Принцип действия «Набор реагентов для иммунохроматографическ... Инструкция
Показания к применению
Для качественного определения наличия антигена SARS-CoV-2 в мазке из носоглотки у лиц с клинической симптоматикой респиратор- ного заболевания с подозрением на инфекцию COVID-19.
Противопоказания
1. Истекший срок годности теста
2. Нарушена упаковка изделия
3. Ненадлежащие условия хранения и транспортирования.
4. Другие противопоказания отсутствуют, за исключением случаев, когда забор материала не может быть осуществлен по медицинским показаниям.
Инструкция
Состав
Тестовая кассета в индивидуальной вакуумной упаковке из алюминиевой фольги с осушителем – 1 шт.
Пробирка с буфером для разведения биологического образца – 1 шт (0,3 мл/пробирка).
Насадка с капельницей – 1 шт.
Стерильный тампон для взятия мазка COVICHEK – 1 шт.
Инструкция по применению – 1 шт.
Описание
Принцип действия «Набор реагентов для иммунохроматографического выявления антигена SARS-CoV-2 (NanoCare COVID-19 Antigen (Ag) Kit).,LOT: 201224-03 в мазках из носоглотки человека, в вариантах исполнения» основан на связывании антигена путем иммунохроматографического анализа для обнаружения вирусного нуклеопротеина SARS-CoV-2 -в образцах мазка из носоглотки.
Сначала вирусные антигены экстагируются из проб с помощью химических реагентов, после чего используется технология твердофазного иммуноферментного анализа для обнаружения экстрагированного антигена.
Моноклональные антитела, специфичные для антигена SARS-CoV-2, связаны с коллоидным золотом, сорбированы на специальной подушке для конъюгатов, а также иммобилизованы в тестовой зоне на нитроцеллюлозной мембране.
После добавления образца конъюгат меченных коллоидным золотом антител взаимодействует с антигеном SARS-CoV-2, при его наличии в образце. Комплекс антиген-антитело-коллоидное золото будет мигрировать в сторону тестового окна через тестовую зону (Т), где будет связан иммобилизованными антителами с формированием видимой розовой линии (тестовая полоса), что указывает на положительный результат анализа.
Если антиген SARS-CoV-2 отсутствует в образце, то в тестовой зоне (Т) не появится розовой линии.
Контрольная полоса была создана в целях внутреннего контроля качества процесса для указания на то, что испытание проведено правильно. Посредством использования различных реакций антиген/антитело этот контрольная линия всегда должна окрашиваться после завершения испытания. Отсутствие розовой контрольной линии в контрольном участке (С) указывает на не действительный результат.
Интерпретация результатов Отрицательный:
Розовая полоса появляется только в контрольной области (С), что говорит об отсутствии инфекции COVID-19.
Положительный:
Появляется четка розовая контрольная полоса (С) и различимая тестовая полоса (Т), что говорит о положительном на наличие инфекции COVID-19 результате.
Недействительный:
Отсутствие видимой полосы в контрольной области. Повторить с новым набором. Если тест по-прежнему дает недействительный результат, свяжитесь с дистрибьютором и сообщите ему номер партии.
Показания к применению
Для качественного определения наличия антигена SARS-CoV-2 в мазке из носоглотки у лиц с клинической симптоматикой респиратор- ного заболевания с подозрением на инфекцию COVID-19.
Противопоказания
1. Истекший срок годности теста
2. Нарушена упаковка изделия
3. Ненадлежащие условия хранения и транспортирования.
4. Другие противопоказания отсутствуют, за исключением случаев, когда забор материала не может быть осуществлен по медицинским показаниям.
Особые указания
МЕРЫ ПРЕДОСТОРОЖНОСТИ
Предназначен только для in vitro диагностики.
Повторное использование запрещено.
Не используйте набор регентов, если нарушена целостность упаковки.
Не используйте набор реагентов после истечения срока годности, указанного на упаковке.
Не перемешивайте и не заменяйте друг другом различные образцы.
Надевайте лабораторный халат, одноразовые перчатки и средства для защиты глаз, во время обработки потенциально инфекционных материалов / поверхностей или постановки теста.
Тщательно вымойте руки после завершения работы с тестами.
Не принимайте пищу, не пейте и не курите в зоне, в которой находят- ся образцы или наборы или могут проводить постановку тестов.
В случае розлива образца (-ов), тщательно вымойте места розлива с использованием подходящих дезинфицирующих средств.
Исследуемые образцы следует рассматривать как инфициро- ванные. Соблюдайте установленные меры предосторожности против микробиологических опасностей на протяжении всей постановки тестов.
