bluuebunny/crossref_metadata_2025_split huggingface dataset:
P3-S1.34 Evaluation of the Roche cobas 4800 for the detection ofChlamydia trachomatisandNeisseria gonorrhoeaeusing endocervical specimens
Authors: Pantone A , Van Der Pol B , Lillis R , Loyd B , Nye M B , Taylor S 
Published: July 2011

BackgroundThe Roche cobas 4800 (cobas) is a new diagnostic assay that utilises an automated workstation to isolate nucleic acids from clinical specimens and a real time instrument for the detection ofC trachomatis(CT) andN gonorrhoeae(NG). The objective of this study was to compare the performance characteristics of the cobas to the BD Viper (Viper) and GenProbe Aptima Combo 2 (AC2) assays for the detection of CT and NG using a patient infected standard (PIS).MethodsSpecimens were obtained from women attending STD, family planning, or OB/GYN clinics from 12 geographically distinct locations. Endocervical swabs (ES) and samples in ThinPrep liquid based cytology medium (LBC) were obtained from each participant as were urine samples (data not shown) and vaginal swabs (data not shown). LBC were sampled prior to cytology (prequot) for cobas and AC2 and after cytology (postquot) for cobas only. A patient was considered infected if at least 2 of the assays with different molecular targets gave positive results from the ES or urine samples.ResultsOverall CT sensitivity ranged from 89.7 to 92.8% and specificity ranged from 99.6 to 99.8% for all sample types. Overall GC sensitivity ranged from 95.6 to 97.1% and specificity from 99.9 to 100% see Abstract P3-S1.34 table 1.Abstract P3-S1.34 Table 1Sample Type CxSample typenCT sensitivity [95% CI]CT specificity [95% CI]nNG sensitivity [95% CI]NG specificity [95% CI]ES425391.6%(240/262) [87.6 to 94.4]99.8%(3984/3991) [99.6 to 99.9]425295.6%(65/68) [87.8 to 98.5]100%(4182/4184) [99.8 to 100]LBC Prequot423892.8%(246/265) [89.1 to 95.4]99.6%(3958/3973) [99.4 to 99.8]423997.1%(67/69) [90.0 to 99.2]99.9%(4167/4170) [99.8 to 100]LBC Postquot420289.7%(235/262) [85.4 to 92.8]99.7%(3930/3940) [99.5 to 99.9]420395.7%(66/69) [88.0 to 98.5]100%(4132/4134) [99.8 to 100.0]ConclusionsThe cobas assay has excellent sensitivity and specificity when compared to PIS. Equivalent performance was observed for the ES and LBC samples, providing clinicians with flexibility to tailor endocervical sample acquisition to their particular setting. There was no statistical difference between the pre- and post-quot LBC samples allowing specimen handling to be suited to the needs of the microbiology and cytology laboratories. The assay is easy to perform, automated, and can be completed in <4 h.
P3-S1.36 Assessing the diagnosis and treatment of urethritis among men attending an urban STD clinic
Authors: Furness B W , Sheriff E A , Sankar S , Elias N Kamanu 
Published: July 2011

