bluuebunny/crossref_metadata_2025_split huggingface dataset:
P3-S6.04 Use of a point of care test device to detect syphilis in a STD clinic
Authors: Barnes M , Ducan D , Agreda P , Hsieh Y H , Holden J , Rompalo A , Gaydos C 
Published: July 2011

BackgroundDiagnosis of syphilis is problematic and an accurate rapid point of care (POC) test could be useful in busy STD clinics. There are no FDA Cleared POC tests for Syphilis serology in the USA.ObjectiveTo determine the performance of a new, rapid point of care (POC) test, Syph-Check, which is not yet FDA cleared, for the serological diagnosis of Treponema pallidum in female and male STD patients.MethodsMen and women >18 yr visiting the Baltimore City Health Department STD clinic were consented to enrol in a trial to determine the accuracy of a new, innovative POC test for syphilis (Veda, manufactured in France) that used a cassette format to test syphilis serology. The Syph-Check One-Step Syphilis test is a point of care, rapid immunoassay screening test for qualitative detection of IgG and IgM antibodies toTreponema pallidumin finger stick blood, plasma, and serum. This product can be used as an initial screening test or as a confirmatory diagnostic test, but is not FDA cleared for use in screening blood or plasma donors. The assay was performed in the STD clinic, required only 20 min to perform, and required no instrumentation. RPR and TPPA tests were performed to determine the sensitivity and specificity of the Syph-Check POC test.Results194 men and 205 women were enrolled. Of the 399 samples tested, 33 were positive and 366 were negative by the Syph-Check. There were 14 positives and 385 negatives by RPR confirmatory testing. Overall sensitivity compared to RPR testing was 85.7% (95% CI 60.3% to 97.5%) and specificity was 94.5% (95% CI 91.9% to 96.5%). There were 32 positives and 367 negatives by TPPA confirmatory testing. Overall sensitivity compared to TPPA was 43.8% (95% CI 27.5% to 61.1%) and specificity was 94.8% (95% CI 92.2% to 96.8%).ConclusionsThe Syph-Check POC test was moderately accurate compared to the RPR test, but not as sensitive compared to TPPA. A more accurate POC test for syphilis could be useful for clinicians to test clinic patients and provide immediate screening results for syphilis to patients during an office or clinic visit.
P3-S6.05 Comparing the analytical sensitivities of six treponemal tests
Authors: Jost H , Kikkert S , Fakile Y , Castro A , Ye T , Zaidi A , Ballard R , Cox D 
Published: July 2011

BackgroundTraditional syphilis testing consists of screening with a non-treponemal test (RPR) and confirmation with a treponemal test (TP-PA, FTA-ABS, EIA, CIA, etc). Recently, that testing algorithm has been reversed due to efforts to reduce labour costs and the availability of automatable tests (EIA, CIA). Large numbers of discordant test results (treponemal +, non-treponemal−) can be obtained using the reverse algorithm and can be due to (1) treated cases of syphilis, (2) a false-positive treponemal test, or (3) a case of early primary syphilis that has yet to seroconvert. Those sera need to be confirmed with a second treponemal test to eliminate false positive specimens. The dilemma arises which treponemal test is best suited for confirmation, and secondly what are the relative analytical sensitivities of available treponemal tests used for both screening and confirmation.MethodsTwo hundred randomised TP-PA positive, cleanascite treated samples (GADPH) were serially diluted with normal human sera to determine the analytical endpoint and sensitivity of six commonly used treponemal tests (TP-PA, FTA-ABS, TrepSure, TrepChek, TrepID, and LIAISON). All dilutions were treated as neat sera in each test, and the tests were performed according to the manufacturer's instructions.ResultsThe FTA-ABS was used as the reference since it has been considered the Gold Standard" among treponemal tests. The analytical sensitivity of the six tests fell into three statistically different groups (from lowest to highest): (1) the FTA-ABS, the TP-PA, and the TrepChek, (2) the LIAISON and the TrepID, and (3) the TrepSure. In addition, there were 24 sera that were found non-reactive by FTA-ABS and nine found non-reactive by TrepChek that were reactive by at least two other treponemal tests.ConclusionsThese results highlight significant differences in the analytical sensitivity of various treponemal tests and could explain some discordant results between treponemal tests used to confirm screening EIAs and CIAs. First, the FTA-ABS should no longer be considered the “Gold Standard”. Second, low titre sera could appear non-reactive if relatively insensitive tests are used for the either screening or confirmatory tests. Third, the question arises, “Should initial screening tests be confirmed by treponemal tests with lower analytical sensitivity?” Future patient studies could verify these results, so that a more accurate standard protocol for syphilis testing can be established.
P3-S6.08 Detection of the 23S rRNA point mutations (A2058G and A2059G) associated with azithromycin resistance in treponema pallidum using a TaqMan-based real-time Triplex-PCR assay
Authors: Chen C Y , Chi K H , Pillay A , Nachamkin E , Ballard R 
Published: July 2011

