SARS-CoV-2 IgG, Nucleocapsid
Order Name
CoV2 IgG NucCap
Test Number: 6901550
Revision Date 12/15/2023
Test Number: 6901550
Revision Date 12/15/2023
| Test Name | Methodology | LOINC Code |
|---|---|---|
|
SARS-CoV-2 IgG, Nucleocapsid
|
Chemiluminescent Micropartical Immunoassay | 94507-1 |
| SPECIMEN REQUIREMENTS | ||||
|---|---|---|---|---|
| Specimen | Specimen Volume (min) | Specimen Type | Specimen Container | Transport Environment |
| Preferred | 2 mL (0.7 mL) | Serum | Clot Activator SST | Room Temperature |
| Instructions | Stability: Ambient 14 days; Refrigerated 14 days; Frozen 14 days, (Freeze if testing will be delayed more than 14 days Freeze/thaw cycles Stable x3) Minimum Volume 0.7 mL (Note: This volume does not allow for repeat testing.) |
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| GENERAL INFORMATION | |
|---|---|
| Expected TAT | 2-4 Days |
| Clinical Use | Qualitative detection of high affinity antibodies to SARS-CoV-2 nucleocapsid (N) protein, the virus that causes COVID-19, to aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Note: This assay will not detect antibodies induced by currently available SARS-CoV-2 vaccines. This assay enriches detection of higher affinity antibodies which are more likely to be specific for SARS-CoV-2 N protein. While this assay in principle can detect high affinity antibodies of all isotypes (i.e., IgG, IgA, IgM), it preferentially detects IgG antibodies since these are more likely to evolve to become high affinity. Serologic results should not be used as the sole basis to diagnosis or exclude recent SARS-CoV-2 infection. This test is recommended for individuals at greater than or equal to 14 days post-symptom onset or following exposure to individuals with confirmed COVID-19.The incubation period for COVID-19 ranges from 5 to 7 days. |
| Notes | This test has not been FDA cleared or approved. This test has been authorized by FDA under an Emergency Use Authorization (EUA). This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. This test has been authorized only for detecting the presence of antibodies against SARS-CoV-2, not for any other viruses or pathogens. Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals. Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. False positive results infrequently occur due to prior infection with other human Coronaviruses. Note: This assay will not detect antibodies induced by currently available SARS-CoV-2 vaccines. |
| CPT Code(s) | 86769 |
| Internal Comments | 05/22/20 Removed EDTA plasma alternate container (Ticket 730264) - SN 3/29/21 old clin use - JK - Detects IgG Nucleocapsid Antibodies against the 2019 novel coronavirus (SARS-CoV-2/COVID-19) to evaluate exposure. This test should not be used for screening of donated blood. 4/2/21 changed mnemonic - JK from SARS-CoV-2 IgG to CoV2 IgG NucCap 12/19/23 old clinical info: Labcorp Oklahoma, Inc. has initiated two assays for the semi-quantitative detection of IgG antibodies to the COVID 19 nucleocapsid and a second to the COVID 19 spike protein. The IgG antibodies to the nucleocapsid can only come about following a SARS-CoV-2 infection. IgG antibodies to the spike protein will follow an infection and/or a vaccination with a spike initiating vaccine. The assays will be valuable in discerning as to whether the patient has or has not had a COVID 19 infection or a vaccination. The semi-quantitative values will be important to determine the degree of antibody activity in seroconversion as well as following the status of the levels of antibody activity over time. They will be available in two formats. One is the COVID 19 IgG anti-spike and the other is COVID 19 IgG anti-nucleocapsid. The results will be reported as a relative value (i.e. positive or negative) as well as a semi-quantitative value. Testing for IgG Nucleocapsid antibody to the novel Coronavirus (SARS-CoV-2/COVID-19) performed at Labcorp Oklahoma, Inc. Central Lab |
| Service Provided By |  |
| Lab Section | Reference Lab |