Chlamydia Nucleic Acid Amplification Tests Research Articles

2019 British Association of Sexual Health and HIV National Clinical Audit of timelines to be seen, test results and treatment for Chlamydia trachomatis

BASHH/MEDFASH (Medical Foundation for HIV and Sexual Health) Standards for the Management of Sexual Health Services 20141 set out a number of recommendations regarding time between contacting a service to being seen, time to receiving results, and time to treatment. This audit investigated if UK practice is compliant with BASHH standards of care in terms of: Time to patient being seen after contacting sexual health services, time to chlamydia (CT) NAAT (nucleic acid amplification test) results and time from positive CT result to treatment. All UK level 2 (non-specialist) and level 3 (specialist) sexual health clinics were invited to take part. Data were collected via a survey of sexual health clinics and a retrospective case-note review of the last 40 people aged 16 or over per service seen with chlamydia but not syphilis or gonorrhoea. Cases were identified using the SHHAPT (Sexual Health and HIV Activity Types) National STI Surveillance code for chlamydia (C4). There were responses from 221 sites. 67% of sites reported offering both appointment and walk-in access, 26.2% appointment-only, 6.8% walk-in only. The mean turn-away rate of individuals seeking walk-in access on the last open day was 6.1%. There were variations in local service specification turnaround times for chlamydia nucleic acid amplification test results; 32% of sites reported no specified turnaround time. Case note audit of individuals seen with chlamydia showed 74.1% of individuals were tested for chlamydia at a level 3 clinic, 11.8% at a level 2 sexual health clinic, 7.3% used a self-sampling kit requested online and 3.9% tested at a different setting. 92.1% of individuals who initially tested at a sexual health service had an attempted notification within 10 working days of a positive chlamydia test. 95% of individuals were treated within a sexual health service. Overall, 94.0% of individuals were treated within 15 working days of the test result. When missing data were excluded, patient initiated GUM/level 3 attenders seen within 2 working days met the audit standard as did patient access to results within 10-working days for those whose initial CT NAAT sample was taken at a GUM/level 3 clinic and treatment within 3 weeks for GUM/level 3 attenders. Patients offered to be seen/assessed within 2 working days and lab report within 5 working days did not meet the audit standard. Recommendations include ensuring that laboratory turn-around times are included in contracts or service level agreements for clinical services, and local monitoring of these. Dates when individuals first seek to access sexual health services should also be recorded and used to monitor performance in comparison with access standards.

High Plasmid Gene Protein 3 (Pgp3) Chlamydia trachomatis Seropositivity, Pelvic Inflammatory Disease, and Infertility Among Women, National Health and Nutrition Examination Survey, United States, 2013-2016.

Chlamydia trachomatis causes pelvic inflammatory disease (PID) and tubal infertility. Plasmid gene protein 3 antibody (Pgp3Ab) detects prior chlamydial infections. We evaluated for an association of high chlamydial seropositivity with sequelae using a Pgp3Ab multiplex bead array (Pgp3AbMBA). We performed chlamydia Pgp3AbMBA on sera from women 18-39 years old participating in the 2013-2016 National Health and Nutrition Examination Survey (NHANES) with urine chlamydia nucleic acid amplification test results. High chlamydial seropositivity was defined as a median fluorescence intensity (MFI ≥ 50 000; low-positive was MFI > 551-<50 000. Weighted US population high-positive, low-positive, and negative Pgp3Ab chlamydia seroprevalence and 95% confidence intervals (CI) were compared for women with chlamydial infection, self-reported PID, and infertility. Of 2339 women aged 18-39 years, 1725 (73.7%) had sera, and 1425 were sexually experienced. Overall, 104 women had high positive Pgp3Ab (5.4% [95% CI 4.0-7.0] of US women); 407 had lowpositive Pgp3Ab (25.1% [95% CI 21.5-29.0]), and 914 had negative Pgp3Ab (69.5% [95% CI 65.5-73.4]). Among women with high Pgp3Ab, infertility prevalence was 2.0 (95% CI 1.1-3.7) times higher than among Pgp3Ab-negative women (19.6% [95% CI 10.5-31.7] versus 9.9% [95% CI 7.7-12.4]). For women with low Pgp3Ab, PID prevalence was 7.9% (95% CI 4.6-12.6) compared to 2.3% (95% CI 1.4-3.6) in negative Pgp3Ab. High chlamydial Pgp3Ab seropositivity was associated with infertility although small sample size limited evaluation of an association of high seropositivity with PID. In infertile women, Pgp3Ab may be a marker of prior chlamydial infection.

