COVID-19

  • SARS-CoV-2 & Influenza A/B Multiplex Real-Time PCR Kit

    SARS-CoV-2 & Influenza A/B Multiplex Real-Time PCR Kit

    REF 510010 Specification 96 Tests/Box
    Detection principle PCR Specimens Nasal / Nasopharyngeal swab / Oropharyngeal swab
    Intended Use

    StrongStep® SARS-CoV-2 & Influenza A/B Multiplex Real-Time PCR Kit is intended  for simultaneous qualitative detection and differentiation of SARS-CoV-2,Influenza A virus and Influenza B virus RNA in healthcare provider-collected nasal and nasopharyngeal swab or oropharyngeal swab specimens and self-collected nasal or oropharyngeal swab specimens(collected in a healthcare setting with instruction by a healthcare provider) from individuals suspected of respiratory viral infection consistent with  COVID-19 by their healthcare provider.

    The kit is intended for use by laboratory trained personnel

     

  • SARS-CoV-2 Antigen Rapid Test for Saliva

    SARS-CoV-2 Antigen Rapid Test for Saliva

    REF 500230 Specification 20 Tests/Box
    Detection principle Immunochromatographic assay Specimens
    Saliva
    Intended Use This is a rapid immunochromatographic assay for the detection of SARS-CoV-2 virus Nucleocapsid Protein antigen in human Saliva swab collected from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms. The assay is used as an aid in the diagnosis of COVID-19.

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

  • System Device for SARS-CoV-2 & Influenza A/B Combo Antigen Rapid Test

    System Device for SARS-CoV-2 & Influenza A/B Combo Antigen Rapid Test

    REF 500220 Specification 20 Tests/Box
    Detection principle Immunochromatographic assay Specimens Nasal / Oropharyngeal swab
    Intended Use This is a rapid immunochromatographic assay for the detection of SARS-CoV-2 virus Nucleocapsid Protein antigen in human Nasal/Oropharyngeal swab collected from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms. The assay is used as an aid in the diagnosis of COVID-19.
  • SARS-CoV-2 IgM/IgG Antibody Rapid Test

    SARS-CoV-2 IgM/IgG Antibody Rapid Test

    REF 502090 Specification 20 Tests/Box
    Detection principle Immunochromatographic assay Specimens Whole Blood / Serum / Plasma
    Intended Use This is a rapid immuno-chromatographic assay for the simultaneous detection of IgM and IgG antibodies to SARS-CoV-2 virus in human whole blood, serum or plasma.

    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.

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

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

    REF 500190 Specification 96 Tests/Box
    Detection principle PCR Specimens Nasal / Nasopharyngeal swab
    Intended Use This 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

     

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

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

    REF 500210 Specification 20 Tests/Box
    Detection principle Immunochromatographic assay Specimens Nasal / Oropharyngeal swab
    Intended Use This is a rapid immunochromatographic assay for the detection of SARS-CoV-2 virus Nucleocapsid Protein antigen in human Nasal /Oropharyngeal swab collected from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms. The assay is used as an aid in the diagnosis of COVID-19.
  • SARS-CoV-2 Antigen Rapid Test

    SARS-CoV-2 Antigen Rapid Test

    REF 500200 Specification 20 Tests/Box
    Detection principle Immunochromatographic assay Specimens Nasal / Oropharyngeal swab
    Intended Use This is a rapid immunochromatographic assay for the detection of SARS-CoV-2 virus Nucleocapsid Protein antigen in human Nasal /Oropharyngeal swab collected from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms. The assay is used as an aid in the diagnosis of COVID-19.

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