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Test Code SV2SN SARS CoV2 Total Ab, Spike and Nucelocapsid, LAB3315

Performing Laboratory

Pathology Laboratory Des Moines, IA

Clinical Testing | Pathology Laboratory

Alias: SARS-CoV-2 spike (S) protein, Total Antibody and SARS-CoV-2 nucleocapside (N) protien, Total Antibody

Specimen Requirements

Preferred Container/Tube:  Gold-top serum gel tube
Acceptable Container/Tube: Plain, red-top tube or Green, lithium heparin (PST)
Specimen: 0.5 mL of serum or plasma, 0.2 mL minimum
Stability:  Stable 7 days refrigerated. Ambiant 7 days, frozen 28 days.

Transport Temperature: Refrigerated
 

Day(s) Test Set Up

Daily

Useful For

Aiding in the identification of individuals with an adaptive immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), indicating prior infection or vaccination.

This test has not been FDA cleared or approved.  This test has been authorized by FDA under an EUA for use by authorized laboratories.

Methodology

Electrochemiluminescence Immunoassay (ECLIA)

Test Classification and CPT Coding

86769 x 2

Reference Range

SARS‑CoV‑2 spike (S) protein, Total 

Negative:

No antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) detected. Negative results may occur in serum collected too soon following infection, in patients who are immunosuppressed, in some individuals with mild or asymptomatic illness, or in individuals vaccinated against SARS-CoV-2 in the past 2 weeks. Follow-up testing with a molecular test is recommended in symptomatic patients. This test should not be used to exclude active or recent coronavirus disease 2019 (COVID-19).

Positive:

SARS-CoV-2 antibodies detected. Results suggest prior SARS-CoV-2 infection or vaccination. 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. False positive results may occur due to cross-reactivity from pre-existing antibodies or other possible causes.

SARS‑CoV‑2 nucleocapsid (N) protein, Total Antibody

 

Negative:

No antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) detected. Negative results may occur in serum collected too soon following infection, in patients who are immunosuppressed, or in patients with mild or asymptomatic infection. This test does not rule out active or recent coronavirus disease 2019 (COVID-19) and will not detect SARS-CoV-2 vaccine-induced antibodies. Follow-up testing with a molecular test is recommended in symptomatic patients.

Positive:

SARS-CoV-2 antibodies to the nucleocapsid protein 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. False-positive results may occur due to cross-reactivity from pre-existing antibodies or other possible causes.