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Objective: To evaluate the sensitivity of human papillomavirus (HPV) tested urine to detect high-grade cervical precancer (cervical intraepithelial neoplasia grade 2+ [CIN2+]) using two urine collection devices., Design: Randomised controlled trial., Setting: St Mary's Hospital, Manchester, UK., Population: Colposcopy attendees with abnormal cervical screening; a total of 480 participants were randomised. Matched urine and cervical samples were available for 235 and 230 participants using a first-void urine (FVU)-collection device and standard pot, respectively., Methods: Urine was self-collected and mixed with preservative - randomised 1:1 to FVU-collection device (Novosanis Colli-pee® 10 mL with urine conservation medium [UCM]) or standard pot. Matched clinician-collected cervical samples were taken before colposcopy. HPV testing used Roche cobas® 8800. A questionnaire evaluated urine self-sampling acceptability., Main Outcome Measures: The primary outcome measured sensitivity of HPV-tested urine (FVU-collection device and standard pot) for CIN2+ detection. Secondary outcomes compared HPV-tested cervical and urine samples for CIN2+ and evaluated the acceptability of urine self-sampling., Results: Urine HPV test sensitivity for CIN2+ was higher with the FVU-collection device (90.3%, 95% CI 83.7%-94.9%, 112/124) than the standard pot (73.4%, 95% CI 64.7%-80.9%, 91/124, p = 0.0005). The relative sensitivity of FVU-device-collected urine was 0.92 (95% CI 0.87-0.97, p McN  = 0.004) compared with cervical, considering that all women were referred after a positive cervical HPV test. Urine-based sampling was acceptable to colposcopy attendees., Conclusions: Testing of FVU-device-collected urine for HPV was superior to standard-pot-collected urine in colposcopy attendees and has promising sensitivity for CIN2+ detection. General population HPV testing of FVU-device-collected urine will establish its clinical performance and acceptability as an alternative to routine cervical screening., (© 2024 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.)

Liquid-based preparation (LBP) cytology is commonly used in most laboratories these days due to its convenience and reliable results for the cervical cancer screening program. The PathTezt™ Liquid-based Pap smear is a second-generation LBP, which uses a filter-based concentration technique in processing the sample., Objective: This study was done to evaluate the cellular fixation, morphology, quality of smear in gynae cytology, and diagnostic interpretation of cervical cytological smears produced by the PathTezt liquid-based processor., Materials and Methods: A total of 400 pap smear samples were taken and processed using the PathTezt 2000 processor. The slides were evaluated in terms of sample adequacy, percentage of the circle covered by epithelial cells, cellular distribution, obscuring factors, and cell fixation., Results: About 95.25% (381) of the samples were satisfactory for the evaluation. In 19 (4.75%) of the samples, epithelial cells covered less than 50% of the circle. A sample with good cellular distribution was seen in 92% of the cases, while 354 (88.5%) samples showed minimal inflammatory background. Almost all the smears (95.75%) had no erythrocytes in the background. All smears showed good quality fixation features toward nuclear, cytoplasm, and microorganisms. The total performance rate was 99%., Conclusion: Although the PathTezt liquid-based processor is still new compared to other first-generation LBP, the smears produced by this method were of high quality and it was cost-effective.

Objective: The aim of the study was to propose a method using saline lubrication and two glass slides to reduce the proportion of inadequate Pap smears., Materials and Methods: This was a retrospective study of patients at a medical center in eastern Taiwan that performs 5000-6000 Pap smears annually. The extracted data only detailed the number and percentage of inadequate Pap smears. We applied two modifications to the conventional Pap smear technique. The first modification was lubricating the speculum with normal saline instead of jelly. The second modification was performing the smear on two glass slides instead of just one. We used the modified technique beginning in January 2017. Therefore, we collected data from 2016 (before the modified technique was employed) and 2018 (after the modified technique was employed). The categorical data are presented as numbers (percentages). The differences in the number and percentage of inadequate smears resulting from both techniques were assessed using the Chi-square test., Results: During 2016 and 2018, 28 and 2 women received inadequate Pap smears among the total of 594 and 613 women who received Pap smears, respectively. The proportion of inadequate Pap smears was 4.71% and 0.33% in 2016 and 2018, respectively (P < 0.001)., Conclusions: The use of this modified technique effectively reduced the percentage of inadequate Pap smears., Competing Interests: Declaration of competing interest None to declare., (Copyright © 2020. Published by Elsevier B.V.)

Background: The purpose of this study was to compare the outcomes of 2 self-collection methods to detect cervical human papillomavirus (HPV) DNA with outcomes from a standard clinical method. The standard method samples were collected by a clinician at a routine pelvic examination. Self-samples were taken at home and mailed to the clinical laboratory., Methods: The 2 self-collection methods were a tampon-based method and a swab-based method using a commercial device, an Eve Medical HerSwab. All HPV samples were processed by a clinical laboratory using the Food and Drugs Administration approved Roche Cobase HPV method, which specifically identifies HPV 16, HPV 18, and a set of 12 other high-risk subtypes. Patients were recruited from 2 cancer screening clinics 2015 to 2017. All patients signed an informed consent. Screening outcomes, such as prevalence, percent agreement with standard, sensitivity, and specificity, were calculated for each self-collection method. Measures of similarity between self and standard collection outcomes, Cohen's κ, percent concordance, McNemar equivalence, and others were tested statistically., Results: One hundred seventy-four patients were randomized. The prevalence of 1 or more positive HPV high-risk subtypes from the standard clinical specimens was 13.5%. All clinical specimens were sufficient for valid HPV detection. For the tampon method, 15 (27%) of the specimens were insufficient quality. Only 1 (2%) swab specimen was insufficient. Only the swab self-collection method was found to be statistically noninferior to the clinical method. The tampon method had an unacceptably high rate of insufficient quality specimens and also failed the equivalency tests., Conclusions: The swab home collection samples were equivalent to the clinical samples, but the tampon method had an unacceptably high rate of specimens insufficient for HPV detection.

Aim: To assess whether self-sampling for cervical-cancer screening is acceptable to New Zealand women., Methods: Māori, Pacific and Asian un- or under-screened women aged 30-69 years were asked to: 1) examine three self-sampling devices; 2) complete a questionnaire on demographics and experiences with the devices; and 3) take a self-sample. Samples were tested 'off-label' using the cobas® 4800 human papillomavirus (HPV) test (Roche Diagnostics NZ)., Results: Thirty-one Pacific, 12 Māori, nine Asian and four women of other ethnicities participated (mean age, 39.5 years). Before trying any devices, 78% indicated a preference to self-sample, compared to 22% who preferred a physician-collected sample (PCS). After trying a device (HerSwab™, 91%; Delphi Screener™, 14%; cobas Swab, 13%; 12.5% used >1 device), fewer women (66%) preferred to self-sample next time, fewer (16%) preferred a PCS, while 18% expressed no preference. One of 32 samples with valid results (35 were tested) was positive for HPV 'other' oncogenic types., Conclusions: This was the first New Zealand study to invite women, including Māori women, to take a self-sample for cervical-cancer screening. The pilot study suggests that un- and under-screened women generally find self-sampling acceptable and all sample types are suitable for use with the cobas HPV test., Competing Interests: NB has been employed by a university to assist with unrelated research funded by Janssen-Cilag Pty Limited. CB has previously received education grants from Roche Diagnostics NZ and research funding from Hologic Australia. In addition, Roche Diagnostics NZ provided swabs and subsidised cobas HPV test kits for the current study.

