Access Bio CareStart Rapid Antigen Test

Access Bio

Access Bio CareStart Rapid Antigen Test

Access Bio
SKU: 550564
MFG Part #: RCHM-02071
  • Detect SARS-CoV-2 nucleocapsid protein antigen
  • No equipment required & For use under the Emergency Use Authorization (EUA) only
  • Rapid results within 10-15 minutes
  • 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
  • For in vitro diagnostic use only & For prescription use only
    In Stock & Shipping Daily
    Bulk pricing available, Please Call us at 877-849-0230 or email sales@heartwellmed.com for Quote.
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    In Stock
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    Usually ships in 1 - 3 Days
    This product is non-returnable

    Price:
    $400.00 20 Test / Kit

    Description

    The CareStart COVID-19 Antigen Test is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal or anterior nasal swab specimens directly collected from individuals who are either suspected of COVID-19 by their healthcare provider within the first five days of symptom onset or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests.

    Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high, or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., inpatient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

    NOTE: For Serial Screening of asymptomatic individuals. The serial screening indication is only applied to products manufactured by Access Bio Inc. after April 12, 2021. The product batches listed in the Official Notification Letter (click to see) should not be marketed or used for POC serial screening purposes.

     

    AMA CPT Codes

    Fact Sheet for Healthcare Providers

    FDA EUA Letter

    Fact Sheet for Patients

    Package Insert

     

    Product Specifications and Resources

    Sensitivity 88.4%
    Specificity 100%
    Determinations Detection of the SARS-CoV-2 nucleocapsid protein antigen
    Processing Time Approximately 10 Minutes
    Storage Requirements 34° – 86° F
    Regulatory Status FDA EUA Authorized
    CPT Code 87426
    Width 3"
    Height 8"
    Depth 6"
    What's in the Box
  • 20 Test devices
  • 20 Assay buffer
  • 20 Extraction vials and Caps
  • 20 Specimen Collection swabs
  • 1 Positive and negative control swabs
  • 1 Instructions for use.
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