BackgroundUrethritis is inflammation of the urethra, the main symptoms of which are dysuria and discharge, and two of the most common causes of which areChlamydia trachomatisandNeisseria gonorrhoeae. The objectives of this study were to: (1) Determine the prevalence of atypical urethritis among participants, (2) Assess the sensitivity and specificity of using gram stain to diagnose gonorrhoea, and (3) Evaluate the effect of diagnostic test used on the time to treatment.MethodsA random sample of 600 eighteen to 60-year-old men who visited the SE STD Clinic from January 2008 to December 2009 and had a gram stain and nucleic acid amplification test (NAAT) performed were studied. Atypical urethritis was defined as having evidence of inflammation on gram stain but no evidence of gonorrhoea (ie, NGU) and a NAAT negative for both bacteria. The sensitivity and specificity of gram stain were calculated using NAAT as the gold standard. An analysis of variance was used to assess the relationship between time to treatment and diagnostic test—F statistics and corresponding p values were calculated. All statistical analyses were performed using SAS software V. 9 (SAS Institute Inc.) and WinPepi (Abramson, J.H. Epidemiologic Perspective and Innovations).ResultsOf the 600 cases, 493 (82.3%) were Black, 253 (42.2%) had clinical urethritis, and 204 (47.0%) had a previous STD history. The mean age was 30.6 years (SD=10.3). One hundred and five cases of gonorrhoea, 110 cases of chlamydia, and three co-infections were diagnosed (Abstract P3-S1.36 table 1). None of the men diagnosed with gonorrhoea via gram stain were co-infected with chlamydia. The prevalence of atypical urethritis among this study population was 31.2%. The sensitivity of gram stain was 84.3%, the specificity was 100%, the positive predictive value (PPV) was 100%, and the negative predictive value (NPV) was 96.7%. The mean time to treatment was 2.52 days (SD=2.17). Analysis of variance revealed that gram stain (F=41.50, p<0.0001) and NAAT (F=19.18, p<0.0001) had significantly different effects on time to treatment.Abstract P3-S1.36 Table 1Concordance between tests used to diagnosis urethritis among menGram stain resultNAAT resultTotalGonorrhoeaChlamydiaNegativeGonorrhoea910091NGU3*87*187277*Negative1426195235Total108*113*382600*Three of these results were positive for both gonorrhoea and chlamydia.ConclusionGram stain is a reliable and relatively inexpensive test for the diagnosis of gonorrhoea among men. Men diagnosed with gonorrhoea or NGU using this point-of-care test were treated earlier than those diagnosed with NAAT only. The prevalence of atypical urethritis among this study population was high and further research should be conducted to investigate the possible aetiologies.
P3-S1.37 The role of microscopy in the diagnosis of proctitis among men who have sex with men (MSM). A retrospective review of rectal screening
Authors: Horner P , Harte D 
Published: July 2011

BackgroundThe rectum is a common site of infection withChlamydia trachomatis(CT),Mycoplasma genitalium(MG) andNeisseria gonnorrhoeae(GC) among men who sex with men (MSM) who engage in receptive anal intercourse (RAI). Whilst the majority of individuals remain asymptomatic, these infections are likely to induce rectal inflammation which may have implications for HIV transmission. Information regarding the association between rectal CT, MG and GC and proctitis is limited.ObjectivesTo calculate the prevalence of proctitis among a cohort of MSM and investigate the association of proctitis with rectal CT and GC.MethodsData were collected retrospectively. All MSM attending the clinic between July and December 2010 were included. Proctitis was defined as >5 PMNLs per high power field on microscopy of a Gram-stained rectal smear. Information including sexual history, clinical presentation, microscopy and GC/CT NAAT (Aptima combo 2 (AC2)) results were recorded on a proforma. Data were analysed using SPSS 16.0. Statistical tests of association were performed using Pearson's χ2test. OR were calculated using logistic regression.ResultsThere were 425 MSM who attended for screening in the review period. Of these 83% were UK born. The median age was 32 years (range=16–69 yrs). RAI in the preceding 3 months was reported by 59% (n=251). Of these 64% (n=160) had rectal microscopy performed. Rectal symptoms were reported by 11%. The majority (96%) of samples were collected using a blind rectal swab technique. Proctitis was diagnosed in 23 (14.4%). Of these five were AC2-positive (CT=2, GC=1, CT+GC=1, LGV=1). Rectal AC2 was positive in 19/160 (11.8%) (GC=7, CT=10, CT+GC=1, LGV=1), five of whom had proctitis. Sensitivity and specificity of microscopy for rectal CT/ GC was 26% and 87% respectively. Factors which were predictive of proctitis included rectal symptoms (p=0.001), and being HIV-1sero-positive (p=0.001) but being CT/GC/LGV positive was not associated (p=0.157 OR 2.4; 95% CI=0.8 to 7.5).ConclusionProctitis is common among MSM, particularly HIV-1 seropositive men. The association with GC/CT infection was weak. The causes of and relevance of proctitis remain poorly understood and further research is warranted.
P3-S1.38 Molecular detection ofChlamydia trachomatisandNeisseria gonnorhoeain rectal swabs and (self) collected vaginal swabs with the Cobas 4800 system
Authors: Morre S 
Published: July 2011

