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

Background: Screening 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.

Methods: We 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.

Results: Of 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).

Conclusion: All 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.