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Competing Interests: Competing interests: we have read and understood BMJ policy on declaration of interest and declare that we have no competing interests.

Objective: To compare vulvovaginal swabs with endocervical swabs as optimal diagnostic sample for detection of Chlamydia trachomatis infection., Design: A diagnostic test study., Setting: An urban sexual health centre., Participants: 3973 women aged ≥ 16 years requesting testing for sexually transmitted infections., Interventions: Participants took a vulvovaginal swab before routine examination, and clinicians took an endocervical swab during examination., Main Outcome Measure: Diagnosis of chlamydia infection with samples analysed using the Aptima Combo-2 assay; positive results confirmed with the Aptima CT assay., Results: Of the 3973 participants, 410 (10.3%) were infected with C trachomatis. Infected women were significantly younger (22 v 25 years, P<0.0001) and more likely to have symptoms suggestive of a bacterial sexually transmitted infection (53% v 41%, odds ratio 1.63 (95% CI 1.30 to 2.04)), be a contact of someone with a sexually transmitted infection (25% v 5%, odds ratio 6.18 (4.61 to 8.30)), clinically diagnosed with cervicitis (17% v 4%, odds ratio 4.92 (3.50 to 6.91)), and have pelvic inflammatory disease (9% v 3%, odds ratio 2.85 (1.87 to 4.33)). When women co-infected with gonorrhoea were included in the analysis, there was an association with mixed ethnicity (10% v 7%, odds ratio 1.53 (1.07 to 2.17)); but when those with gonorrhoea were removed, women of white ethnicity were significantly more likely to have chlamydia (85% v 80%, odds ratio 1.40 (1.03 to 1.91)). On analysis of complete paired results, vulvovaginal swabs were significantly more sensitive than endocervical swabs (97% (95% CI 95% to 98%) v 88% (85% to 91%), P<0.00001); corresponding specificities were 99.9% and 100%. In women with symptoms suggestive of a bacterial sexually transmitted infection, vulvovaginal swabs were significantly more sensitive than endocervical swabs (97% (93% to 98%) v 88% (83% to 92%), P=0.0008), as they were in women without symptoms (97% (94% to 99%) v 89% (84% to 93%), P=0.002)., Conclusions: Vulvovaginal swabs are significantly better than endocervical swabs at detecting chlamydia in women with and without symptoms suggestive of sexually transmitted infections. In those with symptoms, using endocervical samples rather than vulvovaginal swabs would have missed 9% of infections, or 1 in every 11 cases of chlamydia., Trial Registration: ISRCTN42867448.

Objective: To evaluate the effectiveness of register based, yearly chlamydia screening., Design: Controlled trial with randomised stepped wedge implementation in three blocks., Setting: Three regions of the Netherlands: Amsterdam, Rotterdam, and South Limburg., Participants: 317 304 women and men aged 16-29 years listed on municipal registers at start of trial., Intervention: From March 2008 to February 2011, the Chlamydia Screening Implementation programme offered yearly chlamydia screening tests. Postal invitations asked people to use an internet site to request a kit for self collection of samples, which would then be sent to regional laboratories for testing. Treatment and partner notification were done by the general practitioner or at a sexually transmitted infection clinic., Main Outcome Measures: Primary outcomes were the percentage of chlamydia tests positive (positivity), percentage of invitees returning a specimen (uptake), and estimated chlamydia prevalence. Secondary outcomes were positivity according to sex, age, region, and sociodemographic factors; adherence to screening invitations; and incidence of self reported pelvic inflammatory disease., Results: The participation rate was 16.1% (43 358/269 273) after the first invitation, 10.8% after the second, and 9.5% after the third, compared with 13.0% (6223/48 031) in the control block invited at the end of round two of the intervention. Chlamydia positivity in the intervention blocks at the first invitation was the same as in the control block (4.3%) and 0.2% lower at the third invitation (odds ratio 0.96 (95% confidence interval 0.83 to 1.10)). No substantial decreases in positivity were seen after three screening rounds in any region or sociodemographic group. Among the people who participated three times (2.8% of all invitees), positivity fell from 5.9% to 2.9% (odds ratio 0.49 (0.47 to 0.50))., Conclusions: There was no statistical evidence of an impact on chlamydia positivity rates or estimated population prevalence from the Chlamydia Screening Implementation programme after three years at the participation levels obtained. The current evidence does not support a national roll out of this register based chlamydia screening programme., Trial Registration: NTR 3071 (Netherlands Trial Register, www.trialregister.nl).

Objective: To determine the presence of Chlamydia trachomatis in hydrocele fluid., Methods: 90 male patients with hydrocele of tunica vaginalis from an endemic area for bancroftian filariasis were investigated for the presence of Chlamydia trachomatis in their hydrocele fluids. C trachomatis antigen detection tests-a direct immunofluorescence assay and an enzyme immunoassay along with polymerase chain reaction assay for amplification of a 517 bp fragment of C trachomatis endogenous plasmid-were used in this study. The patients were also tested for the presence of microfilaria in their hydrocele fluids and night blood. Histopathological examination was carried out to detect adult filarial worm in tunica vaginalis testes., Results: Eight (8.88%) patients had chlamydia antigen in the hydrocele fluids; C trachomatis plasmid sequences could be amplified from five of these. Seven (7.77%) patients had microfilaria in the hydrocele fluids, three of them having adult worm in tunica vaginalis., Conclusion: C trachomatis infection might be associated with hydrocele in some of these patients.