ObjectivesChlamydia trachomatis(CT) andNeisseria gonnorhoea(NG) are the most prevalent sexual transmitted diseases worldwide. In recent years molecular diagnostics for the standard sample types like cervical swabs and urines has been highly adapted in most laboratories. Currently more difficult samples types, with regard to inhibition, sensitivity and specificity, like rectal swabs and (self collected) vaginal swabs are received more often in the laboratories. This study describes the performance of the new Cobas 4800 for the detection of CT and NG in these difficult sample types.MethodsA total of 1100 co-collected swabs were tested (900 vaginal; 200 rectal). Informed consent was obtained from all patients included in the study for co-collection. All swabs were tested routinely with the M2000 system (Abbott) and the co-collected samples were tested in the Cobas 4800 system (Roche). All swabs were collected in their corresponding transport buffer and tested blinded. Discrepant results were tested with an independent real time PCR method.ResultsIn the 900 vaginal swabs 10% (n=90) were positive for CT and 0.5% (n=4) for NG and in the 200 rectal swabs 11% CT positives (n=22) an 6% NG positives (n=12) were identified. In the vaginal samples nine discrepant results between the Cobas 4800 and M2000 system were identified. Five with borderline values and four with clear different results (1 NG, 3CT). Two M2000 positive results (Ct 35.9; 32.3) were available for home brew analysis and could not be confirmed. In the rectal samples 8 discrepant results were found including three clear differences (2 NG; 1 CT). The CT discrepant sample was positive in the Cobas 4800 system (Cp 33.1) and negative in the M2000 system. For NG two samples were negative in the Cobas 4800 system but positive (Ct 23.8; 32.0) in the M2000 system. All three clear discrepant results were available for home brew analysis and confirmed the Cobas 4800 results.ConclusionBoth samples types showed a high concordance between the two systems (ĸ 0.95 for CT; ĸ 0.93 for NG). For detection of vaginal swabs some small differences were found both for CT and NG but these were equally spread between the two systems. There is no difference between self collected and clinician taken vaginal swabs. All clear rectal swabs discrepancies confirmed the Cobas 4800 results. This remarkable difference has to be further studied. In general, (self collected) vaginal swabs and rectal swabs show reliable results for routine detection of CT and NG.
P1-S1.44 Antimicrobial susceptibility profile ofNeisseria gonorrhoeaeisolates in the Province of QuÉbec - 2010
Authors: Lefebvre B , Bourgault A M 
Published: July 2011

BackgroundRegular monitoring of antimicrobial resistance ofN gonorrhoeaeis necessary to detect the trend in antimicrobial resistance, increases in minimum inhibitory concentrations (MICs) and to assist in the development of treatment guidelines.MethodsIn 2010, allN gonorrhoeaestrains isolated in clinical laboratories throughout the province were submitted to the Laboratoire de santé publique du Québec where their susceptibility profile to azithromycin, cefixime, ceftriaxone, ciprofloxacin and spectinomycin was determined by the agar dilution method.ResultsA total of 831 strains isolated from 607 males and 224 females were tested. The strains were recovered from (data available for 819 strains) the following specimens—urethra, 432; cervix, 191; anus, 100; throat, 90; eye, 4; and synovial fluid, 2. All strains were susceptible to cefixime, ceftriaxone and spectinomycin, 270 (32.5%) were resistant to ciprofloxacin and 11 (1.3%) were resistant to azithromycin (MIC ≥2 mg/l). The azithromycin resistant isolates were retrieved from 11 males aged 16–55 years (mean, 30) from the Montreal area (urethra, 8; throat, 3). The azithromycin MIC distribution was as follows—4 mg/l (n=1), 8 mg/l (n=6), 16 mg/l (n=4). No highly resistant organism (MIC>128 mg/l) was identified. Among the azithromycin resistant isolates, one was resistant to ciprofloxacin but all were susceptible to cefixime, ceftriaxone and spectinomycin. In 2010, 68 (8.2%) isolates exhibited decreased susceptibility to cefixime (MIC=0.125 mg/l [n=62] and 0.25 mg/l [n=6]). Of these 68 isolates, all were susceptible to azithromycin and ceftriaxone but all were resistant to ciprofloxacin. Only one isolate showed decreased susceptibility to ceftriaxone (MIC=0.125 mg/l)—this isolate also showed decreased susceptibility to cefixime.ConclusionsAs observed elsewhere,N gonorrhoeaestrains are showing a worrisome drift in susceptibility to cefixime, a first line treatment for gonococcal infections associated with resistance to ciprofloxacin. Furthermore, resistance to azithromycin, a second line treatment option, is emerging. Sustained collaborative laboratory surveillance programs are mandatory for the design of public health interventions to prevent and control gonococcal infections.
P3-S1.41 Coinfection ofNeisseria gonorrhoeaeandChlamydia trachomatisin symptomatic and asymptomatic women in India: implications in reproductive health
Authors: Sachdev D , Sonkar S , Mishra P , Patel A , Saluja D 
Published: July 2011

