Human Papillomavirus (HPV) Detection, High-Risk Types
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Detection of high-risk genotypes associated with the development of cervical cancer (3,4)
As an aid to triaging women with abnormal Pap smear results
Hybrid Capture/Nucleic Acid Hybridization/Signal Amplification
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
High Risk HPV DNA Detection
High Risk HPV
HPV (Human Papillomavirus) Hybrid Capture
Human Papillomavirus (HPV) Typing
HPV (Human Papillomavirus) Hybrid Capture
Human Papillomavirus (HPV) Typing
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.
Forms: If not ordering electronically, submit a Microbiology Request Form (Supply T244) with the specimen.
Specimen source is required.
Submit only 1 of the following specimens:
ThinPrep (Non-Pregnant Women Only)
Specimen Type: Cervical
Container/Tube: ThinPrep vial
Specimen Volume: Swab with >8 mL PreservCyt solution
1. Bag ThinPrep specimens individually as they have a tendency to leak during transport.
2. Place labels on the vial and on the bag.
SurePath Test Pack
Specimen Type: Cervical
Preferred: SurePath Test Pack (PrepStain/AutoCyte PREP) Cervical Collection Kit
Acceptable: Polypropylene, 6-mL tube (Supply T465)
Specimen Volume: SurePath residual-enriched cell pellet (remaining specimen left after processing) from PrepStain/AutoCyte PREP plus additional SurePath preservative fluid (formerly CytoRich) for a total specimen volume of 2 mL
1. Indicate "SurePath" on vial and batch sheet.
2. Bag SurePath (PrepStain/AutoCyte PREP) specimens individually as they have a tendency to leak during transport.
3. Place labels on the vial and on the bag.
Additional Information: This collection method is not U.S. FDA-approved for human papillomavirus testing (does not require approval from laboratory).
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
ThinPrep vials must contain at least 6 mL PreservCyt solution. SurePath (PrepStain/AutoCyte PREP) vials must contain the remaining 800 microL of specimen left in the centrifuge tube after processing on the AutoCyte PREP system plus 2 mL of SurePath Preser
Specimen containing CytoRich Red preservative fluid
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
Human papillomaviruses (HPV) are composed of an icosahedral viral particle (virion) containing an 8,000 base-pair double-stranded, circular DNA molecule surrounded by a protein capsid.
HPV infections are sexually transmitted. The presence of HPV in the female genital tract is associated with a number of disease states including genital condyloma acuminata, condyloma plana, bowenoid papulosis, and cervical, vaginal, and vulvar intraepithelial neoplasia and carcinoma.
Numerous types of HPV viruses have been identified by molecular analysis. These HPV types also can be categorized into low-, intermediate-, and high-risk groups based on their relative distribution in various histopathological diagnosis categories. Detection of high-risk genotypes (n=13) from genital specimens is considered a major determinant associated with the development of cervical cancer.(1-3) Historically, HPV 16 and HPV 18 have been regarded as high-risk cancer-associated HPVs; HPV types 6 and 11 as low-risk; and HPV types 31, 33, and 35 have been demonstrated to have an intermediate association with cancer. Despite this useful conceptual framework, these 7 HPV types have been found in only about 70% of cervical neoplasms. Additional HPVs including types 42, 43, 44, 45, 51, 52, 56, 58, 59, and 68 have been identified as the principal HPVs detected in the remaining lesions. HPV DNA also is present in approximately 10% of women with normal cervical epithelium, but the actual prevalence is strongly influenced by age and other demographic variables.
Prospective studies have shown that 15% to 28% of HPV DNA-positive women developed squamous intraepithelial neoplasia within 2 years, compared to only 1% to 3% of HPV DNA-negative women. In particular, the risk of progression for HPV types 16 and 18 was greater (approximately 40%) than for other HPV types.
Patients who are positive for a high-risk HPV type may be referred for colposcopy. For patients with "atypical squamous cells of unknown significance" (ASCUS) on Pap smear, HPV typing may be used to determine the need for colposcopy.(5-7) Patients who are negative may be followed according to the usual clinical practice.
