TEST CATALOG ORDERING & RESULTS SPECIMEN HANDLING CUSTOMER SERVICE EDUCATION & INSIGHTS
Test Catalog

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

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

Detection 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

Testing Algorithm Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

In response to the new Centers for Medicare and Medicaid Services (CMS) payment strategy for coronavirus disease 2019 (COVID-19) diagnostic testing, a bill-only code will be added for orders that meet the new CMS turn-around-time requirement. For additional information refer to www.cms.gov/newsroom/press-releases/cms-changes-medicare-payment-support-faster-covid-19-diagnostic-testing.

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) 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 infection. 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, symptoms maybe nonspecific and resemble other common respiratory tract infections, such as influenza. If testing for other respiratory tract pathogens is negative, specific testing for SARS-CoV-2 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 the specimen collected for testing. Result should be correlated with patient’s history and clinical presentation.

 

An "Indeterminate" result suggests that the patient may be infected with a variant SARS-CoV-2 or SARS-related coronavirus. Additional testing with an alternative molecular method may be considered if the patient does not have signs or symptoms of COVID-19.

 

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.

 

Sequence analyses have predicted that this assay will detect the circulating variants reported by the U.S. Centers for Disease Control and Prevention (www.cdc.gov/coronavirus/2019-ncov/more/science-and-research/scientific-brief-emerging-variants.html), such as the United Kingdom (B.1.1.7), South Africa (B.1.351), and Brazil (P.1) variants.

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 and oropharyngeal swab specimens.

 

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

 

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

 

Undetected (ie, negative) results do not rule out 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 the 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. Loeffelholz MJ, Tang YW: Laboratory diagnosis of emerging human coronavirus infections-the state of the art. Emerg Microbes Infect. 2020;9(1):747-756. doi: 10.1080/22221751.2020.1745095

3. Mohammadi A, Esmaeilzadeh E, Li Y, Bosch RJ, Li JZ: SARS-CoV-2 detection in different respiratory sites: a systematic review and meta-analysis. EBioMedicine. 2020 Sep;59:102903. doi: 10.1016/j.ebiom.2020.102903

4. Centers for Disease Control and Prevention. Overview of testing for SARS-CoV-2. 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