Coronavirus Disease 2019 (COVID-19)

Test Information for Hospitals and Labs

 
Page updated February 12, 2021Linkedin     Email

Combined nucleic acid amplification (NAA) testing for influenza, SARS-CoV-2, and respiratory syncytial virus (RSV) is now available. Learn more.

 

 

ARUP offers combined NAA testing to diagnose and differentiate between COVID-19, influenza, and RSV; stand-alone NAA testing for diagnosis of current COVID-19 infection; and two IgG antibody tests to evaluate for exposure to SARS-CoV-2.

Please note: ARUP will report all COVID-19 test results to all states. If ARUP receives a patient address with a molecular test, the health department in the state in which the patient resides will be notified. Otherwise, ARUP will report based on the location of the ordering client.

 
Diagnostic Testing

Diagnostic Tests


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-tubeTest: 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.

Before sending orders for combined influenza/COVID-19/RSV NAA testing:

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-tubeTest: 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.

Before sending orders for stand-alone COVID-19 NAA testing:

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.

Antibody Testing

Use for the qualitative detection of IgG antibodies to evaluate exposure to SARS-CoV-2. The American Association for Clinical Chemistry (AACC) does not recommend the use of serology to assess vaccine response.


Antibody Tests


Both COVID-19 serology assays offered by ARUP have received FDA Emergency Use Authorization (EUA). Please visit the FDA website, EUA Authorized Serology Test Performance, for more information. Additionally, ARUP verified that both assays perform according to the manufacturer’s claims.

Antibody Test Result Interpretation

Detection of IgG antibodies suggests exposure to SARS-CoV-2. However, detection of IgG antibodies to the SARS-CoV-2 spike protein may also indicate COVID-19 vaccination. Importantly, it has not yet been established that the presence of SARS-CoV-2 IgG antibodies implies protective immunity. Furthermore, individuals recovering from COVID-19 may still be infectious for some time after seroconversion occurs and antibodies become detectable. For this reason, a positive antibody result should not alter quarantine, isolation, social distancing, or PPE practices.

IgG results should not be used for diagnosis. Molecular tests are the only tests currently recommended for the diagnosis of COVID-19 infection.

SARS-CoV-2 IgG antibodies are likely to be present in a majority of individuals approximately two weeks after the onset of COVID-19 symptoms. If a specimen is collected too early, antibody tests can yield false-negative results. False-positive results can occur and may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E. False-positive results are also possible in low-prevalence settings, even when an antibody test has >98.0% specificity.

To reduce the likelihood of a false-positive result, the CDC Interim Guidelines for COVID-19 Antibody Testing suggest using an orthogonal testing algorithm so that individuals who are positive by one antibody test are retested with a second antibody test using a different methodology or target antigen.

Before you order: To provide public health departments with vital information on the spread of COVID-19, please submit the Patient Demographics Form for Public Health Reporting with the order.

 

COVID-19 IgG, Qualitative by CIA

test-tubeTest: COVID-19 IgG, Qualitative by CIA (3002776)

Methodology

This chemiluminescent immunoassay (CIA) performed on the Abbott ARCHITECT platform detects IgG antibodies specific to the nucleocapsid protein of SARS-CoV-2 that develop in response to natural infection with SARS-CoV-2. These antibodies do not develop as a result of a COVID-19 vaccination. The AACC does not recommend the use of serology to assess COVID-19 vaccine response.

Results Reporting

Results are reported as “negative” or “positive.”

Sensitivity and Specificity

Performance of COVID-19 IgG, Qualitative by CIA

Antibody Performance Measure Estimate of Performance 95% CI
IgG Sensitivity 100% (88/88) 95.8% to 100%
IgG Specificity 99.6% (1,066/1,070) 99.0% to 99.9%
IgG PPV at prevalence = 5% 93.4% 84.0% to 97.3%
IgG NPV at prevalence = 5% 100% 99.8% to 100%

CI, confidence interval; NPV, negative predictive value; PPV, positive predictive value

Data source: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/eua-authorized-serology-test-performance

Pricing

The price of the COVID-19 IgG, Qualitative by CIA test (3002776) is $40 to our hospital and laboratory clients. ARUP does not charge patients directly for laboratory services.

Fact Sheets

 
 

COVID-19 IgG by ELISA

test-tubeTest: COVID-19 IgG by ELISA (3002723)

Methodology

This enzyme-linked immunosorbent assay (ELISA) performed on the EUROIMMUN platform detects IgG antibodies specific to the S1 domain of the spike protein of SARS-CoV-2 that develop in response to natural infection with SARS-CoV-2 or from a COVID-19 vaccination. The AACC does not recommend using serology to assess COVID-19 vaccine response.

Results Reporting

Results are reported as “negative,” “indeterminate," or “positive,” and include an index value.

Sensitivity and Specificity

Performance of COVID-19 IgG by ELISA

Antibody Performance Measure Estimate of Performance 95% CI
IgG Sensitivity 90.0% (27/30) 74.4% to 96.5%
IgG Specificity

100% (80/80)

95.4% to 100%
IgG PPV at prevalence = 5% 100% 46.1% to 100%
IgG NPV at prevalence = 5% 99.5% 98.6% to 99.8%

CI, confidence interval; NPV, negative predictive value; PPV, positive predictive value

Data source: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/eua-authorized-serology-test-performance

Pricing

The price of the COVID-19 IgG by ELISA test (3002723) is $50 to our hospital and laboratory clients. ARUP does not charge patients directly for laboratory services.

Fact Sheets

 
 
Related Testing

Cytokine Support Testing

This testing is used primarily for research and to support attempts to understand the pathogenesis of immune, infectious, allergic, or inflammatory disorders. Currently, there are not well-defined guidelines on how the results should be interpreted and/or used to guide treatment decisions in patients with COVID-19.