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Test Catalog

Test ID: SARS2    
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) RNA, Varies

Useful For Suggests clinical disorders or settings where the test may be helpful

Diagnosis of coronavirus disease 2019 (COVID-19) illness due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)

 

Recommended only for patients who meet current clinical and/or epidemiologic criteria defined by federal, state, or local public health directives: www.cdc.gov/coronavirus/2019-nCoV/hcp/clinical-criteria.html

Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus is a positive-sense, single-stranded RNA virus that causes coronavirus disease 2019 (COVID-19). Like other coronaviruses that infect humans, SARS-CoV-2 can cause both upper and lower respiratory tract illness. Symptoms can range from mild (ie, the common cold) to severe (ie, pneumonia) in both healthy and immunocompromised patients. SARS-CoV-2 transmission occurs primarily via respiratory droplets. During the early stages of COVID-19 disease, the symptoms maybe nonspecific and resemble other common respiratory infections, such as influenza. If testing for other respiratory infections is negative, specific testing for SARS-CoV-2 (COVID-19) may be warranted.

 

SARS-CoV-2 is likely to be at the highest concentrations in the nasopharynx during the first 3 to 5 days of symptomatic illness. As the disease progresses, the viral load tends to decrease in the upper respiratory tract, at which point lower respiratory tract specimens (eg, sputum, tracheal aspirate, bronchoalveolar fluid) would be more likely to have detectable SARS-CoV-2.

Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Undetected

Interpretation Provides information to assist in interpretation of the test results

A Detected result indicates that severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA is present and suggests the diagnosis of coronavirus disease 2019 (COVID-19). Test result should always be considered in the context of patient's clinical history, physical examination, and epidemiologic exposures when making the final diagnosis.

 

An Undetected result indicates that SARS-CoV-2 is not present in the patient's specimen. However, this result may be influenced by the stage of the infection, quality and type of specimen collected for testing. Result should be correlated with patient’s history and clinical presentation.

 

An Inconclusive result indicates that the presence or absence of SARS-CoV-2 RNA in the specimen could not be determined with certainty after repeat testing in the laboratory, possibly due to RT-PCR inhibition. Submission of a new specimen for testing is recommended.

Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

The FDA has provided emergency use authorization (EUA) of this test for testing human nasopharyngeal, oropharyngeal (throat), and nasal swab specimens. The assay is adapted to test lower respiratory tract specimens, such as bronchial washing, bronchoalveolar lavage (BAL) fluid.

 

The sensitivity of the assay is dependent on the timing of the specimen collection (in relation to symptom onset), quality and type of specimen submitted.

 

The test is specific for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2); therefore, the results do not exclude the possibility of infection with other respiratory viruses.

 

Undetected (ie, negative) results do not rule out coronavirus disease 2019 (COVID-19) in patients and should not be used as the sole basis for treatment or other patient management decisions. Result should be correlated with patient’s history and clinical presentation.

Clinical Reference Recommendations for in-depth reading of a clinical nature

1. Zhu N, Zhang D, Wang W, et al: A novel coronavirus from patients with pneumonia in China, 2019. N Engl J Med 2020;382(8):727-733 doi: 10.1056/NEJMoa2001017

2. Holshue M, DeBolt C, Lindquist S, et al: First Case of 2019 Novel Coronavirus in the United States. N Engl J Med 2020 Jan 31 doi: 10.1056/NEJMoa2001191

3. Loeffelholz MJ, Tang YW: Laboratory diagnosis of emerging human coronavirus infections-State of the art. Emerg Microbes Infect. 2020 (published ahead of print) doi.org/10.1080/22221751.2020.1745095

4. Centers for Disease Control and Prevention. Evaluating and testing persons for Coronavirus Disease 2019 (COVID-19). Available at www.cdc.gov/coronavirus/2019-nCoV/hcp/clinical-criteria.html

5. Food and Drug Administration. FAQs on diagnostic testing for SARS-CoV-2. Available at www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2

Special Instructions Library of PDFs including pertinent information and forms related to the test