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Не допускайте попадания в\nглаза и на чувствительные слизистые оболочки. При попадании реагента экстракционного\nбуфера на кожу или в глаза, смойте его большим количеством воды."}},{"type":"paragraph","data":{"text":"•        Во\nизбежание контакта с инфекционными агентами при работе с реагентами из набора\nнеобходимо надевать одноразовые перчатки и тщательно мыть руки после его\nиспользования."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"•        Биологическим\nматериалом для исследования является мазок из носоглотки человека. Исследованию\nподлежит как нативный носоглоточный мазок, так и мазок, помещенный в\nтранспортную среду."}},{"type":"paragraph","data":{"text":"•        Для\nвзятия образца мазка из носоглотки осторожно введите тампон в ноздрю пациента,\nв которой визуально наблюдается большая секреция. Не касаясь тампоном дна\nносовой перегородки, осторожно протолкните тампон до задней части носоглотки.\nПроверните тампон несколько раз и затем выньте его из носоглотки."}},{"type":"paragraph","data":{"text":"•        Образцы\nследует брать в стандартных лабораторных условиях."}},{"type":"paragraph","data":{"text":"•        Образцы\nнеобходимо протестировать в кратчайшие сроки после взятия."}},{"type":"paragraph","data":{"text":"•        Охлажденным\nили замороженным образцам перед тестированием необходимо дать нагреться до\nкомнатной температуры (20℃ ~ 30℃) и приобрести однородность."}},{"type":"paragraph","data":{"text":"•        Использование\nтранспортных сред (ВТС (вирусной транспортной среды) или УТС (универсальной\nтранспортной среды)) может привести к снижению чувствительности теста из-за\nразбавления, поэтому настоятельно рекомендуется непосредственное тестирование\nмазка, взятого у пациента."}},{"type":"paragraph","data":{"text":"•          В Российской\nФедерации взятие, транспортирование и хранение исследуемого материала\nосуществляется согласно МУ 4.2.2039-05 «Техника сбора и транспортирования\nбиоматериалов в микробиологические лаборатории», утвержденным\nРоспотребнадзором, и Рекомендациям «Организация преаналитического этапа при\nцентрализации лабораторных исследований», одобренным профильной комиссией\nМинздрава России по клинической лабораторной диагностике 30.05.2013. При\nобращении анализируемого биологического материала и проведении исследований\nследует также руководствоваться Временными методическими рекомендациями\nМинистерства здравоохранения РФ «Профилактика, диагностика и лечение новой\nкоронавирусной инфекции COVID-19» в действующей версии."}},{"type":"paragraph","data":{"text":"\u003cb\u003eПроцедура тестирования\u003c/b\u003e"}},{"type":"paragraph","data":{"text":"•        Собрать\nобразцы в соответствии с инструкциями в разделе «Взятие и подготовка образцов»."}},{"type":"paragraph","data":{"text":"•        Тестовой\nкассете и образцу перед тестированием необходимо дать нагреться до комнатной\nтемпературы (20℃ ~ 30℃)."}},{"type":"paragraph","data":{"text":"•        Вынуть\nтестовую кассету из индивидуального герметичного пакета непосредственно перед\nвыполнением теста. Подписать кассету, указав имя пациента или контрольный\nидентификатор."}},{"type":"paragraph","data":{"text":"•        Открыть\nреакционную пробирку с экстракционным буфером и снять крышку."}},{"type":"paragraph","data":{"text":"•        Вставить\nтампон с мазком в реакционную пробирку с экстракционным буфером и провернуть\nтампон, прижав его к внутренней стенке пробирки, более пяти раз. В течение 15\nсекунд совершать тампоном движения вверх и вниз в экстракционном буфере, сжимая\nпри этом пробирку с боков."