COVID-19 Testing

This page will review the test information specific to COVID-19 testing. If you are interested in ordering only COVID-19/Flu Panel testing, please go here.

Information for Ordering Providers

Test Name: COVID-19
Test Code: EXAS1002
CPT Code: U0003

Test Description: The SARS-CoV-2 (multiplex assay) is a real-time RT-PCR assay intended for the qualitative detection of nucleic acids from SARS-CoV-2 in anterior nasal swab specimens. The assay is composed of two principal steps: (1) extraction of total nucleic acid (DNA and RNA) from patient specimens, (2) one-step reverse transcription and PCR amplification with COVID19 N gene and human RPP30 (RP) gene transcripts with specific primers and probes.

Results are for the detection of SARS- CoV-2 RNA.

Positive results are indicative of the presence of SARS-CoV-2 nucleic acids but do not rule out bacterial infection or coinfection with other pathogens not detected by the test; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all SARS-CoV-2 results to the appropriate public health authorities.

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Negative results must be combined with clinical observations, patient history, and/or epidemiological information.

The SARS-CoV-2 (multiplex assay) is only for use under the Food and Drug Administration’s Emergency Use Authorization. Testing is limited to Exact Sciences Laboratories, located at 650 Forward Drive, Madison, WI 53711, which is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.S. 263a, and meets the requirements to perform high complexity tests.

DISCLAIMER:
The COVID-Flu Multiplex Assay is intended for use by qualified laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. The COVID-Flu Multiplex Assay is only for use under the Food and Drug Administration’s Emergency Use Authorization.

LIMITATIONS:

  • Competitive inhibition studies showed that SARS-CoV-2 virus, when present at concentrations above 1x105 copies/mL, can inhibit the detection and amplification of influenza A and influenza B virus RNA if present at or below 4,689 copies/mL and 3,000 copies/mL, respectively, and may lead to false negative influenza virus results. If co-infection with influenza A or influenza B virus is suspected in samples with a positive SARS-Cov-2 result, the sample should be re-tested with another FDA cleared, approved, or authorized influenza test, if influenza virus detection would change clinical management.
  • Results (positive and negative) for influenza should be interpreted with caution. If an influenza result is inconsistent with clinical presentation and/or other clinical and epidemiological information, FDA-cleared influenza NAATs are available for confirmation if clinically indicated.

  • The performance of this test was established based on the evaluation of a limited number of clinical specimens. The clinical performance has not been established in all circulating variants but is anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical evaluation. Performance at the time of testing may vary depending on the variants circulating, including newly emerging strains of SARS-CoV-2 and their prevalence, which change over time.

  • While it has been determined, based on reviewing studies evaluating specimen adequacy (e.g., by evaluating RNase P), that unobserved self-collected anterior nasal swab samples using the Exact Sciences Nasal Swab Home Collection Kit will likely contain similar levels of human cellular genetic material as healthcare provider collected anterior nasal swab samples, performance of testing self-collected anterior nasal swab samples using the Exact Sciences Nasal Swab Home Collection Kit has not been specifically evaluated.

WARNINGS AND PRECAUTIONS:

  • For in vitro diagnostic use under the FDA Emergency Use Authorization Only.
  • For prescription use only.
  • This product has not been FDA cleared or approved but has been authorized for emergency use by FDA under an EUA for use by the authorized laboratory.
  • 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 Cosmetics Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated, or authorization is revoked sooner.
  • This product has been authorized only for the detection and differentiation of nucleic acid from SARS-CoV-2, influenza A and/or influenza B, not for any other viruses or pathogens.
  • Follow necessary precautions when handling specimens. Use personal protective equipment (PPE) consistent with current guidelines for the handling of potentially infectious samples.
  • Do not eat, drink, smoke, or apply cosmetic products in the work areas.
  • Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities.

Performing Laboratory: Testing is performed in Exact Sciences Laboratories, located at 650 Forward Drive, Madison, WI 53711, which is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, and meets the requirements to perform high complexity tests

How to Order

The test must be ordered by a physician or other authorized healthcare provider from an organization that has a fully executed contract with Exact Sciences Laboratories. This test is intended for use with patients who meet the current guidance for evaluation of COVID-19 infections

  • If you are a provider or organization who is interested in contracting with Exact Sciences Laboratories for COVID-19, please contact our support team at 844.570.9730 or click below to request additional information.
  • A completed test requisition is required for every specimen submitted to Exact Sciences Laboratories. We encourage electronic submission of requisitions.
  • Exact Sciences Laboratories can provide nasal collection supplies if needed.

Request Additional Details

Testing Process

Highlights of the testing process are summarized in this section, while detailed test information is provided in the Additional Resources section.

