Test Id : HPVHL
Human Papillomavirus (HPV) High/Low Risk, In Situ Hybridization
Useful For
Suggests clinical disorders or settings where the test may be helpful
Detecting human papillomavirus for both low-risk (6, 11) and high-risk (16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73, and 82.) genotypes
Method Name
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.
Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test
Aliases
Lists additional common names for a test, as an aid in searching
HPV (Human Papillomavirus)
Papillomavirus
GPHPVHLISH
ISHPV611ISH
HPV E6/E7
ISHPV16ISH
ISNEGHPVISH
ISDNAHPVISH
Specimen Type
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.
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
Supplies: Pathology Packaging Kit (T554)
Specimen Type: Formalin-fixed, paraffin-embedded tissue block
Specimen Volume: Entire block
Specimen Type: Slides
Slides: 6 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:
-Oncology Test Request (T729)
-Immunohistochemical (IHC)/In Situ Hybridization (ISH) Stains Request (T763)
Reject Due To
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
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Special | Ambient (preferred) | ||
| Refrigerated | |||
Useful For
Suggests clinical disorders or settings where the test may be helpful
Detecting human papillomavirus for both low-risk (6, 11) and high-risk (16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73, and 82.) genotypes
Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Human papillomavirus (HPV) infections with low-risk genotypes (6, 11) can cause benign hyperplasia such as condylomas and papillomas. Persistent infections with high-risk genotypes (16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73, and 82) 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.
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.
Results are reported as positive or negative for types 6 and 11 (low risk), and 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73, and 82(high risk).
Interpretation
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
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
1. Lindemann ML, Dominguez MJ, de Antonio JC, et al: Analytical comparison of the cobas HPV test with hybrid capture 2 for the detection of high-risk HPV genotypes. J Mol Diagn. 2012 Jan;14(1):65-70
2. Bishop JA, Ma XJ, Wang H, et al: Detection of transcriptionally active high-risk HPV in patients with head and neck squamous cell carcinoma as visualized by a novel E6/E7 mRNA in situ hybridization method. Am J Surg Pathol. 2012 Dec;36(12):1874-1882
3. Mirghani H, Casiraghi O, Guerlain J, et al: Diagnosis of HPV driven oropharyngeal cancers: Comparing p16 based algorithms with the RNAscope HPV-test. Oral oncology. 2016;62:101-108
Method Description
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
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.
Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location
Indicates the location of the laboratory that performs the test
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 account representative. 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 was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It 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.
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.
| Test Id | Test Order Name | Order LOINC Value |
|---|---|---|
| HPVHL | HPV High/Low Risk ISH | 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.
|
|---|---|---|
| 71199 | Interpretation | 50595-8 |
| 71200 | Participated in the Interpretation | No LOINC Needed |
| 71203 | Material Received | 81178-6 |
| 71594 | Disclaimer | 62364-5 |
| 72112 | Case Number | 80398-1 |
| 71201 | Report electronically signed by | 19139-5 |