Набор ИммуноХром-антиВИЧ-1/2-Экспресс предназначен для одноэ... Инструкция
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Набор ИммуноХром-антиВИЧ-1/2-Экспресс предназначен для одноэтапного быстрого качественного in vitro определения наличия антител к вирусу иммунодефицита человека типа 1 и/или типа 2 (ВИЧ-1/2) в сыворотке (плазме) или цельной крови методом иммунохроматографического анализа.
Результат, полученный с использованием набора
ИммуноХром-антиВИЧ-1/2-Экспресс, не должен рассматриваться как единственный критерий в диагностике СПИДа, а должен быть интерпретирован в совокупности с результатами других клинических исследований.
Принцип действия. Определение основано на принципе иммунохроматографического анализа. Испытуемый образец всасывается впитывающим участком полоски иммунохроматографической; при наличии в образце антител к ВИЧ-1/2 последние вступают в реакцию с рекомбинантными ВИЧ-антигенами, связанными с окрашенными микрочастицами, образуя окрашенный комплекс антиген-антитело.
Этот комплекс движется по мембране полоски с фронтом жидкости и вступает в реакцию с рекомбинантными ВИЧантигенами, иммобилизованными на мембране в тестовой зоне полоски, образуя линию розово-фиолетового цвета.
Остальные компоненты образуют розово-фиолетовую линию в верхней части тестовой зоны (контроль). Результат реакции оценивают визуально через 15 минут.
Относительная чувствительность составляет 99,9%, а относительная специфичность - 99,6% по отношению к результатам, полученным методом ИФА на панелях сывороток и клинических образцах.
Время проведения анализа - 15 минут.
Каждый набор предназначен для 1 или 25 определений наличия антител к вирусу иммунодефицита человека (ВИЧ1/2) в сыворотке (плазме) или цельной крови.
С осторожностью
Потенциальный риск применения – класс 3.
Все компоненты набора в используемых концентрациях являются нетоксичными.
Составляющие полоски не содержат вирус ВИЧ или его компоненты, могущие привести к инфицированию.
При работе с набором следует соблюдать “Правила устройства, техники безопасности, производственной санитарии, противоэпидемического режима и личной гигиены при работе в лабораториях (отделениях, отделах) санитарноэпидемиологических учреждений системы Министерства здравоохранения СССР” (М., 1981 г.).
При работе с набором следует надевать одноразовые резиновые или пластиковые перчатки, так как образцы крови человека следует рассматривать как потенциально инфицированные, способные длительное время сохранять и передавать ВИЧ, вирус гепатита или другие возбудители инфекций.
Способ применения и дозы
Перед проведением анализа компоненты набора и исследуемые образцы следует выдержать при комнатной температуре (+18-25°С) в течение 5-10 минут.
Вскрыть упаковку полоски, разрывая ее вдоль прорези, извлечь полоску.
Сыворотка, плазма и венозная кровь:
Внести с помощью пипетки в пробирку для образца 1 каплю (~40 мкл) сыворотки (плазмы) или венозной крови и добавить 2 капли (~80 мкл) реагента для разведения.
Опустить полоску вертикально в пробирку с анализируемым образцом концом со стрелками.
Через 15 минут визуально оценить результат.
Использование капиллярной крови непосредственно из пальца:
Положить полоску на сухую чистую горизонтальную поверхность.
Для получения капиллярной крови обработать палец дезинфицирующей салфеткой и проколоть его скарификатором. Позиционировать проколотый скарификатором палец так, чтобы капля крови находилась над впитывающим участком полоски (ниже линии, ограниченной стрелками). Дать 1 капле упасть на впитывающий участок.
Когда кровь впитается, добавить 2 капли (~80 мкл) реагента для разведения.
Через 15 минут визуально оценить результат.
Не следует интерпретировать результат позднее, чем через 20 минут.
Регистрация результатов визуальная.
Положительный результат. Выявление в тестовой зоне двух линий розово-фиолетового цвета (тест и контроль) свидетельствует о положительном результате анализа, т.е. указывает на то, что в анализируемом образце содержатся антитела к ВИЧ типа 1 и/или 2.
Отрицательный результат. Выявление в верхней части тестовой зоны только одной линии розово-фиолетового цвета (контроль) свидетельствует об отрицательном результате анализа, т.е. указывает на то, что в анализируемом образце антител к ВИЧ типа 1 и/или 2 нет.
Ошибочный результат. В случае отсутствия линии розово-фиолетового цвета на уровне контроля определение необходимо повторить с использованием другой полоски.
