SARS-CoV-2 Antibodies, Nucleocapsid
Also known as: COVID-19, SARS-CoV-2
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.
Special Instructions
Results should be complemented with epidemiological risk factors and other clinical findings. The assay enriches detection of higher affinity antibodies specific to the SARS-CoV-2 N protein. Note: This assay will not detect antibodies induced by currently available SARS-CoV-2 vaccines.
Limitations
The test is authorized for emergency use by the FDA but has not been cleared or approved. It is authorized under an Emergency Use Authorization (EUA) for the detection of antibodies against SARS-CoV-2, not other viruses. Negative results do not exclude infection, particularly following exposure to SARS-CoV-2. False positives may occur due to previous infection with other human coronaviruses or biotin interference. Testing too soon after exposure may yield negative results due to insufficient antibody development.
Methodology
Immunoassay (ECLIA)
Biomarkers
LOINC Codes
- 94762-2
- 94762-2
Result Turnaround Time
1-3 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
0.8 mL
Minimum Volume
0.7 mL
Container
Gel-barrier tube, red-top tube or serum transfer tube
Collection Instructions
Standard aseptic procedures
Storage Instructions
Room temperature
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 14 days |
| Refrigerated | 14 days |
| Frozen | 14 days |