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Test Code LAB8576 Human Papillomavirus Virus Genotype (HPVG)

Additional Codes

HPVG

Collection:

Specimen: Cervical and/or Endocervical sample

Container: ThinPrep Pap Test vial containing PreservCyt Solution

Volume: 2mL

Storage Instructions:

Stable at room temperature for 30 days.

Turnaround Time (TAT):

1-4 days once HPV HR has been verified.

Test Availability

Testing Batched - Performed at least twice a week. Observed holidays may adjust testing schedule.

Assay

Hologic Panther

The Aptima HPV 16 18/45 genotype assay is an in vitro nucleic acid amplification test for the qualitative detection of E6/E7 viral messenger RNA (mRNA) of human papillomavirus (HPV) types 16, 18, and 45 in cervical specimens from women with Aptima HPV assay positive results. The Aptima HPV 16 18/45 genotype assay can differentiate HPV 16 from HPV 18 and/or HPV 45 but does not differentiate between HPV 18 and HPV 45.

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. Studies have shown that different types of high-risk HPV confer different levels of risk for developing severe dysplasia or cervical carcinoma. World-wide, HPV types 16, 18, and 45 are associated with approximately 80% of all invasive cervical cancers. These three types are found in 75% of all squamous carcinomas, with type 16 alone found in over 60% of all squamous carcinomas. In adenocarcinomas, HPV types 16, 18, and 45 are found in 80-94% of cases, with types 18 and 45 comprising almost half of these infections. The presence of HPV type 18 in early-stage cervical cancer has been reported to be associated with a poor prognosis. HPV types 18 and 45 are under-reported in precancerous lesions, which may be caused by the presence of occult lesions of the cervical canal inaccessible to colposcopic examination. In women infected with HPV types 16 and/or 18, the cumulative risk of developing cervical disease is 10-fold higher compared to the risk for disease development due to other high-risk types.

The use of the test is indicated:

1. In women 21 years and older with atypical squamous cells of undetermined significance (ASC-US) cervical cytology results, the Aptima HPV 16 18/45 genotype assay can be used to test samples from women with Aptima HPV High Risk assay (LAB2708) positive results to assess the presence or absence of high-risk HPV genotypes 16, 18, and/or 45. This information, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. The results of this test are not intended to prevent women from proceeding to colposcopy. The Aptima HPV 16 18/45 genotype assay is not intended for use in women under age 30 with normal cervical cytology.

2. In women 30 years and older, the Aptima HPV 16 18/45 genotype assay can be used to test samples from women with Aptima HPV High Risk assay (LAB2708) positive results. The assay results will be used in combination with cervical cytology to assess the presence or absence of high-risk HPV genotypes 16, 18, and/or 45. This information, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management.

The Aptima HPV 16 18/45 genotype assay is not intended for use as a stand-alone assay. The assay should be performed only as a follow-up to an Aptima HPV assay positive result and should be interpreted in conjunction with cervical cytology test results.

Request Form

Cytopathology Consultation Request

Send to

Cytopathology EH314D

Reference Interval

Negative

Interpretive Data

Tis assay has been FDA cleared for cervical specimens in ThinPrep Pap Test vials containing PreservCyt Solution and collected with broom-type or cytobrush/spatula collections devices. This test detects 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 follow low-risk HPV genotypes; 26, 67, 70 and 82.

Limitations:

  • The Aptima HPV 16 18/45 genotype assay is not intended to substitute for regular cervical cytology screening.
  • The Aptima HPV 16 18/45 genotype assay should be interpreted in conjunction with other laboratory and clinical data available to the clinician.
    • A negative Aptima HPV 16 18/45 genotype assay result does not exclude the possibility of cytologic abnormalities or of future or underlying CIN2, CIN3, or cancer.
    • 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.
    • This test is not intended for use in determining the need for treatment (i.e. excisional or ablative treatment of the cervix) in the absence of high-grade cervical intraepithelial neoplasia (CIN). Women who are HPV 16/18/45 positive should be monitored carefully for the development of high-grade CIN according to current practice guidelines.
    • Test results may be affected by improper specimen collection, storage, or specimen processing.
  • Detection of high-risk HPV (types 16, 18, and 45) 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. High concentrations of HPV 45 can reduce the ability of the Aptima HPV 16 18/45 genotype assay to detect the presence of HPV 16 at low levels.
    • The following may interfere with the performance of the assay when present at concentrations greater than those specified: vaginal lubricants (containing Polyquaternium 15) at 1% w/v, antifungal cream (containing tioconazole) at 0.03% w/v, mucus at 0.3% w/v, intravaginal hormones (containing progesterone) at 1% w/v, Trichomonas vaginalis at 3 x 104 cells/mL. The effects of other potential variables such as vaginal discharge, use of tampons, etc. and specimen collection variables have not been evaluated.
  • The use of this test 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

UMC - Molecular Microbiology