Sign in →

Test Code LAB2708 Human Papillomavirus (HPV) Detection - High Risk

Additional Codes:

HPVHR

Collection:

Specimen: Cervical and/or Endocervical sample

Container: ThinPrep Pap Test vial containing PreservCyt Solution

Volume:  2 ML

Storage Instructions:

Stable at room temperature for 30 days.

Turnaround Time (TAT):

1-4 Days Once order is received in Molecular Microbiology

Test Availability:

Testing Batched – Performed at least three times a week. Observed holidays may adjust testing schedule.

Assay:

Hologic Panther

The Aptima HPV assay is an in vitro nucleic acid amplification test for the qualitative detection of E6/E7 viral messenger RNA (mRNA) from 14 high-risk types of human papillomavirus (HPV) in cervical specimens. The high-risk HPV types detected by the assay include: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. The Aptima HPV assay does not discriminate between the 14 high-risk types.

Fourteen HPV genotypes are considered pathogenic or high-risk for cervical disease. Multiple studies have linked genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68 to disease progression. Women with a persistent infection with one of these types have an increased risk for developing severe dysplasia or cervical carcinoma. HPV infections are very common, and most women will clear HPV infections within 6 to 12 months. The presence of HPV nucleic acid does not mean that cervical dysplasia or cervical cancer is present. However, an effective approach for detection of cervical disease is to target those oncogenic elements of HPV that foster persistent viral infection and cellular transformation.

The use of the test is indicated:

1. To screen women 21 years and older with atypical squamous cells of undetermined significance (ASC-US) cervical cytology results to determine the need for referral to colposcopy. The results of this test are not intended to prevent women from proceeding to colposcopy. This assay is not intended for use as a screening device for women under age 30 with normal cervical cytology.

2. In women 30 years and older, the Aptima HPV assay can be used with cervical cytology to adjunctively screen to assess the presence or absence of high-risk HPV types. This information, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management.

Request Form:

Cytopathology Consultation Request

Send To:

Cytopathology EH314D

Reference Interval:

Negative

Interpretive Data:

This assay has been FDA-cleared for cervical specimens in ThinPrep Pap Test vials containing PreservCyt Solution and collected with broom-type or cytobrush/spatula collection devices. The test detects the E6/E7 viral messenger RNA of the following high-risk HPV genotypes; 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Cross reactions may occur with the following low-risk HPV genotypes; 26, 67, 70 and 82. Negative: No High-Risk HPV E6/E7 mRNA detected. Positive: High-Risk HPV E6/E7 mRNA detected.

Limitations:

  • The Aptima HPV assay is not intended to substitute for regular cervical cytology screening.
  • The Aptima HPV assay is designed to enhance existing methods for the detection of cervical disease and should be used in conjunction with clinical information derived from other diagnostic and screening tests, physical examinations, and full medical history in accordance with appropriate patient management procedures.
    • Infection with HPV is not an indicator of cytologic HSIL or underlying high-grade CIN, nor does it imply that CIN2, CIN3, or cancer will develop. Most women infected with one or more high-risk HPV types do not develop CIN2, CIN3, or cancer.
    • A negative Aptima HPV assay result does not exclude the possibility of cytologic abnormalities or of future or underlying CIN2, CIN3, or cancer.
  • Detection of HPV using the Aptima HPV assay does not differentiate HPV types and cannot evaluate persistence of any one type.
    • The Aptima HPV assay detects E6/E7 viral messenger RNA (mRNA) of the high-risk HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. This test does not detect E6/E7 mRNA of HPV low-risk types (e.g. 6, 11, 42, 43, 44) since there is no clinical utility for testing of low-risk HPV types for cervical cancer screening purposes.
    • False positive results may occur with this test. In vitro transcripts from low-risk HPV genotypes 26, 67, 70, and 82 exhibited cross-reactivity with the Aptima HPV assay.
  • Detection of high-risk HPV mRNA is dependent on the number of copies present in the specimen and may be affected by specimen collection methods, patient factors, stage of infection and the presence of interfering substances.
    • Personal lubricants that contain Polyquaternium 15 may interfere with the performance of the assay when present at concentrations greater than 0.025% (v/v or w/v) of a test sample.
    • Anti-fungal medications that contain tioconazole may interfere with the performance of the assay when present at concentrations greater than 0.075% (w/v) of a test sample.
    • The effects of other potential variables such as vaginal discharge, use of tampons, douching, etc. and specimen collection variables have not been evaluated.
  • The use of this assay has not been evaluated for the management of HPV vaccinated women, women with prior ablative or excisional therapy, hysterectomy, who are pregnant, or who have other risk factors (e.g., HIV+, immunocompromised, history of sexually transmitted infection). The Aptima HPV assay has not been evaluated in cases of suspected abuse.

 

Performed in:

Molecular Microbiology