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

Performance Characteristics

Entire test performed in-house

Technical validation of the assay in the qGenomics laboratory has shown that it is capable of detecting between 1 and 4.5 copies of the N1 and N2 regions of the SARS-CoV-2 virus per µL of viral transport medium, which is equivalent to less than 7.5 virus copies per µL in the RT-PCR reaction. Validation tests with clinical samples resulted in 100% sensitivity and specificity. In comparison with independently diagnosed samples, a positive concordance of 100% was observed and a negative agreement was also 100%. The sequences of primers and probes used are those recommended by the CDC. In silico analysis of the same shows that there are no significant homologies (greater than 80%) or with the genome human, nor with any of the thousands of genomes of other coronaviruses or human respiratory microflora, which guarantees zero cross-reactivity of the assays to detect the novel coronavirus 2019 (2019-nCoV). Likewise, this analysis revealed a percentage of identity of 100% in the searches on the alternative sequences of the different publicly available SARS-CoV-2 strains. This ensures that the probe and / or oligonucleotide probe combinations used in the qCOVID-19 RT-PCR assay, will allow the safe detection of any of the known strains.

https://www.fda.gov/media/134922/download

Citations

https://www.fda.gov/media/134922/download
https://www.fda.gov/media/134922/download

Is proficiency testing performed for this test? HelpWhether the test undergoes periodic internal or external evaluation of the accuracy of test results. Lab-provided.: No

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.

qGenomics qCovid-19 (SARS-CoV-2) RT-PCR test

Performance Characteristics

Availability

Analytical Validity

Citations

Proficiency Testing (PT)

FDA Regulatory Clearances of the Test

Reviews

Clinical resources

Practice guidelines

Consumer resources