Objective: To evaluate the commercial microparticle enzyme immunoassay (MEIA), Abbott IMx Select Chlamydia, for the detection of Chlamydia trachomatis in women and to compare its performance with endocervical cell culture. Also, to determine whether sampling the urethral site is an important part of chlamydial diagnosis in women., Setting: The Auckland, Manukau, and Waitakere Sexual Health Clinics, Auckland, New Zealand and the Department of Clinical Microbiology, Auckland Hospital, Auckland, New Zealand., Patients: The study population consisted of 622 consecutive women who attended the three sexual health clinics., Methods: The IMx Chlamydia assay was performed on an IMx analyser, following a specimen treatment procedure. All reactive samples from the IMx Chlamydia assay were confirmed using the IMx Chlamydia blocking antibody reagent. The Syva direct fluorescent antibody (DFA) test was used to aid in resolving discrepancies. The cell culture technique was performed in shell vials using cycloheximide treated McCoy cells, which were stained using a fluorescein conjugated monoclonal antibody., Results: When compared against the endocervical cell culture, the IMx Chlamydia had a sensitivity of 82.1% (23/28) and a specificity of 99.3% (590/594). When compared against an expanded gold standard, the IMx Chlamydia and endocervical cell culture had sensitivities of 84.4% (27/32) and 87.5% (28/32), specificities of 100% (590/590) and 100% (590/590), positive predictive values of 100% (27/27) and 100% (28/28), negative predictive values of 99.2% (590/595) and 99.3% (590/594), and accuracies of 99.2% (617/622) and 99.4% (618/622), respectively. The prevalence rate by endocervical cell culture and the expanded gold standard were 4.5% and 5.1%, respectively. Additional urethral cell culture testing revealed a further nine patients positive from this site only, giving a 28% (9/32) increase in the number of patients diagnosed for chlamydia, thus giving an overall prevalence of 6.6% (41/622)., Conclusions: The IMx Chlamydia assay is an easy and rapid test to perform, it is cost effective, and shows similar performance to endocervical cell culture in the female population studied and is thus an excellent alternative to culture for the diagnosis of C trachomatis. The study also showed the importance of urethral site sampling in these women, as endocervical testing alone will underestimate the prevalence of chlamydial genital infection.

Objective: To investigate, by use of the Amplicor PCR in a routine setting, the recovery rate of Chlamydia trachomatis in ano-rectal and pharyngeal swab samples obtained from males and females attending an STD clinic in relation to sexual practices, symptoms, and signs., Design: Data regarding sexual practices, and symptoms and signs related to the rectum and pharynx, were obtained from 196 females and 208 males, including 31 homosexuals and eight bisexuals. Swab samples were obtained from the urethra, rectum, and pharynx from all the patients. An additional endocervical swab sample was obtained from the females., Methods: All samples were analysed by the Amplicor PCR (Roche)., Setting: Rudolph Bergh's Hospital, a clinic for sexually transmitted diseases situated in the centre of Copenhagen, Denmark., Results: The overall prevalence of urogenital C trachomatis infection was 9.2% (37/404). The specificity of the Amplicor PCR was 100% for both ano-rectal and pharyngeal swab samples. In females three (13%) of the 23 infections were detected only by testing an ano-rectal or throat swab sample. In homosexual males two (67%) of three infections were detected only by the anorectal swab sample. Ano-rectal intercourse without use of condom was reported by 44% of females and by 52% of homosexual males. Fellatio without condom use was reported by 91% of females, and 80% of heterosexual males practised cunnilingus. Pharyngeal infection, however, occurred only in females, and the presence of pharyngeal symptoms or signs seemed predictive for pharyngeal C trachomatis infection, for which the time of incubation or colonisation exceeded 3 months. The presence of ano-rectal signs or symptoms was not predictive for an ano-rectal C trachomatis infection., Conclusion: The Amplicor PCR can be used on ano-rectal and pharyngeal swab samples. Ano-rectal swab samples should be obtained in females and homosexual males at high risk of being infected. Pharyngeal samples should be taken in females at high risk of being infected, especially when pharyngeal signs or symptoms are present.

Objectives: To determine the prevalence of genital Chlamydia trachomatis infections in commercial street sex workers (CSSW) in Jamaica., Methods: The prevalence of C trachomatis infection was determined in 129 Jamaican CSSW using the direct fluorescent antibody (DFA) method and the isolation techniques which utilise fluorescent and iodine staining of endocervical cytobrush specimens cultured in McCoy cells. The seroprevalence of C trachomatis in the CSSW was also compared with that in blood donors (n = 435), using the microimmunofluorescence (MIF) test., Results: The DFA detected C trachomatis in 16% (21/129) of the specimens. The prevalence as determined by the iodine and fluorescein stained cultures was 24% (31/129) and 25% (33/129) respectively. The overall prevalence of current chlamydial infection detected by the isolation techniques used was 25% (33/129). As determined by the MIF test, a statistically significantly higher seroprevalence rate of C trachomatis (95%, 61/64) was found in CSSW compared with blood donors (53%, 229/435; OR 22.6; chi 2 = 49.8; p < 0.001). The prevalence of current infection in CSSW as indicated by the isolation of C trachomatis was not influenced by history of previous pelvic inflammatory disease (PID), sexually transmitted disease, or condom use. N gonorrhoeae (9%) and Candida albicans (7%) were found in comparatively low frequencies, while Trichomonas vaginalis (0%) was not found in specimens from the CSSW., Conclusions: A high seroprevalence rate and a high rate of current infection with C trachomatis occur in Jamaican CSSW. In order to control the spread and prevent the severe clinical complications and sequelae of C trachomatis infection, the diagnosis and treatment in such high risk groups such as CSSW should be optimised.