Утилизируйте все образцы и использованные устройства в подходящем контейнере для биологически опасных отходов. Обработка и утилизация опасных материалов должна соответство- вать местным, национальным или региональным нормативно-пра- вовым требованиям.
Хранить в недоступном для детей месте.
Все образцы, полученные для лабораторного исследования, следует считать потенциально инфицированными, и при работе с ними должны учитываться требования СП 1.3.3118-13 «Безопасность работы с микроорганизмами I - II групп патогенности (опасности).
Медицинские работники, которые собирают или транспортиру- ют клинические образцы в лабораторию, должны быть обучены практике безопасного обращения с биоматериалом, строго соблюдать меры предосторожности и использовать средства индивидуальной защиты (СИЗ).
ВЗЯТИЕ И ХРАНЕНИЕ БИОЛОГИЧЕСКИХ ОБРАЗЦОВ
Вставьте стерильный тампон для взятия мазка в ноздрю пациента.
Сделайте медленное вращательное движение тампоном по поверхности задней стенки носоглотки.
Поместите тампон в пробирку с раствором буферным.
Отожмите тампон о стенки пробирки.
Примечание:
Свежесобранные образцы должны быть обработаны как можно скорее, но не позже, чем спустя 1 час после сбора, важно соблюдать методику сбора и подготовки образцов.
Реагенты, пробы и тестовые кассеты должны быть комнатной температуры (15-30°С) перед началом проведения анализа.
Порядок выполнения тестирования
Перед проведением тестирования прочтите инструкцию.
Этапы тестирования
1. Закройте пробирку насадкой с капельницей и добавьте 3 капли образца в лунку тестовой кассеты.
2. Считайте результат в течение 10-15 минут. Не считывайте результат, если прошло 30 минут и более
3. Транспортировка образцов осуществляется с соблюдением требований СП 1.2.036-95 «Порядок учета, хранения, передачи и транспортирования микроорганизмов I-IV групп патогенности».
ОГРАНИЧЕНИЯ ПРИ ИСПОЛЬЗОВАНИИ
1. Набор реагентов включает предварительно разведенный обрабатывающий реактив в готовых к использованию унифициро- ванных пробирках.
2. Набор НЕ ПРЕДНАЗНАЧЕН для испытания образцов жидкости, включая промывочные или аспирированные образцы или мазки в транспортируемых контейнерах, поскольку результаты могут быть неправильными, вследствие чрезмерного разбавления проб.
3. Используйте в комбинации со стратегией тестирования, описан- ной органами общественного здравоохранения в Вашем регионе.
4. Отклонение влажности и температуры от рекомендованного диапазона могут оказать отрицательное воздействие на результаты.
5. Содержимое этого набора должно быть использовано для качест- венного обнаружения антигена COVID-19 в мазках из носоглотки.
6. Отрицательный результат может иметь место в том случае, если уровень антигена в образце ниже предела обнаружения тест-системы.
7. Несоблюдение процедуры исследования и интерпретации результатов может отрицательно сказаться на результативности испытаний и/или привести к получению неправильного результата испытания.
8. Отрицательный результат испытания не исключает возможные вирусные инфекции, помимо COVID-19.
9. Положительные результаты испытания не исключают сопутствую- щих инфекций, вызванных иными патогенными микроорганизмами.
10. Положительные и отрицательные прогностические значения сильно зависят от распространенности. Ложноотрицательные результаты испытания более вероятны во время пика активности, когда распространенность заболевания высока. Ложноположи- тельные результаты тестирования более вероятны во время периодов низкой активности гриппа, когда распространенность имеет уровень от умеренной до низкой.
ПОТЕНЦИАЛЬНЫЕ ПОТРЕБИТЕЛИ:
Набор предназначен для использования персоналом клинико-диагно- стических лабораторий не моложе 18 лет с высшим и средним медицинским, биологическим образованием, прошедшим соответ- ствующую профессиональную подготовку в области используемых методов и методов безопасной работы с патогенными биологически- ми агентами I-IV групп патогенности.
ГАРАНТИЙНЫЕ ОБЯЗАТЕЛЬСТВА
Производитель гарантирует стабильность медицинского изделия до окончания срока годности при соблюдении условий транспортирова- ния, хранения и применения, указанных в инструкции.
Производитель гарантирует безопасность медицинского изделия, отсутствие недопустимого риска причинения вреда жизни, здоровью человека и окружающей среде при использовании набора реагентов по назначению в условиях, предусмотренных производителем.
