81513 Infectious disease, bacterial vaginosis, quantitative real-time amplification of RNA markers for Atopobium vaginae, Gardnerella vaginalis, and Lactobacillus species, utilizing vaginal-fluid specimens, algorithm reported as a positive or negative result fo

Name of the Procedure:

Quantitative Real-Time Amplification of RNA Markers for Atopobium vaginae, Gardnerella vaginalis, and Lactobacillus species; Commonly referred to as Bacterial Vaginosis RNA Marker Test.

Summary

This procedure involves analyzing vaginal-fluid specimens to detect the presence of RNA markers from specific bacteria associated with bacterial vaginosis. The results are algorithmically reported as positive or negative for each bacterium.

Purpose

Bacterial vaginosis (BV) is a common infection among women. This test aims to diagnose BV by identifying the RNA of specific bacteria (Atopobium vaginae, Gardnerella vaginalis, and Lactobacillus species) in vaginal fluid. Accurate diagnosis aids in effective treatment, preventing complications and improving patient outcomes.

Indications

• Symptoms such as unusual vaginal discharge, odor, itching, or irritation.
• History of recurrent BV infections.
• Pre-surgical evaluation for gynecological procedures.
• Routine screening in pregnancy to prevent complications like preterm birth.

Preparation

• No special preparation is generally needed.
• Patients may be instructed to avoid using vaginal creams, douches, or tampons 24-48 hours before the sample collection.
• Some healthcare providers may recommend scheduling the test when not menstruating.

Procedure Description

1. The patient is placed in a comfortable position, typically lying on an examination table.
2. A healthcare provider uses a sterile swab to collect a sample of vaginal fluid.
3. The sample is then sent to the laboratory for analysis.
4. In the lab, RNA extraction and quantitative real-time amplification are performed to identify and quantify the RNA markers of Atopobium vaginae, Gardnerella vaginalis, and Lactobacillus species.
5. Results are reported as positive or negative for each bacterium based on algorithmic interpretation.

Duration

The specimen collection usually takes a few minutes. Lab analysis might take several hours to a few days, depending on the lab's workflow.

Setting

The specimen collection is typically done in an outpatient clinic, a gynecologist's office, or a healthcare provider’s office.

Personnel

• Gynecologist or primary healthcare provider for sample collection.
• Laboratory technologists and specialists for sample analysis.

Risks and Complications

• Minimal risks associated with the swab collection, including slight discomfort or minor irritation.
• No significant complications are expected.

Benefits

• Accurate diagnosis of bacterial vaginosis.
• Enables targeted treatment to reduce symptoms and prevent complications.
• Potentially quicker relief from symptoms.

Recovery

• No specific recovery period is required after specimen collection.
• Patients can return to their normal activities immediately.
• Follow-up may depend on test results and treatment plans.

Alternatives

• Traditional culture methods for detecting vaginal infections.
• Other molecular diagnostic tests (e.g., PCR-based tests).
• Pros: Traditional methods may be less expensive.
• Cons: Other methods might be less sensitive or slower in delivering results.

Patient Experience

• During the procedure: Mild discomfort during swab collection; comparable to a routine gynecological exam.
• After the procedure: General comfort without restrictions.
• If diagnosed with BV, follow-up treatments will be discussed. Pain management or discomfort should be minimal and short-lived.