Immunoassay for analyte other than infectious agent antibody or infectious agent antigen; qualitative or semiquantitative, multiple step method

CPT4 code

Name of the Procedure:

Immunoassay for Analyte (Qualitative or Semiquantitative, Multiple Step Method)

Common names: Immunoassay, Non-Infectious Analyte Immunoassay
Technical terms: Multiple Step Immunoassay, Non-Infectious Agent Analyte Testing

Summary

This type of immunoassay is a laboratory test used to detect the presence or amount of a specific substance (analyte) in a sample through a series of steps that indicates a qualitative (presence/absence) or semiquantitative (approximate amount) result.

Purpose

To detect and measure a specific analyte in the body that is not associated with infectious agents.
Commonly used to test for hormones, drugs, proteins, and other chemicals in the blood or urine.
The goal is to diagnose and monitor various medical conditions or to ensure therapeutic drug levels are within the desired range.

Indications

Symptoms or suspicion of hormonal imbalances, drug toxicity, or metabolic disorders.
Monitoring therapeutic drug levels in patients on medication.
Screening for specific proteins or biomarkers in research or clinical settings.

Preparation

Some tests may require fasting, typically for 8-12 hours before sample collection.
Patients should inform the healthcare provider of all medications, supplements, and underlying health conditions.
Routine diagnostics like blood or urine samples may be collected.

Procedure Description

Sample Collection: Blood is drawn from a vein or a urine sample is collected.
Preparation: The sample is prepared and treated with specific reagents that bind to the target analyte.
Binding: The sample and reagents undergo multiple binding stages wherein a series of reactions occur.
Detection: The final reaction often involves a detectable signal, such as color change, fluorescence, or radioactivity, indicating the presence or quantity of the analyte.
- Tools/Technology: Microplate readers, spectrophotometers, fluorimeters, or radioimmunoassay counters.
- Anesthesia/Sedation: Not required.

Duration

Typically takes between 1 to 3 hours for the full process, including sample processing and analysis.

Setting

Performed in a clinical laboratory or hospital laboratory setting.

Personnel

Laboratory technicians or technologists.
Pathologists may interpret the results.

Risks and Complications

Minimal risk from blood draw: slight bruising, soreness, or very rarely, infection.
Incorrect results due to sample contamination or improper handling.

Benefits

Provides critical information for diagnosis and treatment management.
Results typically available same day or within a few days.
Non-invasive with minimal discomfort.

Recovery

No recovery time is needed; patients can immediately resume normal activities post-sample collection.
Follow-up with healthcare provider to discuss result interpretation and next steps.

Alternatives

Other testing methods like mass spectrometry or chromatography.
Pros: These may provide more detailed quantitative data.
Cons: Often more expensive and time-consuming, requiring specialized equipment and personnel.

Patient Experience

During: Brief discomfort during blood draw; otherwise no pain or discomfort.
After: Minimal to no side effects; routine care for the blood draw site as recommended in everyday blood collection such as applying a bandage.