Respiratory Pathogen Panel
- 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.: GTR000593026.5
- Last updated: 2023-07-13
- Test version history
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 Mycoplasma pneumoniae pneumonia
Offered by NxGen MDx
Methodology
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
Test comments
HelpAdditional details about the test. E.g., 'Bi-directional sequencing of exons 1-5 with concurrent analysis of Glu234Gly'.DNA is isolated from the sample and array-based qPCR assays simultaneously detect bacterial and viral_x000D_ respiratory pathogens. The qPCR data is interpreted using an algorithm developed at NxGen MDx, and the detected presence and/or absence of microbia is reported.
Array-based qPCR assays are used to detect common molecular antibiotic resistance markers. The qPCR data is interpreted using an algorithm developed at NxGen MDx, and the detected presence and/or absence antibiotic resistance markers is reported. Azole antifungal resistance,_x000D_ tetracycline antibiotic resistance, nitrofuran antibiotic resistance, and antiviral resistance are not detected by_x000D_ this assay.
Test development
HelpHow the test was developed (e.g. Laboratory Developed Test (LDT), FDA reviewed, externally manufactured kit, modified FDA-reviewed test, or combination). Intended to help differentiate certification requirements between the test types. Reflex testing not included here.Not provided
Test procedure
HelpSummary of the test methodology and/ or description of the specific steps for each method used in this assay.Nucleic acids are isolated from the sample and RT-qPCR assays detect SARS-CoV-2 (COVID-19) at analytical sensitivity and specificity >99%. The RT-qPCR data is interpreted as negative if no viral markers are detected and all controls perform as expected, including the exogenous extraction control for that sample. The data is interpreted as positive if two of three viral markers are detected and controls perform as expected. The detected presence or absence of virus is reported.
Citations
Not provided
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