SARS-CoV-2 Antibody Profile, Nucleocapsid and Spike
Also known as: SARS-CoV-2
Use
To evaluate for evidence of previous SARS-CoV-2 infection in individuals with a history of COVID-19 vaccination to aide in the diagnosis of Multisystem Inflammatory Syndrome in children (MIS-C) or adults (MIS-A). The presence of antibodies specific to the SARS-CoV-2 viral nucleocapsid protein is consistent with natural infection as currently available COVID-19 vaccines induce antibodies against the viral spike protein receptor binding domain (RBD) only.
Special Instructions
Not provided.
Limitations
These tests should not be used to diagnose or exclude acute SARS-CoV-2 infection. Results should be assessed alongside patient's medical history and other clinical findings. Negative results do not rule out the possibility of SARS-CoV-2 infection, especially in pre-seroconversion phases. Some patients may not develop antibodies even after confirmed infection. Antibody titers may wane within months post-infection. The test is authorized under FDA EUA but not cleared or fully approved. It is authorized for detecting antibodies against SARS-CoV-2 only, not for other pathogens.
Methodology
Immunoassay (ECLIA)
Biomarkers
SARS-CoV-2 Nucleocapsid
ProteinSARS-CoV-2 Spike
Protein
LOINC Codes
- 94504-8 - SARS-CoV-2 Ab Pnl SerPl IA
- 94762-2 - SARS-CoV-2 Ab SerPl Ql IA
- 94769-7 - SARS-CoV-2 Ab SerPl IA-aCnc
- 94661-6 - SARS-CoV-2 Ab SerPl-Imp
Result Turnaround Time
1-3 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
2.3 mL
Minimum Volume
1.4 mL
Container
Gel-barrier tube, red-top tube, or serum transfer tube; or plasma from lithium heparin tube, EDTA, or sodium citrate tube
Collection Instructions
Standard aseptic technique
Storage Instructions
Room temperature
Causes for Rejection
Gross hemolysis; visible microbial contamination
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 14 days |
| Refrigerated | 14 days |
| Frozen | 28 days |
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