}},{"type":"paragraph","data":{"text":"•        Извлечь\nтампон, сжав стенки пробирки для извлечения максимального количества жидкости\nиз тампона. Утилизировать тампон надлежащим образом."}},{"type":"paragraph","data":{"text":"•        Плотно\nзакрыть реакционную пробирку с экстракционным буфером и добавленным в нее образцом\nс помощью колпачка с фильтром и капельницей."}},{"type":"paragraph","data":{"text":"•        Перевернуть\nреакционную пробирку и удерживать вертикально (на расстоянии примерно 2,5 см над\nлункой для образца на тестовой кассете). Удерживая пробирку за среднюю часть,\nследует слегка нажать на ее, чтобы выдавить две капли образца в соответствующую\nлунку на тестовой кассете."}},{"type":"paragraph","data":{"text":"•        Через\n10 минут необходимо визуально учесть результат. Если с момента нанесения\nобразца прошло более 12 минут, результат теста становится некорректным и учету\nне подлежит."}},{"type":"paragraph","data":{"text":"*        При\nпроведении клинических испытаний на территории Российской Федерации для\nприменения с набором реагентов валидированы тампоны для взятия назальных мазков\nПалочка-тампон\nс ватным намотом медицинская стерильная в упаковках 1 шт., 5 шт., 10 шт., 20\nшт., 25 шт., 50 шт., 100 шт., 200 шт., 500 шт., 1000 шт. по ТУ 9398-012-44881728-2014\n(РЗН 2015/2401)."}},{"type":"paragraph","data":{"text":"\u003cb\u003e\u003ci\u003eИнформация об использовании\nтранспортной среды*\u003c/i\u003e\u003c/b\u003e"}},{"type":"paragraph","data":{"text":"Если для тестирования с помощью «Экспресс-теста\nPBCheck COVID-19 Ag» требуется использовать ранее собранные образцы в\nтранспортной среде, рекомендуется обеспечить минимальное разбавление образцов.\nВнесите ранее собранные образцы в транспортной среде в экстракционный буфер в\nсоотношении один к одному (смешав по 300 мкл каждого из компонентов). Через 1\nминуту закройте пробирку колпачком с дозатором и далее следуйте инструкции по\nвыполнению процедуры тестирования."}},{"type":"paragraph","data":{"text":"*        При\nпроведении клинических испытаний на территории Российской Федерации для\nприменения с набором реагентов валидирована вирусная транспортная среда – Система\nтранспортная со средой для вирусов по ТУ 32.50.50-027-17547866-2020, \u003ca\u003eСистема транспортная со средой для вирусов, материал\nтампона нейлон «СТ со средой для вирусов-Н» (РЗН 2020/9961), производства ООО\n«ПОЛИГЕМ», Россия\u003c/a\u003e."}},{"type":"paragraph","data":{"text":"\u003cb\u003eИнтерпретация результатов\u003c/b\u003e"}},{"type":"paragraph","data":{"text":"\u003cb\u003e\u003ci\u003eОтрицательный:\u003c/i\u003e\u003c/b\u003e\nединственная розовато-красная полоса на линии контроля (С) при отсутствии полосы\nна линии теста (Т) свидетельствует об отрицательном результате тестирования на\nвирус SARS-CoV-2. Отрицательный результат не указывает на полное отсутствие\nвируса SARS-CoV-2 в образце. Отрицательный результат говорит лишь о том, что содержание\nвируса SARS-CoV-2 в образце меньше предела обнаружения теста."}},{"type":"paragraph","data":{"text":"\u003cb\u003e\u003ci\u003eПоложительный:\u003c/i\u003e\u003c/b\u003e наличие\nодновременно розовато-красной полосы на линии контроля (С) и розовато-красной\nполосы любой интенсивности на тестовой линии (Т) свидетельствует об обнаружении\nвируса SARS-CoV-2 в образце."}},{"type":"paragraph","data":{"text":"\u003cb\u003e\u003ci\u003eНедействительный:\u003c/i\u003e\u003c/b\u003e если\nна линии контроля (С) отсутствует цветная полоса, результат теста является недействительным.\nТакой результат теста не засчитывается, и тест необходимо повторить на новой\nтестовой кассете."