Background: To the authors' knowledge, published studies reporting on the performance of the FocalPoint GS (FPGS) imaging system have yielded conflicting results to date. However, the results of the MAVARIC study indicated that the FPGS "No Further Review" (NFR) aspect of the technology demonstrated potential and warranted further investigation. The current validation study was performed prior to implementing the NFR slide reporting technology within the routine cervical screening program in Wales, United Kingdom., Methods: A total of 45,317 SurePath liquid-based cytology cervical screening samples were submitted for FPGS scanning by 4 Welsh laboratories between 2006 and 2011. The current study (Computer Assisted Evaluation, Screening and Reporting [CAESAR]), reports on a comparison between slides categorized as NFR (8130 slides) and slides manually screened as negative (93,473 slides). Both interventions had a subsequent negative quality control screen., Results: The histological outcome rates of cervical intraepithelial neoplasia 2 (CIN-2) (high-grade squamous intraepithelial lesion or worse [HSIL+]) at 2 years and subsequently 3 years after an FPGS NFR result versus a manually screened negative result were compared. Significantly fewer cases were detected in the NFR cohort compared with the manually screened cohort (P = .043 at 2 years and P = .027 at 3 years). When these cases were subcategorized as cancers and precancers, the interval cancer prevalence between NFR and manually screened samples at 2 years and 3 years was similar; however, the interval precancer prevalence for FPGS NFR was significantly lower (P = .023 at 2 years and P = .026 at 3 years) at approximately one-half that of manual screening., Conclusions: The negative predictive potential of the FPGS NFR technology is higher than that of manual screening, and the technology has quality/throughput benefits to support and enhance a laboratory cervical screening service., (© 2019 American Cancer Society.)

Objective: We compared the self-sampling performance of the newly designed HerSwab™ device with a physician-collected cervical sample and another self-sample using the cobas® PCR Female swab for the detection of cervical intraepithelial neoplasia (CIN) and cancer., Methods: Women referred for colposcopy at McGill University affiliated hospital clinics collected two consecutive self-samples, one with HerSwab™ and one with cobas® swab, after receiving instructions. The order of sampling was randomized. The colposcopist then collected a cervical sample and conducted a colposcopic examination. Samples were tested for human papillomavirus (HPV) DNA. Sensitivity and specificity to detect CIN2+ and respective 95% confidence intervals (CI) were calculated to compare sampling approaches. The HPV testing agreement between samples was measured using the Kappa statistic., Results: Of 1217 women enrolled, 1076 had complete results for HPV and cytology; 148 (13.8%) had CIN1, 147 (13.7%) had CIN2/3, and 5 (0.5%) had cancer. There was very good agreement between methods for HPV detection (HerSwab™ versus physician: kappa=0.84; cobas® swabs versus physician: kappa=0.81; HerSwab™ versus cobas® swabs: kappa=0.87). The sensitivity of HPV detection for CIN2+ was 87.6% (95%CI: 79.8-93.2) with self-sampling using HerSwab™, 88.6% (95%CI: 80.9-94.0) with self-sampling using the cobas® swab, and 92.4% (95%CI: 85.5-96.7) with physician sampling. Corresponding estimates of specificity were 58.1% (95%CI: 54.1-62.1), 55.0% (95%CI: 50.9-59.0) and 58.7% (95%CI: 54.6-62.6). Cytology (ASC-US or more severe) done on the physician-collected specimen was 80.2% (95%CI: 70.8-87.6) sensitive and 61.4% (95%CI: 57.2-65.5) specific for CIN2+., Conclusions: The HerSwab™ had good agreement with physician sampling in detecting HPV, and adequate performance in detecting high-grade lesions among women referred to colposcopy for abnormal cytology., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: Comparative data on different self-collection methods is limited., Objectives: To assess the impact of hrHPV testing of two self-collection devices for detection of cervical carcinoma and high-grade lesions., Study Design: Three hundred ten patients collected two cervicovaginal specimens using a brush (Evalyn ® Brush) and a swab (FLOQSwabs™), and filled a questionnaire at home. Then, a physician at the clinic took a cervical specimen into PreservCyt ® buffer for hrHPV testing and cytology. All specimens were tested using Anyplex™ II HPV28, Cobas ® 4800 HPV Test and Xpert ® HPV., Results: Performance comparison included 45 cervical carcinomas and 187 patients with premalignant lesions. Compared to the physician-specimen, hrHPV testing of Evalyn ® Brush showed non-inferior sensitivity for CIN3+ (relative sensitivity of Anyplex™ 0.99; Cobas ® 0.96; Xpert ® HPV 0.97) while hrHPV testing of FLOQSwabs™ showed inferior sensitivity (relative sensitivity of Anyplex™ 0.91; Cobas ® 0.92; Xpert ® HPV 0.93). Similar results were observed for invasive carcinomas albeit that FLOQSwabs™ was statistically non-inferior to the physician-specimen. Self-collection by either Evalyn ® Brush or FLOQSwabs™ was more sensitive for CIN3+ than LSIL or worse cytology. Significant decrease in sensitivity for CIN3+ were observed for FLOQSwabs™ when specimens were preprocessed for hrHPV testing after 28 days. Both devices were well accepted, but patients considered Evalyn ® Brush easier and more comfortable than FLOQSwabs™., Conclusions: Self-collection is comparable to current screening practice for detecting cervical carcinoma and CIN3+ but device and specimen processing effects exist. Only validated procedure including collection device, hrHPV assay and specimen preparation should be used., (Copyright © 2017 The Author(s). Published by Elsevier B.V. All rights reserved.)

Background: Vaginal discharge and vulvitis are common presenting symptoms in general practice. Few studies have specifically looked at the validity of self-taken low vulvovaginal swabs (LVS) for the diagnosis of vulvovaginal candidiasis (VVC) and bacterial vaginosis (BV)., Aim: To assess if patient self-taken LVS are a valid alternative to clinician-taken high vaginal swabs (HVS) for the detection of VVC and BV., Design and Setting: Case-control study with the patient acting as their own control in an urban sexual health centre in Newcastle upon Tyne, UK., Method: Females aged 16-65 years attending with symptomatic vaginal discharge, vulval irritation, genital pain, and an offensive genital smell were recruited into the study. Participants took a self-taken LVS before vaginal examination, during which a clinician took an HVS (reference standard). Main outcome measures were the diagnosis of BV or VVC infection., Results: A total of 104 females were enrolled. Of those, 45 were diagnosed with VVC and 26 with BV. The sensitivities of self-taken LVS for VVC and BV were 95.5% and 88.5% respectively. Cohen's κ coefficient showed 'strong agreement' for the detection of both VVC and BV. Vulval itching was the most common symptom associated with VVC (69%), whereas 50% of females diagnosed with BV presented with an offensive discharge. Both symptoms had poor positive predictive values (0.63 and 0.50, respectively)., Conclusion: Self-taken LVS appears to be a valid alternative to clinician-taken HVS for detecting VVC and BV infections. Symptoms were found to be a poor indicator of underlying infection., (© British Journal of General Practice 2017.)

Aim: The aim of this study was to assess the accuracy of self-collected vaginal samples compared with physician-collected cervical samples for high-risk human papillomavirus (HPV) testing in Japanese women with abnormal cervical cytology. We also assessed the acceptability of self-collected HPV (sHPV) testing using a questionnaire., Methods: Women aged 20-69 years (n = 136) attending Yokohama City University Hospital because of abnormal cervical cytology between April 2014 and January 2015 were enrolled in this study. Cervical samples for conventional cytology and physician-collected HPV (pHPV) testing were obtained before colposcopic examination. After this examination, patients were asked to provide a self-sampled vaginal specimen (sHPV) at home, some time between the following day and the next week and to complete a self-sampling acceptability questionnaire., Results: The overall positive rates of HPV detection with pHPV and sHPV testing were 61.0% (83/136) and 40.4% (55/136), respectively (P < 0.001). sHPV testing had a lower sensitivity compared to pHPV for detection of cervical intraepithelial neoplasia (CIN)2 or worse (CIN2+: 59.4% vs 100%, P < 0.001; CIN3: 66.7% vs 100%, P = 0.248). There were no statistically significant differences in the sensitivity to detect CIN3 among pHPV testing, sHPV testing, and cytology. The self-collecting device had good acceptability., Conclusion: sHPV testing is a possible technique with which to improve poor cervical cancer screening uptake rates in Japan; however, the sensitivity to detect CIN2+ lesions must improve before it can be a substitute for conventional cytology or pHPV testing. Further large-scale acceptability studies involving non-responders are also needed before practical application., (© 2017 Japan Society of Obstetrics and Gynecology.)