Условия хранения
Температура окружающей среды: 2-30°C
• Не замораживайте устройство для проведения испытаний.
• Устройство для проведения испытаний необходимо хранить
в защищённом от прямых солнечных лучей, влаги и тепла месте.
Для описания товара использована информация от партнера 36.6
Мобильное приложение «Все аптеки»
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Информация предоставляется в справочных целях. Не занимайтесь самолечением. При первых признаках заболевания обратитесь к врачу.
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кассета в индивидуальной вакуумной упаковке из алюминиевой фольги с осушителем – 1 шт.","Пробирка с буфером для разведения биологического образца – 1 шт (0,3 мл/пробирка).","Насадка с капельницей – 1 шт.","Стерильный тампон для взятия мазка COVICHEK – 1 шт.","Инструкция по применению – 1 шт."]}}]},{"id":5,"name":"Описание","slug":"common_description","body":[{"type":"paragraph","data":{"text":"Принцип действия «Набор реагентов для иммунохроматографического выявления антигена SARS-CoV-2 (NanoCare COVID-19 Antigen (Ag) Kit).,LOT: 201224-03 в мазках из носоглотки человека, в вариантах исполнения» основан на связывании антигена путем иммунохроматографического анализа для обнаружения вирусного нуклеопротеина SARS-CoV-2 -в образцах мазка из носоглотки."}},{"type":"paragraph","data":{"text":" Сначала вирусные антигены экстагируются из проб с помощью химических реагентов, после чего используется технология твердофазного иммуноферментного анализа для обнаружения экстрагированного антигена."}},{"type":"paragraph","data":{"text":" Моноклональные антитела, специфичные для антигена SARS-CoV-2, связаны с коллоидным золотом, сорбированы на специальной подушке для конъюгатов, а также иммобилизованы в тестовой зоне на нитроцеллюлозной мембране."}},{"type":"paragraph","data":{"text":" После добавления образца конъюгат меченных коллоидным золотом антител взаимодействует с антигеном SARS-CoV-2, при его наличии в образце. Комплекс антиген-антитело-коллоидное золото будет мигрировать в сторону тестового окна через тестовую зону (Т), где будет связан иммобилизованными антителами с формированием видимой розовой линии (тестовая полоса), что указывает на положительный результат анализа."}},{"type":"paragraph","data":{"text":" Если антиген SARS-CoV-2 отсутствует в образце, то в тестовой зоне (Т) не появится розовой линии."}},{"type":"paragraph","data":{"text":"Контрольная полоса была создана в целях внутреннего контроля качества процесса для указания на то, что испытание проведено правильно. Посредством использования различных реакций антиген/антитело этот контрольная линия всегда должна окрашиваться после завершения испытания. Отсутствие розовой контрольной линии в контрольном участке (С) указывает на не действительный результат."}},{"type":"paragraph","data":{"text":"\n\nИнтерпретация результатов Отрицательный:"}},{"type":"paragraph","data":{"text":"Розовая полоса появляется только в контрольной области (С), что говорит об отсутствии инфекции COVID-19."}},{"type":"paragraph","data":{"text":"Положительный:"}},{"type":"paragraph","data":{"text":"Появляется четка розовая контрольная полоса (С) и различимая тестовая полоса (Т), что говорит о положительном на наличие инфекции COVID-19 результате."}},{"type":"paragraph","data":{"text":"Недействительный:"}},{"type":"paragraph","data":{"text":"Отсутствие видимой полосы в контрольной области. Повторить с новым набором. Если тест по-прежнему дает недействительный результат, свяжитесь с дистрибьютором и сообщите ему номер партии.\n\n"}}]},{"id":8,"name":"Показания к применению","slug":"indications","body":[{"type":"paragraph","data":{"text":"Для качественного определения наличия антигена SARS-CoV-2 в мазке из носоглотки у лиц с клинической симптоматикой респиратор- ного заболевания с подозрением на инфекцию COVID-19."}}]},{"id":9,"name":"Противопоказания","slug":"contraindications","body":[{"type":"paragraph","data":{"text":"\n\n1. Истекший срок годности теста"}},{"type":"paragraph","data":{"text":"2. Нарушена упаковка изделия"}},{"type":"paragraph","data":{"text":"3. Ненадлежащие условия хранения и транспортирования."}},{"type":"paragraph","data":{"text":"4. Другие противопоказания отсутствуют, за исключением случаев, когда забор материала не может быть осуществлен по медицинским показаниям.