SARS-CoV-2 (COVID-19) by NAA, COVID-19 IgG antibody tests,cia testing

Long before the World Health Organization declared COVID-19 a pandemic, ARUP Laboratories was developing and validating tests to help meet the extraordinary demand for coronavirus testing placed on hospitals and health systems nationwide. As a trusted partner, ARUP remains committed to providing timely, accurate test results that inform optimal patient care despite the unprecedented challenges all of us in healthcare face.

We offer 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. We ask that you contact Client Services before sending orders for COVID-19 NAA testing to help us plan so that we can ensure timely results for all orders.

Health Department Reporting

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.

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

ARUP’s nucleic acid amplification (NAA) testing is designed to detect SARS-CoV-2 RNA in respiratory specimens and 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.

ARUP does not perform additional on-site confirmatory testing on positive or negative results.

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

Please see our COVID-19 Specimen Collection Guide for more detailed information on collection and transport media.

In 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.

ARUP’s COVID-19 NAA assays are Emergency Use Authorization (EUA) assays performed on two 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. More information about these platforms can be found at the links below:

Test Result Reporting

Test results are reported to our clients as “detected,” “not detected,” or “invalid.”

ARUP will consider a result of “detected” to be a critical result, and the result will be called to the client. Test results are made immediately available in ARUP Connect.

An interview with Dr. David Hillyard: Delving into the Sensitivity of SARS-CoV-2 Diagnostic Testing

Sensitivity and Specificity of the ARUP COVID-19 NAA Assays

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

Test Pricing

The price of our COVID-19 molecular diagnostic test is $95 to our hospital and laboratory clients. ARUP does not charge patients directly for laboratory services.

Additional Resources

Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19

COVID-19 IgG Testing

NOTE: Patients should contact their healthcare providers for testing options. ARUP DOES NOT collect specimens for COVID-19 molecular diagnostic or IgG serology testing.

To meet your testing needs, ARUP is offering two different SARS-CoV-2 IgG antibody tests for COVID-19 as of May 13. These tests have both received FDA Emergency Use Authorization (EUA).

Details about these tests can be found below.

COVID-19 IgG Test Interpretation

An interview with Drs. Patricia Slev and Jenna Rychert: Antibody Testing for COVID-19

Detection of IgG antibodies indicates exposure to SARS-CoV-2. Importantly, it has not yet been established that the presence of IgG antibodies implies immunity to COVID-19. Further, 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.

IgG antibodies are likely to be present in the 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.

Both COVID-19 serology assays offered by ARUP have been evaluated by their individual manufacturers and the FDA in partnership with the National Institutes of Health (NIH), the CDC, and the Biomedical Advanced Research and Development Authority (BARDA). 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.

COVID-19 IgG, Qualitative by CIA

Test Number Test Name
3002776 COVID-19 IgG, Qualitative by CIA

This assay detects IgG antibodies specific to the nucleocapsid protein of SARS-CoV-2. It is reported as “negative” or “positive.”

More information about this test can be found at the links below:

Sensitivity and Specificity

Performance of COVID-19 IgG, Qualitative by CIA*

Antibodies 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

Test 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.

COVID-19 IgG by ELISA

Test Number Test Name
3002723 COVID-19 IgG by ELISA

This assay detects IgG antibodies specific to the S1 domain of the spike protein of SARS-CoV-2. It is reported as “negative,” “indeterminate," or “positive,” and will include an index value.

More information about this test can be found at the links below:

Sensitivity and Specificity

Performance of COVID-19 IgG by ELISA

Antibodys 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

Test 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.

Frequently Asked Questions about the IgG Antibody Tests

I am a patient. How can I get an IgG antibody test?

  • ARUP WILL NOT collect specimens for COVID-19 molecular diagnostic or IgG serology testing directly from patients.
  • Patients should contact their healthcare providers for testing options.

Is ARUP going to develop a COVID-19 IgM assay?

IgM and IgG antibodies develop at nearly the same time in most individuals with COVID-19 (see the CDC Interim Guidelines for COVID-19 Antibody Testing). Since it is uncommon to detect IgM and not IgG, ARUP is not currently developing an IgM assay for COVID-19.

Where can I find more information about the use of serology for COVID-19?

For more information about the role of antibody testing in the rapidly changing environment surrounding COVID-19 testing, visit Understanding the Role of Antibody Testing in Battling the Spread of COVID-19.

Medical professionals from ARUP Laboratories and the Mayo Clinic discuss the role of antibody testing for SARS-CoV-2 in this webinar from the American Society for Microbiology and in this article in the Journal of Clinical Microbiology.

Other Testing Associated with COVID-19

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.

Respiratory Viral Culture Reactivations

Effective June 15, 2020, ARUP has resumed performing respiratory viral cultures.

ARUP has completed validation on an alternative cell line for respiratory viral cultures. This new cell line does not allow for the growth and replication of the SARS virus but has sensitivity equal to that of the cell lines used previously in ARUP’s respiratory viral cultures.

ARUP has performed a thorough site-specific and activity-specific risk assessment and determined that our procedure does not present risks to our staff.

The following tests have been resumed:

  • 2006499 Viral Culture, Respiratory
  • 2006497 Viral Culture, Respiratory and Cytomegalovirus Rapid Culture
  • 2001504 Respiratory Viruses Rapid Culture
  • 0060281 Respiratory Viruses DFA with Reflex to Viral Culture, Respiratory
  • 0060284 Influenza Virus A and B DFA with Reflex to Influenza Virus A and B Rapid Culture
  • 0060286 Influenza Virus A and B Rapid Culture

Molecular testing is available for a variety of specific respiratory viruses. The physician/provider should be consulted for guidance on molecular testing.