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SARS-CoV-2 RT-PCR Assay SARS-CoV-2 RT-PCR Assay SARS-CoV-2 RT-PCR Assay

SARS-CoV-2 RT-PCR Assay

Doctor’s Data, Inc. offers PCR testing of samples for SARS-CoV-2 (COVID-19.) We will accept saliva samples, nasopharyngeal (NP) or oropharyngeal (OP) swab samples for testing.  The cash price for this test is $100 in the US.

Many patients with COVID-19 have developed fever and/or symptoms of acute respiratory illness (e.g., cough, dyspnea), al-though some individuals experience only mild symptoms or no symptoms at all. The current information available to characterize the spectrum of clinical illness associated with COVID-19 suggests that, when present, symptoms include cough, shortness of breath or dyspnea, fever, chills, myalgias, head-ache, sore throat, new loss of taste or smell, nausea or vomiting or diarrhea. Signs and symptoms may appear any time from 2 to 14 days after exposure to the virus, and the median time to symptom onset is approximately 5 days. For further information on the symptoms of COVID-19 please click here.

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Useful for:

    Turnaround Time

    2 to 4 days

    Analytes Tested

    Click any analyte name for additional clinical information, including reference ranges, specimen collection, stability and rejection criteria.

    Analyte
    CPT
    ABN Required
    SARS-CoV-2
    U0003
    No

    List price applies when filing with insurance or Medicare, or when billing a patient directly.

    Doctor's Data offers profiles containing multiple analytes. *Multiple analytes may be billed under a single CPT code. Many analytes can be ordered individually. Pricing may vary. Click on a specific analyte for more information or read our detailed billing and payment policies.

    The CPT codes listed on our website are for informational purposes only. This information is our interpretation of CPT coding requirements and may not necessarily be correct. You are advised to consult the CPT Coding Manual published by the American Medical Association. Doctor's Data, Inc. takes no responsibility for billing errors due to your use of any CPT information from our website.

    Sign in at the top of any page to view pricing and order tests. Or click here to create an account. You may also contact us for assistance placing an order.

    Detailed Information

    Doctor's Data will accept the following specimen types:

    Saliva

    Preferred: Saliva collected in the Zymo Research R1210 DNA/RNA Shield Saliva Collection Kit.
    Alternative: Sputum collected in the Zymo Research R1210 DNA/RNA Shield Saliva Collection Kit.

    Samples should be collected in a healthcare setting with practitioner supervision. Any packages with evidence of leakage will be destroyed and we will not test the sample.

    The cash price for this test is $100 in the US.

    Stability:
    Frozen: 6 months
    Room Temp: 6 days

    To order saliva test kits from Doctor's Data, sign in to your portal at the top of the page. Then go to the Order Test kits page.

    Purchase supplies from manufacturer: We only accept samples transported in Zymo Research DNA/RNA Shield. You can buy R1210 saliva collection kits direct from the manufacturer and ship* them to us. Zymo has distributors in most countries. Other saliva tubes are not acceptable. All SARS-CoV-2 results must be reported to Public Health Authorities. Specimens should be properly labeled with full patient demographics including address and phone number, and properly packaged and shipped according to CDC guidelines. All specimens must be accompanied by a completed requisition form. A sample requisition form and example collection instructions are available for download, located on the left hand side of this page.

    Swab

    Preferred: Nasopharyngeal (NP) swab in in viral transport media
    Alternative: Nasal or Oropharyngeal (OP) swab in viral transport media

    The cash price for this test is $100 in the US.

    NP/OP Swab Collection kits: Due to supply chain shortages, facilities must provide their own collection materials, patient identifiers and shipping* to us. All SARS-CoV-2 results must be reported to Public Health Authorities. Specimens should be properly labeled with full patient demographics including address and phone number, and properly packaged and shipped according to CDC guidelines. All specimens must be accompanied by a completed requisition form. A sample requisition form is available for download on the left hand side of this page. We will accept any brand swab with a synthetic tip, shipped in UTM/VTM. Any packages with evidence of leakage will be destroyed. Calcium alginate swabs and cotton swabs with wooden shafts, BD Eswab (swabs in liquid amies) are unacceptable.

    Stability:
    Frozen (-20C):  6 months
    Refrigerated: (2-8C): 72 hours
    Room Temp: 24 hours

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    *Shipping:
    Specimens must be packaged, shipped, and transported according to the current edition of the International Air Transport Association (IATA) Dangerous Goods Regulation. Follow shipping regulations for UN 3373 Biological Substance, Category B when sending potential SARS-CoV-2 specimens. Alternatively, specimen transportation guidelines from CDC for SARS-CoV-2 specimens can be followed. (https://www.cdc.gov/coronavirus/2019- ncov/lab/guidelines-clinical-specimens.html)

    This test has not been FDA cleared or approved. This test has been authorized by FDA under an Emergency Use Authorization (EUA). This test has been validated in accordance with the FDA's Guidance Document (Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency) issued on February 29th, 2020. FDA independent review of this validation is pending. This test is only authorized for the duration of time the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of SARS-CoV-2 virus and/or diagnosis of COVID-19 infection under section 564(b)(1) of the Act, 21 U.S.C. 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Samples should be collected in a healthcare setting with a practitioner present to supervise collection.

    If you have any questions about required documentation or shipping, please contact us at info@doctorsdata.com or 800.323.2784.

    Please visit this page for other important updates specific to COVID-19 and your Doctor’s Data account.