Anal ThinPrep Cytology with Human Papillomavirus (HPV) Co-Test, Varies
Use
The test is useful for detecting malignant and premalignant changes and high-risk (HR) genotypes associated with the development of anal cancer. Specifically, it detects HR-HPV types, including HPV-16 and HPV-18, which are closely associated with progression to cancer. The test aids in triaging men and women with positive HR-HPV but negative anal Papanicolaou (Pap) smear results to facilitate further management. The detection of HR-HPV DNA, especially genotypes 16 and 18, assists in determining appropriate follow-up and management strategies for patients at risk for anal or cervical cancer.
Special Instructions
The test is not recommended for evaluation of suspected sexual abuse. When this test is ordered, a cytology screen and genotyping for high-risk human papillomavirus types will be performed. Necessary information such as the patient's name, date of birth, physician details, and clinical history must accompany the specimen.
Limitations
The cobas HPV test, while approved for cervical samples, is not FDA-approved for anal specimens, though validation studies have been conducted. The test detects high-risk HPV types but not low-risk types, and its performance may be affected by specimen contamination or improper handling. The test is not indicative of cytological high-grade lesions or cancer development, as most infections are cleared without intervention. The presence of PCR inhibitors may result in false-negative or invalid results.
New York Approved
Methodology
Other
Biomarkers
LOINC Codes
- 77653-4
- 69965-2
- 19139-5
- 35265-8
- 22634-0
- 22633-2
- 22636-5
- 62364-5
- 80398-1
Result Turnaround Time
3-6 days
Related Documents
For more information, please review the documents below
Specimen
Other
Volume
20 mL or entire collection
Minimum Volume
Not provided
Container
ThinPrep
Collection Instructions
Visualize the anal opening by retracting the buttocks. Insert brush past internal anal sphincter until it abuts the distal rectal wall (4-5cm). Rotate the brush 360 degrees, apply lateral pressure, and withdraw slowly. Place the brush in ThinPrep solution immediately, swish for 20 to 30 seconds, and dispose of the brush. Tighten the container cap and label both vial and biohazard bag individually to prevent leakage during transport.
Causes for Rejection
SurePath vial; Specimen containing CytoRich Red preservative fluid
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 21 days |