COVID 19 Antibodies for IgG, IgA, and IgM - KSL Chemiluminescence Assay
- 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.: GTR000593853.1
- Last updated: 2021-08-25
- Annual Review past due read more
- Test version history
- 593853.1, last updated: 2021-08-25
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 KSL Diagnostics
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)
Test comments
HelpAdditional details about the test. E.g., 'Bi-directional sequencing of exons 1-5 with concurrent analysis of Glu234Gly'.This test has been approved by the New York State Department of Health (NYSDOH).
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 SARS-CoV-2 (chemiluminescence immunoassay) is a two-step indirect immunoassay. Samples are incubated with a magnetic bead that is coated with structural protein (S1 domain) from SARS-CoV-2. After all unbound materials are washed away by magnetic separation, the acridinium ester marker is added for incubation. Following a wash step, SARS-CoV-2 antibodies are detected with a substrate that produces a luminescence reaction with the acridinium ester. Individual IgA, IgG, or IgM antibodies are detected with individual conjugates. Luminescence intensity of acridinium ester is proportionate to the amount of antibody against novel coronavirus. The test result is expressed by critical value index (COI).
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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