Chlamydia Prevalence by Age and Correlates of Infection Among Pregnant Women.

There is a paucity of population-based data on chlamydia in pregnancy despite rising rates in US women. Our objectives were to assess chlamydia prevalence by age group and to identify factors associated with infection in pregnant women to inform screening guidelines. This cross-sectional study included pregnant women tested for chlamydia who delivered at the University of Alabama at Birmingham between November 1, 2012, and December 31, 2017. The primary outcome was chlamydia prevalence, defined as a positive urogenital chlamydia nucleic acid amplification test result documented in the electronic medical record. Multivariable logistic regression was used to identify factors associated with infection. Among 17,796 women who delivered during the study period, 13,657 (77%) had chlamydia testing performed at the University of Alabama at Birmingham. Chlamydia prevalence (95% confidence interval) was 7.4% (7.0%-7.9%). Age-stratified prevalence rates were 14.6%, 4.3%, and 1.7% for women younger than 25 years, 25 to 29 years, and 30 years or older, respectively. Chlamydia in pregnancy remained strongly associated with age (adjusted odds ratio [95% confidence interval], 7.2 [5.6-9.2] for age <25 years, and 2.3 [1.7-3.0] for ages 25-29 years, when compared with >30 years) after adjustment for race, urban residence, and insurance status. Among pregnant women living in the southeastern United States, chlamydia was detected in 1 of 14 women who were tested. Chlamydia positivity was highest among women younger than 30 years. Study findings support broad screening for chlamydia in pregnancy.

Evaluation of the performance of nucleic acid amplification tests (NAATs) in detection of chlamydia and gonorrhoea infection in vaginal specimens relative to patient infection status: a systematic review

ObjectiveWe evaluated the performance of nucleic acid amplification tests (NAATs) using vaginal specimens in comparison to specimens from the cervix or urine in their ability to detect chlamydia and gonorrhoea...

What Is the Optimal Time to Retest Patients With a Urogenital Chlamydia Infection? A Randomized Controlled Trial.

Chlamydia trachomatis is a common, often recurring sexually transmitted infection, with serious adverse outcomes in women. Current guidelines recommend retesting after a chlamydia infection, but the optimum timing is unknown. We assessed the optimal retest interval after urogenital chlamydia treatment. A randomized controlled trial among urogenital chlamydia nucleic acid amplification test positive heterosexual clients of the Amsterdam sexually transmitted infection clinic. After treatment, patients were randomly assigned for retesting 8, 16, or 26 weeks later. Patients could choose to do this at home (and send a self-collected sample by mail) or at the clinic. Retest uptake and chlamydia positivity at follow-up were calculated. Between May 2012 and March 2013, 2253 patients were included (45% men; median age, 23 years; interquartile range, 21-26). The overall uptake proportion within 35 weeks after the initial visit was significantly higher in the 8-week group (77%) compared with the 16- and 26-week groups (67% and 64%, respectively, P < 0.001), and the positivity proportions among those retested were comparable (P = 0.169). The proportion of people with a diagnosed recurrent chlamydia infection among all randomized was similar between the groups (n = 69 [8.6%], n = 52 [7.4%], and n = 69 [9.3%]; P = 0.4). Patients with a recent urogenital chlamydia are at high risk of recurrence of chlamydia and retesting them is an effective way of detecting chlamydia cases. We recommend inviting patients for a re-test 8 weeks after the initial diagnosis and treatment.

Treatment efficacy of azithromycin 1\xa0g single dose versus doxycycline 100\xa0mg twice daily for 7\xa0days for the treatment of rectal chlamydia among men who have sex with men \u2013 a double-blind randomised controlled trial protocol