While certain HPV types are strongly associated with cervical cancer, there is clear evidence that cofactors are involved. The nature and roles of these cofactors are under intense study; however, their contributions to malignant progression are still poorly understood. Some of the cofactors thought to interact with cancer-associated HPV types in the genesis of cervical malignancy are the herpes viruses, tobacco products, oral contraceptives, and certain dietary factors.
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.
Negative for types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68
A positive result indicates the presence of human papillomavirus (HPV) DNA due to 1 or more of the following genotypes of the virus: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68. A negative result indicates the absence of HPV DNA of the target genotypes.
For patients with ASCUS Pap smear results and positive for high-risk HPV types, consider referral for colposcopy if clinically indicated.(5-7)
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
This test is not recommended for evaluation of suspected sexual abuse.
The prevalence of human papillomavirus (HPV) infection in a population may affect performance; positive predictive values decrease in populations with high prevalence of individuals with low-risk of infection.
A negative result does not exclude the possibility of HPV infection (eg, sampling errors may cause false-negative results).
If high concentrations of antifungal cream, contraceptive jelly, or douche are present when the specimen is collected, false-negative results may be obtained, especially if the specimen contains HPV DNA levels near the assay cutoff.
Specimens containing glacial acetic acid are inappropriate for testing and should not be submitted.
This test can only be used with cervical specimens collected using a broom-type collection device and placed in Cytic ThinPrep Pap Test PreservCyt Solution, or cervical specimens collected using SurePath.
Cross-reactivity between both HC2 HPV DNA test probes and the bacterial plasmid pBR322 is possible and the presence of pBR322 homologous sequences has been reported in human genital specimens. False-positive results could occur in the presence of high levels of bacterial plasmid.
Comparison of HC2 HPV DNA Test versus ASCUS (referral Pap population, Kaiser)
HSIL or greater of the time of colposcopy
Among patients presenting with an ASCUS referral Pap smear, the negative predictive value of the HC2 HPV DNA test for having HSIL or greater disease of colposcopy is 99.0%. Sensitivity=93.0% (66/71).
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Sanclemente G, Gill DK: Human papillomavirus molecular biology and pathogenesis. J Eur Acad Dermatol Venereol 2001;16(3):231-240
2. Castle PE, Wacholder S, Lorincz AT, et al: A prospective study of high-grade cervical neoplasia risk among human papillomavirus-infected women. J Natl Cancer Inst 2002;94(18):1406-1414
3. Brentjens MH, Yeung-Yue KA, Lee PC, Tyring SK: Human papillomavirus: a review. Dermatol Clin 2002;20(2):315-331
4. Hagensee ME: Infection with human papillomavirus: update on epidemiology, diagnosis treatment. Curr Infect Dis Rep 2000;2(1):18-24
5. Nguyen HN, Nordqvist SR: The bethesda system and evaluation of abnormal pap smears. Semin Surg Oncol 1999;16(3):217-221
6. Wright TC Jr, Cox JT, Massad LS: 2001 consensus guidelines for the management of women with cervical cytological abnormalities. JAMA 2002;287(16):2120-2129
7. Crum CP, Berkowitz RS: Human papillomaviruses. Applications, caveats and prevention. J Reprod Med 2002;47(7):519-528
Method Description Describes how the test is performed and provides a method-specific reference
The hc2 DNA (Digene) test using Hybrid Capture II technology is a nucleic acid hybridization microplate assay with signal amplification that utilizes chemiluminescent detection. Specimens containing the target DNA hybridize with a specific HPV-RNA probe cocktail. The resultant RNA:DNA hybrids are captured onto the surface of a microplate well coated with antibodies specific for RNA:DNA hybrids. Immobilized hybrids are then reacted with alkaline phosphatase conjugated antibodies specific for the RNA:DNA hybrids, and detected with a chemiluminescent substrate. Several alkaline phosphatase molecules are conjugated to each antibody. Multiple conjugated antibodies bind to each captured hybrid resulting in substantial signal amplification. As the substrate is cleaved by the bound alkaline phosphatase, light is emitted that is measured as relative light units (RLUs) on a luminometer. The intensity of the light emitted denotes the presence or absence of target DNA in the specimen. (Package insert: hc2 DNA [Digene] Specimen Collection Kit, Digene Corp., Beltsville, MD)
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; Varies
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 has been modified from the manufacturer’s instructions. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements.
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|
|83344||HPV High Risk Types||30167-1|