High specificity triage of ASC-US and LSIL cytology diagnosis

The E6/E7 proteins from the HPV virus have since the early 90’s been regarded as the main cause of cervical cancer development. If E6/E7 mRNA is present in cervix there is an elevated risk of severe dysplasia or worse.

PreTect HPV-Proofer is a molecular diagnostic test for the presence of E6/E7 mRNA in cervical samples. Since most of the cervical cancers worldwide are caused by only five HPV types (HPV 16, 18, 31, 33, 45), PreTect HPV-Proofer only includes these HPV types (HPV types 35, 52 or 58 are optional for PreTect HPV-Proofer HV). Published studies from cancer patient research show that PreTect HPV-Proofer has the same sensitivity towards invasive cervical cancer as compared to other tests (usually called DNA-tests). However, PreTect HPV-Proofer is more accurate (e.g. has a significantly higher specificity) and results in fewer false positive results thereby reducing the high false positive rate of other HPV tests.

Since 2005 PreTect HPV-Proofer has been applied in follow-up of women having the cytological diagnosis ASC-US and LSIL (also called triage). Published studies show that PreTect HPV-Proofer is significantly more accurate (specific) than other triage tests. High specificity is essential in all triage settings to avoid unnecessary and costly follow-up. PreTect HPV-Proofer is a valuable tool for identifying women having high risk of severe dysplasia and at the same time reducing unnecessary referral costs and psychological stress.

Recommended follow-up procedure

All ASC-US or LSIL cytology samples may be reflex tested using PreTect HPV-Proofer. If positive, please refer to colposcopy/biopsy. If negative, please refer to follow-up within 6 to 12 months for a new control smear.

Please observe that PreTect HPV-Proofer is not intended to prevent women from follow-up based on the cytology ASC-US/LSIL result, but to refer those with the highest risk to colposcopy/biopsy and refer those with lower risk to a more conservative follow-up using cytology only.

Both high sensitivity and high specificity

By combining PreTect HPV-Proofer and cytology in follow-up of women having ASC-US or LSIL cytology, it is possible to achieve both high sensitivity and high specificity (see OUS poster, EUROGIN 2011).

More information

Please contact PreTect for more information about PreTect HPV-Proofer or PreTect HPV-Proofer HV.


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