Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) RNA Detection, PCR, Varies
- 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.: GTR000592499.2
- Last updated: 2021-07-14
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- 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 COVID-19
Offered by Clinical Microbiology
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-PCR
- Cobas® 6800 / 8800 System
- Cobas® SARS-CoV-2 Test
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.The cobas SARS-CoV-2 assay is a TaqMan probe-based, real-time, reverse transcription polymerase chain reaction (PCR) assay designed for qualitative detection of 2019 novel coronavirus (SARS-CoV-2) RNA from human nasopharyngeal and oropharyngeal swabs processed on the fully automated cobas 6800 system. Clinical samples undergo automated sample preparation (nucleic acid extraction and purification), during which viral nucleic acid in patient samples and added internal control RNA (RNA IC) molecules are simultaneously extracted. Nucleic acid is released by the addition of proteinase and lysis reagent to the sample. The released nucleic acid binds to the silica surface of the added magnetic glass particles. Unbound substances and impurities, such as denatured protein, cellular debris and potential PCR inhibitors, are removed with subsequent wash steps and purified nucleic acid is eluted from the magnetic glass particles with elution buffer at elevated temperature. External controls (positive and negative) are processed in the same way in each assay run.
Using target-specific primers and probes, this assay amplifies and detects both the ORF1ab (nonstructural protein) sequence of SARS-CoV-2 and the E gene (structural envelope protein) sequence of Sarbecovirus group. Samples containing SARS-CoV-2 should generate positive results for both targets by this assay.(Package insert: cobas SARS-CoV-2 -Qualitative assay for use on the cobas 6800 / 8800 Systems. Roche Diagnostics; Doc Rev. 2.0 04/2020)
Citations
Not provided
- NICE, 2024UK NICE Guideline NG191, COVID-19 rapid guideline: managing COVID-19, 2024
- PAGAA, 2022Guidance for COVID-19 and People With HIV, 2022
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