How To Use CPT Code 0107U

CPT 0107U describes the Singulex Clarity® C. diff toxins A/B assay, a proprietary laboratory analysis (PLA) code used to detect the presence or absence of Clostridium difficile toxins A and B (TcdA and TcdB) in a stool specimen. This article will cover the official description, procedure, qualifying circumstances, appropriate usage, documentation requirements, billing guidelines, historical information, and examples of CPT code 0107U.

1. What is CPT Code 0107U?

CPT 0107U is a proprietary laboratory analysis (PLA) code used to identify the presence or absence of Clostridium difficile toxins A and B (TcdA and TcdB) in a stool specimen. This code specifically applies to the Singulex Clarity® C. diff toxins A/B assay, which utilizes a rapid, highly sensitive, multi-step immunoassay technique to detect the toxins. It is important to note that CPT 0107U is a unique code for a specific test offered by Singulex Labs.

2. Official Description

The official description of CPT code 0107U is: ‘Clostridium difficile toxin(s) antigen detection by immunoassay technique, stool, qualitative, multiple-step method.’

3. Procedure

1. The lab analyst prepares the stool sample and places it into the Singulex Clarity® instrument.
2. The instrument centrifuges the sample and transfers it to a reaction chamber.
3. In the reaction chamber, toxins A and B in the sample bind to capture and detection antibodies, forming an immune complex.
4. Unbound material is washed away, and a solvent is added to separate the capture antibodies from the detection antibodies.
5. The resulting solution is transferred to a detection chamber where the fluorescently labeled molecules are counted using single-molecule counting technology.
6. An algorithm compares the detected events to an established curve for native TcdA and TcdB, interprets the data, and provides a combined TcdA-TcdB concentration.
7. The results of the test, including the presence or absence of Clostridium difficile toxins A and B, are available in 32 minutes.

4. Qualifying circumstances

CPT 0107U is used for patients suspected to have a Clostridium difficile (C. diff) infection. C. diff is a bacterium found in the stool that releases toxins causing diarrhea, especially in patients on antibiotic therapy. This test helps clinicians confirm the presence or absence of Clostridium difficile toxins A and B in a stool specimen, aiding in the diagnosis of C. diff infection.

5. When to use CPT code 0107U

CPT code 0107U should be used when ordering the Singulex Clarity® C. diff toxins A/B assay from Singulex Labs to detect the presence or absence of Clostridium difficile toxins A and B in a stool specimen. It is important to note that this code should only be reported for the specific test described and should not be used with any other CPT code.

6. Documentation requirements

To support a claim for CPT code 0107U, the following documentation is required:

• Indication for ordering the test, such as suspicion of Clostridium difficile infection
• Date of the test
• Results of the test, including the presence or absence of Clostridium difficile toxins A and B
• Signature of the lab analyst performing the test

7. Billing guidelines

When billing for CPT code 0107U, ensure that the Singulex Clarity® C. diff toxins A/B assay from Singulex Labs is performed. Report one unit of this code for a single specimen analyzed on a single date of service. It is important to check with the appropriate payer as some may pay separately for the collection of the specimen. Do not report this test with any other CPT code.

8. Historical information

CPT code 0107U, the Singulex Clarity® C. diff toxins A/B assay, was added to the Current Procedural Terminology system on October 1, 2019. There have been no updates to the code since its addition.

9. Examples

1. A clinician orders the Singulex Clarity® C. diff toxins A/B assay for a patient with symptoms suggestive of a Clostridium difficile infection.
2. A patient on antibiotic therapy develops diarrhea, and the clinician requests the Singulex Clarity® C. diff toxins A/B assay to confirm the presence or absence of Clostridium difficile toxins A and B.
3. A hospital laboratory performs the Singulex Clarity® C. diff toxins A/B assay for a patient with suspected Clostridium difficile infection based on clinical presentation and risk factors.
4. A gastroenterologist orders the Singulex Clarity® C. diff toxins A/B assay to aid in the diagnosis of a Clostridium difficile infection in a patient with persistent diarrhea.
5. A primary care physician requests the Singulex Clarity® C. diff toxins A/B assay for a patient with symptoms of a gastrointestinal infection and recent antibiotic use.
6. A healthcare provider orders the Singulex Clarity® C. diff toxins A/B assay for a patient with suspected Clostridium difficile infection to guide appropriate treatment decisions.
7. A patient with recurrent episodes of diarrhea undergoes the Singulex Clarity® C. diff toxins A/B assay to determine if Clostridium difficile toxins A and B are present.
8. A laboratory technician performs the Singulex Clarity® C. diff toxins A/B assay on a stool specimen from a patient with suspected Clostridium difficile infection.
9. A clinician orders the Singulex Clarity® C. diff toxins A/B assay for a patient with symptoms of a gastrointestinal infection and a history of Clostridium difficile infection.
10. A hospital laboratory analyzes a stool specimen using the Singulex Clarity® C. diff toxins A/B assay to detect the presence or absence of Clostridium difficile toxins A and B in a patient with diarrhea.