BackgroundTo develop a TaqMan-based real-time allelic discrimination assay for the simultaneous detection of two point mutations (A2058G and A2059G) in the 23S rRNA gene ofT pallidumthat have been associated with azithromycin treatment failures.MethodsInitially, two TaqMan-based real-time duplex PCR assays were used to detect the A2058G and A2059G point mutations within the 23S rRNA gene ofT pallidum. Genotyping results from these assays were then compared to a previously described real-time PCR assay using fluorescence resonance energy transfer (FRET) probes and melting curve analysis that is specific for the detection of the A2058G point mutation. Subsequently, a real-time triplex PCR was developed to distinguish the A2058G from the A2059G point mutation in a single assay and the results were confirmed by pyrosequencing.ResultsSixteen of 67 (23.9%)T pallidum-positive specimens collected from patients with genital ulcer disease in the US were found to have the A2059G point mutation. These strains were previously characterised as having azithromycin-susceptible genotypes (no point mutations in the 23S rRNA gene). The A2059G mutation was confirmed by a real-time duplex PCR assay containing the TaqMan probe specific for the mutation and by pyrosequencing. None of theT pallidumstrains examined to date had both point mutations. The real-time triplex PCR assay was able to differentiate azithromycin-susceptible genotypes from resistant genotypes containing either the A2058G or A2059G point mutation in a single assay. The limit of detection of the assay was 1–10 copies using 23S rRNA gene fragments that were cloned into a plasmid.ConclusionsThe previously reported real-time PCR detection platforms were designed to detect only the A2058G point mutation and were unable to differentiateT pallidumstrains with susceptible genotypes from resistant genotypes with the A2059G mutation. The new TaqMan-based real-time allelic discrimination assay offers an alternative to the previously described PCR/RFLP method to rapidly detect both point mutations associated with azithromycin resistance inT pallidum. The prevalence of T. pallidum strains that harbour point mutations in the 23S rRNA gene associated with resistance to azithromycin might be much higher than previously estimated.
P3-S6.10 Analysis of systemic and cutaneous immune responses helps explain the duality of immune evasion and recognition in secondary syphilis
Authors: Cruz A , Ramirez L 
Published: July 2011

BackgroundDespite the robust adaptive immune responses associated with secondary syphilis (SS), which include the presence of high titres of anti-T pallidum(Tp) antibodies with opsonizing activity, it may take months to years for host defenses to gain control of the infection. Tp's unusual outer membrane architecture is believed to underlie this duality of immune evasion and recognition. To better understand the dynamics of immune evasion and Tp clearance in early syphilis, we studied immune responses of SS patients in peripheral blood (PB) and skin in relation to Tp burdens.Methods27 HIV(-) SS patients and 26 healthy controls were enrolled. Circulating monocytes, dendritic cells (DCs) and natural killer (NK) cells were characterised by flow cytometry and qRT-PCR. SS skin biopsies were analysed by immunohistochemistry (IHC) and microarray. Ex vivo opsonophagocytosis assays were performed with live Tp (Nichols) and purified human monocytes.ResultsDespite the demonstrated presence of Tp in blood, circulating monocytes exhibited only mild activation by flow cytometry without detectable cytokine production by qRT-PCR. We also observed decreased numbers of circulating IFNg-producing and cytotoxic NK cells along with an emergent CD16+/CD56- NK-cell population. In contrast, skin lesions, which contained abundant Tp by IHC and PCR, contained transcripts for a variety of pro-inflammatory cytokines (IFNg, TNFa, IL1b), monocyte chemotactic factors (CCL2, CCL5 and CXCL10) and macrophage and DC surface activation markers (CD80, CD86). Transcripts for genes associated with Fc-mediated phagocytosis (FcgRI, FcgR3), endosomal TLRs (TLR7-9), and cytotoxic T cells (CD8, granzyme, perforin) also were detected in lesional skin. IHC corroborated the presence of macrophages and CD4 and CD8 T cells, but not NK cells, in the biopsies. Patient sera promoted Tp uptake and monocyte activation, although substantial proportions of Tp were capable of evading phagocytosis.ConclusionsOur results support a model in which the duality of immune evasion/recognition which occurs in SS reflects the relative burdens of Tp in skin and blood as well the presence of Tp populations with differential capacity for binding opsonic antibodies. Macrophage activation due to opsonophagocytosis of a subpopulation of Tp drives the recruitment to skin of immune cells that slowly clear infection. Results also suggest that cytotoxic cellular responses may contribute to elimination of Tp.
P3-S7.01 Evaluation of a simple point-of-care rapid test for detecting Trichomonas vaginalis among women in Mysore, India
Authors: Rao K , Madhivanan P , Klausner J , Trammell S , Kotian S , Ravi K , Krupp K , Srinivas V 
Published: July 2011

