DiaSorin LIAISON® SARS-CoV-2 S1/S2 IgG 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.: GTR000593429.1
- Last updated: 2021-07-21
- Annual Review past due read more
- Test version history
- 593429.1, last updated: 2021-07-21
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 Mako Medical Laboratories
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.- Serology
- OAntibody assay
- Chemiluminescent Immunoassay (CIA)
- LIAISON® XL Analyzer (DiaSorin, Inc.)
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 method for qualitative determination of IgG anti-S1 and IgG anti-S2 specific antibodies to SARS-CoV-2 is an indirect chemiluminescence immunoassay (CLIA). The specific recombinant S1 and S2 antigens are used for coating magnetic particles (solid phase) and mouse monoclonal antibodies to human IgG are linked to an isoluminol derivative (isoluminol-antibody conjugate). During the first incubation, the SARS-CoV-2 IgG antibodies present in calibrators, samples, or controls bind to the solid phase through the recombinant S1 and S2 antigens. During the second incubation, the antibody conjugate reacts with IgG to SARS-CoV-2 already bound to the solid phase. After each incubation, the unbound material is removed with a wash cycle. Subsequently, the starter reagents are added and a flash chemiluminescence reaction is thus induced. The light signal, and hence the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is indicative of the presence of IgG to SARS-CoV2 in calibrators, samples, or controls.
Citations
Not provided
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