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Test Code ATPCO Anal ThinPrep Cytology with Human Papillomavirus (HPV) Co-Test, Varies


Necessary Information


1. The following information must accompany the specimen: Patient's name, medical record number, date of birth, sex, source (exact location and procedure used), date specimen was taken, name of ordering physician and pager number.

2. Submit any pertinent history or clinical information.



Specimen Required


Supplies: PreservCyt Vial (T536)

Specimen Type: Anus or rectum

Container/Tube: ThinPrep/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. Moisten 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. Place labels on the vial and on the bag.

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


Secondary ID

614402

Useful For

Detection of malignant and premalignant changes

 

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 Pap smear results

 

The cobas HPV test is not recommended for evaluation of suspected sexual abuse.

Additional Tests

Test ID Reporting Name Available Separately Always Performed
AHPV HPV Anal Detect / Genotyping PCR No Yes

Testing Algorithm

When this test is ordered, a cytology screen and genotyping for high-risk human papillomavirus types will be performed.

Method Name

ATPCO: Light Microscopy

AHPV: Real-Time Polymerase Chain Reaction (PCR)

Reporting Name

Anal ThinPrep Cytology w/HPV CoTest

Specimen Type

Varies

Specimen Minimum Volume

See Specimen Required

Specimen Stability Information

Specimen Type Temperature Time Special Container
Varies Ambient 21 days THIN PREP

Reject Due To

SurePath vial
Specimen containing CytoRich Red preservative fluid
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 the human anogenital mucosa. However, data suggest that 14 of these types (HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) are considered 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)

 

Sexually transmitted infection with 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 any long-term health consequences.

 

DNA testing by real-time polymerase chain reaction (PCR) is a noninvasive method for determining the presence of anal HPV infection. Proper implementation of DNA testing for HPV may:

1. Increase the sensitivity of anal cancer detection

2. Reduce the need for unnecessary biopsy and treatment

 

Recently, data suggest 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 cervical cancer and may be useful in cases of possible anal cancer. Detection of HRHPV DNA, especially genotypes 16 and 18, may assist in triaging patients and determining appropriate management strategies.

Reference Values

ThinPrep ANAL SWAB

Satisfactory for evaluation. Negative for intraepithelial lesion or malignancy.

 

HUMAN PAPILLOMAVIRUS (HPV)

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

Interpretation

Cytology:

Suspicious or atypical results need further confirmation: clinical observation, repeat cytology, or perhaps appropriate biopsy.

 

Positive results should be confirmed by histologic examination of tissue before definitive therapy is instituted.

 

Human papillomavirus:

A positive result indicates the presence of human papillomavirus (HPV) DNA due to 1 or more of the following genotypes: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68.

 

A negative result indicates the absence of HPV DNA of the targeted genotypes. Management of abnormal results requires consideration of baseline risk of anal cancer and prior anal cytology and HPV results.

 

For patients with an anal Pap test result showing atypical squamous cells of undetermined significance (ASC-US) and who are positive for high-risk (HR) HPV, consider referral for anoscopy, if clinically indicated.

 

For men and women with a negative anal Pap test result but who are positive for HPV-16 or HPV-18, consider referral for anoscopy, if clinically indicated.

 

For men and women with a negative anal Pap smear, positive-HR-HPV test result, but who are negative for HPV-16 and HPV-18, consider repeat testing by both cytology and HR-HPV in 12 months.

Day(s) Performed

Monday through Friday

Report Available

3 to 6 days

Specimen Retention Time

Up to 1 week depending on results

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

ATPCO – 88112

AHPV - 87624

LOINC Code Information

Test ID Test Order Name Order LOINC Value
ATPCO Anal ThinPrep Cytology w/HPV CoTest In Process

 

Result ID Test Result Name Result LOINC Value
614403 Interpretation 69965-2
614404 Participated in the Interpretation No LOINC Needed
614405 Report electronically signed by 19139-5
614406 Addendum 35265-8
614407 Gross Description 22634-0
CY088 Source 22633-2
CY089 Clinical History 22636-5
614408 Disclaimer 62364-5
614409 Case Number 80398-1