Use to detect the 2019 novel coronavirus (SARS-CoV-2). Combined testing may also be used to diagnose and differentiate influenza A/B and RSV. This test does not differentiate between influenza A and B.

For the platforms used by ARUP (Hologic, Roche, and Thermo Fisher) to perform NAA testing, all vendors are continuously monitoring available sequences of SARS-CoV-2 strains to ensure that these assays are detecting emerging variants and to understand any implications of these mutations. Currently, there have been no detected mutations or viral variants that will not be detected by the assays offered by ARUP Laboratories.

Influenza, SARS-CoV-2, and RSV by NAA Test

Test: Influenza, SARS-CoV-2, and RSV by NAA (3003443)

ARUP’s combined influenza/SARS-CoV-2/RSV test is designed to detect and differentiate SARS-CoV-2, influenza A/B virus, and/or RSV in individuals with suspected respiratory viral infection consistent with COVID-19. This test is specific to SARS-CoV-2, influenza A/B virus, and/or RSV and does not detect additional coronaviruses. Saliva and lower respiratory specimens are not acceptable specimen types for this test.

Methodology

The combined influenza/SARS-CoV-2/RSV assay is a laboratory-developed test. The combined test is a multiplexed reverse-transcriptase polymerase chain reaction (RT-PCR) assay that uses Thermo Fisher reagents and is run on Thermo Fisher instrumentation.

Results Reporting

Test results are reported to our clients as “detected,” “not detected,” “invalid,” or “inconclusive.” Please note that a result of “detected” is no longer being considered a critical result, so the results will no longer be called directly to the client. Test results are made immediately available in ARUP Connect.

Pricing

The price of our combined influenza/SARS-CoV-2/RSV test (3003443) is $140 to our hospital and laboratory clients.

ARUP does not charge patients directly for laboratory services.

SARS-CoV-2 (COVID-19) by NAA Test

Test: SARS-CoV-2 (COVID-19) by NAA (3002638)

ARUP’s stand-alone NAA test for SARS-CoV-2 is designed to detect SARS-CoV-2 RNA in respiratory specimens. It is recommended for patients who meet the CDC’s clinical and epidemiologic criteria for COVID-19 testing. The testing is specific to SARS-CoV-2 and does not detect any additional coronaviruses.

Methodology

ARUP’s COVID-19 NAA stand-alone assays are Emergency Use Authorization (EUA) assays when performed on nasopharyngeal, oropharyngeal, or nasal swab specimens. These assays are performed on three different platforms. Two tests, an RT-PCR test and a transcription-mediated amplification test (Aptima), are manufactured by Hologic and run on the Panther system. A third test, an RT-PCR, is manufactured by Roche and run on the Cobas 6800 system. Our fourth test is another RT-PCR and uses the Thermo Fisher TaqPath on Thermo Fisher instrumentation. Utilization of multiple platforms helps ensure continuity of high-volume testing.

Results Reporting

Test results are reported to our clients as “detected,” “not detected,” “invalid,” “presumptive positive,” or “inconclusive.” Please note that a result of “detected” is no longer being considered a critical result, so the results will no longer be called directly to the client. Test results are made immediately available in ARUP Connect.

Sensitivity and Specificity

The Hologic, Roche, and Thermo Fisher testing platforms have equivalent sensitivity and specificity performance characteristics.

Pricing

The price of our COVID-19 by NAA test (3002638) is $95 to our hospital and laboratory clients. ARUP does not charge patients directly for laboratory services.

Fact Sheets for the EUA SARS-CoV-2 by NAA Test

Saliva Specimens Acceptable for the SARS-CoV-2 (COVID-19) by NAA Test

Please note that patients should not eat or drink for 30 minutes prior to providing a saliva sample, and the saliva should not surpass the fill line of the collection tube. See the Laboratory Test Directory for complete collection and transport requirements.