AIHTA - Publications - Search - P16/Ki-67 Dual Stain in the triage of PAPIII/IIID cytology in cervical cancer screening

Kisser, A. and Zechmeister-Koss, I. (2013): P16/Ki-67 Dual Stain in the triage of PAPIII/IIID cytology in cervical cancer screening . HTA-Projektbericht 72.

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Each year around 30 000 women in Austria receive a PAPIII or PAPIIID cytology result during routine cervical cancer screening. Roughly equivalent to ASC-US or LSIL cytology according to Bethesda classification, this result means that equivocal cell anomalies or mild to moderate dysplasia were detected in their pap smear. The risk of progression to cancer of these results is unclear and requires further diagnostic investigation: this induces emotional stress to the patients and causes a high number of unnecessary procedures, including biopsies and conisations.
The p16/KI-67 Dual Stain test (CINtec® PLUS) claims to detect virally induced oncogenic molecular changes in the cell through the immune cytochemical double staining of the tumour suppressor gene p16INK4a and the proliferation marker Ki-67 and thereby to improve the triage of women with equivocal cytological results.
We have conducted a systematic review of the studies assessing utility of the p16/Ki-67 Dual Stain test in the triage of equivocal or mild to moderate dysplasia results in cervical cancer screening. We could not identify any studies assessing clinical outcomes such as mortality or morbidity and only one high quality study assessing diagnostic accuracy of the test: the evaluation of the clinical utility of the test was therefore not possible. Consequently the test was not recommended for inclusion in the benefits catalogue of public health insurances.

Item Type:Project Report
Keywords:Pap smear, Human papillomavirus, HPV, CINtec®PLUS, Ki-67, p16INK4a
Subjects:WA Public health > WA 108-245 Preventive medicine
WA Public health > WA 309 Women´s health
QY Clinical pathology
QU Biochemistry > QU 55-70 Proteins. Amino Acids. Peptides
WP Gynaecology > WP 470-480 Cervix uteri. Cervix diseases
WB Practice of medicine > WB 141-293 Diagnosis
QZ Pathology > QZ 200-380 Neoplasms.Cysts
WC Communicable diseases
Series Name:HTA-Projektbericht 72
Deposited on:23 Sep 2013 11:05
Last Modified:15 Jul 2020 17:50

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