Objectives: To screen for certain STD markers in a group of male clients of female sex workers., Method: Condoms with seminal fluid were collected at 10 "massage parlours" in Copenhagen. The seminal fluid samples were examined for HIV antibodies, markers of hepatitis B virus (HBV), Chlamydia trachomatis, and Mycoplasma genitalium., Results: All samples (n = 332) were negative for HIV antibodies. Out of 327 samples examined for HBV markers 32 (9.8%) were positive for HBV core antibodies, one of which was also positive for HBV antigen. C trachomatis could be demonstrated in six out of 122 (4.9%) samples and M genitalium in one out of 122 samples., Conclusions: The finding of a C trachomatis prevalence of 4.9% is considerable higher than expected in men with a presumed age of 35-55 years. The demonstration of a prevalence of HBV markers of 9.8% indicates that these clients have an increased risk of HBV infection, a finding that further consolidates the recommendation of HBV vaccination of sex workers. As shown in this study, STD transmission in commercial sex may also have the client as the source.

Background: It has been established that lack of circumcision increases the risk of urinary tract infection in infants. During the first six months, the presence of foreskin is associated with a greater quantity and a higher concentration of uropathogens in the periurethral area. Very little is known about this association in older males., Objective: To compare the periurethral bacteriology of uncircumcised healthy males of more than one year of age., Methods: The periurethral area of 125 uncircumcised and 46 circumcised healthy males (mean age, 26.5 and 28.3 years, respectively) was swabbed and cultured for facultative and anaerobic bacteria, genital mycoplasmas and Chlamydia trachomatis., Results: Facultative Gram positive cocci predominated in both groups (62% and 80%, respectively). Pure culture of facultative Gram negative rods was more common in uncircumcised males (17% v 4% in circumcised males, p = 0.01). Streptococci, strict anaerobes and genital mycoplasmas were found almost exclusively in uncircumcised males of more than 15 years of age. No case of C trachomatis was identified., Conclusions: The higher prevalence of potential uropathogens in the subpreputial space is in accordance with a previous finding of increased risk of urinary tract infection in uncircumcised young men. Our results also support the role of the prepuce as a reservoir for sexually transmitted organisms.

Objective: To measure the prevalence of urethritis due to Neisseria gonorrhoeae and Chlamydial infection trachomatis in rural Tanzanian men, Design: About 500 men aged 15-54 years were selected from each of 12 rural communities by random cluster sampling; interviewed concerning past or present symptoms of sexually transmitted diseases; and asked to provide a first catch urine specimen, which was tested for pyuria with a leucocyte esterase dipstick test. Subjects with symptoms or with a positive result on testing were examined, and urethral swabs were taken for detection of N gonorrhoeae by gram stain and of C trachomatis by antigen detection immunoassay., Setting: Mwanza region, north western Tanzania., Subjects: 5876 men aged 15-54 years., Main Outcome Measures: Prevalence of urethral symptoms, observed urethral discharge, pyuria, urethritis ( > 4 pus cells per high power field on urethral smear), N gonorrhoeae infection (intracellular gram negative diplococci), and C trachomatis infection (IDEIA antigen detection assay)., Results: 1618 (28%) subjects reported ever having a urethral discharge. Current discharge was reported by 149 (2.5%) and observed on examination in 207 (3.5%). Gonorrhoea was found in 128 subjects (2.2%) and chlamydial infection in 39 (0.7%). Only 24 of 158 infected subjects complained of urethral discharge at the time of interview (15%)., Conclusion: Infection with N gonorrhoeae and C trachomatis is commonly asymptomatic among men in this rural African population. This has important implications for the design of control programmes for sexually transmitted disease.

Objective: The aim of this study was to evaluate the newly developed ligase chain reaction (LCR) assay for the detection of Chlamydia trachomatis in urogenital specimens using cell culture and Amplicor PCR for comparison., Subjects: Two hundred and eighty patients attending hospital or urban STD clinics (high-risk population, 62 men and 84 women) and obstetric/gynaecology clinics (low-risk population, 134 women) in Bordeaux, France., Methods: Specimens from men were tested with LCR on urethral swabs and urine, with Amplicor or urine, with cell culture on urethral swabs. Specimens from women were tested with LCR, Amplicor and cell culture on endocervical swabs and with LCR on urine. When the three methods generated different results, the LCR and Amplicor tests were repeated on the remaining samples. Samples with discordant LCR and Amplicor results and a negative culture were further analysed by major outer membrane protein gene omp1-PCR., Results: After analysis of discrepant results, the overall prevalence was 7.5% (21/280) calculated on the basis of an expanded "gold standard" defined as culture positive or LCR plus Amplicor positive or omp1-PCR positive for discrepant results between LCR and Amplicor tests. Of the 21, 20 were detected by LCR, 17 by Amplicor and culture. The specificity of LCR and Amplicor was 99.6%., Conclusion: The LCR Chlamydia trachomatis test is a highly sensitive nonculture technique and a good alternative test for the detection of chlamydial infections.

