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EPIC CODE: LAB3315 SARS COV2 Total Ab, Spike and Nucleocapsid

Additional Codes

Sunquest:  SV2SN

REGIONAL HOSPITAL PERFORMING

Path Laboratories - Des Moines, IA

Specimen Requirements

Collect 1.0 mL of blood. Transfer 0.5 mL of serum or plasma to a transport vial.

Minimum Sample Volume: 0.20 mL

Collect

 Red top, SST (Serum Separator), Green top, PST (Plasma Separator)

Pediatric Requirements

-

Storage/Transport Temperature

0.50 mL of serum refrigerated in a transport vial

Stability

Refrigerated Stability: 7 days

Frozen Stability: 28 days

Ambient Stability: 7 days

Special Testing Notes

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

ORDERING

-

Day(s) Performed

Daily

Duration of Testing

1 day

Methodology

Electrochemiluminescence Immunoassay (ECLIA)

COMPONENTS

This battery includes the following testing:

SARS‑CoV‑2 spike (S) protein, Total Antibody

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

Reference Interval

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.

CPT

86769 x2