scholarly journals SNIPER: A Novel Assay for Human Papillomavirus Testing Among Women in Guizhou, China

2010 ◽  
Vol 20 (6) ◽  
pp. 1006-1010 ◽  
Author(s):  
Suzanne E. Belinson ◽  
Na Wulan ◽  
Ruizhen Li ◽  
Wei Zhang ◽  
Xuan Rong ◽  
...  

Objective:Clinically validate the SNIPER human papillomavirus (HPV) DNA assay for the detection of cervical intraepithelial neoplasia (CIN)2 or higher and CIN2 or higher in a prospective cross-sectional screening study in Guizhou Province, China.Methods:Between March and April, 2008, 1000 nonpregnant women aged 30 or older were recruited in Guizhou Province, China. Women positive by SNIPER or cytological examination were requested to return for follow-up. A biopsy of all colposcopically detected abnormalities was performed by quadrant. In normal quadrants, biopsies were obtained at the squamocolumnar junction (2-, 4-, 8-, and 10-o'clock positions depending on the quadrant). Samples were placed in 2 mL of saline solution and maintained between 2°C and 30°C for up to 1 week. One milliliter of this suspension was then prepared and tested. For polymerase chain reaction amplification, a pool of HPV primers was designed to amplify HPV DNA from 13 high-risk-HPV genotypes (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68). Test characteristics were calculated according to standard definitions.Results:One thousand women were screened; 175 tested HPV positive, 36 women tested negative but had positive Papanicolaou test results. All but 21 (90%) returned for follow-up. Median age and proportions having CIN2 or higher and CIN3 or higher differed by HPV status. Twenty-five women had CIN2 or higher and 16 had CIN3 or higher. The SNIPER assay was 93.3% and 94% sensitive and 86% and 85% specific for the detection of CIN2 or higher and CIN3 or higher, respectively. The positive predictive value was 17.4 % and 9.9% for CIN2 or higher and CIN3 or higher, respectively. Negative predictive value approached 100% for CIN2 or higher and CIN3 or higher.Conclusion:The SNIPER assay is functionally competitive and in terms of cost holds an advantage over Hybrid Capture 2 in a Chinese healthcare market, and potentially others, around the world.

2021 ◽  
Vol 11 ◽  
Author(s):  
Qiongyan Wu ◽  
Lingfang Wang ◽  
Xiumin Zhao ◽  
Qifang Tian ◽  
Fenfen Wang ◽  
...  

PurposeThis study aims to validate the value of microRNA (miRNA) detection for triaging human papillomavirus (HPV)-positive women in the general population.Patients and MethodsmiR-375 detection in cervical exfoliated cells has been demonstrated to have the superior value to cytology in triaging primary HPV-positive women in the hospital population. In this study, residual samples of cervical exfoliated cells from 10,951 women in a general population were used to detect miRNA. The performance efficiency of miRNA detection in identifying high-grade cervical intraepithelial neoplasia (CIN) was evaluated. Pearson chi-square test and McNemar pairing test were used to compare miRNA detection and cytology.ResultsIn valid 9,972 women aged 25–65, miR-375 expression showed a downward trend along with an increase in cervical lesion severity. The expression level of miR-375 ≤1.0 × 10-3 was identified as positive. In the HPV-positive and 12 HPV genotypes other than 16/18 (HR12)-positive women, miR-375 detection showed equivalent sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) to that of cytology (≥ASC-US) and higher or similar sensitivity and NPV but lower specificity and PPV than that of cytology (≥ASC-H) in identifying CIN3+ and CIN2+. In HPV 16-positive women, miR-375 positivity had higher sensitivity and NPV but lower specificity and PPV than that of cytology (≥ASC-H and HSIL) in identifying CIN3+ and CIN2+. The immediate CIN3+ risk of miR-375 positivity was 19.8% (61/308) in HPV-positive, 10.8% (22/204) in HR12-positive, and 43.5% (37/85) in HPV16-positive women, respectively.ConclusionThe detection of miR-375 in cervical exfoliated cells may be an optional method for triaging primary HPV-positive women in population-based cervical cancer screening.


2008 ◽  
Vol 18 (5) ◽  
pp. 1060-1064 ◽  
Author(s):  
J. F. Bragança ◽  
L. O. Sarian ◽  
D. R. Pitta ◽  
A. B. Maito ◽  
J. Vassallo ◽  
...  

