scholarly journals The “3 in 1” Study: Pooling Self-Taken Pharyngeal, Urethral, and Rectal Samples into a Single Sample for Analysis for Detection of Neisseria gonorrhoeae and Chlamydia trachomatis in Men Who Have Sex with Men

2015 ◽  
Vol 54 (3) ◽  
pp. 650-656 ◽  
Author(s):  
B. Sultan ◽  
J. A. White ◽  
R. Fish ◽  
G. Carrick ◽  
N. Brima ◽  
...  
Keyword(s):  
Chlamydia Trachomatis ◽  
Neisseria Gonorrhoeae ◽  
Standard Of Care ◽  
Nucleic Acid Amplification ◽  
Site Testing ◽  
Predictive Values ◽  
Content Type ◽  
Sexually Transmitted ◽  
Soc Testing ◽  
Sex With Men

Triple-site testing (using pharyngeal, rectal, and urethral/first-void urine samples) forNeisseria gonorrhoeaeandChlamydia trachomatisusing nucleic acid amplification tests detects greater numbers of infections among men who have sex with men (MSM). However, triple-site testing represents a cost pressure for services. MSM over 18 years of age were eligible if they requested testing for sexually transmitted infections (STIs), reported recent sexual contact with eitherC. trachomatisorN. gonorrhoeae, or had symptoms of an STI. Each patient underwent standard-of-care (SOC) triple-site testing, and swabs were taken to form a pooled sample (PS) (pharyngeal, rectal, and urine specimens). The PS was created using two methods during different periods at one clinic, but we analyzed the data in combination because the sensitivity of the two methods did not differ significantly forC. trachomatis(P= 0.774) orN. gonorrhoeae(P= 0.163). The sensitivity of PS testing (92%) was slightly lower than that of SOC testing (96%) for detectingC. trachomatis(P= 0.167). ForN. gonorrhoeae, the sensitivity of PS testing (90%) was significantly lower than that of SOC testing (99%) (P< 0.001). When pharynx-only infections were excluded, the sensitivity of PS testing to detectN. gonorrhoeaeinfections increased to 94%. Our findings show that pooling of self-taken samples could be an effective and cost-saving method, with high negative predictive values. (Interim results of this study were presented at the BASHH 2013 summer meeting.)

scholarly journals Pooling Pharyngeal, Anorectal, and Urogenital Samples for Screening Asymptomatic Men Who Have Sex with Men for Chlamydia trachomatis and Neisseria gonorrhoeae

2020 ◽  
Vol 58 (5) ◽  
Author(s):  
Duygu Durukan ◽  
Tim R. H. Read ◽  
Catriona S. Bradshaw ◽  
Christopher K. Fairley ◽  
Deborah A. Williamson ◽  
...  
Keyword(s):  
Chlamydia Trachomatis ◽  
Neisseria Gonorrhoeae ◽  
Nucleic Acid Amplification ◽  
Urine Specimen ◽  
Site Testing ◽  
Content Type ◽  
Individual Site ◽  
Sex With Men ◽  
Pooled Samples ◽  
Pooled Sample

ABSTRACT Screening for Chlamydia trachomatis and Neisseria gonorrhoeae at the pharyngeal, urogenital, and anorectal sites is recommended for men who have sex with men (MSM). Combining the three individual-site samples into a single pooled sample could result in significant cost savings, provided there is no significant sensitivity reduction. The aim of this study was to examine the sensitivity of pooled samples for detecting chlamydia and gonorrhea in asymptomatic MSM using a nucleic acid amplification test. Asymptomatic MSM who tested positive for chlamydia or gonorrhoea were invited to participate. Paired samples were obtained from participants prior to administration of treatment. To form the pooled sample, the anorectal swab was agitated in the urine specimen transport tube and then discarded. The pharyngeal swab and 2 ml of urine sample were then added to the tube. The difference in sensitivity between testing of pooled samples and individual-site testing was calculated against an expanded gold standard, where an individual is considered positive if either pooled-sample or individual-site testing returns a positive result. All samples were tested using the Aptima Combo 2 assay. A total of 162 MSM were enrolled in the study. Sensitivities of pooled-sample testing were 86% (94/109; 95% confidence interval [CI], 79 to 92%]) for chlamydia and 91% (73/80; 95% CI, 83 to 96%) for gonorrhea. The sensitivity reduction was significant for chlamydia (P = 0.02) but not for gonorrhea (P = 0.34). Pooling caused 22 infections (15 chlamydia and 7 gonorrhoea) to be missed, and the majority were single-site infections (19/22). Pooling urogenital and extragenital samples from asymptomatic MSM reduced the sensitivity of detection by approximately 10% for chlamydia but not for gonorrhea.

