CPT® Code 81515

1. Indications

The procedure associated with CPT® Code 81515 is indicated for the diagnosis of bacterial vaginosis and vaginitis. The following conditions and symptoms may warrant the use of this molecular diagnostic tool:

• Bacterial Vaginosis - A condition characterized by an imbalance in the normal bacterial flora of the vagina, often leading to symptoms such as unusual vaginal discharge, odor, and irritation.
• Vaginitis - Inflammation of the vagina that can result from various causes, including infections, which may present with symptoms like itching, burning, and abnormal discharge.
• Presence of Specific Bacteria - The detection of DNA markers for Atopobium vaginae, Atopobium species, Megasphaera type 1, and BVAB-2 is crucial for confirming bacterial vaginosis.
• Trichomonas Vaginalis Infection - The procedure allows for the identification of Trichomonas vaginalis, a common sexually transmitted infection that can cause vaginitis.
• Candida Species Infection - The detection of various Candida species, including Candida albicans and others, is important for diagnosing yeast infections that may present with similar symptoms.

2. Procedure

The procedure for CPT® Code 81515 involves several key steps to ensure accurate diagnosis through real-time PCR amplification:

• Sample Collection - A sample of vaginal fluid is collected from the patient. This specimen is critical as it contains the DNA markers necessary for the analysis.
• DNA Extraction - The collected vaginal fluid undergoes a process of DNA extraction to isolate the target DNA sequences from the sample. This step is essential for the subsequent amplification process.
• Real-Time PCR Amplification - The extracted DNA is subjected to real-time PCR amplification. This involves the use of specific primers that bind to the DNA markers for Atopobium vaginae, Atopobium species, Megasphaera type 1, and BVAB-2. The amplification process is monitored in real-time using fluorescence measurements, allowing for the quantification of the DNA present.
• Detection of Additional Pathogens - In addition to the primary markers, the procedure also includes the separate detection of Trichomonas vaginalis and various Candida species. This is achieved through the same amplification process, ensuring comprehensive testing for common pathogens associated with vaginitis.
• Result Interpretation - After amplification, the results are analyzed and reported as either positive or negative for a high likelihood of bacterial vaginosis. The algorithm used in this analysis provides clarity on the presence of the detected DNA markers.

3. Post-Procedure

Post-procedure care following the testing associated with CPT® Code 81515 typically involves the communication of results to the patient and the healthcare provider. If the results indicate a positive diagnosis for bacterial vaginosis or any detected infections, appropriate treatment options should be discussed. Patients may be advised on follow-up appointments to monitor symptoms and response to treatment. Additionally, education on preventive measures and the importance of follow-up testing may be provided to ensure comprehensive care and management of the condition.