Objectives: Methods to quantitate Chlamydia trachomatis have never been compared although it would be relevant to periodically evaluate the sensitivity of a detection system. We compared the sensitivity and reproducibility of culture, direct immunofluorescence and the polymerase chain reaction (PCR) to quantitate C trachomatis., Methods: A competitive semiquantitative PCR procedure was developed. The number of inclusions in culture, particles by direct immunofluorescence and DNA copies by PCR were measured for 12 patient specimens. Variation was determined by measuring a sample 10 times for each method., Results: Patient C trachomatis major outer membrane protein gene DNA was measured semiquantitatively by amplifying together with reference DNA. DNA molecules, particles and infectious units were quantitated in clinical samples with, on average, 595 DNA molecules and 87 immunofluorescent particles observed per inclusion-forming-unit. Similar coefficients of variation (47-52%) were observed for the 3 procedures., Conclusion: Competitive PCR and counting immunofluorescent particles provide reproducible and sensitive methods of quantitating C trachomatis.

Objective: To compare the polymerase chain reaction (PCR) Amplicor Chlamydia trachomatis test with the cell culture method, in diagnosing urogenital chlamydial infections., Subjects: 439 patients (327 women and 112 men) attending one STD clinic and Family Planning and Gynaecological Clinics in Lisbon, Portugal, between November 1993 and March 1994., Methods: In women, two endocervical swab samples were collected: one for PCR Amplicor and one for standard culture technique. Men were asked to submit 20 ml of urine (first pass urine) for PCR Amplicor and one urethral specimen was taken for culture. The order of collection of the specimens was rotated every 50 patients. Discrepant results were further analysed by a second PCR with primers directed against the C trachomatis major outer membrane protein (MOMP) and by direct fluorescent antibody (DFA)., Results: After analysis of discrepancies, the adjusted sensitivity and specificity of PCR on endocervical specimens were 92.9% and 100% and the positive and negative predictive values were 100% and 99.7% respectively; on the urine samples these values were 100%, 99.1%, 100% and 99.1%, respectively., Conclusion: These results indicate that the PCR Amplicor test is a rapid sensitive and specific assay for the detection of C trachomatis in urogenital infections and provides a non-invasive technique for screening chlamydia infection in men.

Objectives: The aim of this study was to establish the prevalence of sexually transmitted infections including human immunodeficiency virus (HIV) infection in women with Bartholin's gland abscess., Setting: Gynaecology Clinic of King Edward VIII Hospital, a large urban, referral hospital for the province of Kwa-Zulu Natal, serving an underprivileged population., Methods: Thirty consecutive women presenting with unruptured Bartholin's gland abscesses were studied. Prior to surgical drainage, aspirates from the abscess cavity and swab specimens from the vagina and endocervix were collected for microbiological investigations. In addition peripheral venous blood samples were obtained for syphilis and HIV antibody testing., Results: Antibody to HIV was detected in 9 of the 30 (30%) patients studied. Recognised sexually transmitted pathogens were detected in both aspirates and endocervical specimens: Chlamydia trachomatis was detected in 3 aspirate and 2 endocervical specimens whilst Neisseria gonorrhoeae was cultured in 5 aspirate and 7 endocervical specimens. When comparing microorganisms isolated from HIV antibody positive and negative women, only Bacteroides species yielded a significantly higher growth (p = 0.01) in the antibody positive women., Conclusion: Our findings show that women with Bartholin's gland abscesses have a high prevalence of HIV antibody. Furthermore, this is the only study that demonstrates a role for C trachomatis in the aetiology of Bartholin's gland abscesses. Health workers should be aware of the need for appropriate counselling, and comprehensive treatment of sexually transmitted infections including C trachomatis in women with Bartholin's gland abscesses.

A polymerase chain reaction (PCR) was developed to detect Chlamydia trachomatis in genital tract specimens. Two sets of primers for the PCR were used; one set amplifies a region of the plasmid present in all C trachomatis strains and the other amplifies a conserved region of the genome coding for the major outer membrane protein. The sensitivity of these PCRs were compared with each other, and with the sensitivities of antigen ELISA, Clearview and culture. Southern blotting and probing was used to increase sensitivity of detection.

Objective: To determine how often Chlamydia trachomatis cervical infections are detected in women following completion of a currently recommended treatment regimen and the reason for recurrence., Methods: A longitudinal follow-up study of 43 initially C trachomatis-positive women for periods of up to two years., Results: C trachomatis was detected in three women, 19, 16 and about four months, respectively after completion of treatment. All specimens from the other 40 women which were taken during visits two to seven, that is periods of three to 700 days after treatment, were chlamydia-negative., Conclusion: Although C trachomatis is usually eradicated from the genital tract by conventional treatment, occasionally it may be found again. It is difficult to determine whether detection after treatment is due to persistence or reinfection and further studies are required.

Objective: To evaluate the diagnostic efficacy of chlamydia culture, direct immunofluorescence (DFA), direct enzyme immunoassay (EIA), polymerase chain reaction (PCR) and serology by defining positive culture or at least two positive non-culture tests as true positive., Setting: Three gynaecological departments located in separate areas of Sweden., Patients and Design: All pregnant women requesting abortion during a six month period were included. In cases with unconfirmed non-culture tests, reculture with multiple passage and PCR on the culture transport medium was performed for confirmation. Serum was analysed for chlamydial antibodies type IgG, IgM and IgA using microimmunofluorescence., Results: 18 of 419 (4.3%) patients were positive for chlamydia according to the defined criteria. Twelve of 419 (2.9%) were positive in standard culture (primary inoculation). The sensitivity of standard culture, DFA, EIA and PCR were 66.7%, 77.8%, 64.7% and 71.4% respectively. The specificity 100% (by definition), 99.5%, 100%, 100% respectively. The positive predictive value 100% (by definition), 87.5%, 100%, 100% respectively. Negative predictive value 98.5%, 99.0%, 98.5%, 98.9% respectively. Serum IgG titre of > or = 64 and > or = 1024 gave positive predictive values of 10% and 21% respectively., Conclusions: When an expanded gold standard is used, the specificity and positive predictive value of the non-culture tests used are comparable with that of standard culture even in this low prevalence population. Standard culture underestimated the chlamydia prevalence by 33%. The prevalence found represents a decrease from 10 to 2.9% of culture verified chlamydia during four years in comparable populations. Chlamydial antibodies of certain immunological classes are not necessarily present in cases with chlamydia.