Modified self-obtained pooled sampling to screen for Chlamydia trachomatis and Neisseria gonorrhoeae infections in men who have sex with men

2020 ◽  
pp. sextrans-2020-054666
Author(s):  
Naokatsu Ando ◽  
Daisuke Mizushima ◽  
Koji Watanabe ◽  
Misao Takano ◽  
Daisuke Shiojiri ◽  
...  
Keyword(s):  
Chlamydia Trachomatis ◽  
Neisseria Gonorrhoeae ◽  
Single Site ◽  
Nucleic Acid Amplification ◽  
Site Testing ◽  
Potential Alternative ◽  
Sample Testing ◽  
Sex With Men ◽  
High Consistency ◽  
Pooled Sample

ObjectivesTo assess whether pooled sample testing with nucleic acid amplification tests was a potential alternative to three single-site sample testing to screen for Chlamydia trachomatis and Neisseria gonorrhoeae infections in asymptomatic men who have sex with men.MethodsWe prospectively compared pooled sample testing with single-site sample testing in asymptomatic MSM. Self-obtained paired rectal samples, one gargle sample and one first-void urine sample were collected from participants to generate two sets of samples: one for pooled sample testing and the other for single-site testing. We used modified pooled sampling, which is defined as the use of gargle samples, instead of swabs, for the pooled sample to test for pharyngeal infection.ResultsThis study included 513 MSM. The positive rates of C. trachomatis and N. gonorrhoeae were 20.3% and 11.7%, respectively, for single-site sample testing. Compared with the sensitivity of single-site testing as the gold standard, the sensitivities of pooled sample testing for C. trachomatis and N. gonorrhoeae were 94.2% (95% CI 88.0% to 97.3%) and 98.3% (95% CI 90.9% to 99.9%), respectively. The concordance rate and kappa coefficient were 98.3% (95% CI 96.7% to 99.2%) and 0.945 (95% CI 0.859 to 1.000), respectively, for C. trachomatis and 98.8% (95% CI 90.1% to 100%) and 0.943 (95% CI 0.857 to 1.000), respectively, for N. gonorrhoeae.ConclusionsThe modified pooled sampling had a comparably high consistency with single-site sample testing. The results strongly suggest that the gargle sample is suitable as a part of pooled sample for STI screening of C. trachomatis and N. gonorrhoeae.

scholarly journals In Vitro Activity of Lefamulin against Sexually Transmitted Bacterial Pathogens

2018 ◽  
Vol 62 (5) ◽  
Author(s):  
Susanne Paukner ◽  
Astrid Gruss ◽  
Jørgen Skov Jensen
Keyword(s):  
Chlamydia Trachomatis ◽  
Bacterial Pathogens ◽  
Mycoplasma Genitalium ◽  
Standard Of Care ◽  
Multidrug Resistant ◽  
In Vitro Activity ◽  
First Line ◽  
Content Type ◽  
Sexually Transmitted

ABSTRACT The pleuromutilin antibiotic lefamulin demonstrated in vitro activity against the most relevant bacterial pathogens causing sexually transmitted infections (STI), including Chlamydia trachomatis (MIC 50/90 , 0.02/0.04 mg/liter; n = 15), susceptible and multidrug-resistant Mycoplasma genitalium (MIC range, 0.002 to 0.063 mg/liter; n = 6), and susceptible and resistant Neisseria gonorrhoeae (MIC 50/90 , 0.12/0.5 mg/liter; n = 25). The results suggest that lefamulin could be a promising first-line antibiotic for the treatment of STI, particularly in populations with high rates of resistance to standard-of-care antibiotics.

scholarly journals Simultaneous Evaluation of Diagnostic Assays for Pharyngeal and Rectal Neisseria gonorrhoeae and Chlamydia trachomatis Using a Master Protocol