BackgroundTrichomonas vaginalisis one of the easily treatable sexually transmitted infections in the world. Current methods used to diagnose trichomoniasis rely heavily on training and experience of the technician and have low performance reliability. These methods are unsuitable for settings where accessibility to a continuous electrical source may be a challenge. We examined the performance of OSOM Trichomonas rapid point-of-care test (POC) as compared to the gold standard (culture) and the routine method of diagnosis in clinical laboratories (wet-mount microscopy) in Mysore, India.MethodsSexually active women over age 18 and seeking care at Prerana Reproductive Health Clinic were enrolled into the study from July 2009 to August 2010. Clinician- collected vaginal swabs were evaluated for trichomonads using wet-mount microscopy, InPouchTM culture, and OSOM® Trichomonas Rapid Test in a blinded manner by different investigators.ResultsOf the 417 women enrolled, the prevalence of Trichomoniasis diagnosed by culture was 16.3% (95% CI 12.9% to 20.3%). As compared to culture, the sensitivity, specificity, positive predictive value and negative predictive value for wet mount microscopy was 82.4%, 98.9%, 93.3%, 96.6%; for OSOM rapid test it was 88.2%, 99.4%, 96.8%, 97.8% respectively.ConclusionOSOM Trich rapid test had very good performance with excellent sensitivity, specificity, positive predictive value, and negative predictive value of 88.2%, 99.4%, 96.8%, and 97.8%, respectively. The implementation of OSOM Trichomonas rapid test would significantly reduce the labour and material costs. Furthermore, frequent partner reinfection as a result of wrong or missed diagnosis can be reduced. It will also reduce other complications such as pelvic inflammatory disease and susceptibility to HIV.
P3-S7.02 Performance of a point-of-care diagnostic for Bacterial Vaginosis among young reproductive age women in Mysore, India
Authors: Ravi K , Kotian S , Rao K , Selezneva J , Srinivas V , Krupp K , Madhivanan P 
Published: July 2011

BackgroundBacterial vaginosis (BV) remains the most common cause of abnormal vaginal discharge in Indian women of reproductive age and is associated with increased susceptibility to HIV/STI and preterm delivery. Diagnosis of BV in resource-poor settings is often overlooked; there is a need for cheap, rapid, objective point-of-care diagnostic test.MethodsVaginal swabs were collected from women attending a women's health clinic. Women over the age of 18 with a pH of over 4.5 were invited to participate in the study. BV was diagnosed on the basis of the Nugent score, the Amsel clinical criteria, and results of OSOM BVBlue test independently by study clinician and laboratory personnel who were blinded to the results of the other tests.ResultsFrom August 2009 to May 2010, 313 participants were enrolled. BV prevalence was 45.1% (95% CI 41.5% to 52.8%) according to Nugent score. When compared with the Nugent score, the sensitivity, specificity, positive predictive value, negative predictive value for Amsel clinical criteria was 61.9%, 88.3%, 81.5%, 73.7%; and for BVBlue it was 38.1%, 92.7%, 82.1%, 63.9% respectively. The performance of BVBlue can be increased if it is combined with “Whiff test where the sensitivity increases to 64.4%, sensitivity 85.6%, PPV 79.3% and NPV 73.8%”.ConclusionsThese results highlight the importance of systematic evaluation of rapid test kits as a low-cost alternative to laboratory diagnosis in resource-constrained settings. The BVBlue test is a simple, rapid, and objective test for the diagnosis of BV and has the potential to facilitate prompt diagnosis and appropriate treatment of BV in the absence of microscopy.
P3-S7.03 The prevalence of Bacterial Vaginosis among young women in urban areas in Nigeria and its major risk factors
Authors: Olawuyi O 
Published: July 2011

