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
- 593115.2, last updated: 2021-07-14
- 593115.1, last updated: 2021-05-19

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

Indication

This is a clinical microbial test intended for HelpPurposes or indications for the test. Lab-provided.: Diagnosis, Screening

An acute infection of the respiratory tract that is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Based on currently available information, SARS-CoV-2 is thought to mainly spread from person to person through respiratory droplets. Typically, there is a two- to 14-day incubation period and infected persons can present with no symptoms or mild to severe fever, dry cough, fatigue, and difficulty breathing. Dysgeusia, anosmia, and gastrointestinal and flu-like symptoms have also been reported. Older adults and persons of any age who have serious underlying medical conditions may be of higher risk for severe illness, including secondary infections, respiratory failure, and multi-organ dysfunction. [from NCI]

Conditions tested

Symptomatic / asymptomatic patients with confirmed/possible exposure to COVID-19, screening of patients for pre-op testing, patients with personal history of COVID-19

Citations

Not provided

Positive and negative predictive values (PPV and NPV)

PPV: 100%, NPV: 100%

Not provided

Reviews

Clinical resources

Practice guidelines

NICE, 2024
UK NICE Guideline NG191, COVID-19 rapid guideline: managing COVID-19, 2024

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.

Inform Diagnostics V3.0 SARS-CoV-2 RT-PCR assay

Indication

Clinical summary