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    Home > Biochemistry News > Biotechnology News > Wanfu Bio has changed the registration information of the novel coronavirus antigen detection kit

    Wanfu Bio has changed the registration information of the novel coronavirus antigen detection kit

    • Last Update: 2022-05-23
    • Source: Internet
    • Author: User
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    On March 13, 2022, Wanfu Bio announced that the company has recently received a "Medical Device Registration Change Document" issued by the NMPA
    .
    The product name is novel coronavirus (2019-nCoV) antigen detection kit (colloidal gold method)

    .

    Product Change Description

    Product Change Description

    Before change:

    Before change:

    【expected usage】

    【expected usage】

    This product is used for the detection of novel coronavirus N antigen in oropharyngeal swabs and nasopharyngeal swab samples of people suspected of novel coronavirus pneumonia
    .
    It is generally used for the detection of samples in the acute infection period, that is, within 7 days of the onset of symptoms in the suspected population

    .

    This product should be used by professionally trained personnel in an environment that ensures biosafety and meets the conditions of use
    .
    To carry out the new coronavirus antigen test, it should meet the requirements of the "Technical Guidelines for the Collection and Detection of New Coronavirus Samples"

    .

    After the change:

    After the change:

    【expected usage】

    【expected usage】

    This product is used for in vitro qualitative detection of novel coronavirus N antigen in oropharyngeal swabs, nasopharyngeal swabs, and nasal swab samples, and the sampling method of nasal swab samples has been added
    .
    The applicable population shall be implemented in accordance with the relevant national regulations such as the "New Coronavirus Antigen Detection Application Program (Trial)"

    .

    This product cannot be used alone for the diagnosis of new coronavirus infection, and the infection status should be judged in combination with other diagnostic information such as nucleic acid detection and imaging, as well as medical history and contact history
    .
    Positive results can be used for early triage and rapid management of suspected populations, but positive results only indicate the presence of novel coronavirus antigens in the samples and cannot be used as a basis for diagnosing novel coronavirus infection

    .
    A negative result does not rule out novel coronavirus infection, nor should it be used alone as a basis for making treatment and disease management decisions

    .
    Both positive and negative antigen results in the suspected population should undergo further nucleic acid testing

    .

    Test-positive subjects should follow local epidemic prevention and control policies for reporting and isolation, and seek corresponding medical help; test-negative subjects should strictly abide by local epidemic prevention and control requirements, and if necessary, further use other more sensitive detection methods for confirmation , if it is still negative, continuous monitoring should be carried out and medical help should be sought in time
    .
    The product use environment should follow the relevant national regulations such as the "New Coronavirus Antigen Detection Application Program (Trial)"

    .

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