scholarly journals Molecular Testing for Mycoplasma genitalium in the United States: Results from the AMES Prospective Multicenter Clinical Study

2019 ◽  
Vol 57 (11) ◽  
Author(s):  
Charlotte A. Gaydos ◽  
Lisa E. Manhart ◽  
Stephanie N. Taylor ◽  
Rebecca A. Lillis ◽  
Edward W. Hook ◽  
...  
Keyword(s):  
United States ◽  
Clinical Study ◽  
Reference Method ◽  
Mycoplasma Genitalium ◽  
The United States ◽  
23S Rrna ◽  
Molecular Testing ◽  
Content Type ◽  
Vaginal Swabs ◽  
Multicenter Clinical Study

ABSTRACT A prospective multicenter clinical study involving subjects from 21 sites across the United States was conducted to validate the performance of a new in vitro diagnostic nucleic acid amplification test (NAAT) for the detection of Mycoplasma genitalium. Seven urogenital specimen types (n = 11,556) obtained from 1,778 females, aged 15 to 74 years, and 1,583 males, aged 16 to 82 years, were tested with the Aptima Mycoplasma genitalium assay, an investigational transcription-mediated amplification (TMA) NAAT for the detection of M. genitalium 16S rRNA. Infected status for enrolled subjects was established using results obtained from testing either self-collected vaginal swab or clinician-collected male urethral swab specimens with a composite reference method consisting of three transcription-mediated amplification NAATs targeting unique regions of M. genitalium 16S or 23S rRNA. M. genitalium prevalence was 10.2% in females and 10.6% in males; prevalence was high in both symptomatic and asymptomatic subjects for both sexes. Compared to the subject infected status standard, the investigational test had sensitivity and specificity estimates, respectively, of 98.9% and 98.5% for subject-collected vaginal swabs, 92.0% and 98.0% for clinician-collected vaginal swabs, 81.5% and 98.3% for endocervical swabs, 77.8% and 99.0% for female urine, and 98.2% and 99.6% for male urethral swabs, 88.4% and 97.8% for self-collected penile meatal swabs, and 90.9% and 99.4% for male urine specimens. For all seven specimen types, within-specimen positive and negative agreements between the investigational test and the composite reference standard ranged from 94.2% to 98.3% and from 98.5 to 99.9%, respectively. These results provide clinical efficacy evidence for the first FDA-cleared NAAT for M. genitalium detection in the United States.

scholarly journals Mycoplasma genitalium Prevalence, Coinfection, and Macrolide Antibiotic Resistance Frequency in a Multicenter Clinical Study Cohort in the United States

2016 ◽  
Vol 54 (9) ◽  
pp. 2278-2283 ◽  
Author(s):  
Damon Getman ◽  
Alice Jiang ◽  
Meghan O'Donnell ◽  
Seth Cohen
Keyword(s):  
United States ◽  
Antibiotic Resistance ◽  
Clinical Study ◽  
Macrolide Antibiotic ◽  
Mycoplasma Genitalium ◽  
The United States ◽  
Prevalence Rates ◽  
Content Type ◽  
Sexually Transmitted ◽  
Multicenter Clinical Study

The prevalence rates ofMycoplasma genitaliuminfections and coinfections with other sexually transmitted organisms and the frequency of a macrolide antibiotic resistance phenotype were determined in urogenital specimens collected from female and male subjects enrolled in a multicenter clinical study in the United States. Specimens from 946 subjects seeking care from seven geographically diverse clinical sites were tested forM. genitaliumand forChlamydia trachomatis,Neisseria gonorrhoeae, andTrichomonas vaginalis. Sequencing was used to assess macrolide antibiotic resistance amongM. genitalium-positive subjects.M. genitaliumprevalence rates were 16.1% for females and 17.2% for males. Significant risk factors forM. genitaliuminfections were black race, younger age, non-Hispanic ethnicity, and female symptomatic status. FemaleM. genitaliuminfections were significantly more prevalent thanC. trachomatisandN. gonorrhoeaeinfections, while theM. genitaliuminfection rate in males was significantly higher than theN. gonorrhoeaeandT. vaginalisinfection rates. The macrolide-resistant phenotype was found in 50.8% of females and 42% of males. These results show a high prevalence ofM. genitaliumsingle infections, a lower prevalence of coinfections with other sexually transmitted organisms, and high rates of macrolide antibiotic resistance in a diverse sample of subjects seeking care across a wide geographic area of the United States.

scholarly journals Mycoplasma genitalium Detection in Urogenital Specimens from Symptomatic and Asymptomatic Men and Women by Use of the cobas TV/MG Test

2020 ◽  
Vol 58 (6) ◽  
Author(s):  
Barbara Van Der Pol ◽  
Ken B. Waites ◽  
Li Xiao ◽  
Stephanie N. Taylor ◽  
Arundhati Rao ◽  
...  
Keyword(s):  
United States ◽  
Trichomonas Vaginalis ◽  
Mycoplasma Genitalium ◽  
The United States ◽  
Clinical Samples ◽  
Men And Women ◽  
Content Type ◽  
Sexually Transmitted ◽  
Asymptomatic Individuals ◽  
Asymptomatic Men

