteki.ru/cropping/thumbnails/101/89128/tabletLarge_retina/","default":"https://vseapteki.ru/cropping/thumbnails/101/89128/tabletLarge_default/"}},"image_thumb":{"isTouch":{"retina":"https://vseapteki.ru/cropping/thumbnails/101/89128/previewTouch_retina/","default":"https://vseapteki.ru/cropping/thumbnails/101/89128/previewTouch_default/"},"isFromTablet":{"retina":"https://vseapteki.ru/cropping/thumbnails/101/89128/previewDesktopMedium_retina/","default":"https://vseapteki.ru/cropping/thumbnails/101/89128/previewDesktopMedium_default/"}},"available":false,"price":{"min":null,"max":null},"counters":null,"description":{"data":[{"id":4,"name":"Состав","slug":"ingredients","body":[{"type":"list","data":{"style":"ordered","items":["тест-кассета - 1 шт.,","зонд для взятия образца (пробы) - 1 шт.,","буферный раствор для разведения образца (пробы) - 1 шт.,","инструкция по использованию - 1 шт."]}}]},{"id":5,"name":"Описание","slug":"common_description","body":[{"type":"paragraph","data":{"text":"\n\nНабор реагентов Leccurate для определения иммунохроматографическим методом антигена коронавируса SARS-CoV-2 с применением коллоидного золота по мазку из носоглотки."}},{"type":"paragraph","data":{"text":" Коронавирус относится к большому семейству вирусов и представляет собой одноцепочечный РНК-содержащий вирус с оболочкой (envelope). Известно, что вирус вызывает простуду, ближневосточный респираторный синдром (БВРС), тяжелый острый респираторный синдром (ТОРС) и другие серьезные заболевания. Структурным белком SARS-CoV-2 является нуклеокапсид N (Nucleocapsid), это белковый компонент вируса. Он относительно консервативен среди коронавирусов и часто используется в качестве инструмента для диагностики коронавируса. ACE2, который является ключевым рецептором для проникновения SARS-CoV-2 в клетку, имеет большое значение для изучения механизма развития вирусной инфекции."}},{"type":"paragraph","data":{"text":"\n Данный набор работает по принципу реакции \"антиген-антитело\" и методу иммуноанализа. Тест-кассета содержит моноклональные антитела нуклеокапсида N коронавируса, меченные коллоидным золотом и предварительно нанесенные на мембрану, а также моноклональные антитела нуклеокапсида N коронавируса, иммобилизированные в области тестирования (Т), и соответствующие антитела в области контроля качества (C)."}},{"type":"paragraph","data":{"text":"\n Во время тестирования нуклеокапсид N, содержащийся в образце, связывается с антителами нуклеокапсида N коронавируса, которые мечены коллоидным золотом и предварительно нанесены на мембрану. Затем конъюганты под действием капилляров движутся вверх, где связываются с моноклональными антителами нуклеокапсида N, иммобилизированным в области тестирования (Т). Чем выше содержание нуклеокапсида N в образце, тем больше антител было связано, и тем темнее становится красный цвет тестовой области (Т). Если в образце не содержится коронавирус, или содержание вируса ниже предела обнаружения, то цвет тестовой области Т не изменится.\n\n"}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Набор предназначен для качественного обнаружения методом иммунохроматографии антигена коронавируса SARS-CoV-2 в биологическом материале человека (мазок из носоглотки)."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"\n\nНабор предназначен для качественного обнаружения методом иммунохроматографии антигена коронавируса SARS-CoV-2 в биологическом материале человека (мазок из носо- и ротоглотки)."}},{"type":"paragraph","data":{"text":" Забор образцов: при отборе образцов соблюдайте общие меры предосторожности. Обращайтесь со всеми образцами как с потенциально инфицированными."}},{"type":"paragraph","data":{"text":"\n При работе с отобранными образцами должны учитываться требования СП 1.3.3118-13 \"Безопасность работы с микроорганизмами I-II групп патогенности (опасности)\"."}},{"type":"paragraph","data":{"text":"\n Данный набор реагентов применяется для тестирования образцов - мазков из носо- и ротоглотки."