Endocervical Samples Research Articles

Rapid and sensitive detection of Chlamydia trachomatis sexually transmitted infections in resource-constrained settings in Thailand at the point-of-care.

Chlamydia trachomatis is the leading cause of sexually transmitted diseases (STDs) in females and males in both developed and developing countries, with more than 110 million cases annually. C. trachomatis resists antibiotic treatment and is a cofactor in HIV transmission and human cervical cancer [1]. Infection is often asymptomatic, causing the epidemiology to be underestimated. Therefore, we have developed a rapid, inexpensive, easy-to-interpret, sensitive and specific point-of-care (POC) C. trachomatis detection system, using loop-mediated isothermal amplification (LAMP) for target C. trachomatis DNA amplification, followed by gold nanoparticle probe (AuNP) for colorimetric C. trachomatis specific readout. The assay was evaluated using clinical samples and compared with polymerase chain reaction (PCR) of the same target gene, which is an outer membrane protein A (ompA) gene and a respected standard for C. trachomatis detection [1,2]. For nucleic acid amplification tests, recently LAMP has presented an attractive alternative to standard methods like PCR due to its low price, ease of use, rapid results, and lack of requirement for an expensive thermal cycler and specialized kits for DNA extraction and purification. A simple 5-minute boil for crude DNA lysis is sufficient for the LAMP reaction because the Bacillus stearothermophilus (Bst) DNA polymerase in LAMP has fewer inhibitor problems than Thermus aquaticus (Taq) DNA polymerase in PCR [3]. LAMP amplifies the target at a single temperature with high sensitivity (from 10 to 100 genome copies), and the product can be visualized as a white magnesium pyrophosphate precipitate. However, nebulous precipitate has the potential to cause misreading [3,4], so analysis by agarose gel-electrophoresis (GE), as with PCR, is standard. The positive LAMP reaction appears as multiple bands because several primers amplify amplicons of different sizes that are intercalated. Nevertheless, GE requires an electrophoresis apparatus, time, and often ethidium bromide exposure. In the current study, crude DNA lysis with combined LAMP-AuNP for POC C. trachomatis detection has been developed, and the specificity and limit of detection were validated by several positive and negative C. trachomatis genomes, as well as the possibility for POC diagnostic based on a statistical number of clinical endocervical swab sample tests (see Box 1). Box 1: Advantages and disadvantages of C. trachomatis LAMP-AuNP. Advantages Sensitive to as low as 11.25 copies of target DNA Total assay time is <1 hour Evaluation in independent replicates in 130 clinical samples showed 96% sensitivity and 99% to 100% specificity Disadvantages Cannot diagnose the severity of disease Reaction reagents are in liquid Color change observation may be difficult for low copy numbers of Chlamydia trachomatis Materials and methods Study design and clinical sample collections The criteria for symptomatic C. trachomatis was obtained from the description by the Centers for Disease Control and Prevention (CDC), such as abnormal cervical or vaginal discharge, elevated number of white blood cells in vaginal secretion, and co-infection with Neosseria gonorrhoeae [1]. Endocervical swab samples were randomly selected from a prospective study cohort of STD prevalence in symptomatic and healthy (which may include nonsymptomatic patients) Thai women aged 15 to 54 years in Bangkok and nearby areas. The samples were collected by clinicians during 2011 and 2012 from qualified volunteers attending the Buddhachinaraj Phitsanulok Hospital, and in 2013 and 2014 from Bangrak and Chonburi offices of Disease Prevention and Control [2]. The sample size of 130 (96 symptomatic and 34 healthy) was computed based on a standard statistical formula (http://www.calculator.net/sample-size-calculator.html), given the prevalence rates of C. trachomatis as 22% for symptomatic STDs and 3% for healthy people [2], with a margin of error of 0.05, and a 90% confidence interval. The samples were stored in 3 mL standard C. trachomatis collection medium M4RT (Thermo Fisher Scientific, Kansas, USA) at −80°C.

