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COVID-19 ANTIGEN

RAPID POC TEST

Due to the highly contagious nature and global health crisis, SARS-CoV-2 has been designated as a pandemic by the World Health Organization (WHO) and continues to have devastating impacts on healthcare systems and the world economy including the U.S. To effectively end the SARS-CoV-2 pandemic, systematic screening and detection of both clinical and asymptomatic COVID-19 cases is critical. 


As an intended point-of-care (POC) designated test with a 10 minute processing time, CareStart™ COVID-19 Antigen Test allows effective screening of COVID-19 infection on a large scale.


  •  Lateral flow assay

  •  Rapid results in 10 minutes

  •  Nasopharyngeal swab specimen collection

  •  ​Intended at POC setting (i.e., in patient care settings) by medical professionals operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation

  •  Detect SARS-CoV-2 nucleocapsid protein antigen

  •  Identify acute infection in symptomatic patients with 88.4% sensitivity and 100% specificity

  •  Designated as CLIA waived tests

  • TEST PRINCIPLES

    The CareStart™ COVID-19 Antigen Test is a lateral flow immunochromatographic assay for the detection of extracted nucleocapsid protein antigens specific to SARS-CoV-2 in swab specimens directly collected from symptomatic individuals who are suspected of COVID-19 by their healthcare providers.


    PROCEDURE

    1) Peel off aluminum foil seal and rotate the swab inside the extraction vial vigorously at least 5 times


    2) Remove the swab by rotating against the extraction vial while squeezing the sides of the vial to release the liquid from the swab. Properly discard the swab.


    3) Close the vial by pushing the cap firmly onto the vial and mix thoroughly by flicking the bottom of the tube.


    4) Invert the extraction vial and hold the sample vertically above the sample well. Squeeze the vial gently. Allow three (3) drops of sample to fall into the sample well.


    RESULTS

    INTERPRETATION

    Covid-19 Positive

    Covid-19 Negative

    Invalid

    ORDER INFORMATION

    CAT. NO.

    RCHM-02071

    PACKAGE UNIT

    20 TESTS / KIT

    KIT COMPONENT

  •  20 Test Devices

  •  20 Assay Buffer

  •  20 Extraction Vials and Caps

  •  20 Specimen Collection Swabs

  •  1 Positive and 1 Negative Control Swab

  •  1 Instruction Guide for Use

  • PRODUCT DOCUMENTATION

    FAQs

    Is this test FDA-approved or cleared?

    No. This test is not yet approved or cleared by the United States FDA. When there are no FDA-approved or cleared tests available, and other criteria are met, FDA can make tests available under an emergency access mechanism called an Emergency Use Authorization (EUA).


    The EUA for this test is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics for the detection and/or diagnosis of the virus that causes COVID-19.


    This EUA will remain in effect (meaning this test can be used) for the duration of the COVID-19 declaration justifying emergency of IVDs, unless it is terminated or revoked by FDA (after which the test may no longer be used).

    Can I return, exchange or get a refund for my CareStart™ COVID-19 Antigen Test Kit?

    Due to FDA guidelines and Supply Chain Demands, all orders and sales are final once placed. NO EXCHANGES OR REFUNDS WILL BE MADE.

    What are the differences between antigen tests and other COVID-19 tests?

    There are different kinds of tests for diagnosing COVID-19. Molecular tests (also known as PCR tests) detect genetic material from the virus. Antigen tests detect proteins from the virus. Antigen tests are very specific for the virus, but are not as sensitive as molecular tests. This means that a positive result is highly accurate, but a negative result does not rule out infection.

     

    If your test result is negative, you should discuss with your healthcare provider whether an additional molecular test would help with your care, and when you should discontinue home isolation. If you do not have an additional test to determine if you are infected and may spread the infection to others, the CDC currently recommends that you should stay home until three things have happened:


    • You have had no fever for at least 24 hours (that is one full day of no fever without the use of medicine that reduces fevers)


    AND


    • Other symptoms have improved (for example, when your cough or shortness of breath has improved)


    AND


    • At least 10 days have passed since your symptoms first appeared.

    When and how will I receive my order?

    All orders can be expected to arrive within 3 to 5 business days from your order date. Once your order has shipped you will receive an email notification with tracking information.


    Due to the shipping system picking up orders locally is not available.

    PRICING TIERS BASED ON VOLUME ORDERED:

    (20 Test Kits Per Box - Prices start at $20/test kit)

    Tier 1: 1-5 Boxes

    Tier 2: 6-25 Boxes

    Tier 3: 26-50 Boxes

    Tier 4: 51-100 Boxes

    BUY ANTIGEN TEST

    Purchases over 100 boxes contact us for special pricing.

    [email protected]

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