SARS-CoV-2 Semi-Quantitative Total Antibody, Spike
Also known as: SARS-CoV-2 Antibody Titer
Use
Qualitative and semi-quantitative detection of antibodies to SARS-CoV-2 spike protein receptor binding domain (RBD). Aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time it is unknown how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The performance of this test has not been established in individuals that have received a COVID-19 vaccine. The clinical significance of a positive or negative antibody result following COVID-19 vaccination has not been established and the result from this test should not be interpreted as an indication or degree of protection from infection after vaccination.
Special Instructions
The FDA has issued a safety communication emphasizing that antibody tests should not be used to determine a person's immunity level or protection against COVID-19, especially after vaccination. It is crucial to visit the FDA's website for more information on this matter.
Limitations
This test is not designed to diagnose or exclude acute SARS-CoV-2 infection. Results should be evaluated alongside the patient's medical history and clinical presentation. A negative result does not rule out SARS-CoV-2 infection, especially during the early phase of infection when seroconversion may not have occurred. Additionally, some patients with confirmed infections may not develop detectable antibodies. Antibody titers may decline over time, as observed with other coronaviruses. This test has only been authorized by the FDA under an Emergency Use Authorization (EUA) for detecting antibodies against SARS-CoV-2.
Methodology
Immunoassay (ECLIA)
Biomarkers
LOINC Codes
- 94769-7
- 94769-7
- 94661-6
Result Turnaround Time
1-3 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
1.5 mL
Minimum Volume
0.7 mL
Container
Gel-barrier tube, red-top tube, or serum transfer tube, or plasma from lithium heparin tube, EDTA, or sodium citrate tube
Storage Instructions
Store at room temperature for up to 14 days, refrigerated for up to 14 days, and frozen for up to 28 days (stable through three freeze/thaw cycles).
Causes for Rejection
Gross hemolysis; visible microbial contamination
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 14 days |
| Refrigerated | 14 days |
| Frozen | 28 days |