Human Papillomavirus (HPV), High-Risk DNA Detection Only, In Situ DNA Hybridization
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
The detection of specific high-risk human papillomavirus DNA types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, and 66) in paraffin-embedded human tissue
In Situ Hybridization
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
HPV, High-Risk ONLY, In Situ DNA
HPV (Human Papillomavirus)
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
A pathology/diagnostic report and a brief history are required. One slide will be stained with hematoxylin-and-eosin and retained.
Attach the green pathology address label included in the kit to the outside of the transport container.
Specimen Type: Tissue
Container/Tube: Surgical Pathology Packaging Kit (Supply T554)
Specimen Volume: Formalin-fixed, paraffin-embedded tissue block
Specimen Type: Slides
Container/Tube: Surgical Pathology Packaging Kit (Supply T554)
Specimen Volume: 4 Unstained glass, "positively charged" slides with formalin-fixed, paraffin-embedded tissue
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Many human papillomavirus (HPV)-induced lesions are benign, presenting as warts or condylomas. However, certain HPV types have been strongly associated with risk of development of cervical, vaginal, and vulvar malignancy. These types are: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, and 66.
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.
This test, when not accompanied by a pathology consultation request, will be answered as either positive or negative.
If additional interpretation/analysis is needed, please request 70012 / Pathology Consultation along with this test.
Human papillomavirus (HPV) high-risk types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, and 66 are frequently found in cervical intraepithelial neoplasia (CIN) III (severe dysplasias and carcinoma in situ) and cervical cancer. Recent studies have also shown that HPV high-risk types are associated with a subset of oropharyngeal carcinomas.
If additional interpretation or analysis is needed, order 70012 / 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
This assay has been designed for use with buffered, formalin-fixed, paraffin-embedded human tissue. It has not been tested extensively with frozen tissue and is not qualified for use with other fixatives.
A negative result does not exclude the presence of human papillomavirus (HPV) infection.
Failure to detect target DNA may be a result of such factors as improper sampling, fixation, processing of the specimen, or the presence of target DNA at levels below the sensitivity of this assay.
Some tissues with morphological changes indicative of HPV infection may not be reactive with the HPV probes currently available.
Other HPV types may appear in anogenital lesions, but are not detectable with the probes provided using the hybridization conditions employed in this assay.
Not useful for the detection of HPV DNA of any other types than 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, and 66.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Singhi AD, Westra WH: Comparison of human papillomavirus in situ hybridization and p16 immunohistochemistry in the detection of human papillomavirus-associated head and neck cancer based on a prospective clinical experience. Cancer 2010 May;2166-2173
2. Lorincz AT, Lancaster WD, Kurman RJ, et al: Characterization of human papillomaviruses in cervical neoplasias and their detection in routine clinical screening. Banbury Rep 1986; 21:225-237
3. Faulkner-Jones BE, Tabrizi SN, Borg AJ, et al: Detection of human papillomavirus DNA and mRNA using synthetic, type-specific oligonucleotide probes. J Virol Methods 1993;41:277-296
Method Description Describes how the test is performed and provides a method-specific reference
This test is based on colorimetric in situ hybridization techniques, which detect the presence of nucleic acid in cells or tissues. Nucleic acid isvisualized by hybridization of labeled DNA probes to target DNA in human tissue. Paraffin-embedded biopsies are sectioned and placed on positively-charged slides. One section is used for the probe. The sections are deparaffinized, heat-treated, and digested proteolytically to expose the fixed target DNA. Labeled probe is then applied to the section. Double-stranded probe and target DNAs are simultaneously denatured to single strands by heating. The homologous sequences of probe and target then specifically anneal during the subsequent hybridization step. Hybridization probes are detected using a secondary biotinylated detection antibody followed by an alkaline-phosphatase conjugate (streptavidin), which binds specifically to the detection antibody. Dephosphorylation by alkaline phosphatase of the substrate 5-bromo-4-hloro-3-indolyphosphate in the presence of nitroblue tetrazolium results in the deposition of a purplish blue precipitate at sites of probe hybridization to human papillomavirus (HPV) DNA. Finally, the sections are counterstained with nuclear fast red allowing for morphologic examination along with visualization of the target DNA. The test is capable of detecting 1 distinct group of the virus: HPV 16/18/31/33/35/39/45/51/52/56/58/66 in paraffin-embedded human anogenital tissue by in situ hybridization.(Jin L, Lloyd RV: In situ hybridization: methods and applications. J Clin Lab Anal 1997;11:2-9; Plummer TB, Sperry AC, Xu HS, Lloyd RV: In situ hybridization detection of low copy nucleic acid sequences using catalyzed reporter deposition and its usefulness in clinical human papillomavirus typing. Diagn Mol Pathol 1998;7:76-84; Sperry A, Jin L, Lloyd RV: Microwave treatment enhances detection of RNA and DNA by in situ hybridization. Diagn Mol Pathol 1996;5:291-296)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Friday; 7 a.m.
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
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 The location of the laboratory that performs the test
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's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
This test was developed using an analyte specific reagent. 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 U.S. 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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
|Result ID||Reporting Name||LOINC Code|
|20355||Ref Path/Phys Address||In Process|
|20360||SP Signing Pathologist:||N/A|
|20361||*Previous Report Follows*||N/A|