Coronavirus Disease 2019 (COVID-19)
Test Information for Clinicians, Hospitals, and Labs
Viral detection testing is recommended for COVID-19 diagnosis. Testing decisions should be based on local epidemiology, clinical signs and symptoms, and the course of illness. Antibody testing can be used to evaluate exposure to SARS-CoV-2 but is not recommended for diagnosis of acute illness. Detailed information about COVID-19, including testing recommendations, can be found in the ARUP Consult COVID-19 - SARS-CoV-2 topic.
ARUP COVID-19 Testing
ARUP offers standalone nucleic acid amplification (NAA) testing for diagnosis of current COVID-19 infection, and two immunoglobulin G (IgG) antibody tests (targeting spike and nucleocapsid proteins, respectively) to evaluate individuals 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.
ARUP’s standalone NAA test for SARS-CoV-2 is designed to detect SARS-CoV-2 RNA in respiratory specimens. Detailed information about ARUP’s SARS-CoV-2 by NAA test, including methodology, results reporting, and test performance, can be found in the COVID-19 Test Fact Sheet.
Hologic and Roche, the manufacturers of the platforms used by ARUP to perform NAA testing, 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 identified mutations or viral variants that will not be detected by the assay offered by ARUP Laboratories.
Before sending orders for standalone COVID-19 NAA testing:
ARUP’s COVID-19 serology assays are designed to detect IgG antibodies that bind to SARS-CoV-2. Both assays offered by ARUP have received FDA Emergency Use Authorization (EUA). Please visit the FDA web page, EUA Authorized Serology Test Performance, for more information. Additionally, ARUP verified that both assays perform according to the manufacturer’s claims. Detailed information about ARUP’s COVID-19 IgG tests, including antibody target, methodology, results reporting, and test performance, can be found in the COVID-19 Test Fact Sheet.
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 ONLY if complete demographic information is not transmitted to ARUP.
COVID-19 IgG, Qualitative by CIA (Target: Nucleocapsid Protein)Test: COVID-19 IgG, Qualitative by CIA (3002776)
Use for the qualitative detection of IgG antibodies against the nucleocapsid protein of SARS-CoV-2 that develop in response to natural infection with SARS-CoV-2 (COVID-19). These antibodies do not develop as a result of a COVID-19 vaccination. There are no current recommendations for assessing COVID-19 vaccine response.
COVID-19 IgG, Semi-Quantitative by CIA (Target: Spike Protein)
Test: COVID-19 IgG, Semi-Quantitative by CIA (3003648)
Use for the detection of IgG antibodies against the spike protein (S1) of SARS-CoV-2 that develop in response to natural infection with SARS-CoV-2 (COVID-19) or from a COVID-19 vaccination. There are no current recommendations for assessing COVID-19 vaccine response.
Vaccine-Induced Immune Thrombotic Thrombocytopenia
A rare syndrome of unusual thrombotic events with thrombocytopenia has been reported in a small number of patients following receipt of two SARS-CoV-2 vaccines (AstraZeneca and Johnson and Johnson/Janssen). For more information, please refer to the Vaccine-Induced Immune Thrombotic Thrombocytopenia Testing section in the ARUP Consult COVID-19 - SARS-CoV-2 topic.
- IDSA Diagnostic Guidelines
- Recommendations for molecular diagnostic tests
- IDSA Serologic Testing Guidelines
- Recommendations for serology tests
- CDC Overview of Testing for SARS-CoV-2
- Recommendations for viral and antibody testing
- AACC Antibody Testing Implementation and Interpretation Guidelines
- Guidelines for laboratories and clinicians on the implementation of serology testing
Refer to the COVID-19 Specimen Collection Guide for detailed information on specimen collection and transport media. In addition, healthcare provider fact sheets for the EUA SARS-CoV-2 NAA test offered by ARUP are available on the COVID-19 Test Fact Sheet, and specimens should be collected following the CDC’s Interim Guidelines for Collecting and Handling of Clinical Specimens for COVID-19 Testing. Healthcare providers also may find the following videos useful to help demonstrate specimen collection for SARS-CoV-2 testing.
An Interview with Dr. Kim Hanson: The Pandemic Year in Review
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