2019 ◽  
Author(s):  
Sarah B Doernberg ◽  
Lauren Komarow ◽  
Thuy Tien T Tran ◽  
Zoe Sund ◽  
Mark W Pandori ◽  
...  
Keyword(s):  
Chlamydia Trachomatis ◽  
Neisseria Gonorrhoeae ◽  
Reference Method ◽  
Likelihood Ratios ◽  
Anatomic Site ◽  
Transmitted Infection ◽  
Cross Sectional ◽  
Predictive Values ◽  
Sexually Transmitted ◽  
Percent Agreement

Abstract Background Pharyngeal and rectal Neisseria gonorrhoeae and Chlamydia trachomatis play important roles in infection and antibacterial resistance transmission, but no US Food and Drug Administration (FDA)–cleared assays for detection at these sites existed prior to this study. The objective was to estimate performance of assays to detect those infections in pharyngeal and rectal specimens to support regulatory submission. Methods We performed a cross-sectional, single-visit study of adults seeking sexually transmitted infection testing at 9 clinics in 7 states. We collected pharyngeal and rectal swabs from participants. The primary outcome was positive and negative percent agreement for detection of N. gonorrhoeae and C. trachomatis for 3 investigational assays compared to a composite reference. Secondary outcomes included positivity as well as positive and negative predictive values and likelihood ratios. Subgroup analyses included outcomes by symptom status and sex. Results A total of 2598 participants (79% male) underwent testing. We observed N. gonorrhoeae positivity of 8.1% in the pharynx and 7.9% in the rectum and C. trachomatis positivity of 2.0% in the pharynx and 8.7% in the rectum. Positive percent agreement ranged from 84.8% to 96.5% for different anatomic site infection combinations, whereas negative percent agreement was 98.8% to 99.6%. Conclusions This study utilized a Master Protocol to generate diagnostic performance data for multiple assays from different manufacturers in a single study population, which ultimately supported first-in-class FDA clearance for extragenital assays. We observed very good positive percent agreement when compared to a composite reference method for the detection of both pharyngeal and rectal N. gonorrhoeae and C. trachomatis. Clinical Trials Registration NCT02870101.

scholarly journals Screening for Chlamydia trachomatis and Neisseria gonorrhoeae infection among asymptomatic men who have sex with men in Bangkok, Thailand

2017 ◽  
Vol 29 (6) ◽  
pp. 577-587 ◽  
Author(s):  
Sarika Pattanasin ◽  
Eileen F Dunne ◽  
Punneeporn Wasinrapee ◽  
Jaray Tongtoyai ◽  
Wannee Chonwattana ◽  
...  
Keyword(s):  
Cohort Study ◽  
Nucleic Acid ◽  
Chlamydia Trachomatis ◽  
Neisseria Gonorrhoeae ◽  
Nucleic Acid Amplification ◽  
Anatomic Site ◽  
Number Needed To Screen ◽  
Sex With Men ◽  
Study Participants ◽  
Asymptomatic Men

We report positivity rates of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infection at each anatomic site among asymptomatic men who have sex with men (MSM). We calculated the number needed to screen (NNS) to detect CT and NG infection at each anatomic site. From 2006 to 2010, we enrolled Thai MSM, age ≥ 18 years into the Bangkok MSM Cohort Study. Participants underwent physical examination and had rectal, urethral, and pharyngeal screening for CT and NG infection using nucleic acid amplification tests (NAATs). Of 1744 enrollees, 1696 (97.2%) had no symptoms of CT and NG infection. The positivity rates of CT and NG infection at any site were 14.3% (rectum, urethra, pharynx) and 6.4% (rectum, urethra), respectively. The NNS to detect rectal CT and rectal NG infections was 10 and 16, respectively (p < 0.05). For urethral infection, the NNS of CT was lower than the NNS of NG (22, 121: p < 0.05). The lowest NNS found for rectal CT infection was in HIV-infected MSM (6, 5–8). Asymptomatic CT and NG infection were common among MSM in Bangkok, Thailand and frequently detected in the rectum. In setting where screening in all specimens using NAAT is not feasible, rectal screening should be a priority.

scholarly journals Overdiagnosis of Urinary Tract Infection and Underdiagnosis of Sexually Transmitted Infection in Adult Women Presenting to an Emergency Department

2015 ◽  
Vol 53 (8) ◽  
pp. 2686-2692 ◽  
Author(s):  
Myreen E. Tomas ◽  
Damon Getman ◽  
Curtis J. Donskey ◽  
Michelle T. Hecker
Keyword(s):  
Urinary Tract ◽  
Urine Culture ◽  
Routine Care ◽  
Nucleic Acid Amplification ◽  
Adult Women ◽  
Predictive Values ◽  
Content Type ◽  
Sexually Transmitted ◽  
Positive Urine ◽  
Tract Infections

