GnomeDX RT-PCR COVID-19 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.: GTR000591321.4
Last updated: 2022-06-14
Test version history
- 591321.4, last updated: 2022-06-14
- 591321.3, last updated: 2020-09-30
- 591321.2, last updated: 2020-08-11
- 591321.1, last updated: 2020-08-10

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 Gnome Diagnostics, LLC

Performance Characteristics

Entire test performed in-house

These tests were developed and their performance characteristics determined and validated by Gnome Diagnostics, LLC, a CLIAcertified laboratory qualified to perform high-complexity testing. These are lab-developed tests (LDT) regulated by the Clinical Laboratory Improvement Act (CLIA) and are not required to obtain an FDA Emergency Use Authorization at this time. These tests have not been cleared or approved by the U.S. Food and Drug Administration (21 CFR §809.30[e]). A false negative result may occur if inadequate numbers of organisms are present in the specimen due to low viral load or improper collection, transport or handling of the specimen. Variability such as mismatches between primers and probes and the target sequences can result in diminished assay performance and possible false negative results. RNA viruses, in particular, show substantial genetic variability. This test utilizesassays that were designed and approved by the CDC.

Citations

Not provided

Is proficiency testing performed for this test? HelpWhether the test undergoes periodic internal or external evaluation of the accuracy of test results. Lab-provided.: Yes
Method used for proficiency testingHelpMethod used for external or internal evaluation of the accuracy of test results. Lab-provided.: Formal PT program
PT ProviderHelpProvider used for proficiency testing. Lab-provided.: College of American Pathologists, CAP

FDA Category Designation: Not Applicable

Reviews

Clinical resources

Practice guidelines

NICE, 2024
UK NICE Guideline NG191, COVID-19 rapid guideline: managing COVID-19, 2024
PAGAA, 2022
Guidance for COVID-19 and People With HIV, 2022

Consumer resources

MedlinePlus

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.

GnomeDX RT-PCR COVID-19 Test

Performance Characteristics

Availability

Analytical Validity

Citations

Proficiency Testing (PT)

FDA Regulatory Clearances of the Test

Reviews

Clinical resources

Practice guidelines

Consumer resources