Objective: To evaluate a centrifuge enhanced direct immunofluorescent antigen test (MD test), compared with conventional culture and ELISA testing in the diagnosis of Chlamydia trachomatis infection., Setting: A District General Hospital situated 30 miles from a University Department of Medical Microbiology., Subject and Method: A prospective study on specimens from 638 patients. Culture was performed on 348 specimens from genitourinary medicine patients and ELISA testing was carried out on 272 specimens from Gynaecology patients., Results: When compared with culture the MD test had a sensitivity of 90.6%, specificity of 96.8%, positive predictive value of 74.3% and a negative predictive value of 99%. When compared with confirmed ELISA results the MD test had a sensitivity of 100%, specificity of 98.8%, positive predictive value of 78.5% and negative predictive value of 100%., Conclusion: The MD test compares favourably with other chlamydial diagnostic techniques and in our setting is preferable to sending specimens for chlamydial culture. It is not suitable as the sole diagnostic method for screening large numbers of specimens but is a cost effective confirmatory test for positive ELISA results.

Objective: To evaluate a newly developed polymerase chain reaction (PCR) assay, Amplicor C trachomatis for the detection of C trachomatis in genital samples using cell culture for comparison., Subjects: 501 patients (431 women and 70 men) attending an STD clinic in Hôpital Pellegrin (high-risk population) and gynaecological clinics (low-risk population) in Bordeaux, France., Methods: The genital samples (cervical and urethral) were tested for the presence of C trachomatis using the Amplicor test and using standard cell culture identified by the immunofluorescence test using a monoclonal antibody to C trachomatis. Discrepancies between the results of culture and Amplicor were further analysed by major outer membrane protein gene (omp1)-PCR of the specimens taken in transport media and by direct fluorescent antibody (DFA) staining of elementary bodies in culture transport tubes., Results: After analysis of discrepancies, the revised sensitivity and specificity of PCR were 95.3% and 100% and the positive and negative predictive values were 100% and 99.5%, respectively., Conclusion: The present results indicate that the Amplicor assay is rapid, specific and more sensitive than the culture method. This test provides an excellent non-culture method for the detection of C trachomatis in various prevalence populations.

Background and Objectives: The objective of this study was to determine the performance characteristics of a dipstick test for leukocyte esterase (LE), (Chemstrip 2LN, Boehringer Mannheim) in predicting the presence of urethritis and urethral pathogens in men presenting to a busy sexually transmitted disease clinic and to street outreach facilities., Methods: Urethral swabs for polymorphonuclear (pmn) cell count, gonorrhoea culture and chlamydia enzyme immunoassay (EIA) as well as 15 ml of first voided urine (FVU) were collected from 737 symptomatic and 726 asymptomatic men. Gonorrhoea cultures and pmn counts were processed according to standard methods. Either Abbott Chlamydiazyme EIA (confirmed) or Syva Microtrak EIA (confirmed) test was employed to detect C trachomatis. The LE test was immediately dipped in FVU, read after 60-120 seconds by the clinician and considered positive if trace, 1+ or 2+., Results: Microscopic evidence of urethritis (> or = = 4 pmn cells per 1000 x field) was found on urethral smear of 782 (53.5%) patients. Chlamydia, gonorrhoea or both were present in 104 (7.1%) patients. Performance characteristics of the LE test were as follows: (table below), Conclusion: The LE test did not have adequate sensitivity to be considered a reliable rapid diagnostic test for urethritis or urethral pathogens, particularly in the asymptomatic portion of this STD clinic population.

Objective: This study examined the effects of four variables on the detection of Chlamydia trachomatis in urine from men by enzyme immunoassay (EIA). These variables were: symptoms and signs of urethritis, urine polymorphonuclear leucocytes (PMN), inclusion counts from urethral chlamydia cell cultures and the time between testing and last voiding., Methods: Included were patients with and without symptoms and/or signs of urethritis attending the Edmonton Sexually Transmitted Disease Clinic. Men were asked to submit a 20 ml volume urine sample. Urethral swabs were collected for gram stain, chlamydia and gonorrhea culture., Results: A total of 318 men were evaluated of whom 47 had chlamydia. Excluding six men who were coinfected with gonorrhoea, sensitivities and specificities of the Microtrak, Chlamydiazyme and IDEIA systems were 78.1% and 99.6%, 75.6% and 100%, and 80.5% and 97.8% respectively. Last void time did not affect the sensitivity. However, sensitivity was best when applied to men with severe evidence of urethritis., Conclusion: There is evidence that urine EIA could be used to detect chlamydia in men with acute urethritis but not in those without signs of urethritis.

