Cellular Pathology


High Risk Human Papilloma Virus

Principle of Examination

There are over 100 subtypes of Human Papillomavirus (HPV), most of which do not cause significant disease in humans. Some subtypes (notably types 16 and 18) have been confirmed as agents causing cervical cancer and these are known as high-risk HPV (HR-HPV) types.

HPV infection in most women is transient, as it is cleared by the immune system. However, for reasons that are not clear the virus persists in some women, and it is these women who are at increased risk of cervical intraepithelial neoplasia (CIN) and cervical cancer.

Almost 100% of cervical cancers contain HPV DNA. In women with CIN, the more severe it is the more likely it is that HR-HPV infection will be present. Women with no evidence of HR- HPV infections are extremely unlikely to develop cervical cancer in the short to medium term.

Samples from women with borderline changes in squamous cells, borderline changes in endocervical cells or with low grade dyskaryosis changes are tested for HR-HPV and those that are positive will be referred to colposcopy.

Women that are negative for HR-HPV are unlikely to have significant disease and they can be returned to routine recall, either 3 or 5 years depending on her age.

Samples from women that have been treated for any grade of Cervical intraepithelial Neoplasia (CIN) will be HPV tested.  Samples that have a cytology result of either normal, low grade dyskaryosis or borderline changes will be included. Those that are HR-HPV positive will be referred to colposcopy and those that are HR-HPV negative will be recalled for a cytology screening sample in 36 months.

The test of cure will also apply to women who have received treatment for cervical glandular abnormalities (fully excised CGIN).  These women will require 2 negative TOC results before being returned to a 36 month recall.

The test of cure will not apply to women who have been diagnosed with invasive disease.

 HPV testing platform

The Cytopathology department uses the Roche Cobas® 4800 system for all HPV testing. The Roche Cobas® 4800 system integrates fully automated total nucleic acid isolation directly from primary and secondary sample tubes, automated PCR setup, and real-time PCR. The Cobas® 4800 system is comprised of the Cobas® 4800 software, the Cobas x 480 instrument used for sample preparation, and the Cobas z 480 analyser used for amplification and detection using real-time PCR. The Cobas® 4800 HPV test is a qualitative in vitro test utilising amplification of target DNA by PCR and nucleic acid hybridisation for the detection of 14 HR-HPV types (12 HR types and HR genotypes 16 and 18) in a single analysis.  Uncertainty of measurement is available for this HPV assay, please contact the laboratory.

Specimen Requirements

Cervical cytology samples are tested against NHS CSP protocols.

All request forms and specimen containers must have at least THREE patient identifiers, such as full name, date of birth, hospital number and NHS number.

Turnaround Time 

In order to meet the cancer review standards 2011 and for women to receive their results in 14 days, the laboratory process must be as efficient as possible and delays should be avoided in any part of the laboratory or reporting process.

Specimen Labelling Procedure