  • 1. Specimen Collection
    • Acceptable specimen types: Nasal (anterior nares) swabs
    • Avoid specimens collected with wooden handles, calcium-alginate swabs, or cotton-tipped swabs
    • Note: Nasopharyngeal (NP) specimens will be tested, but result reports will include a notation that the FDA has not evaluated the performance of this EUA assay for nasopharyngeal specimens
    • The following types of transport media may be used:

    -Viral transport media (VTM)
     -Universal transport media (UTM)
    -Amies
    -Saline

    FDA. COVID-19 Testing Supplies: FAQs on Testing for SARS-CoV-2. https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/covid-19-testing-supplies-faqs-testing-sars-cov-2. Accessed January 3, 2022.

    Exact Sciences Collection Supplies: For those who request them, our lab can provide collection supplies which include a synthetic-tipped swab on a plastic shaft and RNAse-free normal saline transport media. If you choose to use supplies from Exact Sciences Laboratories, they may be used for nasal (anterior nares) collection and are intended for testing at Exact Sciences Laboratories. For convenience, nasal collection instructions are provided with Exact Sciences Laboratories supplies. 

    Nasal-Swab-instructions image

  • 2. Specimen Handling and Shipping to Exact Sciences Laboratories

    To ensure reliable test results, each specimen needs to meet several requirements. Specific specimen requirements are listed below:

    Specimen Acceptance Criteria:

     

    Patient Identification Elements:

    • First name of patient 
    • Last name of patient 
    • Date of birth for patient

    *Specimens will only be accepted if these identifiers are clearly evident on the collection device/tube AND on the order documentation — the order form or the electronic information provided via interface.

    Collection Elements:

    • Date of specimen collection
    • Time of specimen collection

    *If the time of collection is not provided, the lab will default to 12:00am on the date of collection for stability determination.
    *Date of collection and time of collection can be on either the tube or order

    Specimen Transport Elements

    • Specimens must arrive within 72 hours of collection if shipped without refrigeration and exposed to temperature ranges encountered during normal transport. Specimen may still be refrigerated for storage and shipment, if a provider prefers to do so.
    • Specimens will be accepted after 72 hours if they were frozen at ≤ -70⁰C immediately after collection and shipped with plenty of dry ice
    • Collection tubes must be intact, not leaking, and without gross contamination

     

    Specimen Delivery Instructions

    • Deliver to 650 Forward Dr. Madison, WI 53711
    • Hand deliveries should arrive at Dock S12 and ring the bell to be greeted by the laboratory sample receipt staff 
    • Semi-trucks can use Dock S14
  • 3. Results Delivery

    The COVID-19 test results are released to the ordering provider using secure electronic methods.

    Most providers utilize our secure online portal, called EpicCare® Link™, which may be used even if a provider does not use Epic® for their medical record system.

    • For healthcare organizations with the IT capability, our team can explore other options for ordering and results delivery. 
    • Results will be reported to state health departments in accordance with communicable disease reporting requirements. 
    • After results have been released to the ordering provider, patients will be invited to view their results through the secure Exact Sciences MyChart® patient portal.

Additional Resources


Contact Us

Call our support team at 844-570-9730 for any additional questions.

Frequently Asked Questions

  • High Demand for Testing — Jan. 2022 Update

    Laboratories across the country are experiencing sudden, increased demand for COVID-19 testing due to the Omicron variant.  Exact Sciences Laboratories continues to process all samples received as quickly as possible. During periods of extreme demand, turnaround times may be affected.

    Questions?

    · Patients/General Public - contact the health care provider office or local testing center where your sample was collected.

    · Health Care Providers – existing customers of Exact Sciences Laboratories can reach Provider Support at 844-870-8870. 

    IMPORTANT NOTES:
    Exact Sciences Laboratories performs PCR tests on COVID-19 samples. Exact Sciences Laboratories does not provide antigen testing. Exact Sciences Laboratories is one of many labs processing COVID-19 tests for the State of Wisconsin. Not all State of Wisconsin tests come to our laboratory.

  • What type of COVID-19 test options does Exact Sciences offer?

    Exact Sciences Laboratories offers two options for COVID-19 testing:

    Option 1:
    Test Name: COVID-19 Test Code: EXAS1002 Real-time RT-PCR test intended for the qualitative detection of nucleic acid from COVID19 in upper respiratory specimens

    Option 2:
    Test Name: COVID-19/Flu Panel Test Code: EXAS2500 Real-time RT-PCR multiplexed assay intended for the simultaneous qualitative detection and differentiation of nucleic acid from COVID19, Influenza A and Influenza B virus in upper respiratory specimens

  • What type of COVID specimen can I send to Exact Sciences Laboratory?
    • Acceptable specimen types: Nasal (anterior nares) swabs
    • Avoid specimens collected with wooden handles, calcium-alginate swabs, or cotton-tipped swabs
    • Note: Nasopharyngeal (NP) specimens will be tested, but result reports will include a notation that the FDA has not evaluated the performance of this EUA assay for nasopharyngeal specimens
    • The following types of transport media may be used:

    -Viral transport media (VTM)
     -Universal transport media (UTM)
    -Amies
    -Saline

    FDA. COVID-19 Testing Supplies: FAQs on Testing for SARS-CoV-2. https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/covid-19-testing-supplies-faqs-testing-sars-cov-2. Accessed January 3, 2022.

