SARS-CoV-2 Semi-Quantitative IgG Antibody, Spike
Also known as: COVID-19, S protein, Severe Acute Respiratory Syndrome (SARS), Spike
Use
Qualitative and semi-quantitative detection of IgG antibodies to SARS-CoV-2 in human serum and plasma. This assay is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Samples should only be tested from individuals that are 15 days or more post symptom onset. IgG antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post-infection is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion.
Special Instructions
The FDA has emphasized that antibody testing should not be used to evaluate a person's immunity level or protection from COVID-19, especially after vaccination. More information is available on the FDA's website. Samples should not be tested if they have not been properly stored or if they show signs of contamination or deterioration.
Limitations
Negative results do not exclude SARS-CoV-2 infection, particularly in individuals with recent exposure to the virus. Testing too early during the infection may yield a negative result due to undetectable antibodies. There's also uncertainty regarding whether the presence of antibodies correlates with immune protection. Additionally, false positives may occur due to cross-reactivity from other antibodies.
Methodology
Immunoassay (CLIA)
Biomarkers
LOINC Codes
- 94563-4
- 94505-5
- 94661-6
Result Turnaround Time
1-3 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
0.5 mL
Minimum Volume
0.4 mL
Container
Gel-barrier tube or serum from red-top tube or serum transfer tube
Collection Instructions
Standard aseptic procedures
Patient Preparation
No special preparation required.
Storage Instructions
Room temperature
Causes for Rejection
Grossly hemolyzed or lipemic samples and samples containing particulate matter or exhibiting obvious microbial contamination
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 14 days |
| Refrigerated | 14 days |
| Frozen | 14 days |
