Evaluation of PathTezt™, a Liquid-Based Cytology System.

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.

Effective reduction in inadequate Pap smears by using a saline-lubricated speculum and two glass slides.

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.

Cervical Human Papillomavirus Testing With Two Home Self-Collection Methods Compared With a Standard Clinically Collected Sampling Method.

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.

Acceptability of human papillomavirus self-sampling for cervical-cancer screening in under-screened Maori and Pasifika women: a pilot study.

AIM: To assess whether self-sampling for cervical-cancer screening is acceptable to New Zealand women. METHODS: Maori, 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 Maori, 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 Maori 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.

A retrospective validation of the FocalPoint GS slide profiler NFR technology by analysis of interval disease outcomes compared with manual cytology.

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.

Validation of a new HPV self-sampling device for cervical cancer screening: The Cervical and Self-Sample In Screening (CASSIS) study.

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.

Safety and acceptability of human papillomavirus testing of self-collected specimens: A methodologic study of the impact of collection devices and HPV assays on sensitivity for cervical cancer and high-grade lesions.

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.

Self-taken vaginal swabs versus clinician-taken for detection of candida and bacterial vaginosis: a case-control study in primary care.

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.

Accuracy of self-collected human papillomavirus samples from Japanese women with abnormal cervical cytology.

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.

Implementation of a real-time reference and calibration grid platform for improved screening - mapping in Pap test slides.

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.

Prevalencia de genotipos del virus del papiloma humano de alto riesgo no vacunables dentro del programa de Detección Precoz de Cáncer de Cérvix en Cantabria / Prevalence of non-vaccinable high risk genotypes of human papillomavirus in the Early Detection of Cervical Cancer Program in Cantabria

OBJETIVO: Estimar la prevalencia de infección por genotipos del virus del papiloma humano (VPH) de alto riesgo no vacunables. DISEÑO: Estudio descriptivo transversal. Emplazamiento: Siete centros de salud de Cantabria seleccionados aleatoriamente. PARTICIPANTES: Se incluyó a todas las mujeres con una citología vaginal valorable (n = 3.359) entre 2010-2011. MEDICIONES PRINCIPALES: Se recogieron diagnóstico citológico, resultado de PCR y método anticonceptivo. Los resultados de las citologías se clasificaron con el sistema Bethesda. Para la tipificación de VPH según el riesgo oncogénico se utilizó la clasificación de Muñoz et al. Se estimaron proporciones y odds ratio (OR) con sus correspondientes intervalos de confianza al 95% (IC95%). RESULTADOS: La prevalencia de infección por VPH fue del 2,71% (IC95%: 2,15-3,27). La prevalencia de genotipos de VPH de alto riesgo oncogénico fue del 2,26%; (IC95%: 1,75-2,78). El genotipo más frecuente fue el 16 (28,89%). Más de la mitad de las mujeres fueron positivas para algún genotipo de alto riesgo no vacunable: 51 (18,89%) o 58 (13,33%) o 68 (12,22%) o 31 (11,11%). En el 23,33% de las mujeres coexistieron al menos 2 genotipos de alto riesgo no vacunables. Las mujeres más jóvenes (≤ 30 años) tuvieron 2 veces más riesgo de infección por cualquier VPH: OR 2,01; (IC95%: 1,02-3,96); y 2 veces más probabilidad de usar anticonceptivos hormonales frente al preservativo: OR 2,09; (IC95%: 1,64-2,67). CONCLUSIONES: Atendiendo al alto porcentaje de VPH de alto riesgo oncogénico no vacunable, habría que replantear la estrategia de prevención en la población, que podría tener una falsa sensación de protección

OBJECTIVE: To assess the persistence of treatment with monthly risedronate and know the reasons of persistence and nontherapeutic persistence and the profile of the non-persistent patients. Desing: Observational, postmarketin and prospective study. LOCATION: Primary care, traumatology, rheumatology, gynecology and geriatrics of Catalonia. PARTICIPANTS: Women with osteoporosis treated with monthly risedronate that previously had abandoned weekly bisphosphonate therapy. MAIN MEASUREMENTS: Percentage of patients on persistent monthly risedronate year of their prescription, reasons for persistent and non persistent and profile of non persistent patients in relation to biodemographic data, clinical data and risk factors for fracture. RESULTS: 289 evaluable patients with a mean age of 68.3. At 12 months of initiation with monthly risedronate, 58.1% of patients remained on treatment. Most frequent reasons for leaving: fear of having side effects and belief that the disease is typical of the age. Reasons remarkable persistence: comfort/ease and dosage. Significant differences were observed between persistent and non-persistent patients relative to: employment status, number of concomitant therapy and height; however the results of possible associated factors must be contextualized within the study characteristics and the difference in size does not seem clinically relevant. CONCLUSIONS: The administration of therapeutic patterns more comfortable as monthly risedronate in osteoporosis, could facilitate persistence in patients improving the effectiveness of the drug. However in that persistence can also influence biodemographic and clinical variables and diverse of various kinds

Cost-effectiveness of using the Cervex-Brush (broom) compared to the elongated spatula for collection of conventional cervical cytology samples within a high-burden HIV setting: a model-based analysis.

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.

Reaching women who do not participate in the regular cervical cancer screening programme by offering self-sampling kits: a systematic review and meta-analysis of randomised trials.

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.

Evaluation of a New Automated Processing System (TACAS™ Pro) for Liquid-Based Procedures.

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.

Assessment of the reliability of a novel self-sampling device for performing cervical sampling in Malaysia.

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.

Self-sampling to increase participation in cervical cancer screening: an RCT comparing home mailing, distribution in pharmacies, and recall letter.

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.

Comparative Assessment of a Self-sampling Device and Gynecologist Sampling for Cytology and HPV DNA Detection in a Rural and Low Resource Setting: Malaysian Experience.

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.

Self-collection tools for routine cervical cancer screening: a review.

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.

Collection, isolation, and flow cytometric analysis of human endocervical samples.

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.

Women's perceptions and attitudes about cervical cancer in Turkey: Kato's device as an alternative to the Pap smear.

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.