A Comparative Study on the Accuracy and Efficacy Between Dalton and CINtec® PLUS p16/Ki-67 Dual Stain in Triaging HPV-Positive Women
BackgroundCINtec® 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 effi...
| Main Authors: | , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Frontiers Media S.A.
2022-01-01
|
| Series: | Frontiers in Oncology |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fonc.2021.815213/full |
| _version_ | 1798025046818553856 |
|---|---|
| author | Ying Li Yunfeng Fu Bei Cheng Xing Xie Xinyu Wang |
| author_facet | Ying Li Yunfeng Fu Bei Cheng Xing Xie Xinyu Wang |
| author_sort | Ying Li |
| collection | DOAJ |
| description | BackgroundCINtec® 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.MethodsA 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.ResultsThe 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+.ConclusionsDalton 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. |
| first_indexed | 2024-04-11T18:13:16Z |
| format | Article |
| id | doaj.art-e4a0e49500f043a89b44f331f3e30833 |
| institution | Directory Open Access Journal |
| issn | 2234-943X |
| language | English |
| last_indexed | 2024-04-11T18:13:16Z |
| publishDate | 2022-01-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Oncology |
| spelling | doaj.art-e4a0e49500f043a89b44f331f3e308332022-12-22T04:10:03ZengFrontiers Media S.A.Frontiers in Oncology2234-943X2022-01-011110.3389/fonc.2021.815213815213A Comparative Study on the Accuracy and Efficacy Between Dalton and CINtec® PLUS p16/Ki-67 Dual Stain in Triaging HPV-Positive WomenYing LiYunfeng FuBei ChengXing XieXinyu WangBackgroundCINtec® 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.MethodsA 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.ResultsThe 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+.ConclusionsDalton 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.https://www.frontiersin.org/articles/10.3389/fonc.2021.815213/fullp16/Ki-67 dual stainhuman papillomaviruscervical cancercervical intraepithelial neoplasiacervical cancer screening |
| spellingShingle | Ying Li Yunfeng Fu Bei Cheng Xing Xie Xinyu Wang A Comparative Study on the Accuracy and Efficacy Between Dalton and CINtec® PLUS p16/Ki-67 Dual Stain in Triaging HPV-Positive Women Frontiers in Oncology p16/Ki-67 dual stain human papillomavirus cervical cancer cervical intraepithelial neoplasia cervical cancer screening |
| title | A Comparative Study on the Accuracy and Efficacy Between Dalton and CINtec® PLUS p16/Ki-67 Dual Stain in Triaging HPV-Positive Women |
| title_full | A Comparative Study on the Accuracy and Efficacy Between Dalton and CINtec® PLUS p16/Ki-67 Dual Stain in Triaging HPV-Positive Women |
| title_fullStr | A Comparative Study on the Accuracy and Efficacy Between Dalton and CINtec® PLUS p16/Ki-67 Dual Stain in Triaging HPV-Positive Women |
| title_full_unstemmed | A Comparative Study on the Accuracy and Efficacy Between Dalton and CINtec® PLUS p16/Ki-67 Dual Stain in Triaging HPV-Positive Women |
| title_short | A Comparative Study on the Accuracy and Efficacy Between Dalton and CINtec® PLUS p16/Ki-67 Dual Stain in Triaging HPV-Positive Women |
| title_sort | comparative study on the accuracy and efficacy between dalton and cintec r plus p16 ki 67 dual stain in triaging hpv positive women |
| topic | p16/Ki-67 dual stain human papillomavirus cervical cancer cervical intraepithelial neoplasia cervical cancer screening |
| url | https://www.frontiersin.org/articles/10.3389/fonc.2021.815213/full |
| work_keys_str_mv | AT yingli acomparativestudyontheaccuracyandefficacybetweendaltonandcintecplusp16ki67dualstainintriaginghpvpositivewomen AT yunfengfu acomparativestudyontheaccuracyandefficacybetweendaltonandcintecplusp16ki67dualstainintriaginghpvpositivewomen AT beicheng acomparativestudyontheaccuracyandefficacybetweendaltonandcintecplusp16ki67dualstainintriaginghpvpositivewomen AT xingxie acomparativestudyontheaccuracyandefficacybetweendaltonandcintecplusp16ki67dualstainintriaginghpvpositivewomen AT xinyuwang acomparativestudyontheaccuracyandefficacybetweendaltonandcintecplusp16ki67dualstainintriaginghpvpositivewomen AT yingli comparativestudyontheaccuracyandefficacybetweendaltonandcintecplusp16ki67dualstainintriaginghpvpositivewomen AT yunfengfu comparativestudyontheaccuracyandefficacybetweendaltonandcintecplusp16ki67dualstainintriaginghpvpositivewomen AT beicheng comparativestudyontheaccuracyandefficacybetweendaltonandcintecplusp16ki67dualstainintriaginghpvpositivewomen AT xingxie comparativestudyontheaccuracyandefficacybetweendaltonandcintecplusp16ki67dualstainintriaginghpvpositivewomen AT xinyuwang comparativestudyontheaccuracyandefficacybetweendaltonandcintecplusp16ki67dualstainintriaginghpvpositivewomen |