}},{"type":"paragraph","data":{"text":"Если недействительный результат\nанализа (отсутствие красной полосы в зоне контроля С) повторяется после\nповторного проведения тестирования, обратитесь к уполномоченному представителю\nпроизводителя на территории Российской Федерации."}}]},{"id":13,"name":"Побочное действие","slug":"side_effects","body":[{"type":"paragraph","data":{"text":"\u003cb\u003e\u003ci\u003eПобочные действия\u003c/i\u003e\u003c/b\u003e, связанные с\nприменением набора, отсутствуют    "}}]},{"id":16,"name":"Особые указания","slug":"","body":[{"type":"paragraph","data":{"text":"Антиген обычно обнаруживается в образцах биологического\nматериала (мазках из носоглотки) во время острой фазы заболевания.\nПоложительные результаты свидетельствуют о присутствии в мазке вирусного\nантигена, но для подтверждения наличия инфекции необходимо сопоставление с\nклинической историей болезни и результатами других анализов. Положительные\nрезультаты не исключают бактериальную инфекцию или сопутствующее заражение\nдругими вирусами. Обнаруженный агент может не быть истинной причиной\nзаболевания. Отрицательные результаты должны рассматриваться как\nпредварительные; они не исключают наличия инфекции SARS-CoV-2 и не должны\nрассматриваться в качестве единственного критерия для принятия решения о\nлечении или наблюдении пациента, включая решения, касающиеся\nсанитарно-эпидемиологического режима. Отрицательные результаты должны\nрассматриваться в контексте недавних контактов пациента, истории болезни,\nналичия клинических признаков (симптомов), присущих COVID-19, и должны подтверждаться\nмолекулярным анализом, если это необходимо для ведения пациента."}},{"type":"paragraph","data":{"text":"\u003cb\u003eОграничения\u003c/b\u003e"}},{"type":"paragraph","data":{"text":"•        Данный\nтест предназначен только для профессиональной \u003ci\u003ein vitro\u003c/i\u003e диагностики."}},{"type":"paragraph","data":{"text":"•        Использование\nвирусной транспортной среды или универсальной транспортной среды может привести\nк снижению чувствительности теста из-за разбавления, поэтому настоятельно\nрекомендуется непосредственное тестирование мазка."}},{"type":"paragraph","data":{"text":"•        Как\nи для других тестов, предназначенных для обнаружения антигенов, характеристики\nданного теста могут ухудшаться при анализе образцов, взятых через длительное\nвремя после проявления симптомов."}},{"type":"paragraph","data":{"text":"•        Окончательный\nклинический диагноз не должен ставиться только на основании результатов данного\nтеста. При диагностике заражения SARS-CoV-2 результаты данного теста следует\nиспользовать в сочетании с другими клиническими данными, такими как клинические\nпризнаки и симптомы, а также результатами других тестов. Подтверждение\nрезультатов теста должно производиться врачом с обязательным учетом клинических\nсимптомов и результатов других лабораторных анализов."}},{"type":"paragraph","data":{"text":"•        Данный\nтест обнаруживает как жизнеспособные (живые), так и нежизнеспособные вирусные\nчастицы SARS-CoV-2. Результаты работы данного теста зависят от количества\nвирусных частиц (антигена) в образце и могут не коррелировать с результатами\nанализа вирусной культуры, выполненными на том же образце."}},{"type":"paragraph","data":{"text":"•        Отрицательный\nрезультат теста может быть получен, если концентрация антигена в образце будет\nниже предела обнаружения теста или если взятие или транспортировка образца\nпроизводились с нарушениями требований."}},{"type":"paragraph","data":{"text":"•        Нарушение\nпроцедуры тестирования может ухудшить характеристики теста и/или привести к\nнекорректности результатов теста."