Cervical cancer screening based on the Papanicolaou (Pap) test is a widely applied but not always efficient practice for detecting Human Papillomavirus (HPV) mediated lesions, partially due to a non-systematic and inadequate screening process. Our aim was to introduce an inexpensive easy-to-use direct screening platform for improved detection of abnormal cells indicative of underlying cervical neoplasia as well as persisting HPV infection. By employing a novel, efficient technique of laser-based micromachining, we achieved the fabrication of spatial grids on commercially available coverslips allowing visual segmentation of the slide for efficient screening. Abnormal and formerly diagnosed as negative for intraepithelial lesion or malignancy (NILM) Pap test slides (n = 200) were analyzed by conventional and grid-based screening. Grid-based microscopy led to a more reliable diagnosis compared to the conventional by identifying an increased number of abnormal cells (P = 0.001). It decreased borderline ASCUS, AGC diagnosis, increasing LSIL, HSIL and in situ AdenoCa detection rates closely related with biopsy (P = 0.015; kappa = 0.978). Concerning the set of NILM diagnoses in rapid re-screening, the method upgraded six cases (n = 6) to LSIL (P = 0.001). The proposed technical solution offers a calibration and orientation visual aid during the on-site screening process providing significant advantages compared to expensive digital imaging techniques., (© 2016 Japanese Society of Pathology and John Wiley & Sons Australia, Ltd.)

Background: From 2010 to 2014, approximately 2 million Pap smears from HIV-infected women were submitted to the South African National Health Laboratory Services (NHLS) through the national cervical cancer screening programme. The objective of this analysis was to determine whether using the plastic Cervex brush ("broom") would be a cost-effective approach to improve cytology specimen quality as compared to the wooden spatula used currently., Methods: A decision analysis model was built using the expected adequacy rates for samples collected with the spatula (<$0.02) and broom ($0.23) and the probability of detecting cervical dysplasia. NHLS data was used for testing volumes and rates of HIV-positivity, suitability of specimens, and presence of endocervical cells. Expected positivity of Pap smears in HIV-infected women (73 %), odds ratios of the effectiveness of the broom (OR: 1.57), and improved sensitivity when endocervical cells present (OR: 1.89) are from literature. NHLS costs were used for the collection devices and conventional cytology ($4.89). Cost of clinic visit is from WHO CHOICE ($8.36)., Results: In 2010, 80 % of specimens submitted to NHLS were adequate for evaluation; in 2014, only 54 % met the same criteria. For HIV-infected women, according to the guidelines model, using the wooden spatula costs $6.25 million per year, $16.79 per woman tested. Under intended practice, for each additional HSIL case detected among HIV-infected women, the South African cervical cancer screening programme could save $13.64 (95 % CI: $13.52 to $13.76) by using the broom as its standard of care collection device through increased collection of endocervical cells and consequent reduction in repeat Pap smears., Conclusion: Under a wide range of parameters tested using a simulation model, the more expensive plastic broom could save the South African cervical cancer screening programme money and increase detection of high-grade cervical dysplasia in HIV-infected women compared to the current wooden spatula.

Introduction: Population coverage for cervical cancer screening is an important determinant explaining differences in the incidence of cervical cancer between countries. Offering devices for self-sampling has the potential to increase participation of hard-to-reach women., Methods: A systematic review and meta-analysis were performed to evaluate the participation after an invitation including a self-sampling device (self-sampling arm) versus an invitation to have a sample taken by a health professional (control arm), sent to under-screened women., Results: Sixteen randomised studies were found eligible. In an intention-to-treat analysis, the pooled participation in the self-sampling arm was 23.6% (95% confidence interval (CI)=20.2-27.3%), when self-sampling kits were sent by mail to all women, versus 10.3% (95% CI=6.2-15.2%) in the control arm (participation difference: 12.6% [95% CI=9.3-15.9]). When women had to opt-in to receive the self-sampling device, as used in three studies, the pooled participation was not higher in the self-sampling compared to the control arm (participation difference: 0.2% [95% CI=-4.5-4.9%])., Conclusion: An increased participation was observed in the self-sampling arm compared to the control arm, if self-sampling kits were sent directly to women at their home address. However, the size of the effect varied substantially among studies. Since participation was similar in both arms when women had to opt-in, future studies are warranted to discern opt-in scenarios that are most acceptable to women., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

Background: We performed a multicentre randomised controlled trial to evaluate the effect on participation in organised screening programmes of a self-sampling device mailed home or picked up at a pharmacy compared with the standard recall letter., Methods: Women aged 30-64 non-responding to screening invitation were eligible. Response rate to first invitation ranged from 30% to 60% between centres. The control was the standard reminder letter to undergo the test used by the programme (Pap test in three centres and HPV DNA test in three other centres). Home mailing of the self-sampler was preceded by a letter with a leaflet about HPV. The analysis was intention-to-treat., Results: In all, 14 041 women were randomised and recruited: 5012 in the control arm, 4516 to receive the self-sampler at home, and 4513 to pick up the self-sampler at a pharmacy. Participation was 11.9% in the control, 21.6% (relative participation: 1.75; 95% CI 1.60-1.93) in home, and 12.0% (relative participation: 0.96; 95% CI 0.86-1.07) in the pharmacy arms, respectively. The heterogeneity between centres was high (excess heterogeneity of that expected due to chance, i.e., I(2), 94.9% and 94.1% for home and pharmacy arm, respectively). The estimated impact on the overall coverage was +4.3% for home mail self-sampling compared with +2.2% for standard reminder., Conclusions: Home mailing of self-sampler proved to be an effective way to increase participation in screening programmes, even in those with HPV as primary testing. Picking up at pharmacies showed effects varying from centre to centre.

Purpose: This study was conducted to assess the agreement and differences between cervical self-sampling with a Kato device (KSSD) and gynecologist sampling for Pap cytology and human papillomavirus DNA (HPV DNA) detection., Materials and Methods: Women underwent self-sampling followed by gynecologist sampling during screening at two primary health clinics. Pap cytology of cervical specimens was evaluated for specimen adequacy, presence of endocervical cells or transformation zone cells and cytological interpretation for cells abnormalities. Cervical specimens were also extracted and tested for HPV DNA detection. Positive HPV smears underwent gene sequencing and HPV genotyping by referring to the online NCBI gene bank. Results were compared between samplings by Kappa agreement and McNemar test., Results: For Pap specimen adequacy, KSSD showed 100% agreement with gynecologist sampling but had only 32.3% agreement for presence of endocervical cells. Both sampling showed 100% agreement with only 1 case detected HSIL favouring CIN2 for cytology result. HPV DNA detection showed 86.2%agreement (K=0.64, 95% CI 0.524-0.756, p=0.001) between samplings. KSSD and gynaecologist sampling identified high risk HPV in 17.3% and 23.9% respectively (p= 0.014)., Conclusion: The self-sampling using Kato device can serve as a tool in Pap cytology and HPV DNA detection in low resource settings in Malaysia. Self-sampling devices such as KSSD can be used as an alternative technique to gynaecologist sampling for cervical cancer screening among rural populations in Malaysia.

Objective: To evaluate a fully automated processing system (TACAS™ Pro) for liquid-based procedures (LBPs)., Methods and Materials: Materials were 3,483 and additionally 502 specimens that were taken at Kanagawa Health Service Association. Specimens obtained with a Cervex-Brush® were first smeared to glass slides using one side of the brush and then processed to TACAS Pro., Results: (1) The microscopy watching time per normal case was 3.65 ± 0.85 min in the conventional procedure, whereas in the LBP it was 1.95 ± 0.60 min, and the latter reduced workload to 53%. (2) The handling time of TACAS Pro per day was 2 h and 25.8 min. The workload at a laboratory offset it and revealed the work saving to be 63.8%. (3) Unsatisfactory rates were 0% in the conventional procedure, whereas in the LBP it was 1.88% at first. The latter rate decreased to 0.5% after system improvement. (4) Specimens which may disturb microscopy analysis were found in 1.06%, including 3 cases of possible carry-over of cells to the following slides. An additional study with the revised system confirmed no carry-over. (5) Incidences of abnormal cytology were consistent between the two methods., Conclusions: The revised automated processing system TACAS Pro is a feasible and useful LBP and reduces the workload of cytology laboratories., (© 2015 S. Karger AG, Basel.)

