SARS-CoV-2 Antibody (IgG), Spike, Semi-Quantitative

Test Code

COVIGG

Quest Code

34499

CPT Codes
86769<br /> <strong>To meet regulatory reporting requirements for COVID-19 testing, the patient's address, phone number and other demographic details are required for this order.</strong>

Preferred Specimen

1 mL serum

Minimum Volume

0.5 mL

Transport Temperature

Room temperature

Specimen Stability

Room temperature: 4 days
Refrigerated: 7 days
Frozen: 30 days

Methodology
Immunoassay (IA)

FDA Status
This test has been authorized by the FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories.

Setup Schedule

Set up: Daily; Report available: 1-3 days

Reference Range

<1.00 index

Clinical Significance

This test is intended as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2 (COVID-19), indicating recent or prior infection. The results of this semi-quantitative test should not be interpreted as an indication of degree of immunity or protection from reinfection.
Individuals who have been vaccinated with a SARS-CoV-2 spike or receptor-binding domain vaccine may be positive with this test; however, the clinical significance of a positive antibody result for individuals who have received a COVID-19 vaccine is unknown, in part because the test's performance characteristics have not been established for that population. It is not known how long antibodies persist following infection and if the presence of antibodies confers protective immunity. This assay should not be used to diagnose acute SARS-CoV-2 infection.

Performing Laboratory

Quest Diagnostics Nichols Institute

14225 Newbrook Drive

Chantilly, VA 20153

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.