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Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative, multiple-step method; Clostridium difficile toxin

CPT4 code

Name of the Procedure:

Infectious agent antigen detection by immunoassay technique, such as enzyme immunoassay (EIA), enzyme-linked immunosorbent assay (ELISA), immunochemiluminometric assay (IMCA); qualitative or semiquantitative, multiple-step method for Clostridium difficile toxin. Commonly referred to as C. difficile toxin testing or C. diff antigen detection.

Summary

This procedure involves testing a sample, usually stool, to detect the presence of toxins produced by the bacterium Clostridium difficile (C. diff). The test uses immunoassay techniques, which may include methods like EIA, ELISA, or IMCA, to identify these toxins either qualitatively (presence or absence) or semiquantitatively (approximate amount).

Purpose

The procedure is used to diagnose infections caused by C. difficile, which often result in severe diarrhea and inflammation of the colon, known as colitis. The goal is to confirm the infection so that appropriate treatment can be administered promptly.

Indications

  • Persistent or severe diarrhea, particularly after antibiotic use.
  • Symptoms of colitis such as abdominal pain and fever.
  • Patients hospitalized or in long-term care facilities exhibiting gastrointestinal symptoms.
  • Recent history of antibiotic-associated diarrhea.

Preparation

  • No specific preparation is typically required.
  • Patients may need to provide a stool sample.
  • It's advisable to inform the healthcare provider about any medications being taken, as some might affect the test results.

Procedure Description

  1. A stool sample is collected from the patient.
  2. The sample is processed in a laboratory using immunoassay techniques (EIA, ELISA, or IMCA).
  3. The immunoassay involves multiple steps where antibodies are used to detect C. difficile toxins.
  4. Results indicate whether toxins are present (qualitative) or provide an estimated amount (semiquantitative).

No anesthesia or sedation is required for this procedure.

Duration

The test itself typically takes a few hours once the sample reaches the laboratory. Results are usually available within 24 to 48 hours.

Setting

This procedure is performed in a laboratory setting. The sample collection can take place at a hospital, outpatient clinic, or the patient’s home.

Personnel

  • Laboratory technicians or clinical laboratorians conduct the test.
  • Physicians (e.g., gastroenterologists or infectious disease specialists) review the results and manage patient care.

Risks and Complications

The procedure is non-invasive and involves minimal risks. The primary risk is the potential for false-positive or false-negative results, which can affect diagnosis and treatment.

Benefits

  • Allows for accurate diagnosis of C. difficile infection.
  • Facilitates timely and appropriate treatment.
  • Helps prevent complications from untreated infections.

Results can often be realized within 24 to 48 hours after the sample is analyzed.

Recovery

  • No recovery time is required as the procedure is non-invasive.
  • Patients should follow their healthcare provider’s instructions based on the test results.

Alternatives

  • PCR (Polymerase Chain Reaction) testing can detect the DNA of C. difficile.
  • Cell cytotoxicity assays, though less commonly used due to being more time-consuming and labor-intensive.
  • Stool culture, which takes longer to obtain results.

Each alternative has its own set of pros and cons regarding sensitivity, specificity, and time to results compared to immunoassays.

Patient Experience

Patients may find sample collection slightly uncomfortable or inconvenient, but it generally involves minimal discomfort. Pain management is not applicable for this procedure as it is non-invasive. Comfort measures are mainly focused on providing clear instructions for sample collection.

Medical Policies and Guidelines for Infectious agent antigen detection by immunoassay technique, (eg, enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative, multiple-step method; Clostridium difficile toxin

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