Fig. 2. Analyzed triage models—flowchart. Abbreviations: HRHPV, 14 high-risk types human papillomavirus test; HPV 16/18+, human papillomavirus types 16 and/or 18 positive results; M1, Triage model 1; M1A, Triage model 1A; M2, Triage model 2; LBC, liquid-based cytology; NILM, negative for intraepithelial lesion or malignancy; ASC-US, atypical squamous cells of undetermined significance; LSIL, low-grade squamous intraepithelial lesion; ASC-H, atypical squamous cells-cannot exclude HSIL; HSIL, high-grade squamous intraepithelial lesion; *HPV 18+ HSIL – colposcopy or expedited treatment, HPV 16+ HSIL – expedited treatment; DS, p16/Ki67 dual staining test; +, positive; −, negative; 1Y FU, 1-year follow-up; COLPO, colposcopy; COLPO or ExT/ExT, colposcopy or expedited treatment/expedited treatment.
Statistical analysis
A diagnostic value of the tests and their variations was assessed using PPV and negative predictive value (NPV), calculated according to standard definitions. The discrepancies in the diagnostic value between combinations of screening tests were evaluated using Leisenring et al. method [37] with the DTComPair package in R. The statistical significance was set at p < 0.05. A licensed PQStat Software in a 1.6.0 full version (2015 PQStat Statistical Calculation Software, Poznan, Poland) was used for the statistical analysis.
Results
In 30,066 cervical cancer LBS tests results (20,605 LBC, 8331 HRHPV and 1130 DS) obtained, 443 cases with colposcopy with biopsy performed at our Center were noted. Among this group, 332 patients were selected as eligible for the study. Only women over 25 years old were included in the final study group with age range from 25 to 67 years old, an average age of 34.7 years and a median age of 33 years old.
All cases in the study group were HRHPV-positive – 45.8% HPV 16/18+ (152/332) and 54.2% HPV HR12+ (180/332). Among HPV 16/18+ cases, 60.5% (92/152) were DS-positive and 39.5% (60/152) were DS-negative. In the HPV 16/18+ group, 17.1% of cases had negative cytology (NILM) (26/152), 40.8% had ASC-US (62/152), 25.0% had LSIL (38/152), and 17.1% had ASC-H+ result (26/152). The histology results in HPV 16/18+ cases were negative or LSIL/CIN1 in 71.7% (109/152) of cases and HSIL/CIN2+ in 28.3% (43/152). The characteristics of the study group are presented in Table 1.
Tab. 1. Study group characteristics.