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Interpretive Handbook

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Test 60483 :
Human Papillomavirus (HPV), High-Risk DNA Detection Only, In Situ DNA Hybridization

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.

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

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

Interpretation Provides information to assist in interpretation of the test results

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.

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.

Clinical References 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