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Test Code AHPV Anal Pap Human Papillomavirus (HPV) with Genotyping, High-Risk Types, PCR, Varies


Necessary Information


Specimen source collection date, and patient identifiers are required.



Specimen Required


Submit one of the following specimens:

 

Preferred

Specimen Type: Anus or rectum

Supplies: ThinPrep Media with Spatula and Brush Kit (T434)

Collection Container/Tube: Brush

Submission Container/Tube: ThinPrep

Specimen Volume: A minimum of 20 mL or entire collection

Collection Instructions:

1. Visualize the anal opening by retracting the buttocks.

2. Insert brush past internal anal sphincter until it abuts the distal rectal wall (4-5cm).

3. Rotate the brush 360 degrees and maintain lateral pressure on brush against the walls of the anus. The brush should bow slightly due to the pressure.

4. While rotating, slowly withdraw the brush.

5. Rotate at least 10 times while withdrawing the brush. This should take 20 to 30 seconds.

6. Immediately place brush in the ThinPrep solution and swish at least 20 to 30 seconds.

7. Dispose of the brush.

8. Tighten the cap so that the torque line on the cap passes the torque line on the vial.

9. Bag ThinPrep specimens individually as they tend to leak during transport.

10. Place labels on the vial and on the biohazard bag.

 

Acceptable

Specimen Type: Anus or rectum

Supplies: PreservCyt Vial (T536)

Collection Container/Tube: Dacron/polyester swab

Submission Container/Tube: PreservCyt solution vial

Specimen Volume: A minimum of 20 mL or entire collection

Collection Instructions:

1. Visualize the anal opening by retracting the buttocks.

2. Insert Dacron or polyester swab past internal anal sphincter until it abuts the distal rectal wall (4-5cm).

3. Rotate the swab 360 degrees and maintain lateral pressure on swab against the walls of the anus. The swab should bow slightly due to the pressure.

4. While rotating, slowly withdraw the swab.

5. Rotate at least 10 times while withdrawing the swab. This should take 20 to 30 seconds.

6. Immediately place swab in the ThinPrep solution. Swish at least 20 to 30 seconds in the ThinPrep solution.

7. Dispose of the swab.

8. Tighten the cap so that the torque line on the cap passes the torque line on the vial.

9. Bag ThinPrep specimens individually as they tend to leak during transport.

10. Place labels on the vial and on the biohazard bag.


Useful For

Detection of high-risk (HR) genotypes associated with the development of anal cancer

 

Individual genotyping of human papillomavirus (HPV)-16 and HPV-18 if present

 

May aid in triaging men and women with positive HR HPV but negative anal Papanicolaou (Pap) smear test results

 

This test is not intended for use in medical-legal applications.

Method Name

Real-Time Polymerase Chain Reaction (PCR)

Reporting Name

HPV Anal Detect / Genotyping PCR

Specimen Type

Varies

Specimen Minimum Volume

1 mL

Specimen Stability Information

Specimen Type Temperature Time
Varies Ambient 21 days

Reject Due To

Specimen containing CytoRich Red preservative fluid Reject
Perirectal or perianal Reject

Clinical Information

Persistent infection with human papillomavirus (HPV) can cause anal cancer, with approximately 90% of all anal cancers being associated with HPV infection. HPV is a small, nonenveloped, double-stranded DNA virus, with a genome of approximately 8000 nucleotides. There are more than 118 different types of HPV and approximately 40 different HPVs that can infect human anogenital mucosa. However, data suggests that 14 of these types (HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) are high risk (HR) for the development of cervical and anal cancer and precursor lesions. Furthermore, HPV types 16 and 18 have been regarded as the genotypes most closely associated with progression to cancer. HPV-16 is the most carcinogenic and is associated with approximately 60% of all HPV-related cancers, while HPV-18 accounts for approximately 10% to 15% of HPV-related cancers.(1-3)

 

Sexual transmission of HPV is extremely common, with estimates of up to 75% of all women being exposed to HPV at some point. However, almost all infected patients will mount an effective immune response and clear the infection within 2 years without long-term health consequences.

 

Testing for HPV DNA by real-time polymerase chain reaction (PCR) is a noninvasive method for determining the presence of HPV infection. Proper implementation of DNA testing for anal HPV may increase the sensitivity of anal cancer detection and reduce the need for unnecessary biopsy and treatment.

 

Data suggests that individual genotyping for HPV types 16 and 18 can assist in determining appropriate follow-up testing and triaging of patients who are at risk for possible anal cancer. Detection of HR HPV DNA, especially genotypes 16 and 18, may assist in triaging patients and determining appropriate management strategies.

Reference Values

Negative for human papillomavirus (HPV) genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68

Day(s) Performed

Monday through Saturday

Report Available

3 to 6 days

Specimen Retention Time

2 weeks

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test has been modified from the manufacturer's instructions. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information

87626

LOINC Code Information

Test ID Test Order Name Order LOINC Value
AHPV HPV Anal Detect / Genotyping PCR 77376-2

 

Result ID Test Result Name Result LOINC Value
AHPVS Specimen Source 31208-2
607831 HPV High Risk type 16, PCR 77396-0
607832 HPV High Risk type 18, PCR 77395-2
607833 HPV other High Risk types, PCR 77394-5