Inform Diagnostics V2.0 SARS-CoV-2 RT-PCR assay
- 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.: GTR000593114.2
- Last updated: 2021-07-14
- Annual Review past due read more
- Test version history
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 Inform Diagnostics
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
- Applied Biosystems™ 7500 real-time PCR system
- ViralXPress
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.Test developed by laboratory (no manufacturer test name)
Test procedure
HelpSummary of the test methodology and/ or description of the specific steps for each method used in this assay.RNA extraction is performed manually using ViralXpress. PCR Reagent Kit used is IDT (multiplex).
Citations
Not provided
- NICE, 2024UK NICE Guideline NG191, COVID-19 rapid guideline: managing COVID-19, 2024
- PAGAA, 2022Guidance for COVID-19 and People With HIV, 2022
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.