}},{"type":"paragraph","data":{"text":"\n Следует принять необходимые меры защиты, чтобы избежать прямого контакта с образцами. В случае случайного контакта необходимо своевременно провести дезинфекционную обработку и принять соответствующие меры."}},{"type":"paragraph","data":{"text":"\n Взятие мазка: основным видом биоматериала для исследования является материал, полученный при заборе мазка из носоглотки и двух носовых ходов для большей потенциальной концентрации вируса."}},{"type":"paragraph","data":{"text":"\n Хранение образцов: необходимо провести тестирование в течение 1 часа после забора образцов."}},{"type":"paragraph","data":{"text":"\n Перед тестированием образцы должны быть доведены до комнатной температуры."}},{"type":"paragraph","data":{"text":"\n Внимательно ознакомьтесь с инструкцией по применению перед проведением теста. Перед тестированием доведите реактивы и образцы до комнатной температуры."}},{"type":"paragraph","data":{"text":"\n 1. Для отбора проб необходимо вскрыть индивидуальную упаковку зонда, взять его в руку и последовательно вставить этот же зонд в оба носовых прохода на всю длину ватного тампона и осторожно повернуть зонд в каждом из них по пять раз."}},{"type":"paragraph","data":{"text":"\n 2. Перед тестом следует заранее удалить двусторонний клейкий защитный слой, чтобы не допустить разбрызгивания жидкости. Если двусторонний клейкий защитный слой снят после добавления жидкости для разбавления, это легко может привести к разбрызгиванию жидкости."}},{"type":"paragraph","data":{"text":"\n 3. Раскройте тест-кассету. Вставьте образец в лунку А через отверстие лунки В. Добавьте шесть капель буферного раствора в ячейку А. Не добавляйте буферный раствор в другие ячейки. Аккуратно поверните вставленный зонд, два оборота в каждом направлении."}},{"type":"paragraph","data":{"text":"\n 4. Во время теста тест-кассета должна быть помещена на горизонтальную поверхность стола."}},{"type":"paragraph","data":{"text":"\n 5. Закройте тест-кассету и осторожно нажмите на клейкий слой в соответствующем месте для равномерного крепления сторон, потом начинайте отсчет времени. Ожидайте появления фиолетовой полосы. Результаты теста следует считать в течение 15-20 минут.\n\n"}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"\n\nИспользуется для проведения диагностики in vitro, все этапы следует выполнять последовательно в соответствии с инструкцией."}},{"type":"paragraph","data":{"text":"Результаты тестирования могут быть недостоверными в случае, если допущено какое-либо отклонение от указанного в инструкции к данному медицинскому изделию."}},{"type":"paragraph","data":{"text":"\nПоверхности следует очищать и обеззараживать до и после тестирования."}},{"type":"paragraph","data":{"text":"\nПродукт содержит тест-кассету, инструкцию по применению, буферный раствор для разведения образца (пробы), зонд для взятия образца."}},{"type":"paragraph","data":{"text":"\nТест-кассета состоит из золотой мембраны (с нанесенными моноклональными антителами нуклеокапсида N SARS-CoV-2, меченными колоидным золотом), мембраны для образца, нитроцеллюлозной мембраны (моноклональные антитела нуклеокапсида N SARS-CoV-2, иммобилизированные в области тестирования (Т); антитела козы к иммуноглобулинам мыши, нанесенные на область контроля качества (С)), абсорбционной бумаги, гидрофобной мембраны."}},{"type":"paragraph","data":{"text":"\n Клиническая диагностика должна быть сделана посредством комплексного анализа специалиста на основе других методов испытаний и клинических симптомов."}},{"type":"paragraph","data":{"text":"\n - Внимательно прочитайте инструкцию перед началом тестирования и следуйте процедуре правильно."}},{"type":"paragraph","data":{"text":"\n - Запрещается повторное использование изделий, поскольку они используются только один раз."}},{"type":"paragraph","data":{"text":"\n - Результат тестирования после истечения срока годности является ненадежным."}},{"type":"paragraph","data":{"text":"\n - Тест-кассета должна оставаться в герметичной упаковке до использования, поскольку она чувствительна к влаге, необходимо использовать тест-кассету сразу после вскрытия упаковки."