BackgroundDespite the recent advances in diagnosis,Neisseraia gonorrhoeae(NG) andChlamydia trachomatis(CT) remain leading cause of STDs worldwide and account for STI's morbidity leading to acquisition of HIV and HPV infection. Coinfection of gonococcus and Chlamydia is reported from various countries. In recent study we reported high rate of infection by CT using an in house developed PCR method. A number of studies also suggest increasing rate of antibiotic resistance in NG. Thus we developed a rapid, specific and cost effective diagnostic method to detect prevalence of co infection by NG and CT. Methodology: (1) Unique gene sequence of CT and NG were amplified from gDNA isolated from endocervical swabs. (2) Validation of in house PCR method using Roche AMPLICOR Micro well plate CT/NG kit. (3) Use of molecular beacon to develop easy visual method. (4) Establishment of multiplex PCR (mPCR) for simultaneous detection of CT and NG.Results360 clinical samples were used to validate in house PCR assay. Discrepancy of the samples was resolved by amplifying genes encoding for outer membrane proteins (rmp for NG and ompA for CT). The resolved PPV and NPV were found to be 94% and 99% for CT, 92.0% and 96% for NG. Molecular beacon probe was used which helped in visualisation of PCR product directly in tube using dark reader which also improved the sensitivity of assay. The overall infection rate by NG was 26% and 8.6% in symptomatic and asymptomatic patients while that of CT was 26.3% and 21% respectively. To make the method easy to use in remote areas with minimum laboratory infrastructure, the in house PCR assay was standardised for detection using dry swabs, with crude DNA preparation and stabilisation of reagents at 4C (up to 6 months) was achieved for easy transportation and storage. Using single PCRs, coinfection by CT and NG was found to be 18% in symptomatic (74/410) and 5 % in asymptomatic patients (18/360). We further developed mPCR for simultaneous detection two pathogens. Sensitivity of in house mPCR was found to be 95% when evaluated against PCR for individual pathogen.ConclusionDetection of both the pathogens in single PCR assay makes it economical both in terms of cost and time. The in house assay is highly sensitive, easy to perform and requires minimum infrastructure as well as technical expertise, making it a better option for routine diagnosis of genital infection in developing countries, which would be of great consequences in disease management.
P3-S1.42 Complex treatment of urogenital chlamydiosis with macrolids and immunostimulants
Authors: Fartushok T , Dasyuk T 
Published: July 2011

ObjectivesThe data concerning treatment of such sexually transmitted infection asChlamydia trachomatis(CTR) among Ukrainian population are still limited and controversial. This information is of great scientific and health care interest. The aim of investigation is to find out efficiency of urogenital chlamydiosis treatment involving new effective ways of treatment and choose the most appropriate and expedient method of treatment, which would completely meet recommendations of WHO.MethodsWe have analysed literature, records and recommendations concerning treatment of patients with chlamydial infection and concluded that there is no a perfect method of treatment, which would ensure complete clinical and laboratory cure. According to literature data, macrolids are good drugs with insignificant resistance to agent, nevertheless, recovery of a patient is, sometimes, incomplete due to complications. We have examined patients with urogenital chlamydiosis. All patients (n=134) were divided into four groups and treated with antimicrobial drugs jozamicyn and azytromicyn, and immunomodulators - manax and kagotsel. Patients from the 1st group (n=35) were treated with jozamicyn and manax, 2nd group (n=35) with azytromicyn and manax, 3rd group (n=34) with jozamicyn and kagotsel, 4th group (n=30) with azytromicyn and kagotsel.ResultsFollowing treatment results of our investigation showed complete laboratory and clinical recovery in 93.2 % of patients from the 1st group, 98.1% of patients from the 2nd group, 91.8% of patients from the 3rd group, and 93.5% of patients from the 4th group.ConclusionAccording to obtained data, our method of treatment, which was used for treatment of patients from the 2nd group, is the most appropriate for common application in the treatment of urogenital chlamydiosis
P3-S1.43 Women friendly gonorrhoea culture by self taken vaginal swabs for the purpose of surveillance of gonorrhoea resistance
Authors: Götz H M , Luijendijk A , Nuradini B , van Westreenen M 
Published: July 2011

