See Specimen Submission Instructions for test requisition, specimen labeling and specimen packaging requirements. 

Test Description

HPV (Human Papillomavirus) HR (High Risk)  – The Cervista™ HPV HR test is an in vitro diagnostic test for the qualitative detection of DNA from 14 high-risk Human Papillomavirus (HPV) types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) in cervical specimens. The Cervista™ HPV HR test uses Invader® chemistry, a signal amplification method for the detection of specific nucleic acid sequences.

Indications

1. To screen patients with atypical squamous cells of undetermined significance (ASCUS) cervical cytology to determine the need for referral to colposcopy.
2. In women 30 years or older the Cervista™ HPV HR test can be used with cervical cytology to adjunctively screen to access the presence or absence of high-risk HPV types.

Specimen Requirements

Cervical specimen collected using routine pap specimen collection technique.

Note: when collected in conjunction with a colposcopy for biopsy, HPV specimen must be collected prior to application of acetic acid/biopsy collection. Failure to do so may yield an HPV specimen that is insufficient for testing or a false negative HPV result.

Acceptable specimen for in-house HR HPV assay

1. ThinPrep® Pap Test PreservCyt Solution* vial collected with a Broom type device (Rovers Cervex® Brush, Wallach Papette®), or Endocervical Brush/Spatula.

      *Cervista™ methodology includes an internal control for the presence of human DNA in each patient sample. Specimens with low cellularity or contaminating substances* may have insufficient DNA present for valid testing, yielding an “Insufficient or Indeterminate” result. *Contamination of the cervix with lubricant, contraceptive jellies or anti-fungal creams. (Clotrimizole or miconazole) may result in an insufficient specimen for HPV testing.

Note: Specimens submitted for HPV testing collected in SurePath Preservative ® vials or DNA Collection Devices will be forwarded to a reference laboratory for testing. Contact the cytology department for specimen requirements.

Stability

ThinPrep® collection vials are stable for 30 days at ambient temperatures for HPV HR

Reference Range

Test is reported as:

1. Negative (Normal reference value)
2. Positive
3. Insufficient human DNA detected – recommend recollection

CPT Code

87621