Coronavirus Disease 2019 (COVID-19)

Test Information for Hospitals and Labs

   
Page updated September 11, 2020Linkedin     Email

Nucleic acid amplification (NAA) testing on saliva specimens is now available. Learn more.

 

 

ARUP offers NAA testing for diagnosis of current COVID-19 infection and two IgG antibody tests to evaluate for exposure to SARS-CoV-2.

Not sure which test to order? Check our COVID-19 test infographic

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.

 
Diagnostic Testing

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:

 

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

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

Saliva Specimens Now Accepted

Saliva was recently validated as an additional specimen type for the SARS-CoV-2 (COVID-19) by NAA test. Saliva specimens were found to provide results equivalent to those obtained with nasopharyngeal swab specimens in a study performed by ARUP and the University of Utah and reported in the Journal of Clinical Microbiology. To date, this is the largest published study examining saliva as a sample type for COVID-19 diagnostic testing.  

The ability to utilize saliva specimens provides many advantages for both patients and healthcare providers. Collection of saliva does not rely on swabs, which have been in short supply during the COVID-19 pandemic, and is more comfortable and less invasive than specimen collection using nasopharyngeal swabs. 

Patient saliva is collected by having the patient spit into a sterile funnel attached to a sample tube, provide saliva to the fill line (saliva should not surpass fill line), securely fasten the lid, and then hand the collection tube to the healthcare provider. This method reduces healthcare professionals’ risk of exposure during the collection process. The saliva specimen must be collected in the presence of a healthcare provider.

All ARUP COVID-19 NAA testing platforms have been validated for use with saliva samples collected using ARUP saliva collection kits. The ability to utilize all test platforms allows ARUP to maintain a fast turnaround time for these tests. ARUP clients that are currently receiving collection supplies may begin ordering the new saliva collection kit and submit patient specimens for SARS-CoV-2 (COVID-19) by NAA testing.

Please contact Client Services if you are a client and would like to start utilizing our new collection kit.

Methodology

ARUP’s COVID-19 NAA 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, 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,” “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.

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

 
 
Antibody Testing

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-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.

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.

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.