Molecular epidemiology of non-viral sexually transmitted infections in the central Alpine province of Bolzano, northern Italy from April 2016 to March 2017

Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Ureaplasma parvum, Ureaplasma urealyticum, Mycoplasma hominis and Mycoplasma genitalium are established or presumed as (??) STI pathogens. The present study aims at ng describing the one-year molecular epidemiology of these seven pathogens in the Province of Bolzano, Northern Italy. From April 2016 to March 2017, a total of 2,949 patients, mainly females, were enrolled and 3,427 urine, vaginal, endocervical and/or urethral samples were subjected to simultaneous analysis of the seven pathogens by means of Real Time Polymerase Chain Reaction (AnyplexTM II STI-7 Detection Kit Seegene, Seoul, Korea). At least one of the seven microorganisms was detected in 40.7% of patients, with an uneven distribution: 43.1% in females (F) and 29.8% (p&lt;0.001) in males (M). The prevalence of microorganisms was as follows: 30.3% U. parvum (F: 35.6%, M: 8.3%), 6.9% U. urealyticum (F: 6.8%, M: 7.0%), 4.9% M. hominis (F: 5.4%, M: 2.3%), 4.9% C. trachomatis (F: 3.4%, M: 11.4%), 1.1% M. genitalium (F: 1.0%, M: 1.2%), 1.2% N. gonorrhoeae (F: 0.17%, M: 5.6%) and 0.40% T. vaginalis (F: 0.38%, M: 0.53%). Mixed infections were detected in 7.4% of patients. The highest prevalence was observed for U. parvum, followed by U. urealyticum and M. hominis and a significant presence of multi-pathogen infections was registered.

Prevalence of bacterial vaginosis and factors associated among women who have sex with women.

ABSTRACTObjective:to describe the prevalence of bacterial vaginosis and factors associated among women who have sex with women. Method:cross-sectional, descriptive and analytical study with 150 women. The vaginal microbiota profile was analyzed by microscopic examination of vaginal swabs according to the Gram method. Endocervical samples were collected with cytobrush for the investigation of endocervicitis by Chlamydia trachomatis. The polymerase chain reaction was used to diagnosis Human Papillomavirus infection. Socio-demographic data, sexual behavior and clinical history were obtained through an interview. Logistic regression was performed to identify risk factors independently associated with bacterial vaginosis. Results:among the 150 participants, 71 (47.3%) presented some alteration in the vaginal microbiota, 54 (36.0%) bacterial vaginosis and 12 (8.0%) Flora II. The variable independently associated with bacterial vaginosis was the use of sexual accessories [2.37(1.13-4.97), p=0.022]. Conclusion:the high prevalence of bacterial vaginosis among women who have sex with women indicates the need for screening this population and association between use of sexual accessories and this disease suggests the possibility of transmission of sexual fluids between the partners during the sexual act, which demonstrates the need for educational actions on sexual and reproductive health.

The association of puerperal sepsis with HIV infection at two tertiary hospitals in Zimbabwe.

To evaluate the association between HIV infection and puerperal sepsis among women in Zimbabwe. A subanalysis was performed using data from a prospective cohort study conducted between September 2, 2014, and July 1, 2015, at two tertiary hospitals in Zimbabwe. Eligible participants were consecutive women who met the WHO criteria for puerperal sepsis. Variables assessed included HIV-infection status and the use of antiretroviral therapy. Severity of immunosuppression was defined by the number of T cells that expressed cluster of differentiation 4 (CD4). Endocervical swabs and blood samples were collected for microbial culture and susceptibility testing. In all, 33 (21.9%) of the 151 women included in the present analysis had HIV. Among women with HIV, severe immunosuppression (CD4-positive T cell count <200/mm3 ) was associated with a mean hospital stay of 19.0days versus 10.2days for mild-advanced immunosuppression (CD4-positive T cell count 200-500/mm3 ) and insignificant immunosuppression (CD4-positive T cell count >500/mm3 ; P=0.030). Use of antiretroviral therapy did not independently influence clinical outcomes. Furthermore, infection with HIV did not influence the microorganisms isolated from blood or endocervical samples. Severe immunosuppression was associated with increased length of hospitalization among women with HIV who had puerperal sepsis.

Female Genital Tract Infection Caused by Streptococcus pneumoniae: Case Report

Streptococcus pneumoniae is an important respiratory pathogen and can also cause meningitis and bacteremia. It is very rarely responsible of genital tract infections. We report the case of a pelvic inflammatory disease due to S. pneumonia in a menopaused woman with no predisposing factors. Bacteriological diagnosis was obtained using endocervical and vaginal samples. The patient recovered well without consequences with antibiotic therapy.

Human papilloma virus genotype distribution and risk factor analysis amongst reproductive-age women in urban Gambia.

