COVID-19/Flu Panel Testing

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

Information for Ordering Providers

Test Name: COVID-19 /Flu Panel
Test Code: EXAS2500
CPT Code: 87636

Test Description: The test is a laboratory-developed high-throughput real-time RT-PCR multiplexed assay developed by Exact Sciences Laboratories for the simultaneous qualitative detection of nucleic acid from COVID19, Influenza A and Influenza B virus in upper respiratory 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 nucleocapsid (N) gene, Influenza A virus matrix (M1) gene, Influenza B virus nonstructural 2 (NS2) gene and human RPP30 (RP) gene transcripts with specific primers and probes.

Results are for the detection of SARS-CoV-2 (COVID-19) RNA, Influenza A and Influenza B.

Positive results are indicative of the presence of SARS-CoV-2, Influenza A and/or Influenza B. 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 results do not preclude SARS-CoV-2, Influenza A or Influenza B 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.

DISCLAIMER:

  • This assay is for in vitro diagnostic use.
  • This test was developed and its performance characteristics determined by Exact Sciences Laboratories, LLC. It has not been cleared or approved by the US Food and Drug Administration (FDA). The FDA does not require this test to go through premarket FDA review. This test is used for clinical purposes. It should not be regarded as investigational or for research. Exact Sciences Laboratories is certified under the Clinical Laboratory Improvement Amendments (CLIA) and qualified to perform high complexity clinical laboratory testing. Performance of the Exact Sciences Laboratories COVID-19/Flu Multiplex Assay has only been established in Nasal and Nasopharyngeal specimens
  • Negative results do not preclude SARS-CoV-2, influenza A, or influenza B virus infection and should not be used as the sole basis for treatment or other patient management decisions.
  • A false negative result may occur if a specimen is improperly collected, transported, or handled. False negative results may also occur if amplification inhibitors are present in the specimen or if inadequate numbers of organisms are present in the specimen.
  • Performance evaluations have shown decreased sensitivity of the SARS-CoV-2, influenza A or influenza B viral target when a high titer of either SARS-CoV-2 or influenza A or B are also present in the sample. Status of co-infection should be interpreted with caution in specimens with a high titer of any single analyte. If co-infection is suspected, additional testing of the sample with individual viral target(s) is recommended.
  • Performance evaluation showed that certain allergy and nasal congestion medications may potentially interfere with detection of viral targets and may lead to false negative results.
  • In the case of influenza A and B viruses, children tend to shed virus more abundantly and for longer periods of time than adults. Therefore, testing specimens from adults for the presence of RNA from influenza viruses will have lower sensitivity than testing specimens from children.
  • Positive and negative predictive values are highly dependent on prevalence. False negative test results are more likely during peak activity when prevalence of disease is high. False positive test results are more likely during periods of low influenza or SARS-CoV-2 activity when prevalence is moderate to low
  • The performance of the assay has not been established in individuals who received nasally administered influenza vaccine. Individuals who received nasally administered influenza A vaccine may have positive influenza A test results for up to three days after vaccination. http://www.cdc.gov/mmwr/preview/mmwrhtml/rr57e717a1.htm
  • Optimum specimen types and timing for peak viral levels during infections caused by a influenza or SARS-CoV-2 virus have not been determined. Collection of multiple specimens from the same patient may be necessary to detect the viruses.
  • If SARS-CoV-2 or an influenza A or B virus mutates in the rRT-PCR target region, the specific novel virus may not be detected or may be detected less predictably.
  • The potential for the epidemiology and pathology of disease caused by a specific novel influenza virus or SARS-CoV-2 virus to affect test performance is not fully known. For example, clinicians and laboratories may not know the optimum types of specimens to collect, and when during the course of infection these specimens are most likely to contain levels of virus that can be readily detected.
  • Detection of viral RNA may not indicate the presence of infectious virus or that influenza or SARS-CoV-2 viruses are the causative agent for clinical symptoms.
  • The performance of this test has not been established for monitoring treatment of influenza A, influenza B, or SARS-CoV-2 infection.
  • The performance of this assay has not been established for screening of blood or blood products for the presence of influenza A, influenza B or SARS-CoV-2.
  • This assay cannot rule out diseases caused by other bacterial or viral pathogens.