\n\n"}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"МЕРЫ ПРЕДОСТОРОЖНОСТИ"}},{"type":"list","data":{"style":"ordered","items":["Предназначен только для in vitro диагностики.","Повторное использование запрещено.","Не используйте набор регентов, если нарушена целостность упаковки.","Не используйте набор реагентов после истечения срока годности, указанного на упаковке.","Не перемешивайте и не заменяйте друг другом различные образцы.","Надевайте лабораторный халат, одноразовые перчатки и средства для защиты глаз, во время обработки потенциально инфекционных материалов / поверхностей или постановки теста.","Тщательно вымойте руки после завершения работы с тестами.","Не принимайте пищу, не пейте и не курите в зоне, в которой находят- ся образцы или наборы или могут проводить постановку тестов.","В случае розлива образца (-ов), тщательно вымойте места розлива с использованием подходящих дезинфицирующих средств.","Исследуемые образцы следует рассматривать как инфициро- ванные. Соблюдайте установленные меры предосторожности против микробиологических опасностей на протяжении всей постановки тестов.","Утилизируйте все образцы и использованные устройства в подходящем контейнере для биологически опасных отходов. Обработка и утилизация опасных материалов должна соответство- вать местным, национальным или региональным нормативно-пра- вовым требованиям.","Хранить в недоступном для детей месте.","Все образцы, полученные для лабораторного исследования, следует считать потенциально инфицированными, и при работе с ними должны учитываться требования СП 1.3.3118-13 «Безопасность работы с микроорганизмами I - II групп патогенности (опасности).","Медицинские работники, которые собирают или транспортиру- ют клинические образцы в лабораторию, должны быть обучены практике безопасного обращения с биоматериалом, строго соблюдать меры предосторожности и использовать средства индивидуальной защиты (СИЗ)."]}},{"type":"paragraph","data":{"text":"ВЗЯТИЕ И ХРАНЕНИЕ БИОЛОГИЧЕСКИХ ОБРАЗЦОВ"}},{"type":"list","data":{"style":"ordered","items":["Вставьте стерильный тампон для взятия мазка в ноздрю пациента.","Сделайте медленное вращательное движение тампоном по поверхности задней стенки носоглотки.","Поместите тампон в пробирку с раствором буферным.","Отожмите тампон о стенки пробирки."]}},{"type":"paragraph","data":{"text":"Примечание:"}},{"type":"list","data":{"style":"ordered","items":["Свежесобранные образцы должны быть обработаны как можно скорее, но не позже, чем спустя 1 час после сбора, важно соблюдать методику сбора и подготовки образцов.","Реагенты, пробы и тестовые кассеты должны быть комнатной температуры (15-30°С) перед началом проведения анализа."]}},{"type":"paragraph","data":{"text":"Порядок выполнения тестирования"}},{"type":"paragraph","data":{"text":"Перед проведением тестирования прочтите инструкцию."}},{"type":"paragraph","data":{"text":"Этапы тестирования"}},{"type":"paragraph","data":{"text":"1. Закройте пробирку насадкой с капельницей и добавьте 3 капли образца в лунку тестовой кассеты."}},{"type":"paragraph","data":{"text":"2. Считайте результат в течение 10-15 минут. Не считывайте результат, если прошло 30 минут и более"}},{"type":"paragraph","data":{"text":"3. Транспортировка образцов осуществляется с соблюдением требований СП 1.2.036-95 «Порядок учета, хранения, передачи и транспортирования микроорганизмов I-IV групп патогенности»."}},{"type":"paragraph","data":{"text":"ОГРАНИЧЕНИЯ ПРИ ИСПОЛЬЗОВАНИИ"}},{"type":"paragraph","data":{"text":"1. Набор реагентов включает предварительно разведенный обрабатывающий реактив в готовых к использованию унифициро- ванных пробирках."}},{"type":"paragraph","data":{"text":"2. Набор НЕ ПРЕДНАЗНАЧЕН для испытания образцов жидкости, включая промывочные или аспирированные образцы или мазки в транспортируемых контейнерах, поскольку результаты могут быть неправильными, вследствие чрезмерного разбавления проб."}},{"type":"paragraph","data":{"text":"3. Используйте в комбинации со стратегией тестирования, описан- ной органами общественного здравоохранения в Вашем регионе."}},{"type":"paragraph","data":{"text":"4. Отклонение влажности и температуры от рекомендованного диапазона могут оказать отрицательное воздействие на результаты."}},{"type":"paragraph","data":{"text":"5. Содержимое этого набора должно быть использовано для качест- венного обнаружения антигена COVID-19 в мазках из носоглотки."}},{"type":"paragraph","data":{"text":"6. Отрицательный результат может иметь место в том случае, если уровень антигена в образце ниже предела обнаружения тест-системы."