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St. John Health System
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SARS-CoV-2 IgG, Spike

Order Name CoV2 IgG Spike
Test Number: 6907251
Revision Date 07/19/2024
Test Name Methodology LOINC Code
SARS-CoV2 IgG Spike
Chemiluminescence, Immunoassay 94661-6 
SARS-CoV2 IgG Spike Index
Chemiluminescence, Immunoassay 94505-5 
SPECIMEN REQUIREMENTS
Specimen Specimen Volume (min) Specimen Type Specimen Container Transport Environment
Preferred 2 mL (0.4 mL) Serum Clot Activator SST Room Temperature
Alternate 1 2 mL (0.4 mL) Plasma Lithium Heparin PST (Light Green Top) Room Temperature
Alternate 2 2 mL (0.4 mL) Plasma EDTA (Lavender Top) Room Temperature
Instructions Minimum Volume: 0.4 mL (Note: This volume does not allow for repeat testing.)
Container: Gel-barrier tube or serum from red-top tube or serum transfer tube, or plasma from lithium heparin or EDTA tube
Cause for Rejection: Grossly hemolyzed or lipemic samples and samples containing particulate matter or exhibiting obvious microbial contamination.
Stability: Ambient 14 days; Refrigerated 14 days; Frozen 14 days (freeze thaw cycle x3) 
GENERAL INFORMATION
Expected TAT 2-4 Days 
Clinical Use The incubation period for COVID-19 ranges from 5 to 7 days. Current literature suggests that detectable IgG-class antibodies against SARS-CoV-2 develop approximately 8 to 11 days following onset of symptoms. Correlation with epidemiologic risk factors and other clinical and laboratory findings is recommended. A positive serological result is not diagnostic but indicates that an individual has likely been infected with SARS-CoV-2 and produced an immune response to the virus. It is not known at this time whether detectable antibody correlates with immunity. A negative serologic result indicates that an individual has not developed detectable antibodies at the time of testing. While contingent on a variety of factors, this could be due to testing too early in the course of infection, the absence of exposure to the virus, or the lack of adequate immune response, which can be due to conditions or treatments that suppress immune function. 
CPT Code(s) 86769
Internal Comments 3/29/21 orig clin use - JK - The IgG antibodies to the nucleocapsid can only come about following a SARS-CoV-2 infection. IgG antibodies to the spike protein will follow an infection and/or a vaccination with a spike initiating vaccine. The assays will be valuable in discerning as to whether the patient has or has not had a COVID 19 infection or a vaccination.

7.22.2024 - BM - RML has initiated two assays for the semi-quantitative detection of IgG antibodies to the COVID 19 nucleocapsid and a second to the COVID 19 spike protein. The IgG antibodies to the nucleocapsid can only come about following a SARS-CoV-2 infection. IgG antibodies to the spike protein will follow an infection and/or a vaccination with a spike initiating vaccine. The assays will be valuable in discerning as to whether the patient has or has not had a COVID 19 infection or a vaccination. The semi-quantitative values will be important to determine the degree of antibody activity in seroconversion as well as following the status of the levels of antibody activity over time. They will be available in two formats. One is the COVID 19 IgG anti-spike and the other is COVID 19 IgG anti-nucleocapsid. The results will be reported as a relative value (i.e. positive or negative) as well as a semi-quantitative value. (this was removed with the move to LCA from LCOK)      Testing for IgG Spike protein antibody to the novel Coronavirus (SARS-CoV-2/COVID-19) performed at Labcorp Oklahoma, Inc. Central Lab  (removed from test notes)
Service Provided By Labcorp Oklahoma, Inc.
Lab Section Reference Lab