COVID-19

  • Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit

    Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit

    The novel coronavirus is an RNA virus, which is composed of proteins and nucleic acids. The virus invades the host (human)body, enters cells through binding site corresponding receptor ACE2, and replicate in host cells, causing the human immune system to respond to foreign invaders and produce specific antibodies. Therefore, the vial nucleic acids and antigens,and specific antibodies against novel coronavirus can theoretically be used as specific biomarkers for the detection of the novel coronavirus. For nucleic acid detection, RT-PCR technology is the most commonly used.

    Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit is intended to be used to achieve qualitative detection of SARS_CoV-2 viral RNA extracted from nasopharyngeal swabs, oropharyngeal swabs,sputum and BALF from patients in association with an FDA/CE IVD extraction system and the designated PCR platforms listed above .

    The kit is intended for use by laboratory trained personnel

     

  • SARS-CoV-2 IgM/IgG Antibody Rapid Test

    SARS-CoV-2 IgM/IgG Antibody Rapid Test

    The StrongStep®  SARS-CoV-2 IgM/IgG Antibody Rapid Test  kit is used for in vitro qualitative detection and identification of SARS-CoV-2 antibody coronavirus disease COVID-19 in serum/plasma/whole blood samples (including venous blood and finger prick blood) of suspected patients the diagnosis of infection can be used to diagnose symptomatic or asymptomatic individuals with acute infection and molecular testing or clinical information.

    The test is limited in the US to distribution to laboratories certified by CLIA to perform high complexity testing.

    This test has not been reviewed by the FDA.

    Negative results do not preclude acute SARS-CoV-2 infection.

    Results from antibody testing should not be used to diagnose or exclude acute SARS-CoV-2 infection.

    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.

  • SARS-CoV-2 Antigen Rapid Test

    SARS-CoV-2 Antigen Rapid Test

    The Dual Biosafety System Device for SARS-CoV-2 Antigen  Test is used for the qualitative detection of novel coronavirus (SARS-CoV-2) nucleocapsid (N) antigen in human Throat/Nasopharyngeal swab  samples in vitro. The kit should only be used as a supplementary indicator or used in conjunction with nucleic acid detection in the diagnosis of suspected COVID-19 cases. It cannot be used as a sole basis for the diagnosis and exclusion of pneumonitis patients infected by the novel coronavirus, and is not suitable for screening of the general population. The kits are very suitable for use for large-scale screening in countries and regions where the novel coronavirus outbreak is rapidly spreading, and for providing diagnosis and confirmation for COVID-19 infection.

    IMPORTANT: THIS PRODUCT IS INTENDED FOR PROFESSIONAL USE ONLY, NOT FOR SELF-TESTING OR TESTING AT HOME !

  • Dual Biosafety System Device for SARS-CoV-2 Antigen Rapid Test

    Dual Biosafety System Device for SARS-CoV-2 Antigen Rapid Test

    The Dual Biosafety System Device for SARS-CoV-2 Antigen  Test is used for the qualitative detection of novel coronavirus (SARS-CoV-2) nucleocapsid (N) antigen in human Throat/Nasopharyngeal swab  samples in vitro. The kit should only be used as a supplementary indicator or used in conjunction with nucleic acid detection in the diagnosis of suspected COVID-19 cases. It cannot be used as a sole basis for the diagnosis and exclusion of pneumonitis patients infected by the novel coronavirus, and is not suitable for screening of the general population. The kits are very suitable for use for large-scale screening in countries and regions where the novel coronavirus outbreak is rapidly spreading, and for providing diagnosis and confirmation for COVID-19 infection. Testing is limited to laboratories certified under the regulations of the national or local authorities.