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Exdia COVID-19 Antibody test & Exdia TRF analyzer

Negotiable | Min. Order

Description
ExdiaCOVID-19 IgG/IgM is a high sensitivity Time-Resolved Fluorescence immunoassay for the qualitative detection of human IgG/IgMantibodies to SARS-CoV-2 in human whole blood, plasma (Heparin/EDTA) and serum sample collected by healthcare workers at the point ofcare. TheExdiaCOVID-19 IgG/IgM is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2,indicating recent or prior infection. Test results ofExdiaCOVID-19 IgG/IgM should not be used as the sole basis to diagnosis. Features • High sensitivity & accuracy• Fast results in 15 minutes• For use with Exdia TRF analyzers - Objective and reliable test results - Built-in printer - Network connectivity (LIS) Application Serology testing for COVID-19 can be used to identify whether people were previously infected by SARS-CoV-2 even if they haven’t shownsymptoms. This is important to determine, because the RT-PCR tests now being used to diagnose the coronavirus can detect the presence ofthe viral material during infection, but it doesn’t indicate if the person was previously infected and subsequently recovered. • Identify asymptomatic patients• Help to verify quarantine release• Rapid screening of suspected case• Epidemiological tracing Test procedure 1. Collect 10mL of whole blood using disposable capillary tube (provided) or 5mL of plasma or serum using liquid handling pipette (not provided).2. Allow the disposable capillary tube or liquid handling pipette to touch lightly on the pad underneath the sample well.3. Add two drops of developer buffer into the developer well right after injecting the specimen.4. Read the results at 15 minutes. The test cassette should be analyzed by theExdiaanalyzer according to the instruction manual. Clinical performance Exdia COVID-19 IgG/IgMComparator RT-PCRTotalPositiveNegativePositiveIgG+/IgM+40040IgG+/IgM-14014IgG-/IgM+055NegativeIgG-/IgM-3145148Total57150207Positive Percent Agreement (PPA) =54/57(94.74%), 95% CI: 85.63 to 98.19%Negative Percent Agreement (NPA) =145/150(96.67%), 95% CI: 92.43 to 98.57%The Overall Percent Agreement (OPA) = 199/207(96.14 %)95% Cl: 92.56-98.03% Order information Catalog No.Product NameSample typesPackageStorage conditionShelf lifePR-FC12ExdiaCOVID-19 IgG/IgMWhole blood, Plasma, Serum20 tests2℃~30℃12 months
Place of Origin
South Korea
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  • 1 Precision Bio Co., Ltd.

    Supplier Activity

    Country South Korea South Korea

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    PRODUCT DESCRIPTION
    COMPANY INFORMATION
    Product Information

     

     

    ExdiaCOVID-19 IgG/IgM is a high sensitivity Time-Resolved Fluorescence immunoassay for the qualitative detection of human IgG/IgM

    antibodies to SARS-CoV-2 in human whole blood, plasma (Heparin/EDTA) and serum sample collected by healthcare workers at the point of

    care. TheExdiaCOVID-19 IgG/IgM is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2,

    indicating recent or prior infection. Test results ofExdiaCOVID-19 IgG/IgM should not be used as the sole basis to diagnosis.

     

     

    Features

     

    • High sensitivity & accuracy

    • Fast results in 15 minutes

    • For use with Exdia TRF analyzers

       - Objective and reliable test results

       - Built-in printer

       - Network connectivity (LIS)

     

     

    Application

     

    Serology testing for COVID-19 can be used to identify whether people were previously infected by SARS-CoV-2 even if they haven’t shown

    symptoms. This is important to determine, because the RT-PCR tests now being used to diagnose the coronavirus can detect the presence of

    the viral material during infection, but it doesn’t indicate if the person was previously infected and subsequently recovered.

     

    • Identify asymptomatic patients

    • Help to verify quarantine release

    • Rapid screening of suspected case

    • Epidemiological tracing

     

     

    Test procedure

     

    1. Collect 10mL of whole blood using disposable capillary tube (provided) or 5mL of plasma or serum using liquid handling pipette (not provided).

    2. Allow the disposable capillary tube or liquid handling pipette to touch lightly on the pad underneath the sample well.

    3. Add two drops of developer buffer into the developer well right after injecting the specimen.

    4. Read the results at 15 minutes. The test cassette should be analyzed by theExdiaanalyzer according to the instruction manual.

     

     

    Clinical performance

     

    Exdia COVID-19 IgG/IgM

    Comparator RT-PCR

    Total

    Positive

    Negative

    Positive

    IgG+/IgM+

    40

    0

    40

    IgG+/IgM-

    14

    0

    14

    IgG-/IgM+

    0

    5

    5

    Negative

    IgG-/IgM-

    3

    145

    148

    Total

    57

    150

    207

    Positive Percent Agreement (PPA) =54/57(94.74%), 95% CI: 85.63 to 98.19%

    Negative Percent Agreement (NPA) =145/150(96.67%), 95% CI: 92.43 to 98.57%

    The Overall Percent Agreement (OPA) = 199/207(96.14 %)95% Cl: 92.56-98.03%

     

     

    Order information

     

    Catalog No.

    Product Name

    Sample types

    Package

    Storage condition

    Shelf life

    PR-FC12

    ExdiaCOVID-19 IgG/IgM

    Whole blood, Plasma, Serum

    20 tests

    2~30

    12 months

     

     

     

     

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    Spec

     

    Company

    Precision Bio Co., Ltd.

    Country South Korea South Korea

    Supplier Activity

    President
    KIM HAN SIN
    Address
    306 Techno 2 ro, Yuseong-gu, Daejeon, Korea
    Product Category
    Examination & Testing Instrument,Monitoring & Diagnostic Equipment,Medical Test Kit,Other Examination & Testing Instrumnet,Other Monitoring & Diagnostic Equipment
    Year Established
    2015
    Company introduction

     

    Verified Certificate

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