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GTR Home > > SynergyDx SARS-CoV-2 RNA Test

Overview

Test name

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SynergyDx SARS-CoV-2 RNA Test

Purpose of the test

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This is a clinical microbial test intended for Help: Diagnosis

Condition

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How to order

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Not provided

Specimen source

Nasal swab

Sample requirements

The SynergyDx SARS-CoV-2 RNA Test is authorized for use with anterior nasal swab specimens that are self-collected using the SynergyDx Home Collection Kit for COVID-19 at home or in a healthcare setting by any individuals, 18 years of age and older, including individuals without symptoms or other reasons to suspect COVID-19, when determined to be appropriate by a healthcare provider. When using the SynergyDx Home Collection Kit for COVID-19, individuals must follow all specimen collection and mailing instructions provided with the kit, as described in the “SynergyDx Home Collection Kit for COVID-19 Kit Components,” and “SynergyDx Home Collection Kit for COVID-19 Shipping Instructions.”

Methodology

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Molecular Genetics
RRNA analysis
RT-PCR

Summary of what is tested

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Clinical utility

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Not provided

Clinical validity

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Not provided

Comments about the test interpretation (e.g. clinical implication of test results)

Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in anterior nasal swab specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.

Clinical resources

Practice guidelines

  • NICE, 2022
    UK NICE Guideline NG191, COVID-19 rapid guideline: managing COVID-19

Consumer resources

IMPORTANT NOTE: NIH does not independently verify information submitted to the GTR; it relies on submitters to provide information that is accurate and not misleading. NIH makes no endorsements of tests or laboratories listed in the GTR. GTR is not a substitute for medical advice. Patients and consumers with specific questions about a genetic test should contact a health care provider or a genetics professional.