Clinician-collected Specimens Research Articles

Clinical Performance of Self-collected Specimen HPV-DNA vs Clinician- collected Specimen HPV-mRNA to Detect High-risk HPV and High-grade Cervical Lesions and Cancer.

Self- collected specimens to detect high-risk (hr) HPV and high-grade cervical lesions (CIN2+) has been introduced aiming to increase cervical cancer screening coverage. The performance of self- collected specimen compared to clinician collected specimen is one major concern. This study aimed to compare self-sampling HPV-DNA and clinician-sampling HPV-mRNA to detect hr-HPV and high-grade cervical lesions. Women with abnormal cervical cytology and/ or positive hr-HPV who attended the colposcopy clinics in 10 tertiary hospitals in Bangkok were enrolled. Self-collected specimens were evaluated for HPV DNA using Cobas® 4800 HPV test prior to the clinician-collected specimens which were tested for HPV mRNA with APTIMA® HPV Assay. Subsequent colposcopy with biopsy was performed. The detection rates of hr-HPV from both HPV tests and their performance to detect high-grade lesions pathology were compared. Data from 497 women's specimens were analyzed. Both samplings had 86.8% concordance rate in detecting hr-HPV (Kappa 0.670; 95% confidence interval [CI] 0.599-0.746, P value < 0.001). The sensitivity (95% CI) of self-collected specimen HPV DNA and clinician- collected specimen HPV-mRNA to detect high-grade lesions were 91.8% (85.4%-96.0%) and 90.2% (83.6%-94.9%) respectively. The corresponding negative predictive values (95% CI) were 91.9% (85.6%-96.0%) and 91.7% (86.0%-95.7%) respectively. HPV DNA testing from self-collected specimen to detect HR-HPV demonstrates high concordance with HPV mRNA testing from clinician-collected specimen. The sensitivity and negative predictive value of both tests to detect high-grade lesions are comparable.

Point-of-care HPV DNA testing of self-collected specimens and same-day thermal ablation for the early detection and treatment of cervical pre-cancer in women in Papua New Guinea: a prospective, single-arm intervention trial (HPV-STAT)

WHO recommends human papillomavirus (HPV) testing and same-day treatment for cervical screening in low-income and middle-income countries (LMICs); however, few published data exist on the validity of the strategy. We aimed to evaluate the clinical performance, treatment completion rates, adverse events profile, and acceptability of a fully integrated strategy, comprising point-of-care HPV DNA testing of self-collected specimens and same-day thermal ablation, for screening of cervical cancer in women in Papua New Guinea. HPV-STAT was a large-scale, prospective, single-arm intervention trial conducted at two clinical sites in Papua New Guinea. Cervical screening clinics with an on-site consultant gynaecologist were selected in consultation with national and provincial health authorities, church health services, and local stakeholders. Eligible participants were women aged 30-59 years attending cervical screening services at the two clinics, who were willing to comply with study procedures and able to provide written informed consent. Women self-collected vaginal specimens for point-of-care GeneXpert testing (Cepheid, Sunnyvale, CA, USA) for oncogenic HPV types. Women testing positive for HPV underwent pelvic examination followed by same-day thermal ablation or referral for gynaecology review. All HPV-positive women and a 15% random sample of HPV-negative women provided a clinician-collected cervical specimen for liquid-based cytology. The primary outcome was clinical performance (ie, sensitivity, specificity, positive predictive value [PPV], and negative predictive value [NPV]) of the strategy for the detection of high-grade squamous intraepithelial lesion (HSIL) or worse. This trial is registered with ISRCTN, ISRCTN13476702. Between June 5, 2018, and Jan 6, 2020, we recruited 4285 women, 3638 (84·9%) of whom tested negative for HPV and 647 (15·1%) tested positive for one or more oncogenic HPV type. Sensitivity of the algorithm to detect HSIL or worse was 85·4% (95% CI 81·0-89·6), with specificity 89·6% (88·6-90·6), PPV 35·2% (31·6-39·0), and NPV 98·9% (98·6-99·2). Among HPV-positive women, 602 (93·0%) received same-day thermal ablation and 42 (6·5%) were referred for gynaecology review, 37 (88·1%) of whom attended. Acceptability was high among both HPV-positive and HPV-negative women. Among the 329 HPV-positive women who attended a 3-month follow-up visit, 51 (15·5%) reported mild adverse symptoms that resolved in all cases by the follow-up visit. There were no serious adverse events. We conducted the first real-world evaluation of a fully integrated point-of-care HPV self-collect, test, and treat strategy for same-day cervical screening in a LMIC and found it to be effective, acceptable, and safe when implemented at scale in primary health-care facilities in Papua New Guinea. Our findings support the introduction and scale-up of HPV screening and treatment for the control and elimination of cervical cancer in LMICs, as recommended by WHO. Australian National Health and Medical Research Council.

