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.

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.

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+.

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.

CINtec ^® PLUS p16/Ki-67 双染色细胞学 (DS) 是一种替代细胞学的检测方法，用于对人乳头瘤病毒 (HPV) 阳性女性进行分类。^{Dalton p16/Ki-67 Dual Stain 试剂盒采用与 CINtec ®} PLUS类似的免疫细胞化学检测和操作程序，但其在分流 HPV 阳性女性中的准确性和有效性需要评估。

共纳入 717 例 HPV 阳性的宫颈脱落细胞标本。随后进行了细胞学、道尔顿和 CINtec ^® PLUS，并在每个相同的样本中分别完成了两个 DS 测试。两个 DS 测试的结果进行了头对头比较，并使用活检的组织病理学作为金标准，评估了它们识别高级别宫颈上皮内瘤变 (CIN) 的功效。

^{Dalton 和 CINtec ®} PLUS的两项 DS 测试的总体阳性率为 28.31% 和 33.89% (p < 0.05)；两者都随着组织病理学和细胞学异常严重程度的增加而上升。与 CINtec ^® PLUS 相比，Dalton 的阳性率在正常组织病理学组中显着降低（p < 0.05），在轻度异常组织病理学和细胞学 NILM 和 LSIL 组中较低，但不显着。两项 DS 测试显示出良好的一致性（Kappa 值，0.63；95% CI，0.557–0.688），在细胞学 HSIL 组中具有 100% 的一致性。不一致主要发生在细胞学 NILM 和 LSIL 组，更多 Dalton 阴性但 CINtec ^® PLUS 阳性。与 CINtec ^®相比PLUS，Dalton 显示出相似的灵敏度（94.59% 对 91.89%），但特异性显着更高（75.29% 对 69.26%，p = 0.013）和准确度（76.29% 对 70.43%，p = 0.012），面积更大在 0.849 (95% CI, 0.800–0.899) 的曲线 (AUC) 下，用于识别 CIN3+。在鉴定 CIN2+ 时观察到类似的结果。

^{与 CINtec ®} PLUS 相比，Dalton在识别高级别 CIN 方面表现出更低的假阳性率和更好的功效，这表明 Dalton 可能优于 CINtec ^® PLUS 和在宫颈癌筛查中对原发性 HPV 阳性女性进行分类的替代技术。