SARS-CoV-2 Total Antibody, Spike, Semi-Quantitative

Cleveland HeartLab S, Test

NEW YORK DOH APPROVED: YES

CPT Code: 86769
Order Code: 39820
ABN Requirement: No
Specimen: Serum
Volume:  1.0 mL
Minimum Volume:  0.5 mL
Container: Gel-barrier tube (SST)

Collection:

  1. Collect and label sample according to standard protocols.
  2. Gently invert tube 5 times immediately after draw. DO NOT SHAKE.
  3. Allow blood to clot 30 minutes.
  4. Centrifuge for 10 minutes.

Transport: Store serum at 2°C to 8°C after collection and ship the same day per packaging instructions included with the provided shipping box.

Stability:

Ambient (15-25°C): 3 days
Refrigerated (2-8°C):
7 days
Frozen (-20°C):
28 days

Causes for Rejection: Specimens other than serum; improper labeling; samples not stored properly; samples older than stability limits; gross hemolysis; gross lipemia; gross icterus; frozen SST specimen.

Methodology: Immunoassay (IA)

Turn Around Time:  3 to 5 days

Reference Range:

<0.8 U/mL        Negative

≥0.8 U/mL        Positive


Clinical Significance:  The results of this semi-quantitative test should not be interpreted as an indication or degree of immunity or protection from reinfection. Individuals that have been vaccinated with a SARS-CoV-2 spike or receptor-binding domain vaccine may be positive in this test, and their sero-positivity may or may not be due to a SARS-CoV-2 infection.

This test is intended as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. This test may be positive in vaccinated patients. It is unknown for 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.

The CPT codes provided 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 payer being billed.