}},{"type":"paragraph","data":{"text":"\n - Не используйте набор, если упаковка повреждена."}},{"type":"paragraph","data":{"text":"\n - Перед испытанием образцы и тестовое устройство должны находиться при комнатной температуре, не следует замораживать или использовать продукт после истечения срока годности (срок годности указан на упаковке)."}},{"type":"paragraph","data":{"text":"\n - Это диагностический продукт in vitro и риск заражения низок, потому что нет прямого контакта с человеком. Однако, пожалуйста, будьте осторожны при обращении с тестовым набором и клиническими образцами, потенциально содержащими инфекционные источники. Утилизируйте использованные образцы, тест-кассеты, выделения из образцов и пробоотборные мазки согласно соответствующим правилам."}},{"type":"paragraph","data":{"text":"\n - Запрещается курение и прием пищи на испытательной площадке при передаче образцов или комплектов реагентов."}},{"type":"paragraph","data":{"text":"\n - Избегайте контакта с кожей и глазами."}},{"type":"paragraph","data":{"text":"\n - Запрещается проводить тестирование в условиях слишком высокой температуры или влажности, рекомендуемая температура - 15-30 C, влажность - ниже 70%."}},{"type":"paragraph","data":{"text":"\n - Запрещается употреблять внутрь осушитель, находящийся внутри упаковки."}},{"type":"paragraph","data":{"text":"\n - При проведении тестирования следует надеть защитную одежду, перчатки и маску."}},{"type":"paragraph","data":{"text":"\n - Утилизация использованных образцов и наборов реагентов должна осуществляться с установленными в данном регионе законами и правилами."}},{"type":"paragraph","data":{"text":"\n - Перед тестированием следует заранее удалить двусторонний клейкий защитный слой, чтобы не допустить разбрызгивания буферного раствора; если двусторонний клейкий защитный слой снят после добавления буферного раствора для разбавления, это легко может привести к разбрызгиванию жидкости."}},{"type":"paragraph","data":{"text":"\n - Не добавляйте капли жидкости для разбавления в другую ячейку.\n\n"}}]}],"source":null},"description_toggle":false,"short_description":"Набор реагентов Leccurate для определения иммунохроматографическим методом антигена коронавируса SARS-CoV-2 с применением коллоидного золота по мазку из носоглотки. Коронавирус относится к большому семейству вирусов и представляет собой одноцепочечный РНК-содержащий вирус с оболочкой (envelope). Известно, что вирус вызывает простуду, ближневосточный респираторный синдром (БВРС), тяжелый острый респираторный синдром (ТОРС) и другие серьезные заболевания. Структурным белком SARS-CoV-2 является нуклеокапсид N (Nucleocapsid), это белковый компонент вируса. Он относительно консервативен среди коронавирусов и часто используется в качестве инструмента для диагностики коронавируса. ACE2, который является ключевым рецептором для проникновения SARS-CoV-2 в клетку, имеет большое значение для изучения механизма развития вирусной инфекции. Данный набор работает по принципу реакции \"антиген-антитело\" и методу иммуноанализа. Тест-кассета содержит моноклональные антитела нуклеокапсида N коронавируса, меченные коллоидным золотом и предварительно нанесенные на мембрану, а также моноклональные антитела нуклеокапсида N коронавируса, иммобилизированные в области тестирования (Т), и соответствующие антитела в области контроля качества (C). Во время тестирования нуклеокапсид N, содержащийся в образце, связывается с антителами нуклеокапсида N коронавируса, которые мечены коллоидным золотом и предварительно нанесены на мембрану. Затем конъюганты под действием капилляров движутся вверх, где связываются с моноклональными антителами нуклеокапсида N, иммобилизированным в области тестирования (Т). Чем выше содержание нуклеокапсида N в образце, тем больше антител было связано, и тем темнее становится красный цвет тестовой области (Т). 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