FREND COVID19 SP

Negotiable | Min Order Quantity Unit
Required
Quantity
Place of Origin
South Korea
Payment Terms
Negotiable
Production
method
Negotiable
Shipping /
Lead Time
Negotiable / Negotiable
Keyword
corona virus, poct, spike protein, covid test,
Category
Medical Devices

14 NanoEnTek Inc.

Supplier Activity

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  • Country

    South Korea South Korea

    Verified Certificate

    • KITA
    Product name FREND COVID19 SP Certification -
    Category Medical Devices Ingredients -
    Keyword corona virus , poct , spike protein , covid test Unit Size -
    Brand name - Unit Weigh -
    origin South Korea Stock -
    Supply type - HS code -
    Product Information

     

     

    Microfluidic Qualitative Immunoassay

    FREND™ COVID-19 SP (Spike Protein)


    The FREND™ COVID-19 SP is

    - a point-of-care testing (POCT) which can be used to check whether patient has developed immune

    response to SARS-CoV-2 using human serum or plasma.

    - a fluorescence immunoassay (FIA) using the FREND™ System intended for the

    qualitative detection of IgG and IgM antibodies to SARS-CoV-2.

    - is intended for use as an aid in identifying individuals with an adaptive immune response

    to SARS-CoV-2, indicating recent or prior infection.

     

     

    KEY FEATURES & BENEFITS

    - 3 minutes  |  Fast result

    - 2 steps  |  Easy to use

    - 97% & 96%  |  Positive & Negative Percent Agreement

    - Microfluidic Qualitative Immunoassay (spike protein)

    - LIS connectivity (data management)

     

    Instructions for use

    Accurate result in 3 minutes!
    With just simple steps of operation, the FREND™ system supports quick decision-making. 

     

     

    Performance evaluation

    Clinical agreement study

    The total of 88 clinical samples (34 positive and 54 negative) confirmed with RT-PCR were tested 

    with the FREND™ COVID-19 SP. It shows 97.06% PPA (Positive Percent Agreement) and 96.30% NPA

    (Negative Percent Agreement) as shown below.

    Performance evaluation

    Interference

    The interference evaluation test of FREND™ COVID-19 SP was conducted according to CLSI Guidelines EP7-A2 using one lot. 

    No interference in the testing of the FREND™ COVID-19 SP with 4 interfering substances was observed.

     

     

    Effective Data Management

    Laboratory Information System Connectivity

    In the event of a pandemic, the management of a vast amount of clinical result is important.

    However, many laboratories face the challenge in arranging the essential information effectively(1).

    The FREND™ System which is LIS compatible provide following features:

     

     

    Notification

    • 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.

     

     

    For more information, please visit www.nanoentek.com


     

     

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    Price (FOB) Negotiable transportation -
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    14 NanoEnTek Inc.

    • Country

      South Korea South Korea
    • Supplier Activity

    • President

      Chanil Chung

    • Address

      Guro-gu, Guro-dong,235-2, Guro-gu, Seoul, Korea

    • Product Category

      Medical Devices

    • Year Established

      2000

    • No. of Total Employees

      101-500

    • Company introduction

       

    • Main Markets
      • Germany Germany
      • U. Kingdom U. Kingdom
      • Italy Italy
      • Japan Japan
      • Taiwan Taiwan
    • Main Product
      • FREND COVID_19 IgG_IgM Duo

        FREND COVID-19 IgG/IgM Duo


      • The En_swer COVID_19 RT_PCR Kit

        The En-swer COVID-19 RT-PCR Kit


      • FREND COVID19 AgFlu AB

        FREND COVID19 AgFlu AB


      • FREND COVID19 SP

        FREND COVID19 SP

    • Other Products from This Supplier

      FREND COVID-19 IgG/IgM Duo

      The En-swer COVID-19 RT-PCR Kit

      FREND COVID19 AgFlu AB

      FREND COVID19 Ag

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