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Определение основано на принципе иммунохроматографического анализа. Испытуемый образец всасывается впитывающим участком полоски иммунохроматографической; при наличии в образце антител к ВИЧ-1/2 последние вступают в реакцию с рекомбинантными ВИЧ-антигенами, связанными с окрашенными микрочастицами, образуя окрашенный комплекс антиген-антитело."}},{"type":"paragraph","data":{"text":"Этот комплекс движется по мембране полоски с фронтом жидкости и вступает в реакцию с рекомбинантными ВИЧантигенами, иммобилизованными на мембране в тестовой зоне полоски, образуя линию розово-фиолетового цвета."}},{"type":"paragraph","data":{"text":"Остальные компоненты образуют розово-фиолетовую линию в верхней части тестовой зоны (контроль). Результат реакции оценивают визуально через 15 минут."}},{"type":"paragraph","data":{"text":"Относительная чувствительность составляет 99,9%, а относительная специфичность - 99,6% по отношению к результатам, полученным методом ИФА на панелях сывороток и клинических образцах."}},{"type":"paragraph","data":{"text":"Время проведения анализа - 15 минут."}},{"type":"paragraph","data":{"text":"Каждый набор предназначен для 1 или 25 определений наличия антител к вирусу иммунодефицита человека (ВИЧ1/2) в сыворотке (плазме) или цельной крови."}}]},{"id":10,"name":"С осторожностью","slug":"cautions","body":[{"type":"paragraph","data":{"text":"Потенциальный риск применения – класс 3."}},{"type":"paragraph","data":{"text":"Все компоненты набора в используемых концентрациях являются нетоксичными."}},{"type":"paragraph","data":{"text":"Составляющие полоски не содержат вирус ВИЧ или его компоненты, могущие привести к инфицированию."}},{"type":"paragraph","data":{"text":"При работе с набором следует соблюдать “Правила устройства, техники безопасности, производственной санитарии, противоэпидемического режима и личной гигиены при работе в лабораториях (отделениях, отделах) санитарноэпидемиологических учреждений системы Министерства здравоохранения СССР” (М., 1981 г.)."}},{"type":"paragraph","data":{"text":"При работе с набором следует надевать одноразовые резиновые или пластиковые перчатки, так как образцы крови человека следует рассматривать как потенциально инфицированные, способные длительное время сохранять и передавать ВИЧ, вирус гепатита или другие возбудители инфекций."}}]},{"id":12,"name":"Способ применения и дозы","slug":"dosage","body":[{"type":"paragraph","data":{"text":"Перед проведением анализа компоненты набора и исследуемые образцы следует выдержать при комнатной температуре (+18-25°С) в течение 5-10 минут."}},{"type":"paragraph","data":{"text":"Вскрыть упаковку полоски, разрывая ее вдоль прорези, извлечь полоску."}},{"type":"paragraph","data":{"text":"Сыворотка, плазма и венозная кровь:"}},{"type":"list","data":{"style":"ordered","items":["Внести с помощью пипетки в пробирку для образца 1 каплю (~40 мкл) сыворотки (плазмы) или венозной крови и добавить 2 капли (~80 мкл) реагента для разведения.","Опустить полоску вертикально в пробирку с анализируемым образцом концом со стрелками.","Через 15 минут визуально оценить результат."]}},{"type":"paragraph","data":{"text":"Использование капиллярной крови непосредственно из пальца:"}},{"type":"list","data":{"style":"ordered","items":["Положить полоску на сухую чистую горизонтальную поверхность.","Для получения капиллярной крови обработать палец дезинфицирующей салфеткой и проколоть его скарификатором. Позиционировать проколотый скарификатором палец так, чтобы капля крови находилась над впитывающим участком полоски (ниже линии, ограниченной стрелками). Дать 1 капле упасть на впитывающий участок.","Когда кровь впитается, добавить 2 капли (~80 мкл) реагента для разведения.","Через 15 минут визуально оценить результат."]}},{"type":"paragraph","data":{"text":"Не следует интерпретировать результат позднее, чем через 20 минут."}},{"type":"paragraph","data":{"text":"Регистрация результатов визуальная."}},{"type":"paragraph","data":{"text":"Положительный результат. Выявление в тестовой зоне двух линий розово-фиолетового цвета (тест и контроль) свидетельствует о положительном результате анализа, т.е. указывает на то, что в анализируемом образце содержатся антитела к ВИЧ типа 1 и/или 2."}},{"type":"paragraph","data":{"text":"Отрицательный результат. Выявление в верхней части тестовой зоны только одной линии розово-фиолетового цвета (контроль) свидетельствует об отрицательном результате анализа, т.е. указывает на то, что в анализируемом образце антител к ВИЧ типа 1 и/или 2 нет."}},{"type":"paragraph","data":{"text":"Ошибочный результат. В случае отсутствия линии розово-фиолетового цвета на уровне контроля определение необходимо повторить с использованием другой полоски."}}]},{"id":18,"name":"Форма выпуска","slug":"","body":[{"type":"paragraph","data":{"text":"тест "}}]},{"id":20,"name":"Срок годности","slug":"expiry_date","body":[{"type":"paragraph","data":{"text":"Длинный срок"}}]},{"id":21,"name":"Условия отпуска","slug":"release_condition","body":[{"type":"paragraph","data":{"text":"Без рецепта"}}]},{"id":22,"name":"Производитель","slug":"","body":[{"type":"paragraph","data":{"text":"\u003ca href=\"https://www.eapteka.ru/goods/manufacturer/med_ekspress_diagnostika/\"\u003eМед-экспресс-диагностика, Россия\u003c/a\u003e"}}]}],"source":null},"description_toggle":false,"short_description":"Набор ИммуноХром-антиВИЧ-1/2-Экспресс предназначен для одноэтапного быстрого качественного in vitro определения наличия антител к вирусу иммунодефицита человека типа 1 и/или типа 2 (ВИЧ-1/2) в сыворотке (плазме) или цельной крови методом иммунохроматографического анализа. 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