Clinical validation of full HR-HPV genotyping HPV Selfy assay according to the international guidelines for HPV test requirements for cervical cancer screening on clinician-collected and self-collected samples

BackgroundAccording to international guidelines, Human Papillomavirus (HPV) DNA tests represent a valid alternative to Pap Test for primary cervical cancer screening, provided that they guarantee balanced clinical sensitivity and specificity for cervical intraepithelial neoplasia grade 2 or more (CIN2+) lesions. The study aimed to assess whether HPV Selfy (Ulisse BioMed – Trieste, Italy), a full-genotyping HPV DNA test that detects and differentiates 14 high-risk HPV (HR-HPV) types, meets the criteria for primary cervical cancer screening described in the international guidelines, on clinician-collected as well as on self-collected samples.MethodsFor each participant woman, consecutively referring to Azienda Sanitaria Universitaria Giuliano Isontina (Trieste, Italy) and CRO—National Cancer Institute (Aviano, Italy) for the cervical cancer screening program, the following samples were tested: (a) a clinician-collected cervical specimen, analyzed with the reference test (Hybrid Capture®2 test, HC2) and HPV Selfy; and (b) a self-collected vaginal sample, analyzed with HPV Selfy. Enrolled women were also asked to fulfill a questionnaire about self-sampling acceptability. As required by guidelines, a non-inferiority test was conducted to compare the clinical performance of the test under evaluation with its reference test.ResultsHPV Selfy clinical sensitivity and specificity resulted non-inferior to those of HC2. By analysis of a total of 889 cervical liquid-based cytology samples from a screening population, of which 98 were from women with CIN2+, HPV Selfy showed relative sensitivity and specificity for CIN2+ of 0.98 and 1.00 respectively (non-inferiority score test: P = 0.01747 and P = 0.00414, respectively); the test reached adequate intra- and inter-laboratory reproducibility. Moreover, we demonstrated that the performance of HPV Selfy on self-collected vaginal samples was non-inferior to the performance obtained on clinician-collected cervical specimen (0.92 relative sensitivity and 0.97 relative specificity). Finally, through HPV Selfy genotyping, we were able to describe HPV types prevalence in the study population.ConclusionsHPV Selfy fulfills all the requirements of the international Meijer’s guidelines and has been clinically validated for primary cervical cancer screening purposes. Moreover, HPV Selfy has also been validated for self-sampling according to VALHUDES guidelines. Therefore, at date, HPV Selfy is the only full-genotyping test validated both for screening purposes and for self-sampling.Trial registration ASUGI Trieste n. 16008/2018; CRO Aviano n.17149/2018

Screening for High Risk Human Papillomavirus Using Passively Self-Collected Menstrual Blood [A91

INTRODUCTION: Globally, cervical cancer is the fourth most common women’s cancer, and the second highest cause of cancer-related mortality. High risk human papillomavirus (HR-HPV) testing is a potential primary test but is conventionally clinic-performed. HR-HPV detection via self-collected samples could increase screening access, reducing opportunity costs and uncomfortable visits. A modified menstrual pad (Q-Pad, www.qvin.com/en), offers passive HR-HPV sample collection and is a potential screening approach alternative. It has a removable collection strip, with specimen-processing as dried blood spots. Objectives: 1) to assess Q-Pad vs. clinician-collected HR-HPV concordance 2) assess Q-Pad acceptability. METHODS: Women presenting for either cervical cancer screening or with an HPV-positive history were eligible. Three samples were requested from participants: 1) clinician-collected cervical specimens (CCS) 2) self-collected swabs (SCS), and 3) a Q-Pad which was taken home for use during the next menstruation (QPS). All conventional samples were processed using the Roche Molecular Systems’ Cobas HPV Test. Q-Pad dried blood spots were eluted, then similarly processed. RESULTS: A total of 153 women participated and 107 provided QPS and CCS. Among HR-HPV positive samples where the CCS to QPS interval (Q-Pad use) was CIN2, Q-Pad and CCS agreement was 100%. Thirty percent expressed discomfort with self-swabbing and refused SCS collection. Ninety-four percent recommended Q-Pad over clinician-collected sampling. Twelve percent of patients were Q-pad HPV-positive but CCS negative. CONCLUSION: Among HPV-positive women, the Q-Pad showed highly concordant results (95-100%) compared to clinician-collected sampling. This collection approach shows promise for integration into cervical cancer prevention programs.

