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

Test Description

HPV (Human Papillomavirus) 16/18 Genotype  – The Cervista™ HPV 16/18 test is an in vitro diagnostic test for the qualitative detection of DNA from Human Papillomavirus (HPV) Type 16 and Type 18 in cervical specimens. The Cervista™ HPV 16/18 test uses Invader® chemistry, a signal amplification method for the detection of specific nucleic acid sequences.

Indications

1. In women 30 years and older the Cervista™ HPV 16/18 test can be used adjunctively with the Cervista™ HPV HR test in combination with cervical cytology to assess the presence or absence of high-risk HPV types 16 and 18. This information, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management.
2. To be used adjunctively with the Cervista™ HPV HR test in patients with atypical squamous cells of undetermined significance (ASC-US) cervical cytology results, to assess the presence or absence of high-risk HPV types 16 and 18. 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 for proceeding to colposcopy.

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 16/18 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 that are 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 16/18

Reference Range

Test is reported as:

1. Negative (Normal reference value): HPV Type 16 and Type 18 not detected
2. Positive: HPV Type 16 and/or Type18 detected
3. Insufficient human DNA detected – recommend recollection

CPT Code

87621