Background: The participation of women in cervical cancer screening in Malaysia is low. Self-sampling might be able to overcome this problem.The aim of this study was to assess the reliability of self-sampling for cervical smear in our country., Materials and Methods: This cross-sectional study was conducted on 258 community dwelling women from urban and rural settings who participated in health campaigns. In order to reduce the sampling bias, half of the study population performed the self-sampling prior to the physician sampling while the other half performed the self-sampling after the physician sampling, randomly. Acquired samples were assessed for cytological changes as well as HPV DNA detection., Results: The mean age of the subjects was 40.4±11.3 years. The prevalence of abnormal cervical changes was 2.7%. High risk and low risk HPV genotypes were found in 4.0% and 2.7% of the subjects, respectively. A substantial agreement was observed between self-sampling and the physician obtained sampling in cytological diagnosis (k=0.62, 95%CI=0.50, 0.74), micro-organism detection (k=0.77, 95%CI=0.66, 0.88) and detection of hormonal status (k=0.75, 95%CI=0.65, 0.85) as well as detection of high risk (k=0.77, 95%CI=0.4, 0.98) and low risk (K=0.77, 95%CI=0.50, 0.92) HPV. Menopausal state was found to be related with 8.39 times more adequate cell specimens for cytology but 0.13 times less adequate cell specimens for virological assessment., Conclusions: This study revealed that self-sampling has a good agreement with physician sampling in detecting HPV genotypes. Self-sampling can serve as a tool in HPV screening while it may be useful in detecting cytological abnormalities in Malaysia.

Despite the public health importance of mucosal pathogens (including HIV), relatively little is known about mucosal immunity, particularly at the female genital tract (FGT). Because heterosexual transmission now represents the dominant mechanism of HIV transmission, and given the continual spread of sexually transmitted infections (STIs), it is critical to understand the interplay between host and pathogen at the genital mucosa. The substantial gaps in knowledge around FGT immunity are partially due to the difficulty in successfully collecting and processing mucosal samples. In order to facilitate studies with sufficient sample size, collection techniques must be minimally invasive and efficient. To this end, a protocol for the collection of cervical cytobrush samples and subsequent isolation of cervical mononuclear cells (CMC) has been optimized. Using ex vivo flow cytometry-based immunophenotyping, it is possible to accurately and reliably quantify CMC lymphocyte/monocyte population frequencies and phenotypes. This technique can be coupled with the collection of cervical-vaginal lavage (CVL), which contains soluble immune mediators including cytokines, chemokines and anti-proteases, all of which can be used to determine the anti- or pro-inflammatory environment in the vagina.

Purpose: This study aimed to investigate the effects of water-based gel application in reducing pain or discomfort associated with speculum examination, and compared the presence of unsatisfactory Papanicolaou smear results between gel-applied and control groups., Methods: In this prospective randomized controlled study, a total of 1,580 patients were analyzed. The subjects were randomized to a gel group and a control group. For the collection of the smear sample, water-based gel was used in the gel group and dry speculum was used in the control group. All patients were asked to score their pain on a numeric pain scale at two time points during the procedure (insertion and opening phase of speculum). Cytopathologists who analyzed the smear cytology were blinded to the study. Pain intensity during speculum examination, as well as unsatisfactory smear results, were analyzed between the groups., Results: The pain scores obtained at two different time points of speculum application were significantly lower in the gel group compared to the control group both in premenopausal and postmenopausal women (p < 0.001). The ratios of unsatisfactory cytopathologic examination results were 1.13 and 1.39% for the gel-applied and control groups, which were not significantly different., Conclusion: Lubrication of the outer superior and inferior blade of the plastic vaginal speculum with a small amount of a water-soluble lubricant gel decreases the pain associated with insertion and opening of the vaginal speculum in both premenopausal and postmenopausal women without affecting the quality of the cytology results during the collection of Papanicolaou test specimens.

Sub-optimal participation is a major problem with cervical cancer screening in developing countries which have no organized national screening program. There are various notable factors such as 'embarrassment', 'discomfort' and 'no time' cited by women as they are often also the bread winners for the family. Implementation of self-sampling methods may increase their participation. The aim of this article was to provide a survey of various types of self-sampling tools which are commonly used in collection of cervical cells. We reviewed currently available self-sampling devices and collated the advantages and disadvantages of each in terms of its acceptance and its accuracy in giving desired results. In general, regardless of which device is used, self-sampling for cervical scrapings is highly acceptable to women in most of the studies cited.

Aims: To determine the status of women's perception and attitudes about cervical cancer and their thoughts on Kato's self-sampling device., Materials and Methods: This descriptive research was conducted between July- December 2012 with a study populationof married women older than 18 years., Results: A total of 246 women volunteered, with a mean age of 34.9±9.22 (19-52). In the last year, 52.0% had been examined by a gynecologist to address a complaint or for a periodic health check. Of the 118 who had not had a gynecological examination, 42.4% indicated negligence, 26.3% stated the reason was no complaint, 14.4% feared they might receive bad results from the examination, and 8.5% stated that were shy or embarrassed. Of all of the women, 35.0% answered that they had information about cervical cancer, and 0.7% had heard about the HPV vaccine. No one in their families had received the vaccine. Of the women, 28.5% had had a Pap smear, and 71.4% of those had normal results. Of those who had never had a Pap smear, 47.2% had never heard about the test; 18.8% explained the reason for not having a test as shyness or embarrassment with a male doctor. None of the women had heard about Kato's device. Once the women were informed, 73.6% expresseed interest in use; 51.9% answered they could use it and not be embarrassed, 30.9% would use it because they did not have to see a doctor, and 17.1% would use it as it allows them to take a smear in all conditions and whenever they want. Of the women, 60.0% thought that they could not successfully use Kato's device; 40.0% thought that a smear should be taken by a doctor., Conclusions: Most of the women in our population had never had a Pap smear and wanted to use the Kato's device.

Background: Recent studies have reported high sensitivity of human papillomavirus (HPV) testing from self-collected vaginal specimens. These results suggest the possibility of introducing self-collection of samples for cervical cancer screening to increase overall participation. The current study compared test results from self-collected and physician-collected specimens., Patients and Methods: Vaginal samples from patients (n = 102) of a colposcopy clinic were taken by both a physician and themselves. All cell samples were tested using cytological diagnostics with a PAP test and for carcinogenic HPV genotypes (Cervista®). Additionally, all patients had a colposcopy (86% with cervical biopsy) and in 40% of patients was carried out a conisation., Results: Of the patients tested 50 had the histological diagnosis of a cervical intraepithelial neoplasia grade 2 (CIN 2+ or 3). Sensitivity of HPV self-collected samples was much lower than that of physician-collected samples (72 % compared to 92 %). The sensitivity of self-collected PAP tests was only 52 % but the positive predictive value of self-collected PAP tests was very high. The cytological diagnosis of high-grade intraepithelial lesion (HSIL) correlated much better with the histological results of conisation (96 %) than with cervical biopsies (76 %)., Conclusion: The results of this study indicate that self-collection may not provide an adequate collection method for improving efficiency in cervical cancer screening in Germany.

Objectives: To assess whether automated screening in the cytologic examination of Papanicolaou smear slides results in smaller margins of error than manual screening., Methods: We compared cytotechnologists' performance and reproducibility of manual and automated screening of 10,165 consecutive cervical cytology slides examined at Barretos Cancer Hospital using the FocalPoint system., Results: In total, 83% of atypical squamous cells of undetermined significance and greater were classified as quintiles 1 and 2; no high-grade squamous intraepithelial lesions and greater were observed in quintile 5. No statistically significant differences were found between manual and automated screening, using cervical biopsy specimens as the gold standard., Conclusions: FocalPoint safely screened high-grade lesions, which can be valuable for high-workload routines.

Based on partially-coherent digital in-line holography, we report a field-portable microscope that can render lensfree colour images over a wide field-of-view of e.g., >20 mm(2). This computational holographic microscope weighs less than 145 grams with dimensions smaller than 17×6×5 cm, making it especially suitable for field settings and point-of-care use. In this lensfree imaging design, we merged a colorization algorithm with a source shifting based multi-height pixel super-resolution technique to mitigate 'rainbow' like colour artefacts that are typical in holographic imaging. This image processing scheme is based on transforming the colour components of an RGB image into YUV colour space, which separates colour information from brightness component of an image. The resolution of our super-resolution colour microscope was characterized using a USAF test chart to confirm sub-micron spatial resolution, even for reconstructions that employ multi-height phase recovery to handle dense and connected objects. To further demonstrate the performance of this colour microscope Papanicolaou (Pap) smears were also successfully imaged. This field-portable and wide-field computational colour microscope could be useful for tele-medicine applications in resource poor settings.