Adolescents may accurately self-collect pharyngeal and rectal clinical specimens for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae infection

BackgroundThe COVID-19 pandemic illuminated the benefits of telemedicine. Self-collected specimens are a promising alternative to clinician-collected specimens when in-person testing is not feasible. In this study, we assessed the adequacy of self-collected pharyngeal and rectal specimens for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae among individuals undergoing chlamydia and gonorrhea screening.MethodsWe used data from a large cohort study that included male and female adolescents between the ages of 12–24 years. We considered self-collected specimens adequate for clinical use if the human synthase gene (a control target of the assay) was detected in the specimen.ResultsIn total, 2,458 specimens were included in the analysis. The human synthase gene was detected in 99.2% (2,439/2,458) of all self-collected specimens, 99.5% (1,108/1,114) of the pharyngeal specimens, and 99.0% (1,331/1,344) of the rectal specimens.ConclusionSelf-collected pharyngeal and rectal specimens demonstrated a very high proportion of human gene presence, suggesting that self-collection was accurate. A limitation of this study is that the sample adequacy control detects the presence or absence of the human hydroxymethylbilane synthase gene, but it does not indicate the specific anatomic origin of the human hydroxymethylbilane synthase gene. Self-collected specimens may be an appropriate alternative to clinician-collected specimens.

Self-collected versus clinician-collected cervical samples for the detection of HPV infections by 14-type DNA and 7-type mRNA tests

BackgroundHPV self-sampling has been widely supported by the scientific community following a strong body of literature on the subject. Self-sampling is important in cervical cancer screening as it has been shown to improve participation. It is well documented that HPV-testing has proven superior to cytology with regards to sensitivity in detection of CIN and cancer. The value of self-collected samples is reliant on the quality of the molecular testing performed, as well as the patients’ preference in sampling procedure and compliance to follow up on positive test results. Due to the incompatibility of self-samples and cytology, triage of HPV-DNA positives by testing for molecular biomarkers is highly warranted.MethodsOur objective was to compare the detection rate of genital Human Papillomavirus (HPV) infection in self- and clinician-collected samples by a 14-type HPV-DNA test and a 7-type mRNA E6/E7 test.ResultsFive hundred five women were recruited. Each study participant had two sample collection procedures performed upon the same visit, alternating order in execution of the self-collection or the clinician-taken procedure first or second, 1010 samples in total. HPV-DNA prevalence was 22.8% in self-collected versus 19.2% in clinician-collected samples (P = 0.19). Overexpression of mRNA E6/E7 from 7 HPV types was 7.1 and 6.3%, respectively (P = 0.71). The difference between HPV-DNA and HPV-mRNA positivity rates were statistically significant in both self-collected (22.8% versus 7.1%, P < 0.001) and clinician-collected samples (19.2% versus 6.3%, P < 0.001). Overall agreement between the two collection methods was fair, with a concordance rate of 78.2% (390/505), k = 0.34 (95% CI: 0.25–0.44), P < 0.001, for the HPV-DNA test and 92.5% (467/505), k = 0.40 (95% CI, 0.25–0.56), P < 0.001, for the mRNA test, respectively. 96.8% of the participants reported they felt confident carrying out the self-collection themselves, and 88.8% reported no discomfort at all performing the procedure.ConclusionsThis comparative study of two sampling methods reports fair agreement of HPV positivity rates between the self-collected and clinician-collected specimens using Abbott hrHPV and PreTect HPV-Proofer’7 tests. Only one third of HPV-DNA positive women had overexpression of mRNA E6/E7.Trial registrationISRCTN77337300.

Performance of a single-use, rapid, point-of-care PCR device for the detection of Neisseria gonorrhoeae, Chlamydia trachomatis, and Trichomonas vaginalis: a cross-sectional study

Timely detection and treatment are important for the control of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. The objective of this study was to measure the performance of the Visby Medical Sexual Health Test, a single-use, point-of-care PCR device. Women aged 14 years and older who presented consecutively to ten clinical sites across seven US states were enrolled for a cross-sectional, single-visit study. Patients who consented to participate, and who had not used any exclusionary products in the genital area in the previous 48 h, provided self-collected vaginal swabs for testing with the investigational device. Untrained operators received the specimens and ran the device using the guide provided. Specimens had to be run within 2 h of collection to be considered valid. For comparison, patient-infected status was derived by testing clinician-collected vaginal specimens with the Hologic Aptima Combo 2 Assay and Aptima Trichomonas vaginalis Assay, as well as the BD ProbeTec CT/GC Qx Amplified DNA Assay and BD ProbeTec Trichomonas vaginalis Qx Assay. If the results of those assays did not match, the BD MAX CT/GC/TV was used as a tiebreaker. The primary outcomes were the sensitivity and specificity of the investigational device for the detection of C trachomatis, N gonorrhoeae, and T vaginalis compared with patient-infected status. Between Feb 25, 2019, and Jan 6, 2020, 1585 participants aged between 14 years and 80 years (mean 34·8 [SD 14·2]) were enrolled. 1555 participants had tests run with the investigational device, of whom 1532 (98·5%) had a valid result on either the first or repeat test. Among the patients with evaluable results (including a determinate patient-infected status), the device had a sensitivity of 97·6% (95% CI 93·2-99·2) and specificity of 98·3% (97·5-98·9) for C trachomatis (n=1457), sensitivity of 97·4% (86·5-99·5) and specificity of 99·4% (98·9-99·7) for N gonorrhoeae (n=1468), and sensitivity of 99·2% (95·5-99·9) and specificity of 96·9% (95·8-97·7) for T vaginalis (n=1449). This innovative, rapid, easy-to-use, single-use, point-of-care device to detect C trachomatis, N gonorrhoeae, and T vaginalis infections showed excellent sensitivity and specificity, and could represent an important advance in the development of rapid diagnostics for sexually transmitted infections and other infectious diseases. Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases.

