High-Risk HPV Genotyping


Useful for

Screening for infection with high-risk human papillomavirus (HPV) associated with the development of cervical cancer

Individual genotyping of HPV-16 and/or HPV-18 if present

This test is not recommended for evaluation of suspected sexual abuse.

This test is not intended for women who have undergone hysterectomy.

This test is not intended for use with samples other than those collected by a clinician using an endocervical brush or spatula and placed in the ThinPrep Pap test PreservCyt solution.

This test is not intended for use in determining the need for treatment (ie, excisional or ablative treatment of the cervix) in the absence of high-grade cervical dysplasia. Patients who are HPV16/18 positive should be monitored carefully for the development of high-grade cervical dysplasia according to current practice guidelines. When this test is ordered, human papillomavirus (HPV) with genotyping by polymerase chain reaction (PCR) will be performed. If the patient is 25 years of age or older and HPV with genotyping by PCR is positive for other high-risk types and negative for types 16 and 18, then HPV cytology reflex test will be performed at an additional charge.



High Risk HPV

HPV (Human Papillomavirus) PCR

Human Papillomavirus (HPV) Genotyping


Specimen Type

Cervical (endocervical or ectocervical), Wart scrub in Thin Prep Media, brush or spatula scrub in Thin Prep Media

Specimen Volume

20 mL of solution in ThinPrep/PreservCyt vial

Rejected Due To 

Specimen containing preservative fluid and/or glacial acetic acid

Human papillomavirus with Genotyping Polymerase Chain Reaction:

A positive result indicates the presence of human papillomavirus (HPV) DNA due to 1 or more of the following genotypes: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68.

A negative result indicates the absence of HPV DNA of the targeted genotypes.

For patients with atypical squamous cells of undetermined significance Pap smear result and who are positive for high-risk-HPV, consider referral for colposcopy, if clinically indicated.

For women 25 years and older who are positive for HPV-16 and/or HPV-18 but negative by Pap smear, consider referral for colposcopy, if clinically indicated.

Method Description

The human papillomavirus (HPV) test targets and detects nucleic acid from the L1, E6 & E7 region of the HPV genome using Taqman Real-time polymerase chain reaction technology.

The assay is able to specifically assess for the presence or absence of HPV genotypes 16 and 18, while concurrently detecting the remaining 12 high-risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68).





Turn-Around-Time (TAT)*

Routine – Weekly

Every day