Background: Prostate-specific antigen (PSA) detected in vaginal fluid can be used in studies of HIV/sexually transmitted infection (STI) and pregnancy prevention as an alternative to relying on participant reports of exposure to semen. Optimal methods for collecting and storing specimens for this testing have not been determined., Study Design: We conducted a controlled, in vitro experiment of 550 specimens spiked with semen to determine the effects of swab type (five types), storage conditions of the swabs (room temperature with or without desiccant or at -80°C without desiccant) and time from collection to testing (seven intervals over the course of 12 months) on the identification of PSA. We performed factorial analysis of variance to identify factors influencing PSA detection., Results: Concentrations of PSA detected in the swabs declined with time of storage over the 1-year experiment (p<.01). The 1-mL, rayon-tipped swab stored immediately at -80°C following collection performed best., Conclusions: If immediate testing or freezer storage is not feasible, investigators should use a swab with 1-mL capacity with processing and testing as soon as possible after specimen collection., (Published by Elsevier Inc.)

Background: High-risk human papillomavirus (hrHPV) testing in cervical screening is usually performed on physician-taken cervical smears in liquid-based medium. However, solid-state specimen carriers allow easy, non-hazardous storage and transportation and might be suitable for self-collection by non-responders in screening and in low-resource settings., Objectives: We evaluated the adequacy of self-collected cervicovaginal (c/v) samples using a Viba-brush stored on an Indicating FTA-elute cartridge (FTA-based self-sampling) for hrHPV testing in women referred to a gynecology clinic due to an abnormal smear., Study Design: 182 women accepted to self-collect a c/v sample. After self-sampling, a physician obtained a conventional liquid-based cervical smear. Finally, women were examined by colposcopy and a biopsy was taken when clinically indicated. Self-samples required only simple DNA elution, and DNA was extracted from physician-obtained samples. Both samples were tested for 14 hrHPVs by GP5+/6+-EIA-LQ Test and SPF(10)-DEIA-LiPA(25)., Results: Both assays detected significantly more hrHPV in physician-collected specimens than in self-collected samples (75.3% and 67.6% by SPF(10); 63.3% and 53.3% by GP5+/6+, respectively). The combination of physician-collected specimen and GP5+/6+ testing demonstrated the optimal balance in sensitivity (98.0%) and specificity (48.1%) for CIN2+ detection in this referral population. A test system of FTA-based self-collection and SPF(10) hrHPV detection approached this sensitivity (95.9%) and specificity (42.9%)., Conclusions: These results show that the clinical performance of hrHPV detection is determined by both the sample collection system and the test method. FTA-based self-collection with SPF(10) testing might be valuable when a liquid-based medium cannot be used, but requires further investigation in screening populations., (Copyright © 2013 Elsevier B.V. All rights reserved.)

Objective: To investigate clinical and cytomorphological determinants of unsatisfactory conventional Papanicolaou (Pap) smears., Study Design: Records of 82,108 conventional cervicovaginal smears received over a ten-year period were retrieved. The significance of clinical determinants, viz. age (<45 or ≥45) and history of hysterectomy, radiotherapy (RT) and chemotherapy (CT), with respect to unsatisfactory outcomes was evaluated using univariate and multivariate analysis by logistic regression. Reasons for unsatisfactory results, i.e. cellularity, obscuration by blood or inflammation and drying artifact, were compared in the women managed by hysterectomy/RT/CT with those without these histories, using Chi square/Fischer's exact test., Results: The overall unsatisfactory rate on conventional cervicovaginal cytology was 4.9%. For post-hysterectomy/RT/CT smears it was 12.5% while it was 4.6% for those without these histories. Age ≥45, and history of hysterectomy, RT or CT were all found to be significant for unsatisfactory outcomes (P<0.001), with the highest odds ratio for RT (2.81). Inadequate cellularity was the major reason for unsatisfactory cytology in both the treatment and non-treatment groups. Marked obscuring by blood was significantly more frequently associated with unsatisfactory tests in the treatment group (mainly in the post-radiotherapy smears) as compared to the control group (P<0.05). Multiple reasons were more commonly present in unsatisfactory smears from treatment group as compared to the control group (P<0.001)., Conclusions: Older age and history of hysterectomy, RT or CT have a significant bearing on unsatisfactory outcome of Pap tests. Inadequate cellularity and obscuring blood are the main morphological determinants of unsatisfactory smears., (Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.)

Purpose: Intra-vaginal traces can serve as supporting physical evidence of vaginal penetration in sex-crime cases. Vaginal trace sampling guidelines prescribe using a speculum and swabs or swabs only. The use of Locard's exchange theory requires samples of trace materials to always be contamination-free and of accurately known origin. If traces from the outer genital area are accidentally introduced into the vagina during sampling, these traces may be recorded as originating in a location where they were not present at the time of evidence collection. The goal of this study was to assess the risks of false positive findings in vitro of traces found inside the vagina due to trace dislocation caused by current vaginal trace sampling methods (swab-only or with speculum), and for a new method that uses a sleeve accessory to prevent trace dislocation., Methods: Starch solution was applied to the labia of three clean female genitalia mock-ups with vaginas of various diameters and structures. The speculum, swab-only, and sleeve methods were each used 30 times on each mock-up, giving a total of 90 repetitions of each method. Iodine was used to determine whether any starch traces had been introduced vaginally., Results: The speculum and swab-only methods gave 100 and 63-87 % false positive results respectively due to trace dislocation. The sleeve method reduced this to 2 % (0 % after correction)., Conclusions: The results suggest that there is a need to conduct clinical in vivo studies to determine whether these results translate into everyday practice and to ensure reliable trace sampling in sex-crime cases.

Background: Attendance rates of cervical screening programs can be increased by offering HPV self-sampling to non-attendees. Acceptability, DNA yield, lavage volumes and choice of hrHPV test can influence effectiveness of the self-sampling procedures and could therefore play a role in recruiting non-attendees. To increase user-friendliness, a frequently used lavage sampler was modified. In this study, we compared this second generation lavage device with the first generation device within similar birth cohorts., Methods: Within a large self-sampling cohort-study among non-responders of the Dutch cervical screening program, a subset of 2,644 women received a second generation self-sampling lavage device, while 11,977 women, matched for age and ZIP-code, received the first generation model. The second generation device was different in shape, color, lavage volume, and packaging, in comparison to its first generation model. The Cochran's test was used to compare both devices for hrHPV positivity rate and response rate. To correct for possible heterogeneity between age and ZIP codes in both groups the Breslow-Day test of homogeneity was used. A T-test was utilized to compare DNA yields of the obtained material in both groups., Results: Median DNA yields were 90.4 μg/ml (95% CI 83.2-97.5) and 91.1 μg/ml (95% CI 77.8-104.4, p= 0.726) and hrHPV positivity rates were 8.2% and 6.9% (p= 0.419) per sample self-collected by the second - and the first generation of the device (p= 0.726), respectively. In addition, response rates were comparable for the two models (35.4% versus 34.4%, p= 0.654)., Conclusions: Replacing the first generation self-sampling device by an ergonomically improved, second generation device resulted in equal DNA yields, comparable hrHPV positivity rates and similar response rates. Therefore, it can be concluded that the clinical performance of the first and second generation models are similar. Moreover, participation of non-attendees in cervical cancer screening is probably not predominantly determined by the type of self-collection device.

