THE ROLE OF P16/KI-67 DUAL STAINING IN CERVICAL CANCER SCREENING

Thị Mây Phạm , Trung Thọ Lê, Hoài Chương Lê, Thị Huyền Trần , Thị Nhường Nguyễn

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Abstract

Cervical cancer screening programs have helped reduce cervical cancer incidence and mortality. Currently, cervical cancer screening programs worldwide are shifting from cytology screening to HPV DNA testing. Although HPV DNA testing provides high sensitivity and negative predictive value, its specificity for precancerous lesions and cervical cancer is limited. The majority of HPV infections are transient and do not cause precancerous lesions and cervical cancer, so effective triage methods are needed to reduce the number of unnecessary colposcopy cases. Many recent studies have demonstrated that the dual staining cytology method with the combination of 2 biomarkers p16/Ki-67 has higher sensitivity and specificity values for detecting CIN2+ and CIN3+ than HPV testing. P16 is a tumor suppressor protein and Ki-67 is a cell proliferation marker. Normal cells will not express both p16 and Ki-67 at the same time. P16/Ki67 dual staining was approved by the United States Food and Drug Administration (US FDA) in 2020 for the triage of HPV positive women, either in primary HPV screening or HPV/cytology co-testing. In this review, we discuss the significance of p16/Ki-67 dual-staining and summarize the application basic of dual staining in screening and classifying cervical precancerous lesions.

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References

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