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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; Shiga-like toxin

CPT4 code

Name of the Procedure:

Infectious Agent Antigen Detection by Immunoassay Technique
Common names: Shiga-like Toxin Immunoassay, EIA, ELISA, IMCA

Summary:

This procedure involves detecting the presence of Shiga-like toxin, a harmful substance produced by certain bacteria, using immunoassay techniques. These methods include enzyme immunoassay (EIA), enzyme-linked immunosorbent assay (ELISA), and immunochemiluminometric assay (IMCA). The test is qualitative or semiquantitative, determining if the toxin is present and sometimes estimating its amount.

Purpose:

The procedure is designed to identify infections caused by bacteria that produce Shiga-like toxin, such as certain strains of E. coli. The primary goal is to diagnose these infections accurately to guide appropriate treatment.

Indications:

  • Severe diarrhea with bloody stools
  • Suspected foodborne illnesses
  • Symptoms of hemolytic uremic syndrome (HUS), such as kidney failure and low platelet count
  • Confirmation of outbreaks caused by toxin-producing bacteria

Preparation:

  • No specific patient preparation is usually required.
  • Patients might be advised to avoid eating or drinking for a few hours before the test in some cases.
  • Any current medications should be discussed with the physician.

Procedure Description:

  1. Sample Collection: A sample of the patient's stool, blood, or other bodily fluid is collected.
  2. Antigen Detection: The sample is treated and placed on a special plate or test strip.
  3. Binding and Reaction: Antibodies specific to the Shiga-like toxin bind to any toxins present. A reaction occurs, often involving an enzyme that produces a color change or light emission.
  4. Reading Results: The intensity of the color or light indicates the presence and possibly the amount of Shiga-like toxin, read using specialized equipment.

Duration:

The procedure typically takes a few hours to yield results, although the time can vary based on the specific assay method used.

Setting:

The test is usually performed in a hospital laboratory or specialized outpatient clinic.

Personnel:

  • Medical Laboratory Technicians
  • Clinical Microbiologists
  • Pathologists (for result interpretation)

Risks and Complications:

  • There are minimal risks associated with the sample collection, such as slight discomfort during stool or blood sampling.
  • Rarely, false positives or negatives may occur, necessitating further testing for confirmation.

Benefits:

  • Provides a quick and accurate diagnosis of infections caused by Shiga-like toxin-producing bacteria.
  • Helps initiate appropriate and timely treatment.
  • Assists in preventing the spread of infections during outbreaks.

Recovery:

  • Most patients require no specific recovery time.
  • Normal activities can be resumed immediately after sample collection.
  • Follow-up may involve additional tests or treatments based on the results.

Alternatives:

  • Bacterial culture to identify the specific strain of bacteria, which may take longer.
  • PCR (Polymerase Chain Reaction) assays for rapid genetic detection of bacterial toxins.
  • Pros: Culture and PCR can provide more detailed information; Cons: They may be more time-consuming or costly.

Patient Experience:

  • Patients may experience minor discomfort during sample collection.
  • There is generally no pain or significant side effects associated with the immunoassay itself.
  • Comfortable measures and pain management are usually not required.

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; Shiga-like toxin

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