Niyati Desai

Utility of CINtec PLUS in Identification of High‐Grade Lesions on Short‐Term Follow‐Up in Patients With Negative Cytologic Interpretation

ABSTRACTBackgroundScreening for cervical cancer may include cervical cytology and/or high‐risk human papillomavirus testing (HPV). The FDA (Food and Drug Administration)‐approved CINtec PLUS dual stain (DS) for p16 and Ki‐67 can provide helpful information for challenging follow‐up care.MethodsWe retrospectively analyzed 272 cases with negative intraepithelial malignancy (NILM) Papanicolaou (Pap) tests and positive HPV test results. All 272 women had colposcopy‐directed biopsies or endocervical curettage (ECC) (histopathology) within a year. We compared DS test results with corresponding ECC/colposcopy specimens. Two subgroup analyses were conducted to examine the correlation of DS results with a prior history of abnormal Pap/colposcopy and to compare DS results with regard to HPV genotype. For analysis purposes, only high‐grade lesions were considered positive, while low‐grade lesions were grouped with negative results.ResultsOf 272 cases, 113 tested positive for DS, while 159 were negative. On follow‐up histopathology within a year, three of the 113 positive cases (2.6%) showed high‐grade lesions. In comparison, none of the 159 negative cases showed any high‐grade lesions (95% confidence interval [CI]: −0.3% to 5.4% [p = 0.14]). Further analysis by HPV status showed that DS helped in risk discrimination in both subcategories (HPV16/18 and other 12 high‐risk HPV), although it was not statistically significant (p = 0.99). Subgroup analysis based on the history of high‐grade lesions demonstrated that in cases with no previous history, the risk difference was 2.8% between DS positive and negative results (95% CI −0.3% to 6%, p = 0.134).ConclusionAll three high‐grade lesions were in the DS positive category, suggesting DS may help in the risk stratification for HPV‐positive NILM women (either HPV16/18 or other). Furthermore, DS may help with risk stratification, specifically in patients with no prior high‐grade lesions.