Cervical cancer is the most frequently diagnosed female cancer in The Gambia, representing approximately 30 % of cases. In 2014, the quadrivalent human papilloma virus (HPV) vaccine was introduced, which offers protection against HPV genotypes 6, 11, 16 and 18. To evaluate the potential effectiveness of this vaccine, genotype distribution and risk factor analysis were assessed. Endocervical samples (n=232) were collected from women aged 20-49 years residing in urban Gambia. A questionnaire was administered to capture socio-demographic and cervical cancer risk factors. HPV detection and genotyping was performed by PCR amplification of the L1 major capsid gene and analysis of sequenced PCR products.Results/Key findings. The prevalence of HPV was 12 % (28/232), and the high-risk (HR) genotype HPV 52 (5/28) was the most prevalent genotype. HR-HPV sequences had high identity (≥90 %) to isolates which originated from America, Europe and Asia but not from Africa. Half (14/28) of participants were co-infected with Ureaplasma urealyticum/parvum, which increases the risk of progression to cervical cancer. Female genital mutilation and the use of hormone contraception for >5 years were identified as potential risk factors for HPV infection. Ethnicity-associated differences were also noted; participants of the Fula ethnic group had a higher prevalence of HR-HPV infection (31.3 %) compared to the Mandinka (18.8 %) and Wollof (12.5 %) groups. These data may have a significant public health impact as the HPV quadrivalent vaccine may be of limited value if the circulating non-HPV 16/18 HR-genotypes are responsible for cytological abnormalities of the cervix.

Prevalence of Chlamydia trachomatis and Neisseria gonorrhoeae infections among pregnant women and eye colonization of their neonates at birth time, Shiraz, Southern Iran

BackgroundChlamydia trachomatis and Neisseria gonorrhoeae are the two common transmissible pathogens from pregnant women to their neonates. Given the lack of routine screening and treatment of pregnant women in some areas, the possibility of transmission rises. This study seeks to determine the prevalence of C. trachomatis and N. gonorrhoeae in the pregnant women with no clinical symptoms and the vertical transmission rate to their neonates.MethodsThe study was conducted on endocervical and eye swab samples of 239 pregnant women and their neonates. Identification was based on PCR method.ResultsThe prevalence rates of C.trachomatis in women and neonates were 37/239 (15.5%) and 28/239 (11.7%), and for N. gonorrhoeae 3/239 (1.3%), 1/239 (0.4%), respectively. The vertical transmission rates to the neonates were 28/37(75.6%) for C. trachomatis and 1/3 for N. gonorrhoeae.ConclusionsIn the areas with a high prevalence of chlamydial or gonococcal infections, and in the absence of screening and treatment of the pregnant women, ocular prophylaxis with antibiotics is suggested as a part of routine neonatal care program for the prevention of chlamydial and gonococcal ophthalmia.

Oncogenic human papillomavirus infection and genotypes characterization among sexually active women in Tenkodogo at Burkina Faso, West Africa

ObjectiveThis study was conducted to determine the prevalence and distribution of high-risk human papillomavirus (HR-HPV) genotypes among sexually active women in Tenkodogo, Burkina Faso. MethodsAmong 131 sexually active women attending the Tenkodogo Urban Medical Center, endocervical samples were collected prior to screening for precancerous lesions. After viral DNA extraction, fourteen HR-HPV genotypes were characterized by real-time multiplex PCR in these cervical samples. ResultsThe mean age was 35.5 ± 9.5 years. Of the 131 women, 45 were infected with at least one HR-HPV genotype. The prevalence of HR-HPV infection among these women was 34.4%. Among the 45 oncogenic HPV-infected women, single HR-HPV genotype was found in 55.6% while 44.4% were infected with more than one HR-HPV genotype. The most frequent genotypes were HPV56 (36.5%), HPV66 (36.5%). ConclusionTenkodogo women included in this study had a higher prevalence of HPV 56, HPV 66. A larger study with a more representative sample would therefore be needed to determine predominant oncogenic genotypes in the subregion and especially in cancer cases.

