A Comparative Study on the Accuracy and Efficacy Between Dalton and CINtec(®) PLUS p16/Ki-67 Dual Stain in Triaging HPV-Positive Women

BACKGROUND: CINtec(®) PLUS p16/Ki-67 dual-stained cytology (DS) is an alternative test to cytology in triaging human papillomavirus (HPV)-positive women. Dalton p16/Ki-67 Dual Stain kit employs the similar immunocytochemical detection and operating procedures with CINtec(®) PLUS, but its accuracy and efficacy in triaging HPV-positive women need to be evaluated. METHODS: A total of 717 HPV-positive specimens of cervical exfoliated cells were included. Cytology, Dalton, and CINtec(®) PLUS were subsequently performed, and two DS tests were separately completed in each of the same specimens. The results of two DS tests were head-to-head compared, and their efficacies to identify high-grade cervical intraepithelial neoplasia (CIN) were evaluated, using histopathology of biopsy as the golden standard. RESULTS: The overall positive rate of two DS tests were 28.31% for Dalton and 33.89% for CINtec(®) PLUS (p < 0.05); both rose with the increased severity of histopathological and cytological abnormalities. Compared to CINtec(®) PLUS, the positive rate of Dalton was significantly lower in the normal histopathology group (p < 0.05) and lower, but not significantly, in mild abnormal histopathology and cytology NILM and LSIL groups. Two DS tests showed a good consistency (Kappa value, 0.63; 95% CI, 0.557–0.688), with 100% of consistency in the cytology HSIL group. Inconsistency occurred mainly in the cytology NILM and LSIL groups, with more Dalton negative but CINtec(®) PLUS positive. Compared to CINtec(®) PLUS, Dalton showed similar sensitivity (94.59% vs. 91.89%), but significantly higher specificity (75.29% vs. 69.26%, p = 0.013) and accuracy (76.29% vs. 70.43%, p = 0.012), with a larger area under the curve (AUC) of 0.849 (95% CI, 0.800–0.899) for identifying CIN3+. The similar results were observed when identifying CIN2+. CONCLUSIONS: Dalton presents the lower false positive rate and better efficacy in identifying high-grade CIN than CINtec(®) PLUS, suggesting that Dalton may be superior to CINtec(®) PLUS and an alternative technique for triaging primary HPV-positive women in cervical cancer screening.