Inform Diagnostics V3.0 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.: GTR000593115.2
- 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
Overview
Test name
HelpThe name the laboratory assigns the test. Used as the default title of the page specific to the test.Inform Diagnostics V3.0 SARS-CoV-2 RT-PCR assay
This is a clinical microbial test intended for HelpPurposes or indications for the test. Lab-provided.: Diagnosis, Screening
Click Indication tab for more information.
Applies to CPT codes: u0003, u0005
Order URL HelpLink to the laboratory webpage with information about how to order this test. Please note that clicking on this link will open a new tab in your internet browser.: https://www.informdx.com/wp-content/uploads/Inform-Dx-COVID-19-Test-Requisition.pdf
Specimen source
Sample requirements
Saliva or Swab Specimen. Saliva Specimens - Important for Saliva Specimens: do not eat, drink, smoke, vape, or chew gum for 30 minutes before saliva specimen collection; Volume for Saliva - Fill with saliva as indicated on package. Swab Specimen - nasopharyngeal or oropharyngeal specimen, in transport vial containing viral transport media (such as UTM® or UVT®) or sterile saline; Volume for Swab - 1 mL. Shipping requirements: Store at 2–8°C and ship overnight on ice pack, or store frozen at -70°C and ship overnight on dry ice. Special Notes: Multiple Swabs or Saliva Specimens from the same patient can be combined in a single vial for testing. Each specimen vial should be enclosed in a biohazard bag, then placed in the 95kPa Transport Bag (if using our provided kit) to avoid leakage during transportation, then securely seal the front pocket of the bag by peeling away the white tape and folding the adhesive down to cover the opening. Each specimen requires a separate requisition; for safety, place the requisition OUTSIDE of the specimen bag(s). Criteria for rejection: Specimen container is unlabeled/mislabeled; Specimen collected using calcium alginate tips, swabs with preservatives, or cotton swabs with wooden shafts; Specimen stored at 4°C received more than 72 hours after collection; Broken or leaking containers; Improper transportation conditions, per instructions aboveTurnaround time
2 daysMethodology
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
- MagMAX™ Viral/Pathogen II nucleic acid isolation kit
Not provided
Clinical validity
HelpHow consistently and accurately the test detects or predicts the intermediate or final outcomes of interest. Lab-provided.Not provided
Positive and negative predictive values (PPV and NPV)
PPV: 100%, NPV: 100%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.