The objective of the study was to investigate the expression of p53 and p16INK4a in cervical intraepithelial neoplasia (CIN) and their relation with disease severity and high-risk human papillomavirus (HR-HPV) status. A series of 125 women with previous positive Pap smear were selected for this cross-sectional study. All patients underwent gynecological examination, including colposcopy. Specimens for Pap smears, Hybrid Capture 2 (HC2) test, and pathologic analysis were obtained. After evaluation of CIN grade, immunohistochemical detection of proteins p53 and p16INK4a was performed on paraffin-embedded sections. The extent of immunoexpression of both proteins was analyzed in relation to CIN grade and HR-HPV status. CIN was graded as 1 in 21, 2 in 17, and 3 in 87 specimens. p16INK4a positivity (at least 5% of epithelial cells stained) was found in 99 of 125 cases (79.2%) and was significantly higher in high-grade lesions as compared to low-grade CIN (P< 0.001). The expression of p53 did not differ across histologic strata. Protein expression neither of p16INK4a nor of p53 correlated with HR-HPV status. Expression of p16INK4a was not related with that of p53. Our study gives further support to previous findings of strong association of p16INK4a immunostaining with severity of epithelial atypia, but this protein may not be considered a predictor of HR-HPV status determined with HC2. By contrast, immunoexpression of p53 was related neither to CIN grade nor to HR-HPV status.


Sexual Health ◽  
2011 ◽  
Vol 8 (3) ◽  
pp. 338 ◽  
Author(s):  
Sepehr N. Tabrizi ◽  
Irwin Law ◽  
Eka Buadromo ◽  
Matthew P. Stevens ◽  
James Fong ◽  
...  

Background There is currently limited information about human papillomavirus (HPV) genotype distribution in women in the South Pacific region. This study’s objective was to determine HPV genotypes present in cervical cancer (CC) and precancers (cervical intraepithelial lesion (CIN) 3) in Fiji. Methods: Cross-sectional analysis evaluated archival CC and CIN3 biopsy samples from 296 women of Melanesian Fijian ethnicity (n = 182, 61.5%) and Indo-Fijian ethnicity (n = 114, 38.5%). HPV genotypes were evaluated using the INNO-LiPA assay in archival samples from CC (n = 174) and CIN3 (n = 122) among women in Fiji over a 5-year period from 2003 to 2007. Results: Overall, 99% of the specimens tested were HPV DNA-positive for high-risk genotypes, with detection rates of 100%, 97.4% and 100% in CIN3, squamous cell carcinoma (SCC) and adenosquamous carcinoma biopsies, respectively. Genotypes 16 and 18 were the most common (77%), followed by HPV 31 (4.3%). Genotype HPV 16 was the most common identified (59%) in CIN3 specimens, followed by HPV 31 (9%) and HPV 52 (6.6%). Multiple genotypes were detected in 12.5–33.3% of specimens, depending on the pathology. Conclusion: These results indicated that the two most prevalent CC-associated HPV genotypes in Fiji parallel those described in other regions worldwide, with genotype variations thereafter. These data suggest that the currently available bivalent and quadrivalent HPV vaccines could potentially reduce cervical cancers in Fiji by over 80% and reduce precancers by at least 60%.


2019 ◽  
Vol 29 (1) ◽  
pp. 23-27 ◽  
Author(s):  
Haley Newman ◽  
Jilin Hu ◽  
Xiao Li ◽  
Jing He ◽  
Leslie Bradford ◽  
...  

ObjectiveTo evaluate the use of a portable, rechargeable colposcope combined with human papillomavirus (HPV) testing, as compared with HPV testing alone, for screening of cervical cancer and pre-cancerous lesions.MethodsThis was a cross-sectional study among 488 women in Baoshan County, Yunnan. The women underwent HPV testing followed by Gynocular portable colposcopy with visual inspection with acetic acid. Obvious lesions were biopsied. If portable colposcopy testing was negative but HPV testing was positive, the women underwent follow-up testing with thin-prep cytology and traditional colposcopy. Cervical biopsies were performed for any abnormalities. Histopathology was followed up with diagnosis and treatment.ResultsAmong 488 women screened with portable colposcopy, 24 women underwent biopsy based on positive colposcopy screening. Of these 24 women, three were HPV positive and 21 were HPV negative. Five women had cervical intra-epithelial neoplasia (CIN) I and one had advanced cervical cancer. Forty-six women tested positive for HPV. Three of these women had screened positive on preliminary colposcopy, with one positive for CIN III/squamous cell carcinoma and one woman with CIN I. Forty-three women underwent follow-up testing with thin-prep cytology. Two women had atypical squamous cells of undetermined significance and five had low-grade squamous intra-epithelial lesions and were biopsied; three women had CIN I, one had CIN II and one had CIN III. HPV testing and portable colposcopy was more sensitive but slightly less specific than portable colposcopy or HPV testing alone.ConclusionWhile HPV testing has high sensitivity and specificity for the detection of pre-cancerous and cancerous lesions and portable colposcopy has lower specificity, both methods of detection have low positive predictive value and high negative predictive value. In tandem, HPV testing and portable colposcopy had higher sensitivity for detection among women who underwent biopsies. In clinical practice, portable colposcopy was an effective, easy and affordable tool to transport to villages where cytology is not currently feasible.


