Severe Acute Respiratory Syndrome

Coronavirus 2 (SARS-CoV-2) RNA Detection

COVID – Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) RNA Detection, Varies

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


Advisory Information

Due to the non-specific clinical presentation of coronavirus disease (COVID-19) during the early stages of illness, testing for other respiratory tract infections (eg, influenza) may be warranted.


Highlights

This test provides qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA from select upper and lower respiratory tract specimens from patients under investigation (PUI) for coronavirus disease 2019 (COVID-19). Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR)

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 may be 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.


Interpretation

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 results should always be considered in the context of a 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. Results should be correlated with the 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 is recommended on a new collection specimen.

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

The FDA has provided emergency use authorization (EUA) of this test for testing human nasopharyngeal and oropharyngeal 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 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. Results should be correlated with the patient’s history and clinical presentation.

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