}},{"type":"paragraph","data":{"text":"7. Несоблюдение процедуры исследования и интерпретации результатов может отрицательно сказаться на результативности испытаний и/или привести к получению неправильного результата испытания."}},{"type":"paragraph","data":{"text":"8. Отрицательный результат испытания не исключает возможные вирусные инфекции, помимо COVID-19."}},{"type":"paragraph","data":{"text":"9. Положительные результаты испытания не исключают сопутствую- щих инфекций, вызванных иными патогенными микроорганизмами."}},{"type":"paragraph","data":{"text":"10. Положительные и отрицательные прогностические значения сильно зависят от распространенности. Ложноотрицательные результаты испытания более вероятны во время пика активности, когда распространенность заболевания высока. Ложноположи- тельные результаты тестирования более вероятны во время периодов низкой активности гриппа, когда распространенность имеет уровень от умеренной до низкой."}},{"type":"paragraph","data":{"text":"ПОТЕНЦИАЛЬНЫЕ ПОТРЕБИТЕЛИ:"}},{"type":"paragraph","data":{"text":"Набор предназначен для использования персоналом клинико-диагно- стических лабораторий не моложе 18 лет с высшим и средним медицинским, биологическим образованием, прошедшим соответ- ствующую профессиональную подготовку в области используемых методов и методов безопасной работы с патогенными биологически- ми агентами I-IV групп патогенности."}},{"type":"paragraph","data":{"text":"ГАРАНТИЙНЫЕ ОБЯЗАТЕЛЬСТВА"}},{"type":"paragraph","data":{"text":"Производитель гарантирует стабильность медицинского изделия до окончания срока годности при соблюдении условий транспортирова- ния, хранения и применения, указанных в инструкции."}},{"type":"paragraph","data":{"text":"Производитель гарантирует безопасность медицинского изделия, отсутствие недопустимого риска причинения вреда жизни, здоровью человека и окружающей среде при использовании набора реагентов по назначению в условиях, предусмотренных производителем."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"\n\nТемпература окружающей среды: 2-30°C"}},{"type":"paragraph","data":{"text":"• Не замораживайте устройство для проведения испытаний."}},{"type":"paragraph","data":{"text":"• Устройство для проведения испытаний необходимо хранить"}},{"type":"paragraph","data":{"text":"в защищённом от прямых солнечных лучей, влаги и тепла месте.\n\n"}}]}],"source":null},"description_toggle":false,"short_description":"Принцип действия «Набор реагентов для иммунохроматографического выявления антигена SARS-CoV-2 (NanoCare COVID-19 Antigen (Ag) Kit).,LOT: 201224-03 в мазках из носоглотки человека, в вариантах исполнения» основан на связывании антигена путем иммунохроматографического анализа для обнаружения вирусного нуклеопротеина SARS-CoV-2 -в образцах мазка из носоглотки. Сначала вирусные антигены экстагируются из проб с помощью химических реагентов, после чего используется технология твердофазного иммуноферментного анализа для обнаружения экстрагированного антигена. Моноклональные антитела, специфичные для антигена SARS-CoV-2, связаны с коллоидным золотом, сорбированы на специальной подушке для конъюгатов, а также иммобилизованы в тестовой зоне на нитроцеллюлозной мембране. После добавления образца конъюгат меченных коллоидным золотом антител взаимодействует с антигеном SARS-CoV-2, при его наличии в образце. Комплекс антиген-антитело-коллоидное золото будет мигрировать в сторону тестового окна через тестовую зону (Т), где будет связан иммобилизованными антителами с формированием видимой розовой линии (тестовая полоса), что указывает на положительный результат анализа. Если антиген SARS-CoV-2 отсутствует в образце, то в тестовой зоне (Т) не появится розовой линии. Контрольная полоса была создана в целях внутреннего контроля качества процесса для указания на то, что испытание проведено правильно. Посредством использования различных реакций антиген/антитело этот контрольная линия всегда должна окрашиваться после завершения испытания. Отсутствие розовой контрольной линии в контрольном участке (С) указывает на не действительный результат. Интерпретация результатов Отрицательный: Розовая полоса появляется только в контрольной области (С), что говорит об отсутствии инфекции COVID-19. Положительный: Появляется четка розовая контрольная полоса (С) и различимая тестовая полоса (Т), что говорит о положительном на наличие инфекции COVID-19 результате. Недействительный: Отсутствие видимой полосы в контрольной области. Повторить с новым набором. 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