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WHO says no evidence shows that having coronavirus prevents a second infection, page-45

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    From TGA .....looks like the doors are open to make sales, regardless of all the negative media..............

    Testing for serious infectious diseases, such as COVID-19, need to be conducted in conjunction with a medical practitioner or other suitably qualified health care professional who can provide an individual with appropriate advice and treatment if required. The misinterpretation of serology results in the point-of-care setting if testing is not performed by suitably qualified persons with appropriate skills and knowledge presents grave risk to public health, which could result in serious illness and death of the patient and other persons that the patient comes into contact with.

    Transmission-based precautions must also be used when collecting specimens from patients with a communicable disease. Blood specimens collected for point-of-care testing should be regarded as potentially infectious not just for SARS-CoV-2, but also for other blood-borne infectious diseases. Staff must be trained in appropriate specimen collection and infection control procedure.

    For these reasons outlined above the following non-standard conditions of inclusion in the Australian Register of Therapeutic Goods apply to serology-based COVID-19 tests for use at the point of care:

    1. The person (the sponsor) in relation to whom the Device is included in the ARTG may only supply the Device to:
      1. laboratories that are accredited pathology laboratories; and/or
      2. medical practitioners who are registered under a law of a State or Territory; and/or
      3. health care professionals in residential and aged care facilities; and/or
      4. Commonwealth, State or Territory department of health; and/or
      5. an agency of the Commonwealth, State or Territory acting on behalf of Commonwealth, State or Territory department of health.

    Further clarification relating to the specific conditions is provided below:

    • 1(a)accredited pathology laboratories(under theHealth Insurance Act 1973) are those accredited as medical testing laboratories eligible for claiming to Medicare for approved pathology services.
    • 1(b) this includes supply to a medical practitioner who may then oversee/guide the performance of testing by a registered/enrolled nurse.
    • 1(c) allows for supply to a medical practitioner or registered/enrolled nurse in a residential or aged care facility.
    • 1(d) and (e) the conditions also allow for supply of the Device to the Government for the purpose of the national stockpile. The Government maintains control of the stockpile and is responsible for ensuring that devices to test for COVID-19 that are included in the stockpile are provided to suitably qualified persons with appropriate skills and knowledge.
    https://www.tga.gov.au/legal-supply-covid-19-test-kits
    Last edited by boiler: 28/04/20
 
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