Objective: This study utilized a combination of HPV self-sampling, iFTA elute specimen cards, and long distance transport for centralized processing of specimens to determine the feasibility of large-scale screening in remote and transient populations., Methods: This study was performed in two locations in Peru (Manchay and Iquitos). The "Just For Me" cervico-vaginal brush and iFTA elute cards were used for the collection and transport of specimens. Samples were shipped via FedEx to China and tested for 14 types of high-risk HPV using PCR based MALDI-TOF. HPV positive women were treated with cryotherapy after VIA triage, and followed-up with colposcopy, biopsy, ECC, and repeat HPV testing at 6 months., Results: Six hundred and forty three women registered, and 632 returned a sample over a 10 day period. Within 2 weeks, specimens were shipped, samples tested, and results received by study staff. Sixty-eight women (10.8%) tested positive, and these results were delivered over 4 days. Fifty-nine HPV positive women (87%) returned for evaluation and treatment, and 2 had large lesions not suitable for cryotherapy. At 6 months, 42 women (74%) returned for follow-up, and 3 had CIN 2 (all positive samples from the endocervical canal). Ninety eight percent of participants reported that they would participate in this type of program again., Conclusions: Utilizing HPV self-sampling, solid media specimen cards for long distance transport, and centralized high throughput processing, we achieved rapid delivery of results, high satisfaction levels, and low loss to follow-up for cervical cancer screening in remote and transient populations., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Aim: Inadequate cervical sampling is the most frequent cause of misdiagnosis in cervical cancer screening. The aim of this study was to test the ability of PapCone® versus the conventional sampling method (Ayre's spatula plus cytobrush) to collect ectocervical and glandular cells., Materials and Methods: In 18 healthy women, two ecto-endocervical samples, obtained by two different methods, were obtained at a three-month interval. Qualitative and quantitative parameters were evaluated. Ultrastructure features of sampling devices were analyzed by scanning electron microscopy (SEM) before and after sampling., Results: The χ(2) test revealed a statistically significant difference between the two methods: PapCone® caused less cell overlap and sampled less white blood cells (p<0.05) and more metaplastic cells (p<0.01). SEM evaluation highlighted the porous and spongy structure of PapCone® that was responsible for the large number of glandular cells on its surface., Conclusion: Cervical smears performed by PapCone® were adequate and generally easier to screen than conventionally performed ones.

Objective: The purpose of this study is to report our experience with the implementation of the ThinPrep Imaging System (TIS) in a tertiary hospital in Korea and to evaluate the effectiveness of the TIS compared to manual methods in the screening of cervical cytology., Study Design: Detection rates of cervical abnormalities in the pre- and post-TIS periods (January 2009 to February 2010 and March 2010 to December 2010, respectively) were compared. Follow-up cytological and histological results with concurrent or subsequent human papillomavirus (HPV) tests were retrieved., Results: ASC-US, ASC-H, LSIL, and HSIL were more frequently detected in the post-TIS period than in the pre-TIS period (p < 0.005). The proportions of correlated cases of ASC-US were 42.2 and 40.4% in the pre- and post-TIS periods, respectively. The detection rates of high-risk types of HPV in ASC-US were not significantly different between the two groups. The proportion of correlated biopsy for ASC-H, LSIL, and HSIL was similar in both periods. HPV positivity for ASC-H, LSIL, and HSIL showed no significant change between the two periods., Conclusion: The TIS is potentially useful for the detection of abnormal cervical cytology on the basis of the increased detection rate of squamous cell abnormalities, with a relatively similar proportion of correlated cases compared to the manual screening method., (Copyright © 2013 S. Karger AG, Basel.)

Objective: To find an appropriate sampling device for a liquid-based procedure in the population screening for cervical cancer, focusing on bleeding at sampling and the amount of cells smeared., Methods and Materials: 1,000 consecutive women who underwent primary screening were studied. The specimens were obtained with the cotton stick/Cytobrush® method in the first 500 cases or with the Cervex-Brush® in the following 500 subjects, and were processed using the Thinlayer Advanced Cytology Assay System (TACAS™) following the manufacturer's instructions., Results: (1) Bleeding at cellular sampling using the cotton stick/Cytobrush and Cervex-Brush methods occurred in 1.2 and 8.8% of the cases, respectively (p < 0.0001). (2) The incidences of cells obtained with the two methods which covered the whole area, <1/2 and ≥1/4, and <1/4 of the observation fields were 55.4 versus 62.2% (p < 0.05), 14.6 versus 9.4% (p < 0.05), and 2.0 versus 4.0% (p < 0.05), respectively. (3) The incidences of endocervical or metaplastic cells obtained with ≥500 and <10 were 34.6 versus 20.0% (p < 0.01) and 9.4 versus 18.4% (p < 0.01), respectively. In cases of cells covering <1/4, incidences with <10 were 0 and 0.6% (n = 3), respectively. (4) Detection rates of abnormal cytology were 3.4 and 5.2% (n.s.), including atypical squamous cells of undetermined significance in 2.4 and 3.2%., Conclusions: The cotton stick/Cytobrush is superior to the Cervex-Brush as a cellular sampling device for the TACAS liquid-based procedure., (Copyright © 2013 S. Karger AG, Basel.)

Objective: Glucyte liquid-based cytology (LBC; BestPrep™;CellSolutions, LLC, Greensboro, N.C., USA) is a recently developed method. Its performance was assessed in comparison with ThinPrep (Hologic Inc., Marlborough, Mass., USA) and SurePath (BD Diagnostics, Burlington, N.C., USA) LBC platforms., Study Design: Two cervical samples obtained from each of 331 patients presenting for colposcopy were utilized. The first sample was placed in PreservCyt (Hologic) and the second in SurePath medium, and both were processed in accordance with the manufacturers' protocols. From the residual SurePath sample, a Glucyte slide was prepared, stained, and read as per the manufacturer's instructions., Results: Considering a threshold cytologic diagnosis of atypical squamous cells of undetermined significance and using a histologic diagnosis of high-grade cervical intraepithelial neoplasia or worse (CIN 2+) as the end point, there was no significant difference in the sensitivity of Glucyte for the detection of CIN 2+ compared with ThinPrep and SurePath (86.9 vs. 81.9% and 83.7%, respectively). However, Glucyte showed a specificity of 49.2% compared with 61.6% for ThinPrep (p = 0.002) and 66.9% for SurePath (p < 0.001). Considering a threshold cytologic diagnosis of high-grade squamous intraepithelial lesion, Glucyte showed a sensitivity of 40.5% for detecting CIN 2+ compared with 20.5% for ThinPrep (p = 0.003) and 54.7% for SurePath (p = 0.013). The corresponding specificities were 93.8, 99.1, and 94.3%. The rate of unsatisfactory specimens for Glucyte was 1.2% compared with ThinPrep (4.8%) and SurePath (0%)., Conclusion: Glucyte appeared to perform reasonably well compared with ThinPrep and SurePath. It offers an alternative to these well recognized LBC systems., (Copyright © 2013 S. Karger AG, Basel.)

Objectives: Automated screening will become important due to an aging workforce, declining numbers of new cytotechnologists, and the need for increased screening sensitivity in the vaccine era, where high-grade abnormalities will decline. This study documents workload in gynecologic cytology throughput before and after the implementation of the BD FocalPoint™ Guided Screener (GS) System., Study Design: We collected daily screening data from 3 time periods: the 12 months prior to GS implementation, the 6 months immediately after implementation, and the ensuing 7-18 months after implementation. Data was tabulated at the individual and total laboratory levels., Results: In the 6-month period immediately following implementation, productivity increased in 3 of 5 cytotechnologists, as compared to the figures 12 months before implementation. The laboratory increased productivity slightly (+2.4%), with individual changes ranging from -6.9 to +14.7%. In the 7- to 18-month 'mature' period after implementation, productivity increased in all 5 cytotechnologists with an average of +15.4%. Individual increases ranged from +6.1 to +26.9%., Conclusions: Overall productivity increased in the period beyond 6 months, and this increase was eventually noted in all personnel. Increased productivity was associated with a short period of learning in which the magnitude of the effect was less than in the mature period., (Copyright © 2013 S. Karger AG, Basel.)

Background: The preferred workflow for high-risk human papillomavirus (hrHPV) testing in the majority of laboratories involves cytology processing of samples collected in liquid-based cytology medium followed by hrHPV testing. The cobas HPV Test received approval from the US Food and Drug Administration in April 2011, and the supporting clinical trial design necessitated prealiquoting the sample used for hrHPV testing from the PreservCyt primary vial into a secondary vial that was placed on the cobas 4800 System., Methods: To validate use of the postcytology residual sample in the primary vial, the authors presented the results of cross-contamination studies and a comparison of the cobas HPV Test results from the prealiquot in the secondary vial with results obtained from the postcytology primary vial on samples processed on either the Hologic ThinPrep 2000 System (T2000) or ThinPrep 3000 System (T3000)., Results: Cross-contamination checkerboard studies with 100 samples processed on the T2000 system and 120 samples processed on the T3000 system indicated no conversion of primary vial results from positive to negative or from negative to positive. For clinical samples, approximately 1100 archived specimens from the ATHENA (Addressing the Need for Advanced HPV Diagnostics) study and 1100 combined archived and fresh primary vial specimens that had been processed on the T2000 and T3000 processors, respectively, were compared. The overall percentage agreement between the primary and secondary vials was at least 93.5%., Conclusions: The postcytology residual of samples collected in PreservCyt primary vials and run on the T2000 and T3000 processors provided reliable cobas HPV Test results that were comparable to results from the precytology secondary vial, without any evidence of contamination., (Copyright © 2012 American Cancer Society.)

