ABSTRACT
Objective:To evaluate the efficacy of high-risk HPV (HR-HPV) genotyping with vaginal self-sampling in primary screening and combining cytology or viral load for HR-HPV positive as secondary screening strategies.Methods:The data referring to HR-HPV genotyping of self-collected sample with mass array matrix-assisted laser desorption-ionization time-of-flight mass spectrometry (MALDI-TOF-MS), HR-HPV viral load of physician-collected sample with hybrid capture Ⅱ (HC-Ⅱ), liquid-based cytology and histology of 8 556 women were from Shenzhen cervical cancer screening trial Ⅱ (SHENCCAST-Ⅱ) conducted between April 2009 and April 2010. The data were reanalyzed to determine the sensitivity and specificity to cervical intraepithelial neoplasia (CIN) of grade 2 or worse (CIN Ⅱ +), CIN of grade 3 or worse (CIN Ⅲ +) when HR-HPV genotyping combining with colposcopy as primary screening strategy based on varied HR-HPV subtype (strategy 1, including 5 sub-strategies: 1a: HPV 16/18 positive; 1b: HPV 16/18/58 positive; 1c: HPV 16/18/58/31/33 positive; 1d: HPV 16/18/58/31/33/52 positive; 1e: any HR-HPV positive). The data were also compared to determine the efficacy of cytology (strategy 2, including 5 sub-strategies: 2a, 2b, 2c, 2d, 2e) or HR-HPV viral load (strategy 3, including 4 sub-strategies: 3a, 3b, 3c, 3d) of physician-collected sample as a triage with HR-HPV genotyping for self-sampling HR-HPV positives. Results:(1) The HR-HPV positive rate was 13.77% (1 178/8 556) in the self-collected samples of 8 556 pregnant women. Of them,the prevalences of HPV 16/18, HPV 16/18/58, HPV 16/18/58/31/33 and HPV 16/18/58/31/33/52 were 3.16% (270/8 556), 5.14% (440/8 556), 6.66% (570/8 556) and 9.81% (839/8 556), respectively. The HR-HPV viral load ≥10 relative light units/control (RLU/CO) was 8.87%(759/ 8 556), while cytological results ≥atypical squamous cell of undetermined signification (ASCUS) were 12.05% (1 031/8 556). (2) The strategy 1e had the highest sensitivities for CIN Ⅱ +, CIN Ⅲ + which were 92.70% and 94.33%,respectively,among 14 sub-strategies,while the lowest specificity and positive predictive value (PPV). Meanwhile,the required colposcopy referral rates were much higher than other 13 sub-strategies (13.77%). The other 4 sub-strategies of strategy 1 (1a, 1b, 1c, 1d), strategy 1a had the highest specificities for CIN Ⅱ + and CIN Ⅲ + (97.92%, 97.69%, respectively), while 1d had the highest sensitivities for CIN Ⅱ + and CIN Ⅲ + (88.41%, 92.20%, respectively). (3) Both strategies of referring self-sampling HPV 16/18 positives for immediate colposcopy followed by triage physician-collected sample cytology (≥ASCUS) or viral load (≥10 RLU/CO) for non-HPV 16/18 positives had significantly higher sensitivity and specificity for CIN Ⅱ, CIN Ⅲ +, as well as lower referral rates (strategy 2a and 3a). Additionally, based on these two secondary screening strategies, cumulatively using the other four HR-HPV (HPV 58, 31, 33 and 52) positives as triage for immediate colposcopy showed an enhanced sensitivity. Conclusions:Primary HR-HPV cervical cancer screening strategy based on self-sampling with triage of cytology (≥ASCUS) or viral load (≥10 RUL/CO) provides a good balance among sensitivity, specificity for CIN Ⅱ + and CIN Ⅲ + and the number of tests required, referral rates. The efficacy of HR-HPV genotyping combining cytology or viral load secondary screening strategies will have a spiral escalation when HPV 58, 31, 33, 52 are included.
ABSTRACT
ObjectiveTo study the value of liquid-based cytology and colposcopy in screening for cervical lesion among urban community women of Beijing.MethodsA total of 795 women aged 20～54 years with sexual activity living in Zhanlanlu Community of Beijing were screened for cervical lesion Cervcal specimen was collected for thin-layer,liquid-based cytology test (LCT) from each of the participants in gynecologic examination.Colposcopy and biopsy were performed for the women with positive LCT.ResultsForty-five of 795 (5.7%) women were positive for LCT[≥ASC-US (atypical squamouscell of undetermined significance)],with 33 of ASC-us,eight of low-grade squamous intraepithelial lesion (LSIL),three of high-grade squamous intraepithelial lesion (HSIL),one of atypical glandular cells (AGC).Five of 45 women with positive LCT refused to accept colposcopy.Among 40 women with colposcopy and biopsy,chronic cervicitis was diagnosed in 11(27.5%),cervical condyloma acurninatum in 14(35.0%),cervical intraepithelial neoplasia (CIN) 1 in seven(17.5%),CIN 2 in three (7.5%),CIN 3 in four(10.0%),and early invasive cervical cancer in one(2.5%).In 750 women with negative LCT,cervical condyloma acuminature was diagnosed in two(0.3%),CIN 1 in five(0.7%)and low-grade glandular intraepithelial lesion (LGIL) bin one(0.1%).Sensitivity and specificity of LCT screening for cervical lesion(≥CIN 1)were 71.4%and 94.2%,respectively,with positive and negative predictive values of 37.5%and 99.2%.respectively,and those screening for cervical lesion more than CIN 2 were 100.0%, 96.0%,20.5%and 100.0%,respectively.ConclusionsMore attention should be paid to early screening for cervical lesion in urban community women.LCT combined with colposcopy and biopsy provide very helpful information in screening for early cervical cancer.