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  • S3104E 2019-nCoV (FDA EUA) — Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit

    For in vitro diagnostic use only.

    For emergency use only.

    For Prescription Use only.

    Brief

    The Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARSCoV-2 in nasopharyngeal swabs, oropharyngeal (throat) swabs, anterior nasal swabs, midturbinate swabs, nasal washes and nasal aspirates from individuals who are suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.

     

    Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.

     

    Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.

    Performance

    • One-tube/fast release technology
    • Simple operation process, less specialist training
    • Room temperature lysis, less contamination
    • Sampling types: nasopharyngeal swabs, oropharyngeal (throat) swabs, anterior nasal swabs, midturbinate swabs, nasal washes and nasal spirates
    • Internal control: human housekeeping gene RNase P

    Parameters

    Product features Parameters
    Specimen Type Nasopharyngeal swabs, oropharyngeal (throat) swabs, anterior nasal swabs, midturbinate swabs, nasal washes and nasal spirates
    Extraction Platform Sample Release Reagent Qiagen QIAamp Viral RNA Mini Kit
    Target Genes
    SARS-CoV-2 ORF1ab, N gene
    Internal Control
    Rnase P gene
    PCR Instrument
    ABI 7500 Real-Time PCR System
    LoD
    200 copies/mL
    Spec.
    24T, 48T
    Qualification
    FDA EUA
      Notes
    • This test has not been FDA cleared or approved;
    • This test has been authorized by FDA under an EUA for use by authorized laboratories;
    • This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and
    • This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the authorization is terminated or revoked sooner.
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