SARS-CoV-2 Total Nucleocapsid Antibody (IgG, IgA, and IgM) - Biorad 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.: GTR000593851.1
- Last updated: 2021-08-25
- Annual Review past due read more
- Test version history
- 593851.1, 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
Overview
Test name
HelpThe name the laboratory assigns the test. Used as the default title of the page specific to the test.SARS-CoV-2 Total Nucleocapsid Antibody (IgG, IgA, and IgM) - Biorad Assay
This is a clinical microbial test intended for HelpPurposes or indications for the test. Lab-provided.: Screening
Click Indication tab for more information.
Online through physician request drawn at the office or in one of our collection sites
CPT Code: 86769
Order URL HelpLink to the laboratory webpage with information about how to order this test. Please note that clicking on this link will open a new tab in your internet browser.: https://www.ksldx.com/covid-19-antibody-test
Specimen source
Turnaround time
24 -48 hoursMethodology
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
- Enzyme-Linked Immunosorbent Assays (ELISA)
Not provided
Clinical validity
HelpHow consistently and accurately the test detects or predicts the intermediate or final outcomes of interest. Lab-provided.Not provided
Comments about the test interpretation (e.g. clinical implication of test results)
SARS-Cov-2 total antibody assay detects IgM, IgG and IgA antibodies to nucleocapsid proteins of SARS-CoV-2 virus. A Positive result by this assay indicates recent or prior exposure to the virus. False positive results with may occur with this assay due to cross reactivity from pre-existing antibodies or other possible causes. A negative or equivocal finding does not preclude acute infection. If acute infection is suspected, direct testing for SARS-CoV-2 is indicated. Antibodies to SARS-CoV-2 are generally detectable in blood several days after infection, though the duration of time the antibodies are present post infection is not well characterized. It is unknown how long antibodies to SARS-CoV-2 will remain present in the blood after infection and it is not known if they confer immunity to infection. The positive percent agreement in 51 serum specimens collected between 2-42 days post onset of clinical symptoms compared to SARS-CoV-2 RT-PCR was 92.16% and negative percent agreement is 99.56% (Platelia SARS-CoV-2 Total Ab package insert, Bio-Rad Laboratories, Inc.). Another study reported a specificity and sensitivity of 97.4% and 94.9% for total antibodies using the adapted cut‐offs (≥ 0.8) with this assay (Tré-Hardy M, Wilmet A, Beukinga I, Favresse J, Dogné JM, Douxfils J, Blairon L. Analytical and clinical validation of an ELISA for specific SARS-CoV-2 IgG, IgA, and IgM antibodies. J Med Virol. 2021 Feb;93[2]:803-811).IMPORTANT NOTE: NIH does not independently verify information submitted to the GTR; it relies on submitters to provide information that is accurate and not misleading. NIH makes no endorsements of tests or laboratories listed in the GTR. GTR is not a substitute for medical advice. Patients and consumers with specific questions about a genetic test should contact a health care provider or a genetics professional.