1998 ◽  
Vol 36 (9) ◽  
pp. 2708-2713 ◽  
Author(s):  
Philip Zazove ◽  
Barbara D. Reed ◽  
Lucie Gregoire ◽  
Alex Ferenczy ◽  
Daniel W. Gorenflo ◽  
...  

Although PCR analysis is a sensitive test for detection of human papillomavirus (HPV) in the cervix, the proportion of cases of cervical dysplasia missed, or the false-negative rate, has been unknown. We determined the accuracy of PCR analysis for HPV DNA as a predictor of HPV-related cervical lesions in a cross-sectional study of sexually active women, aged 18 to 50 years, from the University of Michigan Family Medicine HPV study. Of 133 eligible participants, 41 underwent colposcopy because of a positive result for HPV of the cervix by the PCR method and 92 underwent screening colposcopy with biopsy prior to knowing the HPV PCR results. Twenty-four of those screened were subsequently found to also be HPV DNA positive. In those found to be HPV positive, histological studies revealed the presence of condyloma or cervical intraepithelial neoplasia in 16 women (24.6%) and changes suggestive of condyloma in 5 (7.6%). No HPV-negative woman had an abnormal biopsy or cytology report (P = 0.000001). The false-negative rate (1 − sensitivity) for HPV PCR analysis for detection of the presence of a cervical HPV-related lesion was 0% (95% confidence interval, 0 to 0.047), and the specificity was 60.7%. In summary, PCR analysis for HPV DNA had a very low false-negative rate for predicting HPV-related lesions of the cervix in a community-based population. This supports the validity of using the absence of HPV at the cervix, as determined by PCR testing, as an inclusion criterion for patients in control groups in studies dealing with low-grade cervical lesions.


2021 ◽  
pp. 1-23
Author(s):  
Andrea Maugeri ◽  
Martina Barchitta ◽  
Roberta Magnano San Lio ◽  
Aurora Scalisi ◽  
Antonella Agodi

Abstract Objective To evaluate the association of Composite Dietary Antioxidant Index (CDAI) and Dietary Inflammatory Index (DII) with the prevalence of high-grade cervical intraepithelial neoplasia (CIN). Design A cross-sectional study was conducted on women with abnormal Papanicolaou test, who underwent high-risk HPV screening and histological test through colposcopy. Dietary data were collected using a Food Frequency Questionnaire and used to assess both CDAI and DII. Setting Women were recruited from 2012 to 2015 at the Cervical Cancer Screening Unit of the “Azienda Sanitaria Provinciale” of Catania (Italy). Participants The study included 539 women with a mean age of 40.2 years, who were classified as cases (n=127 with CIN2 or more severe lesions) and controls (n= 412 with normal cervical epithelium or CIN1). Results Although we observed a lower proportion of HPV-positive women among those with higher CDAI (p<0.001), the index was not associated with the diagnosis of CIN2 or more severe lesions. By contrast, women with medium or high DII showed higher odds to be diagnosed with CIN2 or more severe lesions than those with low DII (OR=2.15; 95%CI=1.11–4.17; p=0.024 and OR=3.14; 95%CI=1.50–6.56; p=0.002, respectively), after adjusting for age, HPV status, educational level, body mass index, smoking status, parity, use of oral contraceptives and supplements. Conclusions Our findings suggested that a pro-inflammatory diet might be associated with an increased risk of CIN2 and more severe lesions. However, further prospective studies should be encouraged to support this evidence.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Severien Van Keer ◽  
Annina P. van Splunter ◽  
Jade Pattyn ◽  
Annemie De Smet ◽  
Sereina A. Herzog ◽  
...  

AbstractHost cell DNA methylation analysis in urine provides promising triage markers for women diagnosed with a high-risk (HR) human papillomavirus (HPV) infection. In this study, we have investigated a panel of six host cell methylation markers (GHSR, SST, ZIC1, ASCL1, LHX8, ST6GALNAC5) in cervicovaginal secretions collected within the first part of the urine void (FVU) from a referral population. Cytology, histology, and HPV DNA genotyping results on paired FVU and cervical samples were available. Urinary median methylation levels from HR-HPV (n = 93) positive women were found to increase for all markers with severity of underlying disease. Significantly elevated levels were observed for GHSR and LHX8 in relation to high-grade cervical intraepithelial neoplasia (CIN2 +; n = 33), with area under de curve values of 0.80 (95% Confidence Interval (CI) 0.59–0.92) and 0.76 (95% CI 0.58–0.89), respectively. These findings are the first to support the assertion that methylation analysis of host cell genes is feasible in FVU and holds promise as molecular, triage strategy to discern low- from high-grade cervical disease in HR-HPV positive women. Molecular testing on FVU may serve to increase cervical cancer screening attendance in hard-to-reach populations whilst reducing loss to follow-up and await further optimization and validation studies.