BackgroundRectal infection with Chlamydia trachomatis is one of the most common bacterial sexually transmissible infections among men who have sex with men (MSM) with diagnosis rates continuing to rise. Current treatment guidelines recommend either azithromycin 1 g single dose or doxycycline 100 mg twice daily for 7 days. However, there are increasing concerns about treatment failure with azithromycin. We are conducting the first randomised controlled trial (RCT) to compare treatment efficacy of azithromycin versus doxycycline for the treatment of rectal chlamydia in MSM.Methods/DesignThe Rectal Treatment Study will recruit 700 MSM attending Australian sexual health clinics for the treatment of rectal chlamydia. Participants will be asked to provide rectal swabs and will be randomised to either azithromycin 1 g single dose or doxycycline 100 mg twice daily for 7 days. Participants will be asked to complete questionnaires about adverse drug reactions, sexual behaviour and drug adherence via short message service and online survey. The primary outcome is the treatment efficacy as determined by a negative chlamydia nucleic acid amplification test at 4 weeks post treatment. Secondary outcomes will utilise whole genome sequencing and mRNA assay to differentiate between treatment failure, reinfection or false positive results.DiscussionRectal chlamydia is an increasing public health concern as use of pre-exposure prophylaxis against HIV becomes commonplace. Optimal, evidence-based treatment is critical to halting ongoing transmission. This study will provide the first RCT evidence comparing azithromycin and doxycycline for the treatment of rectal chlamydia. The results of this trial will establish which treatment is more efficacious and inform international management guidelines.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12614001125617.

A recommendation for timing of repeat Chlamydia trachomatis test following infection and treatment in pregnant and nonpregnant women.

The objective of this study was to describe the time required to obtain a negative chlamydia test in pregnant and nonpregnant women following treatment to inform test-of-cure collection and recommend an abstinence period to avoid reinfection. Seventy-two women with Chlamydia trachomatis infection, 36 pregnant and 36 nonpregnant, were enrolled in a prospective cohort study. Women were excluded less than 18 years of age, if they had been treated for chlamydia, reported an allergy to macrolide antibiotics, or if they had Myasthenia Gravis. Women were treated for chlamydia with single-dose therapy and submitted weekly vaginal chlamydia nucleic acid amplification tests (NAATs). Once NAAT were negative, the participants completed the study. Forty-seven women completed the study per protocol. The primary outcome was to determine the time to a negative chlamydia NAAT following treatment, with secondary outcomes of determining the appropriate time to collect a test-of-cure following chlamydia treatment and to recommend an appropriate abstinence period following treatment to avoid reinfection. Results showed that the time to a negative chlamydia NAAT was significantly different between groups (log-rank p = 0.0013). The median number of days to obtain a negative chlamydia NAAT was 8 days (IQR 7-14) in pregnant and 7 days (IQR 6-10) in nonpregnant women (WRST p = 0.04). All participants had a negative chlamydia NAAT by day 29 post-treatment. Following single-dose treatment for chlamydia, both pregnant and nonpregnant women should test negative with NAAT by 30 days post-treatment. Clinicians should collect a test-of-cure in pregnant women no earlier than 1 month. To avoid reinfection, women should avoid condomless intercourse for at least 1 month.

P09.26 Trends in gonorrhoea positivity by nucleic acid amplification testing versus culture in heterosexual men in victoria, australia, 2007–2014

Introduction A three-fold increase in Neisseria gonorrhoeae (gonorrhoea) notifications was reported amongst low prevalence women without a change in the proportion positive by culture, suggesting that screening for gonorrhoea by nucleic acid amplification test (NAAT) is not recommended in low prevalence populations due to low specificity of detection. This study aimed to identify whether there is a change in the rates of gonorrhoea positivity by culture in heterosexual men in Victoria, consistent with increased notifications. Methods Three data sources from 2007 to 2014 were used: notification data from the Victorian Department of Health, Medicare Item numbers for single and duplex chlamydia NAATs, and the proportion of new patients attending Melbourne Sexual Health Centre (MSHC) with gonorrhoea diagnosed by culture. Multivariate logistic regression analyses were used to examine the association between gonorrhoea positivity and known risk factors. Results Gonorrhoea notifications by NAAT in heterosexual men in Victoria increased from 38 in 2007 to 169 in 2014. There has been a five-fold increase in annual Medicare Items for chlamydia and a second NAAT, whilst only a modest increase in chlamydia only NAAT. A total of 28,014 heterosexual men attended MSHC for first consultation between 2007 and 2014, and the overall gonorrhoea positivity by culture at MSHC was 0.93% (n = 260). No significant trend in annual gonorrhoea positivity (aOR 1.04, 95% CI: 0.97–1.10, p = 0.270) was observed after adjusting for age, number of female sexual partners and condom use in the last three months, recent arrival in Australia, and previous sex overseas. Conclusion These data suggest gonorrhoea positivity in heterosexual men is stable, despite increasing notification rates. An increase in false positive results due to low specificity of gonorrhoea NAAT may explain the observed trend. Disclosure of interest statement This work was supported by the National Health and Medical Research Council (NHMRC) program grant APP1071269. No funding was received from pharmaceutical or biotechnology sectors.

