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
Methodology
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
Test development
HelpHow the test was developed (e.g. Laboratory Developed Test (LDT), FDA reviewed, externally manufactured kit, modified FDA-reviewed test, or combination). Intended to help differentiate certification requirements between the test types. Reflex testing not included here.Not provided
Test procedure
HelpSummary of the test methodology and/ or description of the specific steps for each method used in this assay.SARS-CoV-2 nucleic acid is first extracted, isolated and purified from anterior nasal swab specimens. The purified nucleic acid is then reverse transcribed into cDNA followed by PCR amplification and detection using real-time (RT) PCR. The SynergyDx SARS-CoV-2 RNA Test uses the following controls: nCoV Internal Control (IC) – bacteriophage MS2 - monitors the integrity of nucleic acid extraction and RT-PCR for each specimen; nCoV Positive Control - SARS-CoV-2 RNA fragments capsulated in bacteriophage - monitors the integrity of the RT-PCR reagents; nCoV Negative Control - TE buffer - monitors for contamination of reagents and carryover during RNA extraction and RT-PCR; Extraction Control – targeting human RNase P (RP) mRNA – run on all specimens collected using the SynergyDx Home Collection Kit for COVID-19 - controls for specimen quality and demonstrates that nucleic acid was generated by the extraction process.
Citations
Not provided
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