Acceptability of self- collection for human papillomavirus detection in the Eastern Cape, South Africa.

Human papillomavirus (HPV) testing on vaginal self-collected and cervical clinician-collected specimens shows comparable performance. Self-sampling on FTA cards is suitable for women residing in rural settings or not attending regular screening and increases participation rate in the cervical cancer screening programme. We aimed to investigate and compare high-risk (HR)-HPV prevalence in clinician-collected and self-collected genital specimens as well as two different HPV tests on the clinician collected samples. A total of 737 women were recruited from two sites, a community health clinic (n = 413) and a referral clinic (n = 324) in the Eastern Cape Province. Cervical clinician-collected (FTA cards and Digene transport medium) and vaginal self-collected specimens were tested for HR-HPV using the hpVIR assay (FTA cards) and Hybrid Capture-2 (Digene transport medium). There was no significant difference in HR-HPV positivity between clinician-collected and self-collected specimens among women from the community-based clinic (26.4% vs 27.9%, p = 0.601) or the referral clinic (83.6% vs 79.9%, p = 0.222). HPV16, HPV35, and HPV33/52/58 group were the most frequently detected genotypes at both study sites. Self-sampling for HPV testing received a high positive response of acceptance (77.2% in the community-based clinic and 83.0% in referral clinic). The overall agreement between hpVIR assay and HC-2 was 87.7% (k = 0.754). The study found good agreement between clinician-collected and self-collected genital specimens. Self-collection can have a positive impact on a cervical screening program in South Africa by increasing coverage of women in rural areas, in particular those unable to visit the clinics and women attending clinics where cytology-based programs are not functioning effectively.

Evaluation of an isothermal amplification HPV detection assay for primary cervical cancer screening

ObjectiveThe aim of this research was to evaluate independently the performance of a new isothermal amplification assay for cervical cancer screening compared to two previously validated PCR-based assays and histologic endpoints.MethodsThis is a sub-study from the Chinese multi-center screening trial (CHIMUST). The self-collected and clinician-collected specimens stored in PreservCyt at − 4 °C from 6042 women with complete data were tested with the AmpFire assay. These specimens had been previously tested with Cobas and SeqHPV assays. In the primary study all patients with an abnormal test were referred to colposcopy where all had directed and/or random biopsies plus ECC. No additional patients were called back based on the AmpFire results.Results6042/6619 women had complete data (mean age 44.1). There were 57 cases of CIN 2, 35 cases of CIN 3 and 2 cancers. The sensitivity for CIN2+ and CIN3+ were similar among the three assays (both direct and self-collected). For the specificities in all categories (CIN2+/CIN3+ and self and direct collection), isothermal amplification assay was either equal to or more specific than Cobas but consistently less specific than SeqHPV.ConclusionThe AmpFire HPV assay showed similar sensitivity to Cobas and SeqHPV for CIN2+ and CIN3+ on both self and clinician-collections (P>0.05), with good specificity. The speed, low cost, and simplicity of this assay will make it particularly suited for low and middle resource settings. Its accuracy with self-collection makes it applicable for mass screening programs.

Self-Collected Oral Fluid and Nasal Swabs Demonstrate Comparable Sensitivity to Clinician Collected Nasopharyngeal Swabs for Coronavirus Disease 2019 Detection.

We compared self-collected oral fluid swab specimens with and without clinician supervision, clinician-supervised self-collected mid-turbinate (nasal) swab specimens, and clinician-collected nasopharyngeal swab specimens for the detection of SARS-CoV-2. Supervised oral fluid and nasal swab specimens performed similarly to clinician-collected nasopharyngeal swab specimens. No sample type could detect SARS-CoV-2 infections amongst all positive participants.

Performance of Patient-collected Specimens for Neisseria gonorrhoeae Culture.

