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

BackgroundCINtec(R) 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(R) PLUS, but its accuracy and efficacy in triaging HPV-positive women need to be evaluated. MethodsA total of 717 HPV-positive specimens of cervical exfoliated cells were included. Cytology, Dalton, and CINtec(R) 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. ResultsThe overall positive rate of two DS tests were 28.31% for Dalton and 33.89% for CINtec(R) PLUS (p < 0.05); both rose with the increased severity of histopathological and cytological abnormalities. Compared to CINtec(R) 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(R) PLUS positive. Compared to CINtec(R) 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+. ConclusionsDalton presents the lower false positive rate and better efficacy in identifying high-grade CIN than CINtec(R) PLUS, suggesting that Dalton may be superior to CINtec(R) PLUS and an alternative technique for triaging primary HPV-positive women in cervical cancer screening.

Automated summary

The Dalton p16/Ki-67 Dual Stain kit demonstrates a lower false positive rate and better efficacy in identifying high-grade cervical intraepithelial neoplasia (CIN) than the CINtec(R) PLUS test in triaging HPV-positive women.