COVID-19, Total Spike Antibody

Last Modified: 8/25/2021 3:23:41 PM

Medical Necessity Documentation:  
Client Notes:  
Patient Preparation:  
Specimen Requirements: 1.0 mL Serum in an SST Gold Top Tube
Collection Instructions:  
Minimum Volume: 0.5 mL Serum
Transport & Storage: Temperature/Stability: 14 days Refrigerated
Reference Range: A positive result is consistent with previous infection or vaccination.
Critical Ranges:  
Test Comments: Testing performed by electrochemiluminescence immunassay using the Roche Anti-SARS-CoV-2 S assay for the semi-quantitative detection of antibodies to SARS-CoV-2 spike protein receptor binding domain.  This test should not be used to diagnose acute SARS-CoV-2 infection,  If acute infection is suspected, direct testing by molecularmethods for SARS-CoV-2 is necessary.  This test has been authorized by the FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories.  This EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 is terminated or the EUA is revoked.  Please review the "Fact Sheets" available for healthcare providers and patients in the Parkview Health Laboratories Test Directory at http:\\
Methodology: Electrochemiluminescence Immunoassay (ECLIA)
Clinical Significance:  
Custom Panel: No


Turn Around Time: 24 to 48 hours
Days Performed: Sunday, Monday, Tuesday, Wednesday, Thursday, Friday, Saturday
Sites Performed: Parkview Regional Medical Center
PHL Test Code: COVC
EPIC Test Code: IMO5448
Alternate Test Names: SARS-CoV-2; SARS-CoV-2 Ab; SARS-CoV-2 Ab, Quantitative; SARS-CoV-2 Antibody
Included Tests:  
CPT Coding: 86769

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