Visual and modular detection of pathogen nucleic acids with enzyme\u2013DNA molecular complexes

Rapid, visual detection of pathogen nucleic acids has broad applications in infection management. Here we present a modular detection platform, termed enzyme-assisted nanocomplexes for visual identification of nucleic acids (enVision). The system consists of an integrated circuit of enzyme–DNA nanostructures, which function as independent recognition and signaling elements, for direct and versatile detection of pathogen nucleic acids from infected cells. The built-in enzymatic cascades produce a rapid color readout for the naked eye; the assay is thus fast (<2 h), sensitive (<10 amol), and readily quantified with smartphones. When implemented on a configurable microfluidic platform, the technology demonstrates superior programmability to perform versatile computations, for detecting diverse pathogen targets and their virus–host genome integration loci. We further design the enVision platform for molecular-typing of infections in patient endocervical samples. The technology not only improves the clinical inter-subtype differentiation, but also expands the intra-subtype coverage to identify previously undetectable infections.

Polymerase chain reaction versus enzyme-linked immunosorbent assay in detection of &lt;i&gt;Chlamydia trachomatis&lt;/i&gt; infection among gynaecological patients in southwestern Nigeria

Background: Chlamydia trachomatis ( C. trachomatis ), is the most common bacterial Sexually Transmitted Infection, a major cause of Pelvic Inflammatory Disease and female infertility. Since C. trachomatis infections are frequently asymptomatic with higher prevalence in developing countries, highly sensitive and affordable methods are desirable for routine screening and diagnosis. This study aimed to evaluate the performance of C. trachomatis -specific IgG antibody by ELISA as a screening tool for C. trachomatis infection, by comparing the performance of ELISA with the gold standard Polymerase Chain Reaction (PCR). Method: In this cross sectional study, we enrolled 150 women attending infertility clinic at Ibadan between January and November, 2015. ELISA for detection of IgG antibodies specific to C. trachomatis major outer membrane protein (MOMP) was performed on the blood samples using third generation indirect Enzyme Linked Immunosorbent Assay (ELISA) and endocervical samples were analyzed for presence of C. trachomatis nucleic acid using PCR. Socio-demographic bio-data and gynaecological history were obtained with questionnaire; data was analyzed using SPSS version 20.0. Results: Overall, 58 (38.7%) were positive for C. trachomatis specific IgG antibody by ELISA and 11 (7.3%) for C. trachomatis nucleic acid by PCR. Using PCR as the gold standard, ELISA had a sensitivity of 81.8% specificity of 64.8%, positive predictive value of 15.5% negative predictive value of 97.8% and accuracy of 66%. Conclusion: The high sensitivity of the ELISA indicates that over 80% of patients identified as being positive in the screened population are truly infected. Also, the negative predictive value approaches 100% amongst those screened out as being negative. Thus its use as a screening tool for C. trachomatis infection is warranted particularly in developing countries where cheaper and easier to use alternatives to PCR are in dire need. Keywords: C. trachomatis , infertility, polymerase chain reaction, ELISA, sexually transmitted infections

Evaluation of liquid from the Papanicolaou test and other liquid biopsies for the detection of endometrial and ovarian cancers.

We report the detection of endometrial and ovarian cancers based on genetic analyses of DNA recovered from the fluids obtained during a routine Papanicolaou (Pap) test. The new test, called PapSEEK, incorporates assays for mutations in 18 genes as well as an assay for aneuploidy. In Pap brush samples from 382 endometrial cancer patients, 81% [95% confidence interval (CI), 77 to 85%] were positive, including 78% of patients with early-stage disease. The sensitivity in 245 ovarian cancer patients was 33% (95% CI, 27 to 39%), including 34% of patients with early-stage disease. In contrast, only 1.4% of 714 women without cancer had positive Pap brush samples (specificity, ~99%). Next, we showed that intrauterine sampling with a Tao brush increased the detection of malignancy over endocervical sampling with a Pap brush: 93% of 123 (95% CI, 87 to 97%) patients with endometrial cancer and 45% of 51 (95% CI, 31 to 60%) patients with ovarian cancer were positive, whereas none of the samples from 125 women without cancer were positive (specificity, 100%). Finally, in 83 ovarian cancer patients in whom plasma was available, circulating tumor DNA was found in 43% of patients (95% CI, 33 to 55%). When plasma and Pap brush samples were both tested, the sensitivity for ovarian cancer increased to 63% (95% CI, 51 to 73%). These results demonstrate the potential of mutation-based diagnostics to detect gynecologic cancers at a stage when they are more likely to be curable.

A role for the endometrial microbiome in dysfunctional menstrual bleeding.

This study aimed to characterise the microbial community within the endometrial cavity and endocervix in women with menorrhagia or dysmenorrhea. Paired endocervical and endometrial biopsy samples were collected from women undergoing operative hysteroscopy and/or laparoscopy. Samples were cohorted based on pathology, indications for surgery, and histological dating of the endometrium. Samples were interrogated for the presence of microbial DNA using a two-step next generation sequencing technology approach to exploit the V5-V8 regions of the 16S rRNA gene. Pyrosequencing revealed that the endocervix and endometrium share a minor microbial community, but that each site harbours a separate and distinct microbial population (p=0.024). This was also the case for women with menorrhagia and dysmenorrhea (p=0.017). Lactobacillus spp. were the most abundant microbial taxa present in 50% of the cohorts, and across all endocervical groups. Members of the genera Prevotella, Fusobacterium and Jonquetella were the most abundant taxa identified in samples collected from nulliparous women. It can be concluded that the female upper genital tract is not sterile. Microbial community profiling revealed differences in the endometrial microbial community profiles for: (1) the endocervix compared to the endometrium, and (2), women with menorrhagia versus dysmenorrhea. The distinct microbial community profiles in these women may offer insight into the pathology and clinical management of dysfunctional menstrual bleeding.

The relationship between chlamydia infection and infertility at the Lagos University Teaching Hospital, Lagos, Nigeria

Context: Infertility affects 10–15% of couples worldwide and tubal factor is a major component in sub-Saharan Africa. Pelvic inflammatory disease due to chlamydia infection is a known risk factor for tubal infertility. Objective: This case-control study was carried out to determine the relationship between chlamydial infection and infertility as seen at the Lagos University Teaching Hospital, Lagos, Nigeria. Methodology: This was a case-controlled study of 180 participants recruited from the Gynaecology Outpatient and Family Planning Clinics of the Lagos University Teaching Hospital, Lagos, Nigeria (LUTH). The cases were 60 females diagnosed to have tubal infertility and 60 other infertile females with patent tubes. The control group comprised of 60 females attending the family planning clinic. The females were tested for serum chlamydia IgG antibody using a kit that detects serovar specific Chlamydia trachomatis antibody. Endocervical swab samples were also tested for chlamydial antigen using a kit that detects C. trachomatis genus specific lipopolysaccharide antigen. The results were collated and analyzed using the statistical package for the social sciences (SPSS) version 18. Results: All the females tested negative for chlamydia antigen. The odd ratio for having a case testing positive for chlamydial antibody compared to control was 4.0 [95% CI = 1.47–10.88]. The odd ratio for infertile females with blocked tubes compared with those who had patent tubes testing positive for chlamydia antibody was 3.52 (95% CI: 1.46–8.49). Conclusion: This study suggests an etiological relationship between chlamydial infection and infertility in general and tubal infertility in particular.

Prevalence and antimicrobial susceptibility of Ureaplasma species and Mycoplasma hominis in Greek female outpatients, 2012–2016

Mycoplasma hominis and Ureaplasma species are opportunistic pathogens associated with urogenital infections, complications during pregnancy and postpartum infections. Appropriate empirical antimicrobial treatment is necessary to achieve an optimal therapeutic outcome. This study evaluated the prevalence and the antimicrobial susceptibility of Mycoplasma hominis and Ureaplasma spp. isolated from 1,008 endocervical samples of outpatients in Crete, Greece, during a five-year period (2012–2016), using the commercially available Mycoview kit (Zeakon diagnostics, France). Ureaplasma spp. was isolated from 116 patients (11.5%), M. hominis from 6 (0.6%), while coinfection with both mycoplasmas was demonstrated in 17 (1.7%). All Ureaplasma strains were susceptible to josamycin and doxycycline. Doxycycline, minocycline and ofloxacin were the most potent antibiotics against M. hominis. Docycycline was proved the most active and is still the drug of choice for the treatment of genital mycoplasma infections. Local surveillance to monitor changes in antimicrobial susceptibilities is necessary to guide treatment strategies.

User perception of endocervical sampling: A randomized comparison of endocervical evaluation with the curette vs cytobrush.