Neisseria gonorrhoeae culture is necessary to determine antimicrobial resistance, but typically requires specimen collection by clinicians. We sought to determine the sensitivity of patient-collected specimens for N. gonorrhoeae culture. We performed N. gonorrhoeae cultures on paired clinician- and patient-collected specimens from the pharynx (n = 93), rectum (n = 88), endocervix/vagina (n = 89), and urethra/urine (n = 46). We calculated the percent concordance and the kappa statistics for paired-specimen results, and determined the test sensitivity for each specimen type using positivity of either specimen in a pair as a gold standard defining the presence of true infection. At least 1 specimen was positive in 26%, 31%, 61%, and 3% of paired samples in the pharynx, rectum, urethra/urine, and endocervix/vagina, respectively. Patient- and clinician-collected results were highly concordant at the pharynx (95%; kappa = 0.85), rectum (99%; kappa = 0.97), urethra/urine (83%; kappa = 0.87), and endocervix/vagina (100%; kappa = 1.0; P ≤ .005 for all comparisons). Patient-collected pharyngeal and rectal swabs and urine were 92%, 96%, and 96% sensitive, while clinician-collected specimens at these anatomic sites were 87.5%, 100%, and 94% sensitive (P > .05 for all comparisons). Among 24 urine specimens held for 4-22 hours after collection, 100% yielded concordant N. gonorrhoeae culture results, compared to immediate processing. Patient- and clinician-collected specimens are comparably sensitive for N. gonorrhoeae culture. These findings suggest that patient-collected specimens could be used to expand the availability of gonococcal antimicrobial resistance testing for both clinical and surveillance purposes.

Evaluation of p16/Ki-67 dual-stain cytology performed on self-collected vaginal and clinician-collected cervical specimens for the detection of cervical pre-cancer

ObjectivesTo compare the performance of dual immunostaining of p16INK4a and Ki-67 proteins performed on self-collected vaginal specimens and clinician-collected cervical specimens, and to evaluate the performance of this technique in predicting high-grade disease. MethodsWomen aged 30–59 years (n = 1005) were recruited at two well-women clinics in Papua New Guinea. Each woman provided both cervical and vaginal specimens that were tested for high-risk human papillomavirus (hrHPV) DNA using the Xpert HPV Test (Cepheid) at point of care. A subset of paired cervical and vaginal specimens (n = 243) were selected to undergo CINTec® PLUS (Roche) p16/Ki-67 dual-stain cytology and liquid-based cytology (LBC). ResultsFifty-five pairs (22%) were excluded from further analysis because the smears were not assessable. Of the 189 remaining paired specimens, 74 pairs (39.1%) were positive for one or more hrHPV genotypes. When comparing results of the dual stain, the overall percent agreement, positive and negative percent agreements and κ value between the cervical and vaginal specimens were 87.8% (CI 82.3–92.1%), 64.6% (CI 49.5–77.8%), 95.7% (CI 91.0–98.0%) and 0.65 (CI 0.51–0.79%) respectively. The sensitivity of the dual stain performed on the cervical specimen to predict high-grade disease, determined by LBC, was superior to that of the dual stain performed on the vaginal specimen: 100% (CI 84.6–100%) versus 68.2% (CI 45.1–86.1%). ConclusionAlthough further evaluation may be warranted, these findings indicate that dual-stain testing of vaginal specimens cannot be advocated as part of cervical screening programmes in low- and middle-income countries. However, dual-stain cytology performed on cervical specimens may have a role in quality assurance in such settings.

Accuracy of Curable Sexually Transmitted Infections and Genital Mycoplasmas Screening by Multiplex Real-Time PCR Using a Self-Collected Veil among Adult Women in Sub-Saharan Africa.

Background Sexually transmitted infections (STIs) are highly prevalent in sub-Saharan Africa. Genital self-sampling may facilitate the screening of STIs in hard-to-reach remote populations far from large health care centers and may increase screening rates. The cross-sectional GYNAUTO-STI study was carried out to assess the performance of a novel genital veil (V-Veil-Up Gyn Collection Device, V-Veil-Up Pharma, Ltd., Nicosia, Cyprus) as a genital self-sampling device to collect genital secretions to diagnose STIs by molecular biology as compared to reference clinician-collected genital specimens, in adult African women. Methods Adult women living in N'Djamena, the capital city of Chad, were recruited from the community and referred to the clinic for women's sexual health “La Renaissance Plus”. A clinician obtained an endocervical specimen using flocked swab. Genital secretions were also obtained by self-collection using veil. Both clinician- and self-collected specimens were tested for common curable STIs (including Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium, and Trichomonas vaginalis) and genital Mycoplasma spp. by multiplex real-time PCR (Allplex™ STI Essential Assay, Seegene, Seoul, South Korea). Test positivities for both collection methods were compared by assessing methods agreement, sensitivity, and specificity. Results A total of 251 women (mean age, 35.1 years) were prospectively enrolled. Only seven (2.8%) women were found to be infected with at least one common STIs [C. trachomatis: 3 (1.2%), N. gonorrhoeae: 1 (0.4%), M. genitalium: 4 (1.6%) and T. vaginalis: 1 (0.4%)], while the prevalence of genital mycoplasmas was much higher (54.2%) with a predominance of Ureaplasma parvum (42.6%). Self-collection by veil was non-inferior to clinician-based collection for genital microorganisms DNA molecular testing, with “almost perfect” agreement between both methods, high sensitivity (97.0%; 95%CI: 92.5-99.2%), and specificity (88.0%; 95%CI: 80.7-93.3%). Remarkably, the mean total number of genital microorganisms detected per woman was 1.14-fold higher in self-collected specimens compared to that in clinician-collected specimens. Conclusions Veil-based self-collection of female genital secretions constitutes a convenient tool to collect in gentle way cervicovaginal secretions for accurate molecular detection of genital bacteria. Such sampling procedure could be easily implemented in STIs clinics in sub-Saharan Africa.

