Test Catalog

Test Id : ATPCO

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

Useful For
Suggests clinical disorders or settings where the test may be helpful

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
Lists tests that are always performed, at an additional charge, with the initial tests.

Test Id Reporting Name Available Separately Always Performed
AHPV Anal HPV with Genotyping, PCR, V No Yes

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

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

Method Name
A short description of the method used to perform the test

ATPCO: Light Microscopy

AHPV: Real-Time Polymerase Chain Reaction (PCR)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Anal ThinPrep Cytology w/HPV CoTest

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

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

Specimen Type
Describes the specimen type validated for testing

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.

ORDER QUESTIONS AND ANSWERS

Question ID Description Answers
CY088 Source Anal
Rectum
CY089 Clinical History

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

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.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

See Specimen Required

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

SurePath vial
Specimen containing CytoRich Red preservative fluid
Reject

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

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

Useful For
Suggests clinical disorders or settings where the test may be helpful

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.

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

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

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

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
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

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
Provides information to assist in interpretation of the test results

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.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

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.

 

HPV-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.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Swanson AA, Hartley C, Long ME, et al: Evaluation of high-risk human papillomavirus testing and anal cytology to detect high-grade anal intraepithelial neoplasia. J Am Soc Cytopathol. 2021 Jul-Aug;10(4):406-413. doi: 10.1016/j.jasc.2021.03.007

2. Libera SD, et al. 2019. Human papillomavirus and anal cancer: Prevalence, genotype distribution, and prognosis aspects from Midwestern region of Brazil. J Oncol. Sep 18; 2019:6018269

3. Wieland U, and Kreuter A: Anal cancer risk: HPV-based cervical screening programmes. Lancet Infect Dis. 2019 Aug:19(8):799-800

Method Description
Describes how the test is performed and provides a method-specific reference

The specimen is collected by the physician during a procedure. This specimen will be processed using ThinPrep instruments to preserve cellular integrity. The slide is then stained with a Papanicolaou stain, coverslipped, and analyzed microscopically by a cytotechnologist and pathologist.(Instruction manuals: ThinPrep 2000 System Operator's Manual. Hologic; MAN-02585-001 Rev. 006, 02/2017; ThinPrep 5000 Processor Operator's Manual. Hologic; MAN-02203-001 Rev. 002, 2016)

 

The cobas human papillomavirus (HPV) test targets and detects nucleic acid from the L1 region of the HPV genome using real-time polymerase chain reaction (PCR) technology. The cobas HPV test is used for the in vitro qualitative detection of 14 high-risk HPV types commonly associated with cervical cancer. The assay is able to specifically assess for the presence or absence of HPV genotypes 16 and 18, while concurrently detecting the remaining 12 high-risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68). The cobas HPV test is used in conjunction with the cobas 4800 System.(Package insert: cobas HPV test. Roche Diagnostics; Version 05641268001-20E, 07/2021)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Friday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

3 to 6 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

Up to 1 week depending on results

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

ATPCO – 88112

AHPV - 87624

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

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
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
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

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports