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Immunoassay for infectious agent antibody(ies), qualitative or semiquantitative, single-step method (eg, reagent strip); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19])

CPT4 code

Name of the Procedure:

Immunoassay for SARS-CoV-2 Antibodies (COVID-19 Antibody Test), Qualitative or Semiquantitative, Single-Step Method (e.g., Reagent Strip)


This procedure is a simple blood test that checks for the presence of antibodies against SARS-CoV-2, the virus that causes COVID-19. It uses a single-step method like a reagent strip to quickly determine if your body has produced an immune response to the virus.


  • Medical Condition Addressed: COVID-19.
  • Goals: To identify whether a person has been previously infected with SARS-CoV-2 and possibly has immunity.
  • Expected Outcomes: Qualitative results (positive/negative) or semiquantitative results (measure of antibody levels) to assist in understanding past infection and potential immunity.


  • Symptoms or Conditions: Previous symptoms of COVID-19, exposure to confirmed cases, or interest in knowing immunity status.
  • Patient Criteria: Individuals who suspect they have had COVID-19, healthcare workers, or those required to have this information for work or travel.


  • Pre-procedure Instructions: Generally, no special preparation such as fasting or medication adjustments is needed.
  • Diagnostic Tests: None required beforehand, but it may be conducted alongside other tests as recommended by a healthcare provider.

Procedure Description

  • Step-by-Step:
    1. A healthcare provider will clean a site on your arm with an antiseptic wipe.
    2. A small blood sample will be taken from a vein using a needle.
    3. The blood sample is processed using a reagent strip or a similar single-step method.
    4. The test results are usually available within minutes to hours.
  • Tools and Equipment: Sterile needle, antiseptic wipe, reagent strip, and processing equipment.
  • Anesthesia/Sedation: Not applicable.


Typically takes less than 10 minutes for blood draw, with results available in minutes to a few hours.


Can be performed in various settings such as hospitals, outpatient clinics, doctor's offices, or testing centers.


Generally, a nurse, lab technician, or phlebotomist will draw the blood. A laboratory technician or healthcare provider will process the test and interpret the results.

Risks and Complications

  • Common Risks: Mild pain or bruising at the needle site.
  • Rare Risks: Infection or fainting during blood draw.
  • Complications: Generally rare and manageable with basic first aid.


  • Expected Benefits: Knowing if you have been infected with SARS-CoV-2 and possibly have some degree of immunity.
  • Realization of Benefits: Typically immediate upon receiving the test results.


  • Post-Procedure Care: Minimal care required; apply a small bandage to the blood draw site.
  • Recovery Time: Immediate return to normal activities. Follow-up depends on results and healthcare provider's advice.


  • Other Treatment Options: PCR tests for active infection, rapid antigen tests.
  • Pros and Cons: PCR and antigen tests are for active infection; antibody tests are for past infection. Each type of test has its specific use-case, sensitivity, and accuracy.

Patient Experience

  • During Procedure: Brief discomfort from needle prick.
  • After Procedure: Mild soreness or bruising at the blood draw site. Pain is generally minimal and can be managed with over-the-counter pain relief if necessary.

Medical Policies and Guidelines for Immunoassay for infectious agent antibody(ies), qualitative or semiquantitative, single-step method (eg, reagent strip); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19])

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