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KaiBiLi COVID-19 Antigen (Single-Test)

CE Certification

The KaiBiLiTM COVID-19 Antigen is an in vitro diagnostic test based on the principle of immuno- chromatography for the qualitative detection of 2019 Novel Coronavirus nucleocapsid protein antigens in nasal swabs.


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  • Product Detail

    Introduction

    The KaiBiLiTM COVID-19 Antigen is an in vitro diagnostic test based on the principle of immuno- chromatography for the qualitative detection of 2019 Novel Coronavirus nucleocapsid protein antigens in nasal swabs. The detection is based on the antibodies which were developed specifically recognizing and reacting with the nucleoprotein of 2019 Novel Coronavirus. It is intended to aid in the rapid diagnosis of SARS-CoV-2 infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status.

    Donors with a negative result should be treated as presumptive. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions.

    COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main symptoms including manifestations include fever, fatigue and dry cough, nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.

    Detection

    The qualitative detection of 2019 Novel Coronavirus nucleocapsid protein antigens in nasal swabs.

    SPECIMEN

    Nasal

    Limit of Detection (LoD)

    SARS-CoV-2: 140 TCID50/mL

    ACCURACY

    Positive Percent Agreement: 96.6%

    Negative Percent Agreement:100%

    Overall Percent Agreement: 98.9%

    Time to results

    Read results at 15minutes and no more than 30 minutes.

    Kit storage conditions

    2~30°C.

    Contents

    Description

    Qty

    COVID-19 antigen test devices

    1

    Sterile Swab

    1

    Extraction tubes (with 0.5mL extraction buffer)

    1

    Nozzles with filter

    1

    Package Insert

    1

    Ordering Information

    Product

    Cat.No.

    Contents

    KaiBiLiTM COVID-19 Antigen

    P211138-1

    1 Test

    KaiBiLiTM COVID-19 Antigen

    P211138-5

    5 Test


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