Interobserver reproducibility and accuracy of p16/<scp>K</scp>i‐67 dual‐stain cytology in cervical cancer screening

Wentzensen, Nicolas; Fetterman, Barbara; Tokugawa, Diane; Schiffman, Mark; Castle, Philip E.; Wood, Shannon N.; Stiemerling, Eric; Poitras, Nancy; Lorey, Thomas; Kinney, Walter

doi:10.1002/cncy.21473

Cited by 59 publications

(99 citation statements)

References 17 publications

(23 reference statements)

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“…45 It has been demonstrated that the dual stain assay can be implemented with little training and that it is highly reproducible. 46, 47 As part of a HPV-cytology co-testing demonstration project, the dual stain was evaluated for triage of HPV-positive cytology-negative women. 48 In a large study within the Kaiser Permanente Northern California (KPNC) Health System, the dual stain was evaluated for triage of HPV-positive women.…”

Section: Triage Testsmentioning

confidence: 99%

Triage of HPV positive women in cervical cancer screening

Wentzensen

Schiffman

Palmer

et al. 2016

Journal of Clinical Virology

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243

189

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Despite HPV vaccines, screening will remain central for decades to control cervical cancer. Recently, HPV testing alone or with cytology was introduced as an alternative to cytology screening. However, most HPV infections are harmless and additional tests are required to identify women with progressing infections or precancer. With three options for primary screening, and without clear strategies for triage of screen-positive women, there is great confusion about the best approach. Also, increasing HPV vaccination coverage will lead to lower disease prevalence, and force new screening approaches. Currently recommended triage strategies for primary HPV screening include HPV genotyping for HPV16 and HPV18 and cytology. Other alternatives that are currently evaluated include p16/Ki-67 dual stain cytology, host methylation, and viral methylation testing. Clinical management of women with cervical cancer screening results is moving to use risk thresholds rather than individual test results. Specific risk thresholds have been defined for return to primary screening, repeat testing, referral to colposcopy, and immediate treatment. Choice of test algorithms is based on comparison of absolute risk estimates from triage tests with established clinical thresholds. Importantly, triage tests need to be evaluated together with the primary screening test and the downstream clinical management. An optimal integrated screening and triage strategy should reassure the vast majority of women that they are at very low risk of cervical cancer, send the women at highest risk to colposcopy at the right time, when disease can be colposcopically detected, and minimize the intermediate risk group that requires continued surveillance.

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Section: Triage Testsmentioning

confidence: 99%

Triage of HPV positive women in cervical cancer screening

Wentzensen

Schiffman

Palmer

et al. 2016

Journal of Clinical Virology

Self Cite

243

189

View full text Add to dashboard Cite

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“…Cervical cytology immunocytochemistry with "dual staining" (p16 plus Ki-67) could, therefore, be used as a triage for HPV-positive women with mildly abnormal smear results [13,20,[23][24][25][26][27][28][29][30][31][32][33]. This dual biomarker approach is morphology independent [27,34] and, therefore, has good reproducibility [34].…”

mentioning

confidence: 99%

Dual p16 and Ki-67 Expression in Liquid-Based Cervical Cytological Samples Compared to Pap Cytology Findings, Biopsies, and HPV Testing in Cervical Cancer Screening: A Diagnostic Accuracy Study

et al. 2018

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Objective: Our objective was to verify the sensitivity and specificity of dual immunocytochemistry staining for p16 and Ki-67 in liquid-based samples (the “dual” assay) for cervical lesion screening, compared to biopsy findings and human papillomavirus (HPV) DNA molecular detection. Study Design: Sensitivity, specificity, and positive (PPV) and negative (NPV) predictive values for the “dual immunocytochemistry assay” were calculated and compared to histopathological results and to high-risk HPV DNA detection in adult women or teenagers submitted to cervical cancer screening. Results: A total of 151 women were included. The majority (96.2%) of those with negative dual assay results had lower biopsy grades (p < 0.001). Women with cytology results suggestive of cervical cancer had positive dual immunocytochemistry assay results more frequently (p < 0.001), and these positive results were also significantly associated with biopsy findings (p < 0.001) and with high-risk genotype HPV infection (p = 0.007). Specificity and PPV for the dual assay were 0.972 (0.855–0.999) and 0.800 (0.284–0.995), respectively, and 1.000 (0.590–1.000) and 1.000 (0.631–1.000) for HPV detection. Conclusions: The dual immunocytochemistry assay had high specificity and PPV. It reveals a persistent HPV infection, avoiding the need for new tissue collections for biopsies or hybrid capture.

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“…Although the application of the above mentioned cytologic criteria will be useful in most of these difficult cases, some investigators recommended that utilization of immunocytologic markers such as Ki67 would be effective in some of the problematic cases (20,21). Other studies proposed that immunocytochemical detection of P16 and ki67 acts as a more accurate route in establishing a correct diagnosis (22)(23)(24).…”

Section: Discussionmentioning

confidence: 99%

Atrophic Pap Smears, Differential Diagnosis and Pitfalls: A Review

Tabrizi¹

2017

International Journal of Women’s Health and Reproduction Scienc

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Interobserver reproducibility and accuracy of p16/Ki‐67 dual‐stain cytology in cervical cancer screening

Cited by 59 publications

References 17 publications

Triage of HPV positive women in cervical cancer screening

Triage of HPV positive women in cervical cancer screening

Dual p16 and Ki-67 Expression in Liquid-Based Cervical Cytological Samples Compared to Pap Cytology Findings, Biopsies, and HPV Testing in Cervical Cancer Screening: A Diagnostic Accuracy Study

Atrophic Pap Smears, Differential Diagnosis and Pitfalls: A Review

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