Comparison of detection rate of high risk HPV infection between self-collected HPV testing and clinician-collected HPV testing in cervical cancer screening

to correlate the detection rate of high risk HPV (HR-HPV) DNA between self-collected and clinician-collected testing. A cross-sectional analytic study was conducted in 400 women undergoing cervical cancer screening program during February and May 2015. The procedure began with self-collected method and then clinician-collected method. Then, the specimens were processed and interpreted with the same technique. If the results from either methods were positive for HPV genotype 16 or 18, colposcopy was performed. We also conducted cytology testing for the participants. If the results were abnormal (ASC-US+), colposcopy was also performed. The detection rate of HR-HPV DNA was 10.0% and 7.5% by self-collected and clinician-collected specimen, respectively (kappa=0.73). HR-HPV positive rate in cytology ASC-US+ was no significantly different between groups. HR-HPV DNAs were positive in every HSIL (100% detection rate). HPV DNA test positive for detection CIN+ was not significantly different between self-collected and clinician-collected testing. self-collected HPV testing can be used as an alternative option for primary cervical screening program. Detection rate of high grade lesion is similar to clinician-collected test.

High-risk human papillomavirus infection and abnormal cervical cytology among Nepali and Bhutanese refugee women living in eastern Nepal

BackgroundCervical cancer is the leading cause of cancer morbidity and mortality among women in Nepal and Bhutan. Data on high-risk human papillomavirus (HR-HPV) infection and cervical abnormalities among Nepali and Bhutanese women are sparse. The objectives of this study were to assess and compare the prevalence of HR-HPV infection and cervical abnormalities among Nepali and Bhutanese women living in Jhapa District in eastern Nepal; and examine the risk factors for HR-HPV infection and cervical abnormalities in those women.MethodsStudy participants were recruited from a women’s health camp organized by NFCC-International, a Nepal-based non-governmental organization, in 2014. Consenting participants were administered a demographic and health questionnaire and cervico-vaginal specimens collected. Both self-collected and clinician-collected cervico-vaginal specimens were tested for HR-HPV infection. Cytologic exam was performed on clinician-collected samples and cervical cytology results were categorized according to the Bethesda classification. A participant was classified as a Bhutanese if they were either born in Bhutan or currently lived in one of the United Nations administered Bhutanese refugee camps in Jhapa; otherwise, the participant was classified as a Nepali.ResultsOf the 647 study participants, 15.9% were Bhutanese women living in refugee camps and the overall age (± standard deviation) was 38.8 ± 8.2 years. The prevalence of HR-HPV infection was 8.9% and abnormal cervical cytology was 7.1% respectively, with no significant difference in HR-HPV positivity (p = 0.399) or abnormal cervical cytology (p = 0.698) between Nepali and Bhutanese women. Compared to women whose husbands had not migrated for employment, women whose husbands had migrated outside of the district had 3.30 times (95% Confidence Interval [CI]: 1.13–9.64) the odds of being HR-HPV positive and women whose husbands had migrated outside the country had 2.92 times (95% CI: 1.32–6.49) the odds of having abnormal cervical cytology.ConclusionsHR-HPV positivity and abnormal cervical cytology were similar among Nepali and Bhutanese women. Husbands migrating for employment within or outside the country was a significant risk factor for high-risk HPV infection and cervical cytology, indicating the important role spousal behavior may play in HR-HPV acquisition and cervical abnormalities among these women.

