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PBCheck COVID-19 IgG/IgM rapid chromatographic immunoassay

Negotiable | Min. Order

Description
PBCheck COVID-19 IgG/IgM is a rapid immunoassay for the qualitative detection of human IgG/IgM antibodies to SARS-CoV-2in human whole blood, plasma and serum sample. The PBCheck COVID-19 IgG/IgM Antibody Test is intended for use as an aid in identifyingindividuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Features • Quick and Easy to use• Fast results in 10 minutes• No equipment required• Multiple sample type 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 presenceof 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 Clinical performance PBCheckCOVID-19IgG/IgM Antibody TestComparator / RT-PCRTotalPositiveNegativePositiveIgM+/IgG+35035IgM+/IgG-123IgM*/IgG+16016NegativeIgM-/IgG-398101Total55100155Positive Percent Agreement (PPA)= 52/55 (94.55%), 95% CI: 85.15% to 98.13%Negative Percent Agreement (NPA)= 98/100 (98.00%), 95% CI: 93.00% to 99.45% Test procedure Interpretation of results ·IgM only positive: Appearance of pinkish red colored bands at the control line andthe IgM test line indicate that the SARS-CoV-2 IgM antibody was detected. · IgG only positive: Appearance of pinkish red colored bands at the control line andthe IgG test line indicate that the SARS-CoV-2 IgG antibody was detected. · IgM and IgG positive: Appearance of pinkish red colored bands at the control line,the IgG test line and the IgM test line indicate that the SARS-CoV-2 IgG and IgM antibodies are detected. · Invalid: If no colored line appears in the control region (C), the test results is invalid.The test result is inconclusive, and assay should be repeated with a new test cassette. Product Specification Sample volume10μL Whole Blood5μLSerum, PlasmaMeasuring time10 minPack size20ea/boxShelf life12 monthsStorage conditionRoom Temperature (2-30℃)
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

    PBCheck COVID-19 IgG/IgM is a rapid immunoassay for the qualitative detection of human IgG/IgM antibodies to SARS-CoV-2

    in human whole blood, plasma and serum sample. The PBCheck  COVID-19 IgG/IgM Antibody Test is intended for use as an aid in identifying

    individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

     

     

    Features

     

    • Quick and Easy to use

    • Fast results in 10 minutes

    • No equipment required

    • Multiple sample type

     

     

    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

     

     

     

    Clinical performance

     

     

    PBCheckCOVID-19

    IgG/IgM Antibody Test

    Comparator / RT-PCR

    Total

    Positive

    Negative

    Positive

    IgM+/IgG+

    35

    0

    35

    IgM+/IgG-

    1

    2

    3

    IgM*/IgG+

    16

    0

    16

    Negative

    IgM-/IgG-

    3

    98

    101

    Total

    55

    100

    155

    Positive Percent Agreement (PPA)= 52/55 (94.55%), 95% CI: 85.15% to 98.13%

    Negative Percent Agreement (NPA)= 98/100 (98.00%), 95% CI: 93.00% to 99.45%

     

     

    Test procedure

     

     

    Interpretation of results

     

     

    ·IgM only positive: Appearance of pinkish red colored bands at the control line and

    the IgM test line indicate that the SARS-CoV-2 IgM antibody was detected.

     

    · IgG only positive: Appearance of pinkish red colored bands at the control line and

    the IgG test line indicate that the SARS-CoV-2 IgG antibody was detected.

     

    · IgM and IgG positive: Appearance of pinkish red colored bands at the control line,

    the IgG test line and the IgM test line indicate that the SARS-CoV-2 IgG and IgM antibodies are detected.

     

    · Invalid: If no colored line appears in the control region (C), the test results is invalid.

    The test result is inconclusive, and assay should be repeated with a new test cassette.

     

     

    Product Specification

     

    Sample volume

    10μL Whole Blood

    5μLSerum, Plasma

    Measuring time

    10 min

    Pack size

    20ea/box

    Shelf life

    12 months

    Storage conditionRoom Temperature (2-30℃)

    Image
    • PBCheck COVID-19 IgG IgM

    Feature

     

    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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