}},{"type":"paragraph","data":{"text":"•        Положительные\nрезультаты теста не исключают параллельное заражение другими патогенами."}},{"type":"paragraph","data":{"text":"•        Отрицательные\nрезультаты для пациентов, у которых симптомы появились более чем за пять дней\nдо тестирования, должны рассматриваться как предварительные, и в случае\nнеобходимости должен быть проведен молекулярный анализ."}}]},{"id":19,"name":"Условия хранения","slug":"storage","body":[{"type":"paragraph","data":{"text":"\u003cb\u003e\u003ci\u003eУсловия хранения и\nтранспортировки\u003c/i\u003e\u003c/b\u003e"}},{"type":"paragraph","data":{"text":"Хранить изделие необходимо в\nоригинальной упаковке, защищенной от прямого солнечного света, в сухом,\nпрохладном и хорошо проветриваемом помещении, вдали от продуктов питания и\nнапитков, при температуре плюс (2 – 30) °C."}},{"type":"paragraph","data":{"text":"Транспортировать изделия следует\nтранспортом всех видов в крытых транспортных средствах в соответствии с\nправилами перевозок, действующими на транспорте данного вида, в упаковке\nпроизводителя при температуре плюс (2 – 30) °C, без замораживания."}},{"type":"paragraph","data":{"text":"\u003cb\u003e\u003ci\u003eУсловия эксплуатации\u003c/i\u003e\u003c/b\u003e"}},{"type":"paragraph","data":{"text":"Тест-кассету после\nвскрытия упаковки и вскрытую реакционную пробирку с экстракционным буфером следует\nиспользовать в течение 1 часа."}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"\u003cb\u003e\u003ci\u003eСрок годности набора\u003c/i\u003e\u003c/b\u003e –\n15 месяцев."}},{"type":"paragraph","data":{"text":"Примечание: Срок годности не\nверифицирован испытаниями в реальном времени. Исследование стабильности в\nреальном времени продолжается."}}]},{"id":22,"name":"Производитель","slug":"","body":[{"type":"paragraph","data":{"text":"\u003cb\u003eПресижен Биосенсор Инк. (Precision Biosensor Inc.),\nРеспублика Корея\u003c/b\u003e"}}]},{"id":23,"name":"Организация, принимающая претензии потребителей","body":[{"type":"paragraph","data":{"text":"Общество с ограниченной ответственностью «ДИЛОС» (ООО «ДИЛОС»)"}}]}],"source":null},"description_toggle":false,"short_description":"Экстракционный буфер представляет собой натрий-фосфатный буфер и поверхностно активное вещество (Tween 20/Triton X-100). Тест-полоска в тестовой кассете содержит биотинилированные и конъюгированные с наночастицами целлюлозы антитела к нуклеопротеину SARS-CoV-2, козьи антитела к куриному IgY, стептавидин. Контрольный тампон с положительной реакцией на антиген COVID-19 «COVID-19 Positive» содержит нуклеопротеин SARS-CoV-2. Контрольный тампон с отрицательной реакцией на антиген COVID-19 «COVID-19 Negative» содержит бычий сывороточный альбумин. Биологические материалы животного и микробного происхождения, входящие в состав компонентов набора реагентов, безопасны для человека.","substance":[],"branding":null,"valid_for_quick_buy":false,"is_available_to_delivery":false,"comments":null,"image_alt":"Экспресс-тест PBCheck Covid-19 Ag для обнаружения антигенов SARS-COV-2 (комплект 1)","image_share":{"isTouch":{"default":"https://vseapteki.ru/cropping/thumbnails/101/85503/share_default/"},"isFromTablet":{"default":"https://vseapteki.ru/cropping/thumbnails/101/85503/share_default/"}},"diseases":[],"other_packages":[],"other_product_forms":[],"related_products":{"title":"Похожие товары","type":"nondrugs","products":[{"id":152851,"title":"Leccurate Экспресс-тест для определения антител IgG/IgM к коронавирусу SARS-CoV2","subtitle":{"full":"Тест, коробка, 1 шт","short":"Тест, 1 шт","package":"1 шт"},"prescription":false,"catalog_section_id":100406,"manufacturer":{"id":6036,"title":"Lepu Medical 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