qGenomics qCovid-19 (SARS-CoV-2) RT-PCR 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.: GTR000594010.1
- Last updated: 2021-09-03
- Annual Review past due read more
- Test version history
- 594010.1, last updated: 2021-09-03
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 Quantitative Genomic Medicine Laboratories, SL
Overview
Test name
HelpThe name the laboratory assigns the test. Used as the default title of the page specific to the test.qGenomics qCovid-19 (SARS-CoV-2) RT-PCR test
This is a clinical microbial test intended for HelpPurposes or indications for the test. Lab-provided.: Diagnosis
Click Indication tab for more information.
Not provided
Specimen source
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-qPCR
Not provided
Clinical validity
HelpHow consistently and accurately the test detects or predicts the intermediate or final outcomes of interest. Lab-provided.Not provided
Comments about the test interpretation (e.g. clinical implication of test results)
The qGenomics qCOVID-19 RT-PCR Test is based on the molecular method of real-time RT-PCR. It is intended for the qualitative detection of the presence of RNA of the virus that causes severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 or 2019-nCoV) responsible for the coronavirus disease 2019 (COVID-19) pandemic. The detection is carried out in biological samples obtained from the respiratory tract of individuals suspected of having COVID-19. SARS-CoV-2 RNA is generally detectable in the respiratory tract during the acute phase of infection. A positive result indicates the presence of SARS-CoV-2 RNA, however correlation is necessary with the patient's history and other diagnostic information to determine the patient's infection status. A positive result does not rule out a bacterial infection or co-infection with other viruses. The pathogen detected may not be the definitive cause of the disease. A negative result does not exclude the possibility of SARS-CoV-2 infection and should not be used as the only evidence for diagnosis, treatment, or other decisions regarding patient management. By virtue of the ministerial provision published in the BOE of April 14, 2020, prescription of diagnostic tests to detect COVID-19 must be prescribed by a physician in accordance with the guidelines, instructions, and criteria agreed for this purpose by the competent health authority [Spain Order SND / 344/2020, of April 13, which establishes exceptional measures to strengthen the National Health System and contain the health crisis caused by COVID-19. Official State Gazette, April 14, 2020, no. 104, pp. 28956 to 28958]. Likewise, SARS-CoV-2 is a microorganism with a mandatory microbiological declaration in the framework of the Microbiological Notification System of Catalonia (Decree 203/2015). Said notification is made to the Subdirectorate of Surveillance and Response to Public Health Emergencies of the Department of Health of the Generalitat de Catalunya Methodology.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.