Direct comparison of two vaginal self-sampling devices for the detection of human papillomavirus infections

Background and objectivesTwo devices for vaginal self-sampling of dry cell material (Evalyn Brush, Rovers Medical Devices; Qvintip, Aprovix) were compared using the Abbott RealTime High Risk HPV test. Study designBoth self-sampling devices (change of order with every patient) including instructions for use and a questionnaire were handed to 146 patients in a colposcopy clinic prior to scheduled colposcopies with collection of cervical reference specimens by gynaecologists using a broom-like device. Matched self-collected and physician collected specimens were transferred to ThinPrep medium and tested for the presence of hr-HPV. Biopsies were taken if indicated by colposcopy. ResultsEvaluation of 136 patients with complete data (136/146; 93.2%) showed high agreement of overall hr-HPV detection rates between self-collected and clinician-collected specimens (Evalyn: 91.2% [kappa 0.822]; Qvintip: 89.0% [kappa 0.779]). Colposcopy and histological evaluation revealed 55 women without cervical intraepithelial neoplasia (CIN), 32 CIN1, 34 CIN2, 14 CIN3 and one adenocarcinoma in situ. Hr-HPV testing detected all CIN3+ cases on the clinician-taken or Evalyn self-samples (14/14) and 93% of them on the Qvintip samples (13/14). There was no significant difference regarding the sensitivity for CIN2+ or CIN3+ and specificity of hr-HPV testing on self- vs. clinician samples and on Evalyn vs. Qvintip. Based on signal intensities of β-globin, the observed DNA concentration with Evalyn samples (mean CN: 22.0; 95%-CI: 21.5–22.6) was found to be significantly higher compared to that of Qvintip samples (mean CN: 23.8; 95%-CI 23.2–24.4), regardless of the order of self-sampling (p<0.0001). Most women considered self-sampling easy and comfortable. Qvintip was considered easier than the Evalyn Brush to understand (p<0.001) and to use (p=0.002). DiscussionThis study confirms that hr-HPV testing with a clinically validated PCR-based HPV assay is as accurate on self-samples as on clinician-samples without significant difference between both self-sampling devices.

Effectiveness of novel, lower cost molecular human papillomavirus-based tests for cervical cancer screening in rural china.

This study examined the efficacy of the OncoE6™ Cervical Test, careHPV™ and visual inspection with acetic acid (VIA) in identifying women at risk for cervical cancer and their capability to detect incident cervical precancer and cancer at 1-year follow-up. In a population of 7,543 women living in rural China, women provided a self-collected and two clinician-collected specimens and underwent VIA. All screen positive women for any of the tests, a ∼ 10% random sample of test-negative women that underwent colposcopy at baseline, and an additional ∼ 10% random sample of test-negative women who did not undergo colposcopy at baseline (n = 3,290) were recruited. 2,904 women were rescreened 1 year later using the same tests, colposcopic referral criteria, and procedures. Sensitivities of baseline tests to detect 1-year cumulative cervical intraepithelial neoplasia Grade 3 or cancer (CIN3+) were 96.5% and 81.6% for careHPV™ on clinician-collected and self-collected specimens, respectively, and 54.4% for OncoE6™ test. The OncoE6™ test was very specific (99.1%) and had the greatest positive predictive value (PPV; 47.7%) for CIN3+. Baseline and 1-year follow-up cervical specimens testing HPV DNA positive was sensitive (88.0%) but poorly predictive (5.5-6.0%) of incident CIN2+, whereas testing repeat HPV16, 18 and 45 E6 positive identified only 24.0% of incident CIN2+ but had a predictive value of 33.3%. This study highlights the different utility of HPV DNA and E6 tests, the former as a screening and the latter as a diagnostic test, for detection of cervical precancer and cancer.

P10.02 Field evaluation of the xpert hpv test for the detection of human papillomavirus infection in women using self-collected vaginal compared to clinician-collected cervical specimens

Background The Cepheid Xpert® HPV Test has high sensitivity and specificity for the detection of HPV infection in women compared to the Roche cobas 4800 HPV assay using cervical specimens. In many high-burden, low-resource countries it will not be feasible to achieve high cervical screening coverage using HPV-DNA technologies that require clinician-collected samples. We are conducting the first evaluation of self-collected vaginal specimens compared to clinician-collected cervical specimens for the detection of HPV infection using the Xpert® HPV Test. This study is being conducted in Papua New Guinea, which has among the highest rates of cervical cancer globally, with an age-standardised incidence of 23.7/100,000 compared to 5.0/100,000 in Australia and New Zealand. Methods Women aged 30–54 years attending two Well Woman Clinics are invited to participate and following informed consent procedures, complete a short interview, clinical examination, and provide self-collected and clinician-collected cytobrush specimens for clinic-based HPV testing. Women are given their cervical test result the same day. Those with a positive HPV test and a positive examination on visual inspection of the cervix with acetic acid are offered same-day cervical cryotherapy. Results A total of 313 women were recruited to end-Feb 2015. There was 94.2% overall percentage agreement (OPA) between vaginal and cervical tests for all high-risk HPV (hrHPV) types; 100% OPA for HPV-16; and 99.7% OPA for HPV 18/45. Based on cervical test results, the prevalence of HPV-16 was 4.2% (13/313); HPV 18/45 was 1.6% (5/313); and other hrHPV, 11.8% (37/313). Overall, 15.7% (49/313) of participants had one or more hrHPV infection. Conclusion Preliminary results suggest that self-collected vaginal specimens compare favourably to clinician-collected cervical specimens for the detection of HPV infection using the Xpert® HPV Test. If confirmed, this finding is likely to have significant implications for future HPV-based cervical screening programs in high-burden, low-resource settings worldwide. Disclosure of interest statement Nothing to Disclose.

