Liquid-Based Screening Tests Results: HPV, Liquid-Based Cytology, and P16/Ki67 Dual-Staining in Private-Based Opportunistic Cervical Cancer Screening.

Martyna Trzeszcz,Zofia Jach,Anna Prokopyk,Agnieszka Halon,Mariola Wantuchowicz,Maciej Mazurec,Magdalena Kania,Piotr Barcikowski,Joanna Wach,Izabela Kotkowska-Szeps,Robert Jach,Karolina Mazurec,Marcin Przybylski

doi:10.3390/diagnostics11081420

Abstract

The baseline data from the private-based opportunistic cervical cancer screening with HRHPV14, liquid-based cytology (LBC) and p16/Ki67 testing, and its quality assessment/quality control (QA/QC) tools are lacking. The age-stratified analysis of 30,066 screening tests results in a Polish population, including the investigation of HRHPV14 status, LBC, and p16/Ki67 dual-staining reporting rates, along with immediate histopathologic correlations, was conducted. For cytopathologic QA/QC, the College of American Pathologists (CAP) benchmarks and enhanced safety protocol were used. The NILM/ASC-US/LSIL/ASC-H/HSIL/AGC reporting rates were 93.9/3.4/2.0/0.22/0.24/0.11, respectively, with correlating HRHPV14-positive rates of 8.4/48.9/77.2/84.6/90.7/26.7. The reporting rates for HSIL (CIN2+) in HRHPV-positive women with NILM/ASC-US/LSIL/ASC-H/HSIL/AGC referred for a colposcopy with biopsy were 19.1/25.8/22.5/12.4/19.1/1.1% of the total HSIL (CIN2+). In total, of the 1130 p16/Ki67 tests, 30% were positive. In NILM HRHPV14-positive women with available histology result, HSIL(CIN2+) was detected in 28.3% of cases. In the first such large-scale Polish study presenting HRHPV14, informed LBC and HSIL (CIN2+) results, the reporting rates were highly consistent with data from American and other CAP-certified laboratories, confirming the possibility of using the 2019 ASCCP risk-based guidelines as one of the screening strategies outside of the US, in conditions of proper QA/QC. The private-based screening model can be effective in cervical cancer prevention, particularly in countries with low population coverage of public funds-based systems.

Highlights

HPV testing is globally recommended as a primary screening strategy in cervical cancer prevention in all resource settings [1]
Of 20.605 cases, 402 (2.0% of all study group) with liquid-based cytology (LBC) and 14 high-risk types human papillomavirus test (HRHPV14) results had a colposcopy with a biopsy procedure in our Center
The strengths of the study include: (1) this is the first study analyzing such a large number of liquid-based screening (LBS) results in Poland and Central Eastern Europe countries; (2) the large age range of the analyzed population; (3) our study provides insight into the screening tests results performed in the private-based opportunistic cervical cancer screening; (4) this is one of the largest studies presenting cytologic-virologic-immunocytochemical-histologic correlations in cervical cancer screening; (5) the time elapsed from the abnormal initial screening result and a colposcopy with a biopsy not exceeding 3 months, for an immediate histologic correlation; (6) the study shows the efficacy of QA/quality control (QC) protocols for gynecologic cyto- and histopathology introduced outside of the laboratory

Summary

Introduction

HPV testing is globally recommended as a primary screening strategy in cervical cancer prevention in all resource settings [1]. According to the European guidelines, it should be implemented under the population-based organized system, which is currently the most effective model of screening [2]. In Poland, a Central Eastern Europe country, two main models of cervical cancer screening have been coexisting for years: a public funds-based and a private-based model. In the years 2006–2016, the only organized population-based national program with primary cytology screening in 3-year screening intervals was implemented [3,4,5]. There are various models in Polish private-based screening, from cytology to cotesting; the latter was approved in 2013 [10]

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