Performing Laboratory: All testing is performed in Exact Sciences Laboratories’ two locations in Madison, WI. These laboratories are certified under the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high complexity clinical laboratory testing. CLIA numbers: 52D2072838 and 52D2162828

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, Influenza A or Influenza B infections.

  • If you are a provider or organization who is interested in contracting with Exact Sciences Laboratories for COVID/Flu Panel Testing, please contact our support team at 844.570.9730. 
  • 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.

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

The following specimen types are accepted by Exact Sciences Laboratories for COVID-19 and COVID-19/Flu Panel testing.

  1. Nasopharyngeal (NP)
  2. Nasal (Anterior Nares)

Please note that Exact Sciences Laboratories cannot accept specimens collected with wooden handles, calcium-alginate swabs, or cotton-tipped swabs.

The following types of transport media may be used:

  • Viral transport media (VTM),
  • Universal transport media (UTM),
  • Amies
  • RNAse-free saline

FDA. FAQs on Diagnostic Testing for SARS-CoV-2. https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/faqs-testing-sars-cov-2. Accessed October 28, 2020.

CDC. Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons for Coronavirus Disease 2019 (COVID-19). https://www.cdc.gov/coronavirus/2019-ncov/lab/guidelines-clinical-specimens.html. Accessed October 28, 2020.

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:

  • Chilled specimens must arrive within 72 hours of collection—on ice packs, cold packs, or refrigerated at 2-8⁰C 
  • Frozen specimens will be accepted after 72 hours if they were frozen at ≤ -70⁰C (minus 70 degrees Celsius--much colder than a residential freezer ) immediately after collection and shipped with plenty of dry ice
  • Collection tubes should 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, Influenza A and Influenza B 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

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 types of specimens do you accept?

The supplies that Exact Sciences Laboratories distributes can be used for nasal (anterior nares) specimens. However, our lab accepts nasopharyngeal (NP) and anterior nares (nasal) upper respiratory specimens in VTM, UTM, Amies, saline, or other CDC-recommended transport media. These recommendations can be found at the following links.

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 chilled within 72 hours of collection—on ice packs, cold packs, or refrigerated at 2-8⁰C 
    • Frozen specimens will be accepted even after 72 hours if they were frozen at ≤ -70⁰C (minus 70 degrees Celsius) immediately after collection and shipped with plenty of dry ice--much colder than a residential freezer
    • Collection tubes should be intact, not leaking, and without gross contamination 
    • If specimens are refrigerated or frozen, please clearly note this on the transportation container

How should I store and ship the samples?

Samples should be chilled to 2-8⁰C, which can be done with a refrigerator or ice packs in a cooler. It is very important to ship the specimens to our lab as soon as possible, preferably sending the specimens the day of collection. Any specimens that do not arrive within 72 hours will have to be rejected, unless they were frozen at ultra-low temperatures (-70⁰C or lower) and sent with plenty of dry ice.

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 COVID-19 Response Team at 844-570-9730.

What is the test code and CPT code for the COVID-19/Flu Panel option?

COVID-19/Flu Panel
Test Code: EXAS2500
CPT Code: 87636

COVID-19 Test
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 72 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/Flu Panel option?

  • Results are for the detection of SARS-CoV-2 RNA, Influenza A and Influenza B.
  • Positive: Positive results are indicative of the presence of SARS-CoV-2, Influenza A or Influenza B. 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, Influenza A or Influenza B 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/Flu Panel cost?

The list price of our COVID-19/Flu panel is $189.
The list price of our COVID-19 test is $149.

Is this testing available to the general public?

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

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