Objective: To determine the extent to which testing of multiple sites and samples is required to define whether a woman is Chlamydia trachomatis-positive., Design: One-hundred and fifty women attending the Genitourinary Medicine clinic at St Mary's Hospital were enrolled; they had not received antichlamydial antibiotics in the previous three months, were not in a high-risk group for HIV infection, or pregnant, or using an intrauterine contraceptive device. Thirty-two women were re-examined three months after recruitment., Methods: An urethral specimen was Gram stained (smear) and cultured for gonococci. Another urethral specimen was taken to detect C trachomatis elementary bodies (EBs) by the MicroTrak direct fluorescent antibody (DFA) test (Syva). An endocervical swab specimen was Gram stained (smear) and cultured for gonococci. One of two other endocervical swabs was used for the DFA test and was then placed in medium which was centrifuged in a MicroCentaur at 13,000 rpm for 10 min; the deposit was examined by using the DFA test. The first 15-20 ml of voided urine (first pass urine; FPU) was also centrifuged and the deposit tested similarly., Results: Of 182 cervical smears and/or deposits tested for C trachomatis, 38 were positive; more cervical deposits (37) than smears (26) were positive and, of these, one-fifth of the deposits and one-third of the smears contained fewer than 10 elementary bodies. Of 162 paired urethral smears and FPU deposits available, one or other specimen of 36 pairs was chlamydia-positive, that is 31 smears and 32 deposits; of these, two-fifths of the smears and half of the deposits contained fewer than 10 EBs. Of 150 sets of cervical and urinary tract samples tested, 31 were chlamydia-positive at both sites, six in the cervix alone and four in the urinary tract alone. Of 139 women for whom there were valid first visit sample results, 36 (26%) were chlamydia-positive in the cervix, 34 (25%) in the urinary tract and 41 (29%) had at least one sample from either site positive. Overall, DFA tests of deposits from centrifuged cervical specimens achieved the highest sensitivity (88%) and those of cervical smears the lowest (70%)., Conclusions: Deposits from centrifuged cervical specimens were C trachomatis-positive more often than were cervical smears. Testing deposits from centrifuged urines was as successful as testing urethral smears. One-fifth (cervical deposits) to one-half (urine deposits) of specimens contained fewer than 10 EBs. The urinary tract was chlamydia-positive almost as frequently as the cervix but both sites needed to be tested to define whether a woman was chlamydia-positive.

Background and Objectives: The leukocyte esterase (LE) strip is a useful tool for the screening of men with urethritis. In developing countries, where laboratory facilities are limited, and sexually transmitted diseases endemic, simple and inexpensive diagnostic tests which perform well, would be of great value., Methods: Men presenting with urethritis to a referral clinic for sexually transmitted diseases in Nairobi, Kenya participated in this cohort analytical study. First-void urine was collected for LE dipstick testing as part of the diagnostic work-up. The results of the dipstick measurement were compared with the laboratory detection of Chlamydia trachomatis and Neisseria gonorrhoeae., Results: Of 200 men with symptoms of urethritis, 33 (17%) had a pathogen detected from the urethra or the urine. Chlamydia was detected in urine by PCR in 22 (11%), and gonorrhoea was cultured from the urethra in 11 (6%). Esterase activity (trace or greater) had a sensitivity of 76%, a specificity of 80%, a positive predictive value of 42% and a negative predictive value of 94% for the presence of chlamydia or gonorrhoea., Conclusions: The use of the LE dipstick for the screening of men with symptomatic urethritis can improve diagnostic accuracy and reduce the amount of empiric antimicrobial therapy. The low detection rate of chlamydia in these men with a clinical diagnosis of nongonococcal urethritis needs further study.

OBJECTIVE--To determine the association of sexually transmitted pathogens in women with cervical intra-epithelial neoplasia (CIN). SETTING--An urban tertiary referral hospital serving a large indigent developing community. PARTICIPANTS--48 women attending a colposcopy clinic and 49 women attending a family planning clinic. METHODS--Vaginal, endocervical, rectal swab specimens and sera were collected for the detection of sexually transmitted pathogens. Cervical cytology was performed on all patients. Women attending the colposcopy clinic had confirmation of abnormal cervical cytology by colposcopic directed biopsy. RESULTS--The mean age of women with CIN (33 years) was significantly greater than that of the women without CIN (28 years) and that of the family planning group (26 years). There was a high prevalence of sexually transmitted pathogens in all women. A significantly higher prevalence of bacterial vaginosis was found in women with CIN compared to those without (50% vs 20%; p = 0.034). The human papilloma virus (HPV) was detected in 46% of women with CIN and 65% of those without CIN. Chlamydia trachomatis (21%) and Trichomonas vaginalis (39%) were detected frequently in women with CIN. C. trachomatis (14%-21%) was detected more frequently than Neisseria gonorrhoeae (3-5%) in all asymptomatic women studied. CONCLUSION--This study demonstrates a high prevalence of sexually transmitted pathogens in women with and without CIN as well as family planning clinic attenders. Bacterial vaginosis was a significant finding in women with CIN. C. trachomatis was detected in a high proportion of all women studied and found more commonly than N. gonorrhoeae. We therefore recommend that all women attending gynaecological services in a developing community be investigated and treated for sexually transmitted diseases.

Objectives: To compare a new sampling device, a brush, Accellone-Multi-Instrument (AMI), with a dacron-tipped swab for detection of Chlamydia trachomatis in endocervical specimens, and to evaluate if consecutive multiple cervical sampling as compared with such a single specimen would increase the sensitivity., Methods: 501 females attending an STD clinic and 172 females attending a family planning clinic were examined prospectively. Two cervical specimens were collected from each woman. C trachomatis were detected by culture or enzyme immunoassay (IDEIA-III). Positive EIA samples were confirmed by a direct immunofluorescent test., Results: When cervical specimens were collected with the brush as the first device, 92% of the culture-positive cases were detected, and when the samples were collected with the dacron-tipped-swab first, 84% of the culture-positive cases were detected (p < 0.05). The first collected specimen detected 89% of the culture-positive cases and 81% of those that were positive by IDEIA., Conclusions: The study indicates that the AMI brush is superior to non-toxic, dacron-tipped swabs for detection of C trachomatis in cervical samples by cell culture but not by ELISA, and that the sensitivity could be improved by analysing multiple cervical samples.