Studies examining the effects of increased workload on the performance of individual cytotechnologists are limited. Using FocalPoint GS, the performance of 3 cytotechnologists was evaluated. The study consisted of 3 phases. In phase I, cytotechnologists were asked to screen at their usual pace. In phase II, cytotechnologists were asked to screen as fast as possible without feeling that the quality of their work was diminished. In phase III, cytotechnologists were asked to screen at least 15% more than their daily workload from phase II. Productivity was increased by decreasing the percentage of cases that underwent full manual review (from 38% to 19%) and by decreasing the time spent on each slide (from 5.5 min to 3.7 min). Overall, the total abnormal rate decreased by 31.9% from phase I to phase III of the study. In addition, the false-negative fraction increased significantly, from 1% to 6.9%. Our results indicated a negative association between increased cytotechnologist daily workload with FocalPoint GS and CT screening performance. Workloads were increased by decreasing the time spent reviewing 10 fields of view and the percentage of cases that underwent full manual review.

Purpose: To determine the effects of lubrication of the vaginal speculum before insertion during a Papanicolaou test on perceived pain and quality of the cytology specimen., Methods: Four hundred eligible women participating in cervical cancer screening and an early detection program were randomized with respect to lubricant gel use before speculum insertion. Perceived pain during speculum insertion and cytology results were assessed in study groups., Results: The mean age of the patients was 45.7 years (range, 23-77 years). Pain score of the NO GEL group was significantly higher than that of the GEL group (2.3 and 1.6, respectively; P < .05). For premenopausal women, lubricant gel use significantly reduced the pain scores of the participants (P < .05). Cytological interpretations of the Papanicolaou test specimens were comparable among all groups., Conclusions: During the collection of Papanicolaou test specimens, lubrication of the vaginal speculum with a small amount of K-Y Jelly (a water-soluble lubricant gel) decreases the pain associated with insertion of the vaginal speculum among postmenopausal women without obscuring the cytological interpretation of conventional or liquid-based cytology. In women of reproductive age, lubrication of the speculum with K-Y Jelly does not cause a meaningful effect with respect to perceived pain.

Background: Persistent infection with high-risk (HR) human papillomavirus (HPV) is a well-recognized cause of cervical cancer, but little is known about the situation in Laos. The aims of the study were to determine the prevalence of HR-HPV among Lao women and to evaluate the use of a filter paper card (FTA Elute Micro Card) for collection of cervical cells in the humid tropical climate., Methods: This is a cross-sectional study including 1922 women from 3 provinces in Laos. During a gynecological examination, cervical cells were collected and applied to the FTA card followed by HPV typing using a real-time polymerase chain reaction (PCR)-based assay., Results: Overall, 213 of the 1922 women were positive for HR-HPV (11%). The most common type was the group HPV33/52/58 (3%), followed by the single type 16 (2%) and the group 18/45 (1%), respectively. Only 11 cards (0.6%) did not contain a sufficient amount of genomic DNA for polymerase chain reaction-based analysis., Conclusions: The prevalence of HR-HPV infections in Laos is similar to other Asian countries, and 40% of the women with an HR-HPV infection will be target of the present HPV vaccines. The FTA card is suitable for collection of cervical cells for HR-HPV typing in tropical conditions. This information is important for planning and establishing primary and secondary prevention of cervical cancer in Laos.

The success of cytology in screening programs for cervical cancer is highly dependent on the smear quality. Interdisciplinary projects which evaluate the smear quality and the results of collection devices could be helpful for an improvement and a successful example for quality improvement is presented here. An average of 83% technically adequate and representative smears was documented for 12 million conventional PAP smears; however only an average of 68% technically adequate and representative smears was found for the group of least successful smear takers of all laboratories. This indicates a potential for improvement. Following an interdisciplinary project on smear quality improvement the average rate of representative smears increased from 69 to 83% and in another project this rate remained stable at 86%. Based on 158,411 conventional smears, representative smears were achieved in 92% using Cervex-Brush®, 86% using Szalay Spatula and 82% Cytobrush methods. The combinations of Cytobrush with the Ayre wooden spatula, cotton wool swab or Szalay Spatula achieved 97%, 94% and 92% representative smears, respectively.

Purpose: The aim was to evaluate the use of liquid-based gel during cytologic follow-up and the effect of liquid-based gel application during speculum examination on satisfactory level of smear., Methods: A total of 1,999 patients were taken into the study. Patients were divided into two groups as gel-applied group and control group. Age and menopausal status of patients, and the physicians taking the smear (resident or specialist) were recorded. In control group, dry speculum was used for the collection of smear sample. All specimens were evaluated for correlation of the cytopathology, the number of "unsatisfactory" samples, and any secondary diagnoses., Results: Assessment of smear satisfactoriness revealed that 2.2% (43) of them were unsatisfactory. Unsatisfactory smear ratio was significantly high in gel-applied group. Screening done by residents increased unsatisfactory result risk for about 5.5 times. Evaluation of effect of menopausal status on smear adequency revealed no difference between premenopausal and postmenopausal women., Conclusion: Cervical smear seems to be more accurate without gel application. Experience of the physician is also important. Water-based gel can be used in some women who experience overt pain during speculum examination, but these patients must be warned about unsatisfactory results and the need of repeat test.

The Papanicolau (Pap) test is a routine cytological procedure for early detection of dysplastic lesions in cervical epithelium. A reliable screening method is crucial for triage of women at risk; however manual screening and interpretation are associated with relatively low sensitivity and substantial interobserver diagnostic variability. P16 and Ki67 biomarkers have been recently proposed as adjunctive tools in the diagnosis of high-risk human papillomavirus (hrHPV) associated dysplasias to supplement the morphological characteristics of cells by additional colorimetric features. In this study, an automated technique for the evaluation of dual p16/Ki67 immunoreactivity in cervical cell nuclei is introduced. Smears stained with p16 and Ki67 antibodies were digitized, and analyzed by algorithms we developed. Gradient-based radial symmetry operator and adaptive processing of symmetry image were employed to obtain the nuclear mask. This step was followed by the extraction of features including pixel data and immunoreactivity signature from each nucleus. The features were analyzed by two support vector machine classifiers to assign a nucleus into one of four types of immunoreactivity: p16 positive (p16(+)/Ki67(-)), Ki67 positive (p16(-)/Ki67(+)), dual p16/Ki67 positive (p16(+)/Ki67(+)) and negative (p16(-)/Ki67(-)), respectively. Results obtained by our method correlated well with readings by two cytopathologists (n = 18,068 cells); p16(+)/Ki67(+) nuclei were classified with respective precisions of 77.1% and 82.6%. Specificity in identification of p16(-)/Ki67(-) nuclei was better than 99.5%, and the sensitivity in detection of all immunopositive nuclei was 86.3 and 89.4%, respectively. We found that the quantitative characterization of immunoreactivity provided by the additional highlighting of classified nuclei can positively impact the efficacy and screening outcome of the Pap test.

