CoVid 19, Total Antibodies

Last Modified: 9/25/2023 2:32:14 PM

Medical Necessity Documentation:  
Patient Preparation: Roche Patient Information
Specimen Requirements:  1.0 mL Serum in a SST Gold Top Tube
Collection Instructions:  
Minimum Volume: 0.5 mL Serum
Transport & Storage: Temperature/Stability: 3 days Refrigerated
Reference Range: Non-Reactive
Critical Ranges:  
Test Comments: This 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.  Results are for the detection of SARS-CoV-2 antibodies.  At this time, it is unknown for how long antibodies persist following infection or if the presence of antibodies confers protective immunity.  Negative results do not preclude acute SARS-CoV-2 infection.  This test should not be used to diagnose acute SARS-CoV-2 infection.  If acute infection is suspected, direct testing by molecular methods for SARS-CoV-2 is necessary.  False positive for the test may occur due to cross-reactivity from pre-existing antibodies or other possible causes.  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.
Methodology: Electrochemiluminescence Immunoassay (ECLIA)
Clinical Significance:  
Documentation:  This assay targets the nucleocapsid protein of the SARS-CoV-2 molecule and is able to identify previous infection by the SARS-CoV-2 virus (COVID-19).  This assay is not intended for determination of vaccination efficacy.

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: COVTA
EPIC Test Code: IMO5257
Alternate Test Names: COVID Abs; COVID, IgG; COVID-19 Serology; SARS CoV-2 Total Ab
Included Tests:  
CPT Coding: 86769

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