Rapid PCR Kit Accula™ SARS-CoV-2 Test FDA-EUA Approved

PRODUCT INFORMATION


    FDA-EUA Approved Accula™ SARS-CoV-2 Test

    The Accula™ SARS-CoV-2 Test combines RT-PCR accuracy with a portable platform and elegantly simple workflow to provide fast and convenient RT-PCR results in just 30 minutes and to quickly and reliably identify patients who are COVID-19 positive for isolation or deferment of treatment.

    The Accula™ SARS-CoV-2 Test is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection of nucleic acid from SARS-CoV-2 in clinician-collected nasal specimens, collected from patients suspected of COVID-19 by their healthcare provider.

    Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high, moderate, or waived complexity tests. The Accula SARS-CoV-2 Test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

    Rapid PCR COVID-19

    Test type: Molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection of the coronavirus SARS-CoV-2 viral RNA.
    Specimen type: Nasal
    Turnaround time: Approximately 30 minutes

    Each Box Contains

    • Collection Swabs: 25 sterile nasal swabs
    • SARS-CoV-2 Buffer: 25 single-use vials of solution containing 5 mL of buffer
    • Transfer Pipette: 25 single-use, fixed volume pipettes
    • Accula SARS-CoV-2 Test Cassette: 25 Single-use, foil-pouched with desiccant and Test Cassette
    • SARS-CoV-2 High Positive Control Swab: DNA Based Synthetic Oligo dried onto a swab well-above the limit of detection
    • SARS-CoV-2 Low Positive Control Swab: DNA Based Synthetic Oligo dried onto a swab near the limit of detection
    • SARS-CoV-2 Negative Control Swab: Buffer solution dried onto a swab
    • Documentation: 1 Self-collection Quick Reference and 1 Electronic Instructions for Use (EIFU) card

    Interpretation of Results

    Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status.

    Negative results should be treated as presumptive, 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.

    Limitations

    • This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories
    • This product has been authorized only for the detection of proteins from SARS-CoV-2, influenza A and influenza B, not for any other viruses or pathogens
    • The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated, or authorization is revoked sooner

    Frequently Asked Questions

    No. This test is not yet approved or cleared by the United States FDA. It is authorized under EUA by the 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).

    There are no approved available alternative tests. FDA has issued EUAs for other tests that can be found at: https://www.fda.gov/emergency-preparedness-andresponse/mcm-legal-regulatory-and-policyframework/emergency-use-authorization

    The Accula SARS-CoV-2 Test uses a nasal or nasal mid-turbinate swab specimen collected from patients who meet CDC SARS-CoV-2 clinical criteria and in conjunction with epidemiological criteria to aid in the diagnosis of SARS-CoV-2 infection.

    This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens

    The Accula SARS-CoV-2 Test is authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high, moderate or waived complexity tests. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities.

    This product is not available in Canada at this time.

    Get more information on FDA-EUA Accula™ SARS-CoV-2 Test:

    • Allow Aurora to send requested information
    • This field is for validation purposes and should be left unchanged.