Objective: To investigate the aetiology of acute epididymitis in a developing community with a view of determining appropriate antimicrobial therapy., Setting: City Health Sexually Transmitted Diseases Clinic, King Edward VIII Hospital, Durban, South Africa., Participants: 144 adult men with clinically diagnosed acute epididymitis., Method: Endourethral swab and midstream urine (MSU) specimens were processed to detect sexually transmitted pathogens and urinary tract infections., Results: The majority of patients (93%) were less than 35 years of age. Neisseria gonorrhoeae and/or Chlamydia trachomatis were detected in 78% of patients: N gonorrhoeae in 57%, C trachomatis in 34% and both in 13%. Escherichia coli was cultured more frequently from MSU specimens of older patients, 30% versus 3%. In 53% of patients urethritis was diagnosed by the presence of inflammatory cells in endourethral smears in the absence of a visible urethral discharge., Conclusion: In our setting of a busy clinic with limited facilities, we recommend the performance of a Gram stain on endourethral specimens from patients with acute epididymitis. If inflammatory cells and Gram negative diplococci are detected, treatment with antimicrobial agents to cover both penicillinase-producing N gonorrhoeae strains and C trachomatis is recommended. If Gram negative diplococci are not detected in the presence of microscopic evidence of urethritis, treatment for chlamydial infection alone is recommended.

Objectives: A method based on a nested polymerase chain reaction (PCR) was developed to detect and to type Chlamydia trachomatis from low titre samples by amplifying a large portion of the major outer membrane protein gene. The sensitivity of this procedure was evaluated in urogenital clinical samples in comparison with culture., Specimens: A series of 787 urogenital specimens, including 37 (4.7%) positive by culture, together with 227 other samples that had been found to yield less than 25 chlamydial inclusions in culture were tested., Methods: Samples were pelleted, resuspended in 1 mM NaOH, heated and amplified without further purification. After 40 cycles of PCR, 1 microliters of product was amplified by a further 30 cycles of PCR using a second set of primers nested within the initial pair. Positives were detected by agarose gel electrophoresis and confirmed by repeating the PCR analyses and determining the serovar of both amplified samples by restriction fragment length polymorphism., Results: Nested PCR allowed detection of 96% and culture 77% of positives with only three samples repeatedly positive by PCR but considered false positives because a different serovar was identified in the two amplifications. Of culture-positive samples with less than 11 chlamydia inclusion-forming-units 97% could be detected by nested PCR and most still gave a positive signal when diluted hundred fold., Conclusions: Nested PCR provided the basis for a very sensitive C trachomatis detection and typing strategy. Repetition and typing positive samples facilitated detection of false-positive PCR specimens resulting from contamination of the PCR process or any reagent except the original sample.

Objective: To assess correlation between nonspecific cervicitis, inflammation, or exudate on cervical smears tests and confirmed presence of known cervical pathogens., Design: Investigation of women attending a family practice clinic for smear test by microbiological screening for Chlamydia trachomatis, Mycoplasma hominis, Ureaplasma urealyticum, Trichomonas vaginalis, Candida species, group B streptococcus, Gardnerella vaginalis, and Neisseria gonorrhoeae., Setting: Family practice teaching clinic in a university hospital., Patients: 411 women presenting for a smear test., Main Outcome Measures: Prevalence of genital infections associated with presence or absence of inflammatory changes on cervical smear., Results: Of the 132 women with inflammatory changes on cervical smear, 64 (48%) had positive cultures. Of the 248 without inflammatory changes, 117 (47%) had positive cultures. Subgroup analysis on individual organisms also showed no significant difference between the two groups., Conclusion: Reports of inflammatory changes on cervical smear testing are a poor indicator of infection.

Objective: To evaluate a new enzyme immuno assay, Antigenz Chlamydia, for the detection of chlamydial antigen in urogenital samples using cell culture as the gold standard for comparison and direct immuno fluorescence to aid resolving the discrepancies., Subjects: 212 men and 303 women attending an STD clinic and 404 women of child bearing age attending gynaecological clinics., Results: Sensitivity, specificity, predictive value of positive result and predictive value of negative result of the new test were 77.6%, 99.0%, 94.3%, and 95.7% respectively in the high risk population with a prevalence of 16.5%. In the low risk population the figures were 84.2%, 94.5%, 43.2% and 99.2% respectively with a prevalence of 4.7%., Conclusion: Antigenz Chlamydia is an easy and quick test to perform. The test is suitable for use in high risk and low risk populations provided all positive samples are confirmed.