2014 ◽  
Vol 49 (10) ◽  
pp. 1219-1229 ◽  
Author(s):  
Paulo Freire ◽  
Pedro Figueiredo ◽  
Ricardo Cardoso ◽  
Maria Manuel Donato ◽  
Manuela Ferreira ◽  
...  

2021 ◽  
Vol 20 (1) ◽  
pp. 113-120
Author(s):  
N.V. Zarochentseva ◽  
◽  
L.K. Dzhidzhikhiya ◽  
V.N. Nabieva ◽  
◽  
...  

Cervical intraepithelial neoplasia (CIN) refers to precancerous changes in the cervix. After surgical treatment, a certain proportion of patients remain at risk of disease reccurence. Therefore, monitoring of patients after CIN surgery is an important and necessary part of their management tactics. Objective. Review of world literature on modern approaches to patients monitoring after using excisional methods of CIN treatment. Materials and methods. The information material includes data from scientific articles on the subject available in Pubmed and published over the past 20 years. Results. The analysis of data contained in modern literature on the frequency and risk factors for the development of reccurent CIN after excisional methods of treatment, diagnostic methods, the timing of follow-up examinations during post-operative monitoring, the main approaches to monitoring in different countries and the effectiveness of the proposed strategies for postoperative follow-up of patients after treatment was conducted. It was established that the approaches to the observation of this category of patients differ in various countries. Almost everywhere, the priority tool for monitoring of patients with CIN after treatment is a combined test, which involves a joint use of cytology and human papillomavirus tests. The main difference between countries is the timing of the first post-treatment follow-up visit. In some countries a follow-up visit is recommended within 24 months, while in others it is suggested to return to routine screening if the primary combined test is negative. Conclusion. Despite existing disagreements, the proposed post-operative monitoring strategies for CIN patients provide a fairly high percentage of “healing” and return to routine screening. Key words: human papillomavirus, monitoring, cervical cancer, cervical intraepithelial neoplasia, excisional treatment


BMJ Open ◽  
2017 ◽  
Vol 7 (8) ◽  
pp. e015867 ◽  
Author(s):  
Matti Lehtinen ◽  
Camilla Lagheden ◽  
Tapio Luostarinen ◽  
Tiina Eriksson ◽  
Dan Apter ◽  
...  

ObjectiveDue to long lag time between infection/cancer diagnoses human papillomavirus (HPV) vaccination programs will deliver vaccine efficacy (VE) estimates against cancer end-points late. Cancer registry follow-up of population-based, randomised trial cohorts of vaccinated and unvaccinated women was undertaken for the estimation of VE against cervical intraepithelial neoplasia grade three and invasive cancer (CIN3+).MethodsWe report interim results with 98 561 person years of Finnish Cancer Registry -based follow-up of individually and/or cluster randomised cohorts of HPV-16/18 vaccinated and unvaccinated adolescent women enrolled in June 2003/2005, and between May 2004 and April 2005, respectively. The cohorts comprised 15 627 18- to 19-year-old unvaccinated women (NCT01393470), and 2 401 and 64 16- to 17-year-old HPV-16/18 vaccinated women participating the PATRICIA (NCT00122681) and HPV-012 (NCT00169494) trials, respectively. The age-aligned passive follow-up started 6 months after the clinical trials’ end.ResultsDuring the follow-up of 4.5 to 10 years post enrolment we identified 75 cases of cervical intraepithelial neoplasia grade 3 (CIN3) and 4 cases of invasive cervical cancer (ICC) in the unvaccinated cohort, and 4 CIN3 cases in the HPV-16/18 vaccinated women. Diagnostic blocks were available for HPV typing from 87% of the cases. CIN3+ lesions were detectable in 54 cases. HPV16 was found in 26 of 50 unvaccinated CIN3+ cases, and in 3 CIN3+ cases in the HPV-16/18 vaccinated women. The latter were all baseline positive for cervical HPV16 DNA. Baseline data was not available for the unvaccinated women. Intention-to-treat VE against any CIN3+ was 66% (95% CI 8, 88).ConclusionsTen years post vaccination the AS04-adjuvanted HPV-16/18 vaccine shows continued efficacy against CIN3+ irrespectively of HPV type. Vaccine efficacy was not observed in baseline HPV16 DNA positive subjects.Trial registration numberNCT01393470.


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