IssueVaginitis is polymicrobial Sexually Transmitted Diseases (STDs), associated with some STD agents, presenting signs/symptoms such as foul smelling vaginal discharge, irritation, and itching. Among the leading infectious agents causing vaginitis among young women in urban communities in Nigeria,Gardnerella vaginalis(cause of Bacterial Vaginosis) was found to top the list. Also, unprotected sex during first sexual intercourse and multiple sexual partners are found to be the major risk factors for the wide spread of Bacterial vaginosis among the study's young women.MethodBacteriological and differential laboratory tests (microscopic examination, normal physiological saline wet-preparation, Potassium Hydroxide (OH) solution, whiff test, the litmus paper/PH level test, and gram staining) were carried out on High vaginal swab (HVS) specimens collected aseptically within 6 months from non-pregnant, non-menstruating young women who are not on antibiotics for a week before specimens were collected, and whose consent is sought before the study. The Study population is made up of both STD center attending and non-attending young women (mean age=25.50). In addition, a standard questionnaire (r=0.77) was administered to answer the major research/study questions on the major risk factors for Bacterial vaginosis.ResultFrom the 200 HVS collected, 68 % of primary isolates were isolated:G vaginalis(51.72%),C albicans(41.92%), andT vaginalis(06.36%) respectively (p<0.0001). According to the result from the study questionnaire, among 200 respondents, 37.71% had their first sexual intercourse without any protection, 39.16% were protected during their first sexual intercourse, and 23.13% did not recollect. Also, 31.65% had engaged in sexual intercourse with more than one sexual partner before with no protection in few occasions, 37.21% had had multiple sexual partners before with protection, 31.14% declined to provide answer to the multiple sexual partner questions.ConclusionsBacterial vaginosis was found to be the most prevalent among young women in urban cities in Nigeria, and the major risk of contracting the infectious disease is unprotected sexual intercourse with multiple partners, and during first sexual intercourse. However, there is need for effective and efficient sex education and awareness to encourage the partners to be faithful to one another and for the promotion of safe sexual intercourse by using preventive means such as condoms.
P3-S7.05 Phenotypic characterisation of clinical trichomonas vaginalis isolates among AAWSW in sexual partnerships
Authors: Muzny C , Rivers C , Mena L , Schwebke J 
Published: July 2011

BackgroundTrichomonas vaginalis(TV) is the most common non-viral sexually transmitted infection in the world. TV prevalence in US women is consistently highest among African Americans (AA). However, little data exists on the risk of TV infection among women who have sex with women (WSW) and the mechanism of transmission is poorly understood. The goal of this study was to evaluate the concordance of TV isolates among AAWSW involved in sexual partnerships using the random amplified polymorphonuclear DNA (RAPD) technique.MethodsAAWSW involved in sexual partnerships and participating in a cross-sectional study of STI prevalence rates at the Mississippi State Department of Health STD clinic in Jackson, MS, were selected for this study if both women in the partnership were infected with TV. All women completed a confidential survey asking detailed sexual history questions about female and male partners during the past 12 months. The RAPD technique utilising six unique PCR primers was performed on TV clinical isolates from each sexual partnership. RAPD amplicons were collated and categorised to determine genetic similarity between isolates from paired couples.ResultsTV isolates from three paired couples were included in this study. RAPD profiling demonstrated that only one out of the three pairs of TV isolates was concordant see Abstract P3-S7.05 figure 1. Within this concordant pair, both women reported engaging in oral sex and sharing wet towels during sexual activity. One woman in this pair reported recent sex with a male partner while the other woman denied history of other sexual partners during the past 3 months and had not had sex with a male partner in 5 years. Additionally, a follow-up visit of one of the members of this concordant union demonstrated a RAPD pattern discordant with previous findings indicating that the individual's initial treatment was successful and that she had acquired a new TV infection.Abstract P3-S7.05 Figure 1Primer Set 1.ConclusionsGiven the phenotypic similarity of banding patterns within one AAWSW sexual partnership, female to female transmission of TV may have occurred. The frequency of TV transmission between WSW is unknown at this time; however, the use of RAPD appears to be informative for differentiating isolates of TV. A prospective study examining the epidemiology and incidence of TV infection among WSW is necessary.
P3-S7.06 Vaginal discharge in women living with HIV attending an AIDS clinic in Manaus, Brazil
Authors: Miranda A , Silva L , Braga J V , Montes R , Talhari S 
Published: July 2011

