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Coronavirus Disease 2019 (COVID-19)
Test Information for Hospitals and Labs
ARUP offers nucleic acid amplification (NAA) testing for diagnosis of current COVID-19 infection and two IgG antibody tests to evaluate for exposure to SARS-CoV-2.
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Please note: ARUP will report all COVID-19 test results to all states. If ARUP receives a patient address with the 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.
Use to detect the 2019 novel coronavirus (SARS-CoV-2).
Diagnostic Tests
ARUP’s nucleic acid amplification (NAA) testing 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 COVID-19 NAA testing:
- Contact Client Services to help us plan so that we can ensure timely results for all orders.
- Submit Patient Demographics Form with the order. This is to provide public health departments with vital information on the spread of COVID-19.
- Download COVID-19 Specimen Collection Guide for detailed information on specimen collection and transport media.
SARS-CoV-2 (COVID-19) by NAA Test
Test: SARS-CoV-2 (COVID-19) by NAA (3002638)
Methodology
ARUP’s COVID-19 NAA assays are Emergency Use Authorization (EUA) assays performed on three different platforms. Two tests, a reverse-transcription polymerase chain reaction (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,” or “invalid.” 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 Providers
Use for the qualitative detection of IgG antibodies to evaluate exposure to SARS-CoV-2.
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 indicates exposure to SARS-CoV-2. Importantly, it has not yet been established that the presence of SARS-CoV-2 IgG antibodies implies immunity. Furthermore, individuals 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: 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.
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% to 99.9% |
| IgG | PPV at prevalence = 5% | 92.9% | 83.4% to 98.1% |
| 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 |
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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
For Providers
For Patients
COVID-19 IgG by ELISA
Test: 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.
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% (27/30) | 74.4% to 96.5% |
| IgG | Specificity |
100% (80/80) |
95.4% to 100% |
| IgG | PPV at prevalence = 5% | 100% | 46% 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 |
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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
For Providers
For Patients
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.
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