ObjectivesTo evaluate whether the endocervical brush (ECB) is better accepted by patients and health care providers for endocervical evaluation when compared to the endocervical curette (ECC), without a decrease in the quality of sampling.MethodsTwo hundred patients with cervical dysplasia were randomized at the colposcopy clinic of the University Hospital of Geneva into two groups according to technique. Patients and physicians’ preference regarding the technique as well as the quality of samples were assessed. ECB samples were analyzed using both cytological (cell block) and histologic analysis, while ECC samples were analyzed using standard histologic analysis.ResultsOf the 200 patients, 89 were randomized to ECC, 101 to ECB and 10 were excluded due to incomplete information or cervical stenosis. Physicians preferred ECB against ECC, classifying it more frequently as an easy technique (94.1% vs.61.4%, p<0.001). Physicians more frequently evaluated the ECB as little or not uncomfortable for patients (28.7% vs.10.2%, p<0.001), though patients themselves didn’t express a preference for either technique. From a quality standpoint, the brush allowed for a better quality of samples, with a lower rate of inadequate samples (2.0% vs 14.3%, p = 0.002) and greater amount of material.ConclusionEndocervical sampling using ECB seems to be easier to perform and provides better quality samples. ECB can therefore be an acceptable alternative to ECC in standard practice.Trial registrationClinicalTrials.gov NCT01435590

139 - Vaginal Bleeding in the Post-Supracervical Hysterectomy Patient: The Role of Endocervical Sampling in Preoperative Evaluation

139 - Vaginal Bleeding in the Post-Supracervical Hysterectomy Patient: The Role of Endocervical Sampling in Preoperative Evaluation

Frequency and genotypes of Chlamydia trachomatis in patients attending the obstetrics and gynecology clinics in Jalisco, Mexico and correlation with sociodemographic, behavioral, and biological factors

BackgroundChlamydia trachomatis is the causative agent of the most common bacterial sexually transmitted infection worldwide. The aim of this study was to investigate the frequency and genotypes of C. trachomatis in patients attending an obstetrics and gynecology clinic in Jalisco, Mexico and correlates them with sociodemographic, behavioral, and biological factors.MethodsC. trachomatis detection was performed in endocervical samples from 662 patients by direct fluorescence assay (DFA) and two PCR assays that amplified the phospholipase D endonuclease superfamily protein (PLDESP) and OmpA genes. Positive samples were genotyped using PCR–restriction fragment length polymorphism assays. Sociodemographic, behavioral, and biological data were collected.ResultsThe mean age of the study population was 31 (range, 14–78) years. C. trachomatis positivity was detected by DFA in 16.7% (n = 111), PLDESP gene amplification in 14.2% (n = 94), and OmpA gene amplification in 14.5% (n = 96) of the population. Eight C. trachomatis genotypes were detected: E (39.6%), F (29.2%), D (15.6%), K (6.3%), L2 (3.1%), G, J, and I (2.1% each). C. trachomatis infection was associated with age, marital status, pregnancy, and hormonal contraceptive use (all p = 0.01); intrauterine device use and previous premature birth (both p = 0.03); and infection during pregnancy, previous ectopic pregnancy, pelvic inflammatory disease (PID), and green vaginal discharge (all p = 0.04). C. trachomatis genotype K was more likely to be detected in women histories of ≥2 sexual partners, genotype F was more likely in pregnant women, genotype L2 was more likely in women with PID, genotype D was more likely in women who had had infection during previous pregnancies, and genotype E was more likely in those with previous ectopic pregnancies and green vaginal discharge (all p = 0.01).ConclusionsThe frequency of C. trachomatis in our population was higher than previously reported worldwide, but within the range reported for Mexico. Genotype E was detected most frequently in the study population. Infection by C. trachomatis and C. trachomatis genotypes K, F, D, and E was strongly associated with multiple sociodemographic, behavioral, and biological factors. C. trachomatis genotype L2 was detected in women with PID.

