A B C D E F G H I J K L M N O P Q R S T U V W X Y Z # |
SARS-CoV-2 Total Antibody, Spike, Semi-Quantitative
Test CodeLAB5211532
Quest Code
39820
CPT Codes
86769 <br /> <strong>To meet regulatory reporting requirements for COVID-19 testing, the patient's address, phone number and other demographic details are required for this order.</strong>
Preferred Specimen
1 mL serum
Minimum Volume
0.5 mL
Transport Temperature
Refrigerated (cold packs)
Specimen Stability
Room temperature: 72 hours
Refrigerated: 7 days
Frozen: 28 days
Refrigerated: 7 days
Frozen: 28 days
Methodology
Immunoassay (IA)
FDA Status
This test has been authorized by the FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories.
Setup Schedule
Sets up 7 days a week.
Report Available
Reports in 1 to 3 days.
Reference Range
<0.8 U/mL | Negative |
≥0.8 U/mL | Positive |
Clinical Significance
This test is intended as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2 (COVID-19), indicating recent or prior infection. The results of this semi-quantitative test should not be interpreted as an indication of degree of immunity or protection from reinfection.
Individuals who have been vaccinated with a SARS-CoV-2 spike or receptor-binding domain vaccine may be positive with this test; however, the clinical significance of a positive antibody result for individuals who have received a COVID-19 vaccine is unknown, in part because the test's performance characteristics have not been established for that population. It is not known how long antibodies persist following infection and if the presence of antibodies confers protective immunity. This assay should not be used to diagnose acute SARS-CoV-2 infection.
Individuals who have been vaccinated with a SARS-CoV-2 spike or receptor-binding domain vaccine may be positive with this test; however, the clinical significance of a positive antibody result for individuals who have received a COVID-19 vaccine is unknown, in part because the test's performance characteristics have not been established for that population. It is not known how long antibodies persist following infection and if the presence of antibodies confers protective immunity. This assay should not be used to diagnose acute SARS-CoV-2 infection.
Performing Laboratory
Quest Diagnostics Nichols Institute
33608 Ortega Highway
San Juan Capistrano, CA 92675-2042