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HelpTest ID VCOV2 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) IgG Antibody, Serum
Advisory Information
Molecular testing is the recommended for diagnosis of coronavirus disease 2019 (COVID-19) in symptomatic patients. For more information see:
-COVID / Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) RNA Detection, Varies
-SARS2 / Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) RNA, Varies
For the most up-to-date COVID-19 epidemiology and testing recommendations, visit
https://www.cdc.gov/coronavirus/2019-ncov/index.html
Necessary Information
1. Patient’s race and ethnicity, as well as collection date, are required.
2. If ordering electronically, answers must be provided for the order entry questions.
3. If not ordering electronically, patient race and ethnicity must be provided on the request form.
Specimen Required
Patient Preparation: For 24 hours before specimen collection do not take multivitamins or dietary supplements containing biotin (vitamin B7), which is commonly found in hair, skin, and nail supplements and multivitamins.
Supplies: Aliquot Tube, 5 mL (T465)
Collection Container/Tube: Serum gel
Submission Container/Tube: Plastic vial
Specimen Volume: 2 mL
Collection Instructions:
1. Centrifuge blood collection tube per collection tube manufacturer's instructions (eg, centrifuge and aliquot within 2 hours of collection for BD Vacutainer tubes).
2. Aliquot serum into plastic vial.
Useful For
Detection of IgG-class antibodies against severe acute respiratory syndrome coronavirus 2, agent of coronavirus disease 2019 (COVID-19)
Method Name
Chemiluminescence Immunoassay
Reporting Name
SARS-CoV-2 IgG Ab, SSpecimen Type
SerumSpecimen Minimum Volume
0.5 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum | Refrigerated (preferred) | 7 days | |
| Frozen | 30 days | ||
| Ambient | 24 hours |
Clinical Information
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a positive-sense, single-stranded RNA virus that causes coronavirus disease 2019 (COVID-19). Like other coronaviruses that infect humans, SARS-CoV-2 can cause both upper and lower respiratory tract infection. Symptoms can range from mild (ie, the common cold) to severe (ie, pneumonia) in both healthy and immunocompromised patients. SARS-CoV-2 transmission occurs primarily via respiratory droplets. During the early stages of COVID-19, symptoms maybe nonspecific and resemble other common respiratory tract infections, such as influenza.
The incubation period for COVID-19 ranges from 5 to 7 days. Typically, immunocompetent individuals with COVID-19 develop detectable IgG-class antibodies against SARS-CoV-2 approximately 8 to 11 days following onset of symptoms. Patients tested prior to this time may be negative for SARS-CoV-2 IgG antibodies.
Reference Values
Negative
Interpretation
Negative: No IgG antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) detected. Negative results may occur in serum collected too soon following infection, in immunosuppressed patients, or in some individuals with prior mild illness. Follow-up testing with a molecular test is recommended in symptomatic patients. This test should not be used to exclude active/recent coronavirus disease 2019 (COVID-19).
Positive: SARS-CoV-2 IgG antibodies detected. Results suggest recent or prior infection with SARS-CoV-2. Correlation with epidemiologic risk factors and other clinical and laboratory findings is recommended. Serologic results should not be used to diagnose recent SARS-CoV-2 infection. Protective immunity cannot be inferred based on these results alone. Infrequently, false-positive results may be due to prior infection with other human coronaviruses.
Clinical Reference
1. Okba N, Muller MA, Li W, et al: Severe acute respiratory syndrome coronavirus 2-specific antibody responses in coronavirus disease 2019 patients. Emerg Infect Dis. 2020 Apr 8;26(7). doi: 10.3201/eid2607.200841
2. Amanat F, Stadlbauer D, Strohmeier S, et al: A serologic assay to detect SARS-CoV-2 seroconversion in humans. Nat Med. 2020;26(7):1033-1036. doi:10.1038/s41591-020-0913-5
3. Liu L, Liu W, Wang S, Zheng S: A preliminary study on serological assay for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in 238 admitted hospital patients. Microbes Infect. 2020;22(4-5):206-211. doi:10.1016/j.micinf.2020.05.008
4. Zhang W, Du RH, Li B, et al: Molecular and serologic investigation of 2019-nCoV infected patients: implication of multiple shedding routes. Emerg Microbes Infect. 2020 Feb 17;9(1):386-389. doi: 10.1080/22221751.2020.1729071
Day(s) and Time(s) Performed
Monday through Saturday; Varies
Analytic Time
Same day/1 dayTest Classification
This test has received Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.CPT Code Information
86769
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| VCOV2 | SARS-CoV-2 IgG Ab, S | 94563-4 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| VSARS | SARS-CoV-2 IgG Ab, S | 94563-4 |
| SRACE | Patient's Race | 72826-1 |
| SETHN | Patient's Ethnicity | 69490-1 |
Forms
If not ordering electronically, complete, print, and send a General Request (T239) with the specimen.