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SARS-CoV-2 IgG (Spike protein)
Alternate Name: COVID-19 IgG
| Covid Antibodies
SAL Code:
2019
CPT:
86769
Loinc:
94563-4
Turn Around Time:
1 Day
Setup:
Daily
Department:
SARS-CoV-2 IgG
Performing Laboratory:
Sherman Abrams Laboratory
Methodology:
Chemiluminescent Immunoassay (CLIA)
Specimen Requirements:
Primary Tube:
SST
Primary Substance:
Serum
Alternate Sample Info:
Lavender (EDTA); Green Top (Lithium Heparin)
Temperature
Period
Stable Ambient:
1 Day
Stable Fridge:
7 Days
Stable Frozen:
30 Days
Rejection Criteria:
Gross hemolysis; improper labeling
Clinical Info:
This test is a chemiluminescent immunoassay (CLIA) intended for the qualitative and semi-quantitative detection of IgG antibodies to SARS-CoV-2 in human serum, and plasma (lithium heparin and dipotassium EDTA). The test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.
At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. This test should not be used to diagnose or exclude acute SARS-CoV-2 infection.
Results are for the detection of SARS CoV-2 antibodies. 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.
Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS CoV-2 is necessary (SAL Test # 2018). False positive results may occur due to cross-reactivity from pre-existing antibodies or other possible causes. Samples should only be tested from individuals that are 15 days or more post symptom onset.
Test results are reported as positive or negative along with a numeric value for semi-quantitative measurement for values between 13 AU/mL and 800 AU/mL. Results above 800 CU are reported as >800, Results below 13 CU are reported as <13
This test is only for use under the Food and Drug Administration's Emergency Use Authorization.
Additional Information:
This test has not been FDA cleared or approved. This test has been authorized by FDA under an Emergency Use Authorization (EUA). This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. 360bbb-3(b) (1), unless the authorization is terminated or revoked sooner.
False positive results may occur due to cross-reactivity from pre-existing antibodies or other possible causes.
Sample Collection:
Collect patient samples using standard phlebotomy techniques. Click here for additional collection instructions.
Specimen Handling Instructions:
Maintain at ambient temperature; or refrigerated if more than 12 hours. Avoid exposure to heat or freezing temperatures.
Test Information:
Components:
| Component Name | CPT | Loinc |
| SARS-CoV-2, IgG (Spike protein) | - | SARS-CoV-2, IgG Interpretation | 94563-4 |