O2 Who should have gonorrhoea cultures in addition to gonorrhoea and chlamydia nucleic acid amplification tests? Cost effectiveness study

BackgroundNucleic acid amplification tests (NAATs) can now detect chlamydia (CT) and gonorrhoea (GC) but cultures are needed in GC NAAT positive people prior to treatment. This necessitates re-evaluation, examination and...

Shortening the voiding interval for men having chlamydia nucleic acid amplification tests

Male patients are assessed for a sexually transmitted infection provided a considerable length of time has elapsed since last micturition. The current availability of highly sensitive nucleic acid amplification tests (NAATs) for Chlamydia trachomatis (CT) and Neisseria gonorrhoea such as APTIMA Combo2 (AC2) led us to investigate the impact of voiding interval on the positivity of urine tests for CT. Male patients attending a genitourinary medicine clinic at high clinical risk for CT infection and known CT positives returning for treatment were included. Two first-void urine (FVU) specimens were collected: the first sample in the standard manner and the second sample was collected 20 minutes later or as soon as possible thereafter. Fifty-two CT-positive males were included in the analysis. All of the second samples were also CT positive and none were in the equivocal range. Paired t-test analysis did not show a significant difference between relative light unit readings of the first and second urine samples (P = 0.127). Even in male patients who have recently passed urine, FVU tested by AC2 can still reliably detect CT. This provides us opportunity for more flexible and effective patient management.

Sexually transmitted diseases in incarcerated adolescents

The objectives of this review are to summarize recent developments in the epidemiology of sexually transmitted disease in incarcerated adolescents and to review screening and treatment recommendations for sexually transmitted disease in juvenile corrections facilities. The introduction of non-invasive, urine-based nucleic acid-amplification tests for chlamydia and gonorrhea has led to a dramatic increase in the ability to screen for chlamydia and gonorrhea in non-traditional settings, including corrections facilities. The prevalence of chlamydia and gonorrhea has been uniformly high in incarcerated adolescents. The prevalences of chlamydia and gonorrhea in adolescents aged 18-19 years incarcerated in adult corrections facilities were higher than those incarcerated in juvenile facilities. The prevalence was higher in incarcerated adolescent women than adolescent men and in black adolescents than non-black adolescents. Screening for chlamydia in incarcerated adolescents has been shown to be a cost-effective strategy for preventing adverse health consequences. Syphilis prevalence in incarcerated adolescents is relatively low. Hepatitis B is relatively common among incarcerated adolescents. The high prevalence of chlamydia in incarcerated adolescents and gonorrhea in incarcerated adolescent women suggests that screening of these populations should be a priority. The reasons for the higher prevalence of chlamydia and gonorrhea in young adults aged 18-19 years incarcerated in selected adult corrections facilities compared with those incarcerated in juvenile facilities should be investigated. Hepatitis B virus vaccination in juvenile correction facilities is recommended to prevent and control the transmission of this disease.

Performance of urine leukocyte esterase in asymptomatic male youth: Another look with nucleic acid amplification testing as the gold standard for Chlamydia detection

Purpose To re-evaluate the sensitivity and specificity of leukocyte esterase (LE) for screening adolescent and young adult males for Chlamydia trachomatis using a nucleic acid amplification test (NAAT) as the gold standard. Methods This study was conducted at two Massachusetts Department of Youth Services sites and one Job Corps site. Recently admitted asymptomatic sexually active male youth aged 14 to 25 years (mean 16.6 years) were recruited between January 2001 and July 2003 (N = 1008). Participants provided first part voided urine specimens for testing with LE and Chlamydia NAAT. The sensitivity, specificity, and positive and negative predictive value of urine LE for identification of Chlamydia infection were determined using NAAT as the gold standard. Results Fifty-seven (5.7%) participants were infected with Chlamydia as defined by a positive NAAT. Defining trace + as the LE cut point resulted in sensitivity and specificity of 57.9% and 78.3%, respectively. Defining 1+ as the cut point resulted in sensitivity and specificity of 47.4% and 96.1%, respectively. Conclusions Urine leukocyte esterase is a moderately sensitive method to screen for Chlamydia. Nevertheless, a substantial proportion of infections are not detected with LE screening. When feasible, urine NAAT provides a much more sensitive and equally noninvasive method of detecting Chlamydia. However, if LE is used as an initial screen followed by NAAT confirmation of LE positive samples, we recommend using trace LE as the cut point for positive results.