COVID-19/Flu Panel Testing

Information for Ordering Providers

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

Test Description: The COVID-Flu multiplex assay is a real-time RT-PCR assay intended for the simultaneous qualitative detection and differentiation of nucleic acid from SARS-CoV-2, influenza A virus, and/or influenza B virus 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, influenza A, influenza B and human RPP30 (RP) gene transcripts with specific primers and probes.

Results are for the simultaneous detection and differentiation of SARS- CoV-2, influenza A, and/or influenza B viral nucleic acid in clinical specimens and is not intended to detect influenza C.

Positive results are indicative of the presence of SARS-CoV-2, influenza A and/or influenza B nucleic acid but do not rule out bacterial infection or co-infection with other pathogens not detected by the test; clinical correlation with patient history andother 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 influenza A, and/or influenza B 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 COVID-Flu 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.C. § 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, 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 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.