Self-collected vaginal specimens tested for high-risk human papillomavirus (HR-HPV) have been shown to be less sensitive for the detection of cervical intraepithelial neoplasia or cancer (≥CIN 3) than physician-collected endocervical specimens. To increase the sensitivity of self-collected specimens, we studied a self-sampling device designed to obtain a larger specimen from the upper vagina (POI/NIH self-sampler) and a more sensitive polymerase chain reaction (PCR)-based HR-HPV assay. Women (10,000) were screened with cervical cytology and HR-HPV testing of vaginal self-collected and endocervical physician-collected specimens. Women were randomly assigned to use either a novel self-collection device (POI/NIH self-sampler) or conical-shaped brush (Qiagen). The self-collected and clinician-collected specimens were assayed by Cervista (Hologic) and the research only PCR-based matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF). Women with any abnormal screening test underwent colposcopy and biopsy. Women (8,556), mean age of 38.9, had complete data; 1.6% had ≥ CIN 3. For either HR-HPV assay, the sensitivity was similar for the two self-collection devices. Tested with Cervista, the sensitivity for ≥CIN 3 of self-collected specimens was 70.9% and for endocervical specimens was 95.0% (p = 0.0001). Tested with MALDI-TOF, the sensitivity for ≥CIN 3 of self-collected specimens was 94.3% and for endocervical specimens was also 94.3% (p = 1.0). A self-collected sample using a PCR-based assay with the capability of very high throughput has similar sensitivity as a direct endocervical specimen obtained by a physician. Large population-based screening "events" in low-resource settings could be achieved by promoting self-collection and centralized high-throughput, low-cost testing by PCR-based MALDI-TOF., (Copyright © 2011 UICC.)

DNA-based molecular testing for human papillomavirus has emerged as a novel approach to cervical cancer screening in the context of well-entrenched existing technology, the Pap smear. This article seeks to elucidate the process of molecularisation in the context of screening programmes. We illustrate how, although Pap has long been problematised and could be seen as a competing technological option, the existing networks and regime for Pap were important in supporting the entrenchment process for the artefacts, techniques and new diagnostics industry entrant, Digene, associated with the new test. The article provides insights into how the molecularisation of screening unfolds in a mainstream market. We reveal an incremental and accretive, rather than revolutionary, process led by new commercial interests in an era when diagnostic innovation is increasingly privatised. We show Digene's reliance on patents, an international scientific network and their position as an obligatory point of passage in the clinical research field with regard to the new technology's role, as well as on controversial new marketing practices. The article is based on a mixed method approach, drawing on a wide range of contemporary sources (including patents, statutory filings by companies, scientific literature and news sources) as well as interviews., (© 2011 The Authors. Sociology of Health & Illness © 2011 Foundation for the Sociology of Health & Illness/Blackwell Publishing Ltd.)

Context: Our cytology laboratory, like many others, is under pressure to improve quality and provide test results faster while decreasing costs. We sought to address these issues by introducing new technology and lean principles., Objective: To determine the combined impact of the FocalPoint Guided Screener (GS) Imaging System (BD Diagnostics-TriPath, Burlington, North Carolina) and lean manufacturing principles on the turnaround time (TAT) and productivity of the gynecologic cytology operation., Design: We established a baseline measure of the TAT for Papanicolaou tests. We then compared that to the performance after implementing the FocalPoint GS Imaging System and lean principles. The latter included value-stream mapping, workflow modification, and a first in-first out policy., Results: The mean (SD) TAT for Papanicolaou tests before and after the implementation of FocalPoint GS Imaging System and lean principles was 4.38 (1.28) days and 3.20 (1.32) days, respectively. This represented a 27% improvement in the average TAT, which was statistically significant (P < .001). In addition, the productivity of staff improved 17%, as evidenced by the increase in slides screened from 8.85/h to 10.38/h. The false-negative fraction decreased from 1.4% to 0.9%, representing a 36% improvement., Conclusions: In our laboratory, the implementation of FocalPoint GS Imaging System in conjunction with lean principles resulted in a significant decrease in the average TAT for Papanicolaou tests and a substantial increase in the productivity of cytotechnologists while maintaining the diagnostic quality of gynecologic cytology.

Objective: Taking a biopsy is a standard procedure to make the correct diagnosis in patients with suspicious premalignant vulvar lesions. The use of a less invasive diagnostic tool as triage instrument to determine whether biopsy is necessary may improve patient comfort especially in patients with chronic vulvar disorders that may warrant consecutive biopsies. This study was conducted to investigate whether vulvar brush cytology is feasible and may be used to detect (pre)malignant vulvar lesions., Methods: A pilot study was performed with patients having clinically normal vulvar skin, lichen sclerosus (LS), usual or differentiated vulvar intraepithelial neoplasia or squamous cell carcinoma. A total of 65 smears were taken with the use of a vulvar brush and biopsies were performed for histopathological analysis., Results: Out of 65 smears, 17 (26%) were discarded because of poor cellularity. A total of 28 of 29 (97%) smears with a histological proven (pre)malignancy had a smear classified as 'suspicious' or 'uncertain'. Cytology classified 11 smears as 'non-suspicious', of which 10 (91%) were indeed normal skin or LS. The accuracy, based on the presence of a lesion, for (pre)malignant lesions with the use of the brush showed a sensitivity of 97% and a negative predictive value of 88%., Conclusion: Vulvar brush cytology is feasible and may be a first step in the development of a triage instrument to determine whether subsequent biopsy of a clinically (pre)malignant lesion is necessary.

Introduction: Communities of socially excluded immigrant women, especially Muslim, Asian, Aboriginal and Maroon, are among the groups of women with low rates of cervical screening. Exclusion of the pelvic examination could result in a higher acceptance of the cervical screening among these communities and an increase in screening coverage., Aim: To assess the performance of the Fournier(®) cervical specimen self-sampling device for the cytological diagnosis of precursor or neoplastic lesions in the uterine cervix using the Papanicolaou method., Methods: A case-control study was conducted at the Cervical Pathology Outpatient Clinic. Liquid-based cytology slides were obtained by the Fournier device and stained using the Papanicolaou method. The slides were analyzed by two pathologists, blinded for the colposcopic and histological results and compared to Papanicolaou smears that were obtained using the traditional method of speculum examination., Results: There were 68 patients who were considered free from precursor or neoplastic cervical lesions. There were 35 cases of low-grade lesions, 13 cases of high-grade lesions and 3 cases of squamous-cell carcinoma. According to the first and second pathologists, the sensitivities of the device for identifying precursor or neoplastic cervical lesions were 50.0 and 60.0%, and the specificities of the method were 81.8 and 73.8%. According to the first and second pathologists, the positive predictive values of the diagnostic test were 0.67 and 0.63, and the negative predictive values were 0.68 and 0.71, respectively., Conclusion: Sensitivity and specificity of the Fournier device test was comparable to Papanicolaou smears tests obtained using the traditional method with speculum examination., (Copyright © 2012 S. Karger AG, Basel.)

Cervical cancer is the most common cancer in Laos women and a screening programme, even with the PAP smear test (PAP test), has yet to be established for routine use. The Pap test is accepted as the most appropriate for cervical cancer screening in some settings but it is not commonly available in Laos hospitals, because there are few cytopathologists and gynecologists have little experience. As a pilot program, seminars for the PAP test were given in 2007 and 2008, and then PAP tests were carried out using self-sampling instrument (Kato's device) with 200 healthy volunteers in Setthathirath hospital, Laos, in 2008. The actual examination number was 196, divided into class I 104 (53.1%), class II 85 (43.3%), class IIIa 4 (2.0%), class IIIb 1 (0.5%), and class V 1 (0.5%) by modified Papanicolau classification. Four cases had menstruation. There were 6 cases with epithelial cell abnormalities including malignancy. There were 7 cases with fungus and 2 cases with trichomonas in Class II. More than 70% volunteers felt comfortable with the Kato's device and wanted to use it next time, because of the avoidance of the embarrassment and a low cost as compared with pelvic examination by gynecologists. This first trial for PAP test for healthy Laos women related to a hospital found three percent to have abnormal cervical epithelial cells. Therefore, this appraoch using a self-sampling device suggests that it should be planned for cervical cancer prevention in Laos.

Object: In the present study, we compared the positive cytodiagnostic test rates with discrepancies using self-collection devices for cervical cancer screening. We made this survey to examine whether or not our self- smear preparation method using the Kato self-collection device contributed to an improved rate of detecting atypical cells compared with existing recommended preparation methods., Methods: Specimens were collected at 14 facilities handling self-collection methods, and samples were collected by a physician in 2 facilities. The chi- squared test was performed using the SPSS ver. 20 statistical software to determine the relationships between the positive cytodiagnostic rate, specimen preparation methods, and self-collection devices., Results: Collecting cells using the Kato self-collection device and preparing liquid-based specimens, we obtained a significantly higher rate of positive cytodiagnosis and our results were equal to those obtained with the direct method., Conclusions: Taking into consideration increased needs for screening using the self-collection method in future, with even more improved test accuracy, a screening test that is acceptable to society needs to be established.