1. Validity Parameters of the Human Papillomavirus Detection Test Hybrid Capture 2 With and Without Cytology After Laser Destruction and Large Loop Excision of the Transformation Zone Treatment of High-Grade Cervical Intraepithelial Neoplasia Lesions.
- Author
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Hansen J, Waibel J, Timme S, Gitsch G, Bossart M, Oehler MK, and Klar M
- Subjects
- Adult, Female, Follow-Up Studies, Humans, Middle Aged, Predictive Value of Tests, Sensitivity and Specificity, Young Adult, Uterine Cervical Dysplasia surgery, Histocytochemistry methods, Molecular Diagnostic Techniques methods, Papillomaviridae isolation & purification, Uterine Cervical Dysplasia diagnosis, Uterine Cervical Dysplasia pathology
- Abstract
Objective: The aim of this study was to calculate the validity parameters of the Digene Hybrid Capture 2 (HC2) high-risk human papillomavirus DNA test with and without cytology in the follow-up examinations after laser treatment of the transformation zone or large loop excision of the transformation zone (LLETZ) for cervical intraepithelial neoplasia (CIN)., Methods: We performed a standardized follow-up examination in 113 postlaser and 153 post-LLETZ patients in our colposcopy clinic. Routine cytology, HC2 tests, and colposcopically-guided cervical biopsies were performed and sensitivity, specificity, and positive and negative predictive values were calculated using the histological cervical biopsy result as the criterion standard., Results: After a median follow-up time of 25.5 months, the overall posttreatment recurrence/persistence rate of CIN 2 or higher (CIN 2+) was 24% after laser and 12.4% after Post-LLETZ treatment. Hybrid Capture 2 alone had a sensitivity/NPV of 70/88% in post-laser and 70/93% in post-LLETZ patients. Cytology alone had a sensitivity/NPV for CIN 2+ of 48/84% in post-laser and 58/91% in post-LLETZ patients. Combined testing of HC2 with cytology had a sensitivity/NPV of 81/92% in postlaser and 88/95% in post-LLETZ patients., Discussion: In this test of cure study, combined testing of cytology with HC2 resulted in a high sensitivity and NPV. Hybrid Capture 2 and cytology-negative women may safely return to routine recall. Cytology alone is not an adequate follow-up strategy in postlaser patients.
- Published
- 2017
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