Urinary tract infections (UTIs) and sexually transmitted infections (STIs) are commonly diagnosed in emergency departments (EDs). Distinguishing between these syndromes can be challenging because of overlapping symptomatology and because both are associated with abnormalities on urinalysis (UA). We conducted a 2-month observational cohort study to determine the accuracy of clinical diagnoses of UTI and STI in adult women presenting with genitourinary (GU) symptoms or diagnosed with GU infections at an urban academic ED. For all urine specimens, UA, culture, and nucleic acid amplification testing for Neisseria gonorrhoeae , Chlamydia trachomatis , and Trichomonas vaginalis were performed. Of 264 women studied, providers diagnosed 175 (66%) with UTIs, 100 (57%) of whom were treated without performing a urine culture during routine care. Combining routine care and study-performed urine cultures, only 84 (48%) of these women had a positive urine culture. Sixty (23%) of the 264 women studied had one or more positive STI tests, 22 (37%) of whom did not receive treatment for an STI within 7 days of the ED visit. Fourteen (64%) of these 22 women were diagnosed with a UTI instead of an STI. Ninety-two percent of the women studied had an abnormal UA finding (greater-than-trace leukocyte esterase level, positive nitrite test result, or pyuria). The positive and negative predictive values of an abnormal UA finding were 41 and 76%, respectively. In this population, empirical therapy for UTI without urine culture testing and overdiagnosis of UTI were common and associated with unnecessary antibiotic exposure and missed STI diagnoses. Abnormal UA findings were common and not predictive of positive urine cultures.

scholarly journals A pilot study to determine Neisseria gonorrhoeae–Chlamydia trachomatis coinfection rates in symptomatic patients attending STI Clinics, New Delhi, India

2021 ◽  
Vol 0 ◽  
pp. 1-5
Author(s):  
Anjana Aravinda ◽  
Seema Sood ◽  
Rama Chaudhry ◽  
Arti Kapil ◽  
Prafulla K Sharma ◽  
...  
Keyword(s):  
Chlamydia Trachomatis ◽  
Neisseria Gonorrhoeae ◽  
Treatment Guidelines ◽  
Tertiary Care ◽  
Nucleic Acid Amplification ◽  
New Delhi ◽  
Sexually Transmitted ◽  
Male Patients ◽  
A Prospective Study ◽  
Tertiary Care Hospitals

Background: Neisseria gonorrhoeae and Chlamydia trachomatis are the two most prevalent bacterial sexually transmitted infections. For over two decades, treatment guidelines have recommended empirical co-treatment for N.gonorrhoeae and C.trachomatis as symptoms overlap and co-infection is common. Studies from India estimating the same are limited and mostly based on conventional techniques. Aim and Objective: The aim of this study was to determine the frequency of N.gonorrhoeae and C.trachomatis coinfection using nucleic acid amplification tests. Further, we assessed the utility of pus cell estimation in Gram stained smears as a screening tool for inclusion of samples for molecular diagnosis. Methods: This was a prospective study conducted at two tertiary care hospitals; 100 patients (55 females and 45 males) with genitourinary discharge attending STI clinics were recruited, and endocervical or urethral swabs were collected. PCRs for N.gonorrhoeae and C.trachomatis were put up. In addition, microscopy and culture for gonococcus was performed followed by antimicrobial susceptibility testing. Statistical analysis was performed using the SPSS 16 software. Results: N.gonorrhoeae infection was more common than C.trachomatis. A total of 14 patients were positive by PCR (9 males and 5 females) for gonococcus. However, culture was positive only in 8 male patients. PCR for C.trachomatis was positive in 9 (4 males and 5 females) and the co-infection rate was 5%. The sensitivity and negative predictive value of pus cell estimation was 100% for males and 64% and 94.6% respectively for females. All isolates were susceptible to extended spectrum cephalosporins and azithromycin. Limitation: The sample size of the study was small. Conclusion: Frequency of N.gonorrhoeae/C.trachomatis coinfection in symptomatic STI patients is low. Coinfection is considerably overestimated and necessary confirmation of etiological diagnosis could reduce widespread empirical administration of broad-spectrum antibiotics.

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