  • What information is required by your lab to test my samples?

    While all the specimen and order information are important, the minimum criteria for a specimen to be tested are listed below.

    • Patient Identification Elements (listed on BOTH the specimen tube and order documentation)
      • First name of patient
      • Last name of patient 
      • Date of birth for patient

    *Specimens will only be accepted if these identifiers are clearly evident on the collection device/tube and on the order documentation--the order form or the electronic information provided via interface

    • Collection Elements (listed on EITHER the specimen tube or order documentation) 
      • Date of specimen collection 
      • Time of specimen collection

    *If the time of collection is not provided, the lab will default to 12:00am on the date of collection for stability determination

    • Specimen Transport Elements
      • Specimens must arrive within 72 hours of collection if shipped without refrigeration and exposed to temperature ranges encountered during normal transport. Specimen may still be refrigerated for storage and shipment, if a provider prefers to do so.
      • Specimens will be accepted after 72 hours if they were frozen at ≤ -70⁰C immediately after collection and shipped with plenty of dry ice
      • Collection tubes must be intact, not leaking, and without gross contamination
  • How should I store and ship the samples?
    • Specimens must arrive within 72 hours of collection if shipped without refrigeration and exposed to temperature ranges encountered during normal transport. Specimen may still be refrigerated for storage and shipment, if a provider prefers to do so.
    • Specimens will be accepted after 72 hours if they were frozen at ≤ -70⁰C immediately after collection and shipped with plenty of dry ice
    • Collection tubes must be intact, not leaking, and without gross contamination
  • Where do I deliver the samples?
    • Deliver to 650 Forward Dr. Madison, WI 53711 
    • Hand deliveries should arrive at Dock S12 and ring the bell to be greeted by the laboratory sample receipt staff 
    • Semi-trucks can use Dock S14
  • How do I order testing from Exact Sciences Laboratories?

    Wisconsin providers and healthcare organizations should visit the state website (https://covid19supplies.wi.gov/Testing) to set up ordering and to request testing supplies, if needed.

    For non-Wisconsin providers and healthcare organizations, please call our Exact Sciences Customer Care Center at 844-570-9730.

  • What is the test code and CPT code for the COVID-19 test option?

    Test Code: EXAS1002
    CPT Code: U0003

  • How long does it take to get results from Exact Sciences Laboratories?

    From the time that our lab receives the specimen, please expect it to take 48 hours to deliver the result to the ordering provider. It is important to note that this time does not include specimen transport time to our lab.

  • The Exact Sciences Laboratories swabs look different from shipment to shipment. Are there any differences in performance or how they are used?

    Specimen collection swabs distributed by Exact Sciences may vary in physical appearance from packet to packet. All provided swabs meet the recommendations from the FDA and CDC for general nasal specimen collection, and Exact Sciences has performed analyses to ensure that the swabs function as expected with our tests. All swabs can be used to collect nasal samples per the nasal collection instructions provided.

  • What do each of the possible results mean for the COVID-19 only option?
    • Positive: Positive results are indicative of the presence of SARS-CoV-2. Clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results are indicative of active infection but do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The laboratory may be required to report positive results to the appropriate public health authority
    • Negative: Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history and epidemiological information 
    • Invalid: A result was not able to be produced because either something prevented the assay from performing as expected or the specimen did not contain enough clinical material. Recollection is recommended if clinically indicated.
  • How much does the COVID-19 only option cost?

    The list price of our test is $149.

  • Is this testing available to the general public?

    Individuals who are interested in COVID-19 testing should contact their healthcare provider or follow local health department announcements for testing locations.

  • What type of billing options are available for COVID-19 Testing?
    • Client Bill - Client is contracted with Exact Sciences and is billed/invoiced directly for services provided
    • Insurance Bill - Patient's insurance will be billed for services provided. Patient might have financial responsibility based on their insurance coverage.
    • Patient Self-pay – If a patient does not want to bill their insurance or does not have insurance, there is an option for patient self-pay.
  • Why have I received a bill from Exact Sciences for COVID-19 testing?

    Your physician is utilizing Exact Sciences to provide testing related to the date of service listed on the front of your billing statement. We have provided the results to your physician to assist in making decisions related to your care. For questions regarding insurance and billing for this testing, please contact us at 1-866-512-2941.

Epic®, EpicCare® Link™, and MyChart® are trademarks of Epic Systems Corporation®
MyChart® is licensed from Epic Systems Corporation®

Our state of the art contact center can assist you and answer your questions. 

Call 1-844-870-8870