CINtec PLUS Immunocytochemistry as a Tool for the Cytologic Diagnosis of Glandular Lesions of the Cervix Uteri

Abstract

Cytologic findings of glandular lesions of the cervix uteri are often difficult to evaluate. We studied the usefulness of CINtec PLUS p16/Ki-67 double stain (mtm laboratories, Heidelberg, Germany) for the diagnosis of glandular lesions. The study included 47 abnormal results on liquid-based cytologic tests with a subsequent histologic diagnosis of adenocarcinoma in situ or with early invasion, and 16 samples with negative results on follow-up. All samples were stained with CINtec PLUS p16/Ki-67 double stain. Of the neoplastic samples, 7 were excluded because of insufficient residual cellularity or loss of neoplastic cells. Of the samples that were adequate, 92.5% were stained with CINtec PLUS, whereas 7.5% were judged inconclusive. All inconclusive cases were at least 3 years old. Of the 16 negative samples, 15 (93.8%) stained negative and only 1 (6.2%) showed several positive clusters of cells. Our study shows that CINtec PLUS is a robust and useful tool for the diagnosis of glandular lesions of the cervix uteri.

Screening for Cervical Cancer Precursors With p16/Ki-67 Dual-Stained Cytology: Results of the PALMS Study

“…Previous studies were limited to the triage of abnormal Pap cytology (14,17,19–22) or positive HPV test results (15,16,18). Initial studies were also predominantly based on p16 single-stained cytology protocols combined with the morphologic interpretation of immunoreactive cells (14).…”

Prospective evaluation of p16/Ki‐67 dual‐stained cytology for managing women with abnormal Papanicolaou cytology: PALMS study results

“…There are a growing number of studies evaluating the analytical performance and clinical usefulness of p16/Ki‐67 dual‐stained cytology in cervical cancer screening and diagnosis . The majority of the previously reported studies on the use of dual‐stained cytology for triaging abnormal screening results, such as ASC‐US and LSIL Pap cytology results, have been retrospective evaluations.…”

“…Testing for the presence of cervical epithelial cells simultaneously coexpressing the tumor‐suppressor protein p16 INK4a (p16) and the proliferation marker Ki‐67 using a dual immunocytochemical staining protocol (p16/Ki‐67 dual‐stained cytology) has been shown in several, mostly retrospective, studies to be an effective triage tool for abnormal Pap cytology results. Dual‐stained cytology testing has been reported to significantly increase the specificity over HPV testing, without substantially reducing the detection rates of underlying CIN2+ in women with ASC‐US and LSIL cytology results …”

“…Dual-stained cytology testing has been reported to significantly increase the specificity over HPV testing, without substantially reducing the detection rates of underlying CIN21 in women with ASC-US and LSIL cytology results. [9][10][11][12][13][14][15][16][17] In the current study, we analyzed the performance of p16/Ki-67 dual-stained cytology for the triage of ASC-US and LSIL cytology results as a subanalysis of the Primary, ASC-US, LSIL Marker Study (PALMS), a large, prospective, multicenter cervical cancer screening trial conducted in Belgium, France, Germany, Italy, and Spain. 18 The results of the evaluation of dual-stained cytology compared with Pap cytology and Hybrid Capture 2 (HC2) HPV testing (Digene Corporation, Gaithersburg, MD) in primary screening have been published recently.…”

Cytological Diagnoses of Adenocarcinoma in situ of the Cervix: Common Misdiagnoses

“…Second, some nonneoplastic changes and neoplastic lesions that present cytologically are frequently misdiagnosed as cervical glandular lesions, which leads to a high false-positive rate [6,7]. This high false-positive rate has been attributed to misdiagnoses due to some nonneoplastic changes such as metaplastic, inflammatory and pregnancy-related changes [8,9,10].…”