Evaluation Of The Performance Of Cintec (R) Plus In Surepathtm Liquid-Based Cervico-Vaginal Samples
TURKISH JOURNAL OF PATHOLOGY(2021)
摘要
Objective: Cervical cytology and Human papillomavirus (HPV) testing are effective screening techniques but both have limitations. A few recent studies in the literature have highlighted the role of co-expression of pl6(INK4a) and Ki-67 for cervical cancer screening. The present study was undertaken to evaluate the diagnostic performance of the CINtec (R) PLUS kit (dual immunostaining for p16 and Ki-67) in SurePathTM liquid-based (LBC) cervico-vaginal samples.Materials and Methods: This was a prospective study performed on 52 cervico-vaginal SurePath (TM) LBC samples reported as having squamous epithelial cell abnormality (ECA). All the samples were stained using CINtec (R) PLUS kits. Additionally, I IPV-DNA testing was also done and the results were compared.Results: The age range was 34-74 years. ECA included 18 (34.6%) cases of ASC- US, 9 (17.3%) cases of low-grade squamous intraepithelial lesion (LSIL), 11 (21.2%) cases of high-grade squamous intraepithelial lesion (HSIL), and 14 (26.9%) cases of squamous cell carcinoma (SCC). Cervical biopsies were available in 19 (36.5%) cases. A total of 34/52 (65.4%) cases were positive for HPV-DNA (5/18-ASC-US; 619-LSIL; 10/11-HSIL; 13/14-SCC). The CINtec (R) PLUS test was positive in 41/52 (78.8%) cases (11/18-ASC-US; 619-LSIL; 11/11-HSIL; 13/14-SCC). On comparing CINtec (R) PLUS positivity (78.8%) with HPV positivity (65.4%), dual positivity was seen in 3/18 cases of ASC-US, 6/9 cases of LSIL, 10/11 cases of HSIL, and 12/14 cases of SCC. One case each of HSIL and SCC was negative on the HPV test and was positive on CINtec (R) PLUS.Conclusions: CINtec (R) PLUS test helps to improve the detection of pre-cancerous cervical lesions as compared to cervical cytology or HPV testing alone and hence can serve as a potentially useful diagnostic and triage tool, especially for indeterminate cases.
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关键词
Cervical cytology, Pap smear, Liquid-based cytology, CINtec PLUS, p16, Ki-67
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