COVID-19 Spike Domain Antibody COVIDSDAB

Synonyms

Allscripts (AEHR) Order Name

COVID-19 Spike Domain Antibody

Sunrise Clinical Manager (SCM) Order Name

COVID-19 Spike Domain Antibody

EPIC Order Name

COVID-19 Antibody (Spike Domain)

Clinical Info

Intended for semiquantitative detection of antibodies to SARS‑CoV‑2 spike protein. This test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS‑CoV‑2, indicating recent/prior infection and/or COVID-19 vaccination.

Specimen Type

Blood

Container

Gold or Lithium Heparin (Mint-green) top tube

Collection Instructions

Specimen: 1.0 mL serum or plasma (0.5 mL min)
 

Transport Instructions

Refrigerated

Specimen Stability

14 days Room Temperature
14 Days Refrigerated
6 Months Frozen
 

Methodology

Days Performed

Sunday - Saturday
TAT: 2 Days

Performing Laboratory

Northwell Health Laboratories

CPT

86769

PDM

2153036

Result Interpretation

    Instrument (Assay)       Methodology   Anti-SARS-CoV-2 Antibody Interpretation
Roche 801 (Elecsys Anti-SARS-CoV-2 S) Electrochemiluminescence immunoassay < 0.80 U/mL : Negative for anti‑SARS‑CoV‑2‑S
≥ 0.80 U/mL : Positive for anti‑SARS‑CoV‑2‑S

The Roche Elecsys Anti‑SARS‑CoV‑2 S has been approved by the FDA for Emergency Use Authorization only. It has been validated to be accurate by Northwell Health Laboratories.

Positive results indicate that antibodies against SARS-CoV-2 were detected in your blood either from previous infection with SARS-CoV-2 virus and/or COVID-19 vaccination. Presence of antibodies to SARS‑CoV‑2 may not guarantee protection from SARS-CoV-2 reinfection.

Negative results do not preclude SARS‑CoV‑2 infection and should not be used as the sole basis for patient management decisions. A negative result can occur if the quantity of the anti‑SARS‑CoV‑2 antibodies is below the detection limits of the assay, or the antibodies that are detected are not present during the stage of disease in which a sample is collected. Follow-up testing with a molecular diagnostic tets should be considered to rule out infection in these individuals.

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