SynergyDx SARS-CoV-2 RNA Test
- GTR Test IDHelpEach Test is a specific, orderable test from a particular laboratory, and is assigned a unique GTR accession number. The format is GTR00000001.1, with a leading prefix 'GTR' followed by 8 digits, a period, then 1 or more digits representing the version. When a laboratory updates a registered test, a new version number is assigned.: GTR000597242.1
- Last updated: 2021-12-21
- Annual Review past due read more
- Test version history
- 597242.1, last updated: 2021-12-21
Clinical microbial testHelpIn the U.S., clinical tests must be performed under CLIA certification. When a lab uses the same methods for a test in both clinical and research settings, the test appears as two separate GTR records. for COVID-19
Offered by Synergy Diagnostic Laboratory INC
Overview
Test name
HelpThe name the laboratory assigns the test. Used as the default title of the page specific to the test.SynergyDx SARS-CoV-2 RNA Test
This is a clinical microbial test intended for HelpPurposes or indications for the test. Lab-provided.: Diagnosis
Click Indication tab for more information.
Not provided
Specimen source
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
HelpThe assay's major method category (biochemical, cytogenetic or molecular genetics); method category (i.e. enzyme assay, chromosome breakage studies, targeted mutation analysis); methodology (i.e. the name of the method used) and instruments used when performing this test.- Molecular Genetics
- RRNA analysis
- RT-PCR
Not provided
Clinical validity
HelpHow consistently and accurately the test detects or predicts the intermediate or final outcomes of interest. Lab-provided.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.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.