| Web: | mayocliniclabs.com |
|---|---|
| Email: | mcl@mayo.edu |
| Telephone: | 800-533-1710 |
| International: | +1 855-379-3115 |
| Values are valid only on day of printing | |
Test Id : HPVHR
Human Papillomavirus (HPV), High-Risk, DNA In Situ Hybridization
Useful For
Suggests clinical disorders or settings where the test may be helpful
Suggests clinical disorders or settings where the test may be helpful
Detection of human papillomavirus DNA from high-risk genotypes (16, 18, 31, 33, and 51)
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
Human papillomavirus (HPV) High Risk E6/E7 RNA ISH could be performed and reported at the discretion of the Mayo pathologist if clinically indicated but will not be billed separately.
Method Name
A short description of the method used to perform the test
A short description of the method used to perform the test
In Situ Hybridization
NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.
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
Lists a shorter or abbreviated version of the Published Name for a test
HPV High-Risk ONLY DNA ISH
Aliases
Lists additional common names for a test, as an aid in searching
Lists additional common names for a test, as an aid in searching
HPV (Human Papillomavirus)
HPVHR
GPHPVHRISH
ISHPVFAM16ISH
ISNEGHPVISH
ISDNAHPVISH
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
Human papillomavirus (HPV) High Risk E6/E7 RNA ISH could be performed and reported at the discretion of the Mayo pathologist if clinically indicated but will not be billed separately.
Specimen Type
Describes the specimen type validated for testing
Describes the specimen type validated for testing
Special
Additional Testing Requirements
If additional interpretation or analysis is needed, request PATHC / Pathology Consultation along with this test.
The probe set used in this human papillomavirus (HPV) DNA in situ hybridization (ISH) test cannot detect all potential HPV serotypes that are associated with oropharyngeal squamous cell carcinoma. If this test is negative, a more sensitive test, Human Papillomavirus (HPV) High Risk E6/E7 RNA In Situ Hybridization, could be performed and reported if clinically indicated but will not be billed separately.
Shipping Instructions
Attach the green pathology address label included in the kit to the outside of the transport container.
Necessary Information
A pathology/diagnostic report and a brief history are required.
Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing
Defines the optimal specimen required to perform the test and the preferred volume to complete testing
Supplies: Pathology Packaging Kit (T554)
Specimen Type: Formalin-fixed, paraffin-embedded tissue block
Specimen Volume: Entire block
Specimen Type: Slides
Slides: 5 unstained glass, positively charged slides with 5 (+ or - 1)-microns formalin-fixed, paraffin-embedded tissue
Forms
If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:
-Immunohistochemical (IHC)/In Situ Hybridization (ISH) Stains Request (T763)
-Oncology Test Request (T729)
Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected
Identifies specimen types and conditions that may cause the specimen to be rejected
| Wet/frozen tissue Cytology smears Nonformalin fixed tissue Nonparaffin embedded tissue Noncharged slides ProbeOn slides | 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
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 |
|---|---|---|---|
| Special | Ambient (preferred) | ||
| Refrigerated | |||
Useful For
Suggests clinical disorders or settings where the test may be helpful
Suggests clinical disorders or settings where the test may be helpful
Detection of human papillomavirus DNA from high-risk genotypes (16, 18, 31, 33, and 51)
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
Human papillomavirus (HPV) High Risk E6/E7 RNA ISH could be performed and reported at the discretion of the Mayo pathologist if clinically indicated but will not be billed separately.
Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Persistent infections with high-risk human papillomavirus (HPV) genotypes (16, 18, 31, 33, and 51) are associated with cervical, vaginal, vulvar, and head and neck malignancies. Patients with HPV-related oropharyngeal squamous cell carcinoma (OPSCC) have shown better disease-specific survival and overall survival when compared to HPV-negative cases of OPSCC.
Interpretation
Provides information to assist in interpretation of the test results
Provides information to assist in interpretation of the test results
This test, when not accompanied by a pathology consultation request, will be answered as either positive or negative. If additional interpretation or analysis is needed, request PATHC / Pathology Consultation along with this test.
Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Age of a cut paraffin section can affect staining quality. Stability thresholds vary widely among published literature. Best practice is for paraffin sections to be cut within 6 weeks.
Clinical Reference
Recommendations for in-depth reading of a clinical nature
Recommendations for in-depth reading of a clinical nature
1. Belobrov S, Cornall A, Young R, et al: The role of human papillomavirus in p16-positive oral cancers. J Oral Pathol Med. 2018;47(1):18-24
2. Ducatman B: The role of human papillomavirus in oropharyngeal squamous cell carcinoma. Arch Pathol Lab Med. 2018;142(6):715-718
3. Windon M, D'Souza G, Rettig E, et al: Increasing prevalence of human papillomavirus–positive oropharyngeal cancers among older adults. Cancer. 2018;124(14):2993-2999
Method Description
Describes how the test is performed and provides a method-specific reference
Describes how the test is performed and provides a method-specific reference
In situ hybridization on sections of paraffin-embedded tissue.(Unpublished Mayo method)
PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information
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.
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.
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.
5 to 7 days
Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Until staining is complete.
Performing Laboratory Location
Indicates the location of the laboratory that performs the test
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.
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.
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 was developed, and its performance characteristics 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.
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.
CPT codes are provided by the performing laboratory.
88365-Primary
88364-If additional ISH
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.
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 |
|---|---|---|
| HPVHR | HPV High-Risk ONLY DNA ISH | 49896-4 |
| 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.
|
|---|---|---|
| 71194 | Interpretation | 50595-8 |
| 71195 | Participated in the Interpretation | No LOINC Needed |
| 71196 | Report electronically signed by | 19139-5 |
| 71198 | Material Received | 81178-6 |
| 71593 | Disclaimer | 62364-5 |
| 72111 | 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.
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.
Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.
Normal and Abnormal sample reports are provided as references for report appearance.
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.
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.
Test Update Resources
| Change Type | Effective Date |
|---|---|
| Test Status - Test Resumed | 2022-01-06 |
| Test Status - Test Down | 2021-10-15 |