2019 Novel Coronavirus (COVID-19), NAA

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.: GTR000597298.1
Last updated: 2022-01-20
Test version history
- 597298.1, last updated: 2022-01-20

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 Integrated Genetics – Sequenom

Performance Characteristics

Entire test performed in-house

Analytical Sensitivity: A dilution panel of virus spiked into 10 negative NP swab samples and 10 BAL wash samples was created at concentrations of 50cp/uL, 25 cp/uL, 12.5 cp/uL, 6.25 cp/uL, 3.125 cp/uL, and 1.25 cp/uL. These results establish an LOD of 6.25 for this assay (19/20 positive). Additionally, as part of the original EUA validation study, 5 positive and 5 negative samples from production runs were sent to the North Carolina Department of Health (NCDOH) and tested on the CDC assay. All results were concordant Analytical Specificity: Specificity is not applicable formal experimentation in this validation plan. Since COVID-19 RT-PCR is an FDA-cleared assay under the EUA statutory authority, specificity information may be taken from the FDA-submission. Accuracy: 278/279 (99.64%) of previously resulted negative samples showed concordant results. 38/39 (97.43%) of previously positive samples showed concordant results.

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.: No

Not provided

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

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2019 Novel Coronavirus (COVID-19), NAA

Performance Characteristics

Availability

Analytical Validity

Citations

Proficiency Testing (PT)

FDA Regulatory Clearances of the Test

Reviews

Clinical resources

Practice guidelines

Consumer resources