BackgroundA vaginal discharge and/or vulvar itching and irritation usually characterise Vaginitis, and a vaginal odour might be present. The three diseases most frequently associated with vaginal discharge are BV (replacement of the normal vaginal flora by an overgrowth of anaerobic microorganisms, (Gardnerella vaginalis), trichomoniasis, and candidiasis.ObjectivesTo estimate the prevalence of vaginal discharge in HIV women attending the Institute of Tropical Medicine in Manaus, Amazonas, Brazil.MethodsA cross-sectional study performed among women attending the AIDS clinic from March to December 2010. They were invited to take pat in the study and answered an interview including demographic, behavioural and clinical data. They underwent in a gynaecological examination and it was collect vaginal samples for diagnosingTrichomonas vaginalis, Gardnerella vaginalisandCandida spp.ResultsA total of 338 women were included in the study. Median age was 32 (IQR (IQR): 27; 38) years and median of schooling nine (IQR: 4; 11) years. Prevalence rate of vaginal discharge was 45.8% (95% CI 40.5% to 51.1%). Prevalence ofTrichomonas vaginaliswas 1.2% (95% CI 0.5% to 2.4%),Gardnerella vaginalis35.8% (95% CI 30.7% to 40.9%) and Candidiasis 21.3% (95% CI 16.9% to 25.7%). Median of first sexual intercourse was 16 (IQR: 14; 17) years and 53.6% were married or reported a stable partner. Risk factors reported were: injecting drug use (1.2%), no-injecting drugs (15.2%), previous STI (32.4%), commercial sex workers (16.4%), more than one partner in the last year (12.4%) and in life (94.7%). Regarding clinical symptoms, 50,9% reported chronic pelvic pain, 53.3% vaginal discharge, 47.6% vaginal itching, 22.8% dysuria and 9.5% genital bleeding. CD4 counts were more than 500 cells/mm3in 29.4% and viral load were <1.00 copies/ml in 53.8%. A total of 53.9% of women reporting vaginal discharge had a positive test for at least one disease. In the final model of logistic regression the only variable remained was having viral load <1000 copies/ml decreased the risk of vaginal discharge.ConclusionsRegardless the low cost and large availability of GRAM stain and cytological tests in health services for women with AIDS, there are difficulties which remain to identify interventions that refer to social, cultural and environmental influences on vaginal infections in this group.
P3-S7.07 Detection ofTrichomonas vaginalisin HIV positive women in Pretoria, South Africa
Authors: Kock M , Rukasha I , Dijkmans A , Hoosen A 
Published: July 2011

BackgroundThe aim of this study was to detectTrichomonas vaginalisinfection in HIV positive women receiving anti-retroviral therapy in Pretoria, South Africa.MethodsSelf-collected vaginal swab specimens from 95 consecutive patients attending the anti-retroviral clinic (Tshwane District Hospital) were analysed.Trichomonas vaginaliswas diagnosed by wet mount microscopy, culture using InPouch and a commercial PCR assay targeting the DNA repeat units. Trichomoniasis was diagnosed if any test was positive.ResultsFive (5.3%) of the 95 specimens were positive by wet mount microscopy, 21 (22.1%) were culture positive and 28 (29.5%) were detected by PCR. All culture and wet mount positive specimens were PCR positive. The sensitivity and specificity of wet mount microscopy compared to culture were 23.8% and 98.7% respectively. PCR detected seven additional positive specimens than culture. The specificity of PCR compared to culture was 100%, with a sensitivity of 90.5%. The prevalence ofT vaginaliswas found to be 29.5% in this study.ConclusionsPrevious studies in South Africa focused on the prevalence of trichomoniasis in pregnant women and women without HIV status and from lower socio-economic groups. This is the first report in HIV positive women receiving ARV treatment. There was a high prevalence (29.5%) ofT vaginalisin this group. This is similar to that reported from Nigeria (24.4%) and Ivory Coast (27.0%), whilst the rate reported in Congolese (18.6%) HIV positive women was lower. Using microscopy alone for the diagnosis of trichomoniasis as is the current practice in most laboratories in South Africa is inadequate and leads to missed infections.