Search Specimen Collection Manual
HPV (Human Papillomavirus) HR (High Risk) Assay
See Specimen Submission Instructions for test requisition, specimen labeling and specimen packaging requirements.
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.
- To screen patients with atypical squamous cells of undetermined significance (ASCUS) cervical cytology to determine the need for referral to colposcopy.
- 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.
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
- 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.
ThinPrep® collection vials are stable for 30 days at ambient temperatures for HPV HR
Test is reported as:
- Negative (Normal reference value)
- Insufficient human DNA detected – recommend recollection