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Throat Swab Nasal Swab Covid 19 Antibody rapid test Cassette

Categories Coronavirus Test Kit
Brand Name: Newscen
Model Number: COVID-19 Antigen
Certification: ISO9001, CE, TUV, FDA
Place of Origin: China
MOQ: 10 Boxes or 400 Kits (40 Kits/Box)
Price: USD0.37/Cassette
Payment Terms: T/T, Western Union, MoneyGram
Supply Ability: 50,000 Kits Per Day
Delivery Time: 8 days
Packaging Details: 40 Kits/Box, 50 Boxes/Carton, 317g/Box, 18kgs/Carton, Box Size: 250x125x65mm, Carton Size: 650x510x330mm
Specimen: throat or nasal swab
Format: Cassette
Result Time: 15-20 Minutes
Usage: For In Vitro Diagnostic Use Only
Box Color: Blue / White
Temperature Request: 2-30°C
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    Throat Swab Nasal Swab Covid 19 Antibody rapid test Cassette

    Where To Get Tested For Covid 19 FDA CE Certification Throat Swab Or Nasal Swab For Covid 19 Antibody Testing Kit


    COVID-19 Antigen Rapid Test Cassette


    For the qualitative detection of SARS-CoV-2 antigen in human throat swab or nasal swab


    Main Features


    ☀ High Sensitivity, Some Products can reach 100%


    ☀ High Specificity, Some Products can reach 100%


    ☀ Reliable: High Accurate, Early Detection of The Presence Of Virus


    ☀ Simple: No complicated Instrument Required


    ☀ Convenient: Room Temperature Storage, patented Built-In Control line for easy operation with high accuracy


    ☀ Fast: Results in 5-30 minutes, strong positive results may be observed promptly within 3 minutes


    ☀ Certified by Authoritative Certification System and Standards


    ☀ Winner of "the National Rapid Diagnostic Kit for Clinical Performance Assessment"



    Intended Use


    COVID-19 Antigen Rapid Test Cassette is for in vitro qualitative detection of specific antigens to SARS-CoV-2 present in human throat or nasal cavity. It cannot be used as the basis for the diagnosis and exclusion of COVID-19.


    This reagent is used to detect cases with suspected symptoms of COVID-19 within 7 days. If suspected symptoms are more than 7 days, it is recommended to test with COVID-19 antibodies or nucleic acid reagents.



    Principle


    This kit uses double antibody sandwich immunoassay to detect specific antigens to SARS-CoV-2 in human throat or nasal cavity. The membrane was precoated with SARS-CoV-2 specific antibody on the test zone and goat anti mouse IgG antibody on the control zone.


    During the test, the specimen is allowed to react with SARS-CoV-2 specific antibody-colloidal gold particles conjugate, which was predried on the test. The conjugate binds to the SARS-CoV-2 forming an Antibody~Antigen complex.


    The complex moves forward on the membrane by the capillary action, then the complex is captured by specific antibody to SARS-CoV-2 on the test zone to produce a visual red color line. The color of line is positive correlated with the amount of SARS-CoV-2 in specimen.


    Regardless of the presence of SARS-CoV-2, as the mixture continues to move across the membrane to the control zone, the complex is captured by immobilized goat anti mouse IgG antibody to form a distinct red line.



    Reagents and Materials Provided


    Specification20 cassettes per kit1 cassette per kit
    Component20 test cassettes1 test cassette
    20 desiccant bags1 desiccant bag
    20 sample extraction solution1 sample extraction solution
    20 sample collection tubes1 sample collection tube
    1 Instruction for use1 Instruction for use
    1 disposable sampling swab

    Assay Procedure


    1. All clinical samples must be at room temperature before beginning the assay.


    2. Open the package, the pouch should be sealed well. If the test reagent store in the refrigerator, it should be restored to room temperature. Then open the pouch and take out the test cassette, place it on the platform.


    3. Add 2 drops of patient sample extraction solution which from the tube into S Well, Observe the result in 15~20 minutes, interpret the test result after 20 minutes may cause false result.



    Interpretation of Results



    ☀ Positive: One color line in the control zone (C) and one color line in the test zone (T). This indicates that the sample contains SARS-CoV-2 antigen.


    ☀ Negative: Only one color line in the control zone (C). This indicates that no SARS-CoV-2 antigen has been detected.


    ☀ Invalid: If no color line appears in the control zone (C), the test is invalid. Discard the test cassette and perform with new cassette.


    Built-In Control


    COVID-19 Antigen Rapid Test Cassette has a built-in procedural control that demonstrates assay validity. A color line appeared on the control zone (C) indicates that the test runs correctly.


    Sample Storage


    Samples should be tested as soon as possible after collection. Throat or nasal swabs are stable for up to 24 hours at 2~8°C.


    Warning


    For Medical Professional and In Vitro Diagnostic use ONLY


    Read the package insert completely before use. It is very important that the correct procedure is followed. Fail to add the patient sample may lead to a false result.




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