Abstract
BackgroundIn 2013, Jinan KingMed Diagnostics (JKD) first established a systematic cervical cytology training and quality control (QC) program in Shandong Province, China. We compared the efficacy of high-risk human papillomavirus (HR-HPV) detection, cytology, and their combination in routine clinical practice after the implementation of the training and QC program to identify the optimal first-line screening method in this region.MethodsThe data of patients histologically diagnosed with cervical intraepithelial neoplasia (CIN) 1, CIN2/3, and invasive cervical cancer (ICC) between January 2014 and December 2017 were retrieved from the JKD database. Cytology and/or HR-HPV testing results within 3 months preceding the CIN1 diagnoses and 6 months preceding the CIN2/3 and ICC diagnoses were analyzed.ResultsPrior screening data were available for 1829 CIN1 patients, 2309 CIN2/3 patients, and 680 ICC patients. Cytology alone and HR-HPV testing alone had similar rates of positive results for CIN2/3 (97.2% [854/879] vs. 95.4% [864/906], P = 0.105) and ICC detection (89.1% [205/230] vs. 92.7% [204/220], P = 0.185). Compared with either method alone, co-testing slightly increased the screening sensitivity for CIN2/3 (99.8% [523/524], all P < 0.001) and ICC (99.6% [229/230], all P < 0.001) detection. In the CIN1 group, cervical cytology alone (92.9% [520/560]) was more sensitive than HR-HPV testing alone (79.9% [570/713], P < 0.001), and co-testing (95.3% [530/556]) did not significantly improve the screening sensitivity (P = 0.105).ConclusionsAfter the implementation of a systematic training and QC program, both cytology and HR-HPV testing may be adopted for primary cervical cancer screening in Shandong Province.
Highlights
In 2013, Jinan KingMed Diagnostics (JKD) first established a systematic cervical cytology training and quality control (QC) program in Shandong Province, China
After the implementation of a systematic training and QC program, both cytology and high-risk human papillomavirus (HR-HPV) testing may be adopted for primary cervical cancer screening in Shandong Province
These results suggest that a systematic cervical cytology training and QC program can improve the screening efficiency of cervical cytology for the detection of CIN1, CIN2/3, and invasive cervical cancer (ICC), so that it is equivalent to or even slightly higher than that of HRHPV detection
Summary
In 2013, Jinan KingMed Diagnostics (JKD) first established a systematic cervical cytology training and quality control (QC) program in Shandong Province, China. The transformation from CIN to invasive cancer generally takes about 5 to 10 years [2, 3]. If these precancerous lesions are obliterated, the occurrence of most cases of invasive cervical cancer (ICC) can be effectively prevented. In the United States and most other developed European countries, systematic training programs for cytotechnologists and/or cytopathologists as well as detailed regulations governing cytopathological quality control (QC) processes are well-established to ensure the efficacy of screening [4, 5]. At the beginning of this century, the cytological efficiency of cervical cancer screening was further improved with the widespread application of liquidbased cytology (LBC) [9, 10]
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