BackgroundSurveillance of Gonorrhoea resistance is a public health priority. At the Rotterdam STI clinic diagnostic tests for gonorrhoea are done by NAAT techniques from urine in men, and (self taken) vaginal swabs in women. For the purpose of resistance monitoring confirmation by culture is performed from urethra in men and cervix in women. In this study we evaluated whether culture is possible from vaginal swab, and whether women could perform this by self taken vaginal swabs.MethodsGonorrhoea diagnostic is performed by SDA technique (BD-USA). For Culture swabs are put on GC-lect agar plates and incubated overnight at 30°C in CO2atmosphere. The next day transport to the laboratory is done in CO2jars. Cultures are examined for a maximum of 72 h. (Presumed) Positive cultures are identified by AccuProbe (BioMerieux-France). In phase 1 culture in female patients was performed by a health care provider by cervical swabs, in phase 2 by cervical and vaginal swab, in phase 3 a vaginal swab by the patient was added.ResultsIn Phase 1, 8/26 (31%) cervical cultures showed growth of gonorrhoea, 18 were negative. Mean time between PCR and culture was 18 days in positive and negative cases. In Phase 2, 21 women were cultured cervically and vaginally; 6/21 (29%) showed growth of gonorrhoea without discrepancies between the sites. In 17 women only vaginal swabs were taken, of whom 29% positive in culture. Mean time between PCR and culture was 20 days in positive and negative cases. In phase 3, seven women were cultured three times. 2/7 cultures (29%) were positive cervically and vaginally (professional and patient swab). The five other cases were all negative.ConclusionsConfirmation of vaginal gonorrhoea infection by culture was only achieved in 30% despite optimal laboratory methods. Gonococci can be grown from vaginal swabs, and no discrepancy was found between health care provider and patient taken swabs. Cultures taken for surveillance of resistance can be taken by women themselves without having to undergo physical examination.
P3-S1.44 Comparison of self-taken vulvo-vaginal swabs and clinician-taken endocervical swabs using the Gen-Probe Aptima Combo 2 assay vs clinician-taken urethral and endocervical swabs for culture of gonorrhoea
Authors: Wilson J , Stewart C , Schoeman S , Booth R , Smith S , Wilcox M 
Published: July 2011

BackgroundThe role of non-invasive testing for gonorrhoea (GC) in women has not yet been fully established in the UK. Validation of NAATs in low prevalence populations has been recommended. Our study is the first to compare gonorrhoea detection on self-taken VVSs by AC2 assay with gold-standard culture of clinician-taken urethral and endocervical (endocx) samples. As it is unclear whether a VVS or endocx swab is better for the detection of chlamydia (CT) by AC2 assay in women needing an examination we also compared the sensitivities of these samples for CT detection.MethodsWomen aged 16+ requesting STI testing consenting to perform a self-taken VVS prior to routine examination were included. Clinicians took urethral and endocx samples for gonorrhoea culture and an endocx swab for AC2 assay. AC2 positives were confirmed with Aptima GC and Aptima CT assays.Results3973 women included, 100 (2.5%) were infected with GC. Overall sensitivities were culture 82%; clinician taken endocx AC2 96%; self-taken VVS AC2 99% (p=0.0002). The specificity of all the AC2 tests was 100%. In women with symptoms the sensitivities were culture 84%; clinician taken endocx AC2 100% and VVS AC2 100% (p=0.003). In women with no symptoms 1.9% had GC. The sensitivities were culture 79%; clinician taken endocx AC2 91% and self-taken VVS AC2 97.5% (p=0.015). The endocx AC2 performed less well in women without symptoms, 91% vs 100% (p=0.031); the VVS AC2 assay performed equally well, 97.5% vs 100% (p=0.41). Overall sensitivities for CT were clinician taken endocx AC2 89%; self-taken VVS AC2 97% (p=0.0001). In women with symptoms the sensitivities were clinician taken endocx AC2 88%; self-taken VVS AC2 97% (p=0.001). In women with no symptoms the sensitivities were clinician taken endocx AC2 89%; self-taken VVS AC2 98% (p=0.002).ConclusionAC2 assay of self-taken VVSs was significantly more sensitive for the detection of GC than culture of urethral and endocx samples and equivalent to detection by AC2 assay from clinician-taken endocx swabs. The specificity and PPV of the AC2 assay was very high in this low prevalence population. AC2 assay of self-taken VVSs was significantly more sensitive for the detection of CT than AC2 assay of clinician-taken endocx samples. On the basis of these findings a self-taken VVS is the sample of choice in women who do not need an examination. In those who are being examined either a self-taken or clinician-taken VVS is the sample of choice giving better detection rates of GC and CT than an endocx swab.