P07.23 Evaluation of the cobas®hsv 1 and 2 test for the detection of hsv from clinician-collected anogenital lesion swab specimens compared with elvis®hsv id and d³ typing test and sanger sequencing

Introduction Diagnosis of anogenital herpes is definitively established by testing anogenital lesion specimens from symptomatic patients by culture or molecular methods. The objective of this study was to evaluate the cobas ® HSV 1 and HSV 2 Test using clinician-collected swab specimens from external anogenital lesions as part of a large multicenter clinical trial conducted in the United States of America. Methods Two swabs were collected from patients with possible HSV infection at 8 geographically diverse sites. The first swab was used for culture by the ELVIS ® HSV ID and D³ Typing Test (Diagnostic Hybrids, Inc., Athens, OH) and PCR followed by Sanger sequencing for HSV-1 and HSV-2. The second swab was for the cobas ® HSV 1 and 2 Test. Sensitivity and specificity were calculated compared to the combined results of culture and Sanger sequencing using the “any positive rule”. The positive (PPA) and negative percent agreement (NPA) were calculated compared with culture. Results There were 243 HSV positive subjects, with 84 HSV-1 (51 female, 33 male) and 167 HSV-2 (85 female, 82 male) positive subjects, among 408 evaluable participants (205 female, 203 male). The sensitivity and specificity of the cobas ® HSV 1 and HSV 2 Test compared the Reference Method for HSV-1 was 92.9% (78/84) and 98.8% (320/324), respectively, and for HSV-2 was 97.0% (162/167) and 94.6% (228/241), respectively. The PPA and NPA of the cobas ® HSV 1 and HSV 2 Test compared to the culture for HSV-1 was 100% (67/67) and 93.9% (199/212), respectively, and for HSV-2 was 99.2% (128/129) and 83.2% (232/279), respectively. Conclusion The cobas ® HSV 1 and 2 Test displayed excellent performance compared to the combined results of culture and Sanger sequencing. The test is highly suitable to detect HSV in clinician-collected anogenital swab specimens from patients with suspected HSV infection. Disclosure of interest statement This clinical trial study was supported by Roche Molecular Diagnostics.

P07.25 Comparison of cobas® hsv 1/2 test, quidel lyra™ direct hsv 1+2/vzv, bd probetectm hsv 1/2 qx assay and sanger sequencing using clinician-collected anogenital lesion swabs

Objectives The objective of this study was to evaluate the cobas ® HSV 1 and HSV 2 Test using clinician-collected swab specimens from external anogenital lesions as part of a large multicenter clinical trial. Methods Two swabs were collected from patients with possible HSV infection at 8 geographically diverse sites. The first swab was used for the Quidel Lyra™ Direct HSV 1+2/VZV on the Cepheid SmartCycler II System and the second for the cobas ® HSV 1 and 2 Test. The Quidel Lyra™ Direct HSV 1+2/VZV test was performed at a reference laboratory and the cobas ® HSV 1 and HSV 2 Test was performed at 3 sites. Discrepant analysis included HSV culture using the ELVIS ® HSV ID and D³ Typing Test, a second FDA-cleared nucleic acid amplification test (BD ProbeTec TM Herpes Simplex viruses [HSV 1 and 2] Q x Amplified DNA Assays) and Sanger sequencing. The sensitivity and specificity were calculated by comparing cobas ® HSV 1 and HSV 2 Test results with the Quidel Lyra™ Direct HSV 1+2/VZV test following discrepant analysis using the majority result from the three comparator tests. Results There were 229 HSV positive subjects, with 73 HSV-1 (44 female, 29 male) and 157 HSV-2 (78 female, 79 male) positive subjects, among 409 evaluable participants (205 female, 204 male). The sensitivity and specificity of the cobas ® HSV 1 and HSV 2 Test compared to the Quidel Lyra™ Direct HSV 1+2/VZV following discrepant analysis for HSV-1 was 98.6% (72/73) and 97.0% (326/336), respectively, and for HSV-2 was 100% (157/157) and 92.9% (234/252), respectively. Conclusion The cobas ® HSV 1 and 2 Test, on the automated cobas ® 4800 system, displayed excellent performance compared Quidel Lyra™ Direct HSV 1+2/VZV Test combined with discrepant analysis. The test is highly suitable to detect HSV in clinician-collected anogenital swab specimens from patients with suspected HSV infection. Disclosure of interest This clinical trial study was supported by Roche Molecular Diagnostics.