Abstract KP01: UNITED KINGDOM COLLABORATIVE TRIAL OF OVARIAN CANCER SCREENING – (UKCTOCS) – EXPLORING THE RESULTS

Abstract The continued high case fatality ratio in ovarian cancer has underpinned efforts to develop a screening strategy that could impact on mortality. In the general population randomised control trial - United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) two screening strategies (multimodal MMS and ultrasound USS) were compared to no screening (control C). Of 202,638 women randomised between April 2001-October 2005, 50,624 MMS; 50,623 USS; and 101,299 C were eligible for analysis. By the end of screening (December 2011) 345,570 MMS and 327,775 USS annual screens were performed. At censorship for the initial mortality analysis on 31st December 2014, there was an overall significant stage shift in invasive epithelial ovarian/tubal/peritoneal cancer in the MMS group compared to C in an ‘intention to screen’ analysis. More detailed analysis has shown this stage shift seen in the MMS group was limited to Type II (high grade serous) ovarian cancers. This was associated with a delayed but not yet statistically significant mortality reduction. Disease specific mortality rates in the C arm were continuing to rise while they appeared to have plateaued in the screen arms. Further follow-up is now underway to confirm the mortality reduction and determine its full extent. Meanwhile a focus on detecting low volume disease using cancer specific markers, novel biospecimens such as endocervical samples, targeted imaging and time series algorithms for interpreting marker profile suggest that a new era in ovarian cancer screening is underway. Citation Format: Usha Menon. UNITED KINGDOM COLLABORATIVE TRIAL OF OVARIAN CANCER SCREENING – (UKCTOCS) – EXPLORING THE RESULTS [abstract]. In: Proceedings of the 11th Biennial Ovarian Cancer Research Symposium; Sep 12-13, 2016; Seattle, WA. Philadelphia (PA): AACR; Clin Cancer Res 2017;23(11 Suppl):Abstract nr KP01.

Brief Report: Hormonal Contraception Is Not Associated With Reduced ART Effectiveness Among Women Initiating ART: Evidence From Longitudinal Data.

To explore the association between concomitant hormonal contraceptive and antiretroviral therapy (ART) use and (1) plasma viral suppression and (2) genital HIV shedding among HIV-positive women initiating ART. We analyzed plasma viral load and genital viral RNA shedding from 1079 HIV-positive women initiating ART who were followed prospectively in 3 sub-Saharan African HIV prevention studies. Plasma and endocervical swab samples were collected every 6 months. Self-reported contraceptive use was categorized into injectable, implant, oral, or nonhormonal/no contraception. We used multivariate Cox regression to assess time to plasma viral suppression and logistic regression with generalized estimating equations to assess genital viral shedding for each contraceptive method. At the time of ART initiation, there were 211 (20%) injectable, 69 (6%) implant, 50 (5%) oral, and 749 (69%) nonhormonal or no method users. Plasma viral suppression was high (90% by 6 months) and hormonal contraceptives did not diminish time to plasma viral suppression as compared to nonhormonal/no methods [adjusted hazard ratios: injectables 0.89 (95% confidence interval: 0.75 to 1.07), implants 0.91 (0.68 to 1.23), and oral methods 1.33 (1.06 to 1.66)]. Genital viral shedding was uncommon any time after ART initiation (only 9% of samples had detectable viral shedding) and hormonal contraceptives were not associated with an increased detection of genital viral shedding [adjusted odds ratios: injectables 1.07 (0.69 to 1.65), implants 0.67 (0.31 to 1.49), and oral methods 0.56 (0.19 to 1.69)]. The hormonal contraceptives assessed were not associated with reduced ART effectiveness among HIV-positive women initiating ART. HIV-positive women should continue to be offered contraceptive options, including hormonal ones that best meet their needs.

Profile of the triplex assay for detection of chlamydia, gonorrhea and trichomonas using the BD MAX™ System

ABSTRACTIntroduction: Chlamydia, gonorrhea and trichomonas are the most common curable STI. improved access to testing could reduce infection rates and prevent sequelae. nucleic acid amplification tests are the recommend class of diagnostic assay for these infections which are often asymptomatic.Areas covered: A description of the BD MAX™ System (MAX) and the BD MAX CT/GC/TV assay is provided along with data from a large US clinical trial. The capacity of the system for other tests and for lab developed assays is also described.Expert commentary: The CT/GC/TV assay on the MAX is a triplex PCR assay suitable for use with female urine and vaginal or endocervical swab samples. Male urine can be tested by ordering the CT/GC results but has not yet been evaluated for trichomonas. The assay performance characteristics are similar to those of assays run on high-throughput platforms with sensitivity ≥91.5% and specificity ≥98.6% for all analytes. Screening with the CT/GC/TV assay can be combined with testing for vaginitis which would provide a greater depth of coverage for common co-infections. The throughput is moderate (1–48 samples per 8-hour shift) but the menu includes assays beyond STI pathogens making this a suitable platform for moderate volume laboratories.