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HelpTest Code LAB3849 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
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.
Secondary ID
614402Useful 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 Papanicolaou (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 CoTestSpecimen Type
VariesSpecimen 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 |
Reference Values
ANAL THINPREP CYTOLOGY
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
Cautions
Cytology: No significant cautionary statements
Human papillomavirus:
The cobas human papillomavirus (HPV) test is US Food and Drug Administration (FDA) approved for cervical and endocervical samples collected in PreservCyt (ThinPrep) media. Other specimen types (eg, anal) are not considered FDA-approved sources; however, verification studies have been completed by Mayo Clinic Laboratories and Mayo Clinic in compliance with CLIA regulations.
The cobas HPV test detects DNA of the high-risk types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. This test does not detect DNA of HPV low-risk types (eg, 6, 11, 42, 43, 44) since these are not associated with cervical cancer and its precursor lesions.
Prevalence of HPV infection in a population may affect performance. Positive-predictive values decrease when testing populations with low prevalence or individuals with no risk of infection.
Infection with HPV is not an indicator of cytologic high-grade squamous intraepithelial lesion (HSIL) or underlying high-grade cervical intraepithelial neoplasia (CIN), nor does it imply that CIN2-3 or cancer will develop. Most patients infected with 1 or more high-risk (HR) HPV types do not develop CIN2-3 or cancer.
A negative HR-HPV result does not exclude the possibility of future cytologic HSIL or underlying CIN2-3 or cancer.
Anal specimens may show visibly detectable levels of whole blood or stool as a pink or light brown coloration. These specimens are processed normally on the cobas 4800 System. If concentrations of whole blood or stool are high, results may be impacted.
The cobas HPV test performance has not been validated with PreservCyt specimens that have been treated with glacial acetic acid for removal of red blood cells. Any such processing of PreservCyt specimens prior to HPV testing would invalidate the cobas HPV test results.
The cobas HPV test performance has not been validated with PreservCyt specimens that have been filled past the maximum fill line of the primary vial. ThinPrep vials that have had any additional PreservCyt fluid volume added or any dissimilar fluid volume added to the initial specimen should not be submitted for testing.
Human papillomavirus-negative cancers of the cervix or anus do occur in rare circumstances. Also, no cancer screening test is 100% sensitive. Use of this device for primary anal cancer screening should be undertaken after carefully considering the performance characteristics put forth in the cobas HPV test label as well as recommendations of professional guidelines.
The presence of real-time polymerase chain reaction inhibitors may cause false-negative or invalid results.
Anal specimens that are grossly contaminated with stool may yield invalid or false-negative results.
Day(s) Performed
Monday through Friday
Report Available
3 to 6 daysPerforming 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
88112
87626
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| ATPCO | Anal ThinPrep Cytology w/HPV CoTest | 77653-4 |
| 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 |