COVID19 IgG & IgM 快篩檢測試劑 (IVD)

依法規定快篩試劑只能販售給疾管局核可之實驗室、醫療單位以及具有醫療器材許可證之公司行號,不得販售給一般民眾

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-   Is only provided for use by clinical laboratories or to healthcare workers for point-of-care testing,and not for at home testing.

-   Includes instructions that the test report (instructions for use) include information along the following lines:

-   This test has not been reviewed by the FDA.

-   Negative results do not rule out SARS-CoV-2 infection,particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.

-   Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.

-   Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains ,such as coronavirus HKU1, NL63, OC43, or 229E.

-   Not for the screening of donated blood.

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檢測步驟

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可能出現的檢測結果

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TAF 實驗室

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CE認證

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國家衛生研究院