SARS-CoV-2 Infection Molecular rRT-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.: GTR000593288.2
- Last updated: 2021-07-14
- 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 PrimBio Research Institute
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
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 Coronavirus (SARS-CoV-2) Real Time RT-PCR Nucleic Acid Detection Kit is based on the PCR method, which uses primers to amplify three specific regions within the novel coronavirus (SARS-CoV-2) nucleocapsid protein N gene, and a fluorescent probe to detect amplification. The kit includes 3 primer-probe sets corresponding to those used in the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel (cat no. 2019-nCoVEUA-01). The oligonucleotide primers and probes for detection of SARS-CoV-2 RNA are designed for a multiplex assay that amplify and detect the N1 and N2 gene regions of the virus specific to SARS-CoV-2 RNA. An additional internal control and probe set detects the RNaseP in human nucleic acid to confirm that the amplification process has proceeded correctly. Virus from nasopharyngeal or nasal swabs are lysed to release encapsulated viral RNA and human DNA. The RNA from the virus is reverse transcribed to cDNA and subsequently amplified by multiplex PCR. In the process, the probe anneals to a specific target sequence located between the forward and reverse primers. During the extension phase of the PCR cycle, the 5' exonuclease activity of Taq polymerase degrades the probe, causing the reporter probe to separate from the quencher probe, generating a fluorescent signal which increases and is monitored with each PCR cycle.
Citations
Not provided
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