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J Cytol. 2019 Jul-Sep;36(3):152-156. doi: 10.4103/JOC.JOC_131_18.

Evaluation of p16/Ki-67 Dual Staining Compared with HPV Genotyping in Anal Cytology with Diagnosis of ASC-US for Detection of High-Grade Anal Intraepithelial Lesions.

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Hospices Civils de Lyon, Virology Department, Institut des Agents Infectieux, Centre de Biologie et de Pathologie Nord, Hôpital de la Croix Rousse, Lyon, France.
Hospices Civils de Lyon, Pathology Department, Centre de Biologie et de Pathologie Sud, Pierre Bénite, France.
Hospices Civils de Lyon, Reproduction Department, Hôpital Femme Mère Enfant, Hospices Civils de Lyon, Bron, France.



Human Papillomavirus (HPV) infection is the main risk factor for anogenital cancer. The objective of this study was to compare p16/Ki-67 dual staining to HPV genotyping in anal cytology samples with an atypical squamous cell of undetermined significance (ASC-US) for the identification of high-grade squamous intraepithelial lesion (HSIL).


Anal cytology samples with an ASC-US result (n = 111) were collected from patients of a university hospital (Lyon, France) from 2014 to 2015. Cases with remaining squamous cells (n = 82) were stained using p16/Ki-67 dual staining (CINtec-Plus kit) and analyzed for HPV screening (CLART2-PCR kit) using a composite endpoint of biopsy and cytology results on follow-up specimens.


Detection of HSIL on follow-up specimens (5/22 biopsies; 1/29 cytology samples) was obtained in two out of six cases with p16/Ki-17 versus. five out of six with HPV genotyping alone. Sensitivity and specificity to detect HSIL for p16/Ki-67 was 33% (95% confidence interval [CI] [4; 77]) and 49% (95%CI [34; 64]) versus. 83% (95%CI [36; 99.6]) and 13% (95%CI [5; 27]) for HPV genotyping.


Herein, HPV genotyping was more sensitive but less specific than p16/Ki-67 staining for the detection of subsequent HSIL in ASC-US anal cytology. A larger study is required to evaluate the combination of these biomarkers for triage.


Anal cytology; CINtec; Human Papillomavirus; anal intraepithelial neoplasia; p16/Ki-67

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