Objective: Provide evidence from prospective data that Neisseria gonorrhoeae may be an important cause of premature delivery and low birth weight in areas with high prevalence of genital infections., Setting: Department of Obstetrics and Gynaecology, Kalafong University Hospital, Pretoria, South Africa in collaboration with the Departments of Microbiology and of Gynaecology and Obstetrics, Katholieke Universiteit, Leuven, Belgium., Subjects: Two hundred and fifty six consecutive black pregnant women were examined during the first antenatal visit, and one to four weeks later a second culture for N gonorrhoeae was taken at random in 67 of them. Hundred and sixty seven were analysable, 75 were lost to follow up., Methods: After obtaining detailed clinical history, an endocervical specimen for N gonorrhoeae culture (Thayer-Martin) and C trachomatis antigen detection (Chlamydiazyme (R)) was taken. Syphilis was diagnosed when both reactive plasma protein (RPR) and T pallidum haemagglutination inhibition assay (TPHA) were positive. Prematurity was defined as delivery at less than 37 gestational weeks., Results: Infection with N gonorrhoeae (n = 9) and untreated syphilis (n = 7) were both associated with prematurity and low birth weight. After multi-variate regression analysis, age-adjusted parity, late sexual debut, number of recent sexual partners, infection with N gonorrhoeae and infection with syphilis revealed significant associations with low birth weight. However, infection with C trachomatis, presence of abundant vaginal discharge, social class, Trichomonas vaginalis infection, gestational weeks at first antenatal visit and number of previous miscarriages did not reveal such an association. Attributable risk of untreated gonorrhoea for premature birth was 72% and routine cultures were cost-benefit efficient., Conclusions: At least in countries where the prevalence is high, genital infections as well as the risk factors for acquiring them (young age, late sexual debut, number of recent partners) play a major role in the aetiogenesis of prematurity and low birth weight. N. gonorrhoeae is a main contributor, and in high prevalence areas it should be routinely looked for and treated for during pregnancy.

Objective: To determine whether the use of urine samples from male patients can replace urethral swabs for the rapid detection of Chlamydia trachomatis by the Pharmacia EIA., Setting: The STD clinic, Adelaide, South Australia., Patients: There were two separate groups of male patients. Group A (398) patients provided urethral specimens for the EIA and culture tests. The patients in Group B (356) provided an urethral swab and a urine sample for the EIA test., Methods: The urine samples and urethral swabs were tested for the presence of C trachomatis by the Pharmacia Chlamydia EIA. In addition, the urethral swabs from Group A patients were cultured for the organism by standard cell cultures. The infected cell cultures were identified by an immunofluorescence test using a FITC-monoclonal antibody to C trachomatis (Kallestad)., Results: When the EIA was validated against culture, it showed a sensitivity of 100% and a specificity of 95% with the urethral swabs from Group A patients. The urine specimens were positive in 24% of those patients who yielded a positive EIA result in the urethral swabs., Conclusions: Although the EIA test on urethral swabs showed high sensitivity and specificity when validated against culture, our results showed that the use of urine samples cannot replace urethral swabs for the laboratory diagnosis of this sexually transmitted disease.

First pass urine (FPU) samples were compared with urethral swab culture from 304 males attending a genitourinary medicine clinic using an enzyme immuno assay (EIA). All of the EIA positive samples were retested by incorporating a novel blocking reagent into the EIA protocol; 101 were positive by culture of which 83 were also positive by FPU EIA, an additional four were detected in FPU only and not by culture; 86 of these 87 were also confirmed positive by the blocking reagent. Discrepant results were evaluated by Syva MicroTrak. The sensitivity and specificity of FPU EIA as compared with urethral swab culture was 82.2% (83/101) and 98% (199/203) respectively with positive and negative predictive values of 95.4% (83/87) and 91.7% (199/217). Male urethral swab culture is more sensitive than FPU EIA; however, when culture is not available then FPU offers a reliable non-invasive alternative to swab EIA which may be of enormous benefit in community screening of asymptomatic as well as symptomatic patients.

Objective: To evaluate the first void urine (FVU) specimen in screening for urethritis and its microbial aetiologies in a male African population in which urinary schistosomiasis is also prevalent., Patients and Methods: Two hundred and forty eight males aged 15-54 years provided FVU specimens: 55 patients from a clinic for sexually transmitted diseases (STD), 151 patients from a medical outpatient clinic and 42 villagers from an area of high endemicity for S haematobium. Specimens were tested for leucocyte esterase (LE) using a dipstick (Nephur-Test+Leuco, Boehringer-Mannheim France SA). Ova of S haematobium were sought in terminal urine samples from all subjects. For all STD patients, and all medical outpatients with a positive LE test, urine and urethral swabs were tested for Chlamydia trachomatis antigen, and urethral swabs were tested for Neisseria gonorrhoeae by gram stain and isolation., Results: The prevalence of LE positivity was 38/41 in STD patients with urethral signs or symptoms (93%), 5/14 among other STD patients (36%), 21/151 among medical outpatients (15%) and 13/42 among villagers (31%). As a screening test for urethral infection (detection of gonorrhoea or chlamydia and/or > or = 5 polymorphs per high power field on gram stain) the LE test had a sensitivity of 94% and a specificity of 53% among STD patients. Of 24 STD patients with gonococcal or chlamydial infection, 23 had a positive LE test (96%). Among general medical outpatients, 12 of 22 with a positive LE test had either conventionally defined urethritis or gonococcal or chlamydial infection, giving a positive predictive value of 55% for the LE test in this group. Of 18 subjects in all groups with urinary schistosomiasis nine had a positive LE test (50%), although three of these also had gonorrhoea. Chlamydial antigen was detected in the FVU specimen of all six subjects in whom it was detected in a urethral swab, and in an additional three subjects in the outpatient group., Conclusions: The FVU, which is an easily collected and non-invasive specimen, can provide valuable information on the prevalence of urethritis and on its microbial aetiology among the general male population in African countries.