ABSTRACT Mycoplasma genitalium (MG) infections are a growing concern within the field of sexually transmitted infections. However, diagnostic assays for M. genitalium have been limited in the United States. As most infections are asymptomatic, individuals can unknowingly pass the infection on, and the prevalence is likely to be underestimated. Diagnosis of M. genitalium infection is recommended using a nucleic acid test. This multicenter study assessed the performance of the cobas Trichomonas vaginalis (TV)/MG assay (cobas) for the detection of M. genitalium, using 22,150 urogenital specimens from both symptomatic and asymptomatic men and women collected at geographically diverse sites across the United States. The performance was compared to a reference standard of three laboratory-developed tests (LDTs). The specificity of the cobas assay for M. genitalium ranged from 96.0% to 99.8% across symptomatic and asymptomatic men and women. The sensitivities in female vaginal swabs and urine samples were 96.6% (95% confidence interval [CI], 88.5 to 99.1%) and 86.4% (95% CI, 75.5 to 93.0%), respectively. The sensitivities in male urine and meatal swab samples were 100% (95% CI, 94.0 to 100%) and 85.0% (95% CI, 73.9 to 91.9%), respectively. This study demonstrated that the cobas assay was highly sensitive and specific in all relevant clinical samples for the detection of M. genitalium.

scholarly journals Mutations within therplDGene of Linezolid-Nonsusceptible Streptococcus pneumoniae Strains Isolated in the United States

2014 ◽  
Vol 58 (4) ◽  
pp. 2459-2462 ◽  
Author(s):  
W. Dong ◽  
S. Chochua ◽  
L. McGee ◽  
D. Jackson ◽  
K. P. Klugman ◽  
...  
Keyword(s):  
United States ◽  
Streptococcus Pneumoniae ◽  
Ribosomal Protein ◽  
Ribosomal Proteins ◽  
Structural Changes ◽  
Binding Pocket ◽  
The United States ◽  
Target Site ◽  
23S Rrna ◽  
Content Type

ABSTRACTThree invasiveStreptococcus pneumoniaestrains nonsusceptible to linezolid were isolated in the United States between 2001 and 2012 from the CDC's Active Bacterial Core surveillance. Linezolid binds ribosomal proteins where structural changes within its target site may confer resistance. Our study identified mutations and deletions near the linezolid binding pocket of two of these strains within therplDgene, which encodes ribosomal protein L4. Mutations in the 23S rRNA alleles or therplVgene were not detected.

scholarly journals Macrolide-Resistant Mycoplasma pneumoniae in the United States as Determined from a National Surveillance Program

2019 ◽  
Vol 57 (11) ◽  
Author(s):  
K. B. Waites ◽  
A. Ratliff ◽  
D. M. Crabb ◽  
L. Xiao ◽  
X. Qin ◽  
...  
Keyword(s):  
United States ◽  
Clinical Significance ◽  
Mycoplasma Pneumoniae ◽  
The United States ◽  
Antimicrobial Treatment ◽  
23S Rrna ◽  
Surveillance Program ◽  
National Surveillance ◽  
Radiographic Findings ◽  
Content Type

ABSTRACT There are sparse data to indicate the extent that macrolide-resistant Mycoplasma pneumoniae (MRMp) occurs in the United States or its clinical significance. Between 2015 and 2018, hospitals in 8 states collected and stored respiratory specimens that tested positive for M. pneumoniae and sent them to the University of Alabama at Birmingham, where real-time PCR was performed for detection of 23S rRNA mutations known to confer macrolide resistance. MRMp was detected in 27 of 360 specimens (7.5%). MRMp prevalence was significantly higher in the South and East (18.3%) than in the West (2.1%). A2063G was the predominant 23S rRNA mutation detected. MICs for macrolide-susceptible M. pneumoniae (MSMp) were ≤0.008 μg/ml, whereas MICs for MRMp were 16 to 32 μg/ml. Patients with MRMp infection were more likely to have a history of immunodeficiency or malignancy. Otherwise, there were no other significant differences in the clinical features between patients infected with MRMp and those infected with MSMp, nor were there any differences in radiographic findings, hospitalization rates, viral coinfections, the mean duration of antimicrobial treatment, or clinical outcomes. There was no significant change in MRMp incidence over time or according to age, sex, race/ethnicity, or status as an inpatient or an outpatient. Patients with MRMp were more likely to have received a macrolide prior to presentation, and their treatment was more likely to have been changed to a fluoroquinolone after presentation. This is the first national surveillance program for M. pneumoniae in the United States. Additional surveillance is needed to assess the clinical significance of MRMp and to monitor changes in MRMp prevalence.

scholarly journals Clinical Validation of the Aptima Bacterial Vaginosis and Aptima Candida/Trichomonas Vaginitis Assays: Results from a Prospective Multicenter Clinical Study

2019 ◽  
Vol 58 (2) ◽  
Author(s):  
Jane R. Schwebke ◽  
Stephanie N. Taylor ◽  
Ronald Ackerman ◽  
Robert Schlaberg ◽  
Neil B. Quigley ◽  
...  
Keyword(s):  
Clinical Study ◽  
Bacterial Vaginosis ◽  
Sensitivity And Specificity ◽  
Significant Proportion ◽  
The United States ◽  
Species Group ◽  
Diagnostic Methods ◽  
Content Type ◽  
Multicenter Clinical Study

ABSTRACT Infectious vaginitis due to bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), and Trichomonas vaginalis accounts for a significant proportion of all gynecologic visits in the United States. A prospective multicenter clinical study was conducted to validate the performance of two new in vitro diagnostic transcription-mediated amplification nucleic acid amplification tests (NAATs) for diagnosis of BV, VVC, and trichomoniasis. Patient- and clinician-collected vaginal-swab samples obtained from women with symptoms of vaginitis were tested with the Aptima BV and Aptima Candida/Trichomonas vaginitis (CV/TV) assays. The results were compared to Nugent (plus Amsel for intermediate Nugent) scores for BV, Candida cultures and DNA sequencing for VVC, and a composite of NAAT and culture for T. vaginalis. The prevalences of infection were similar for clinician- and patient-collected samples: 49% for BV, 29% for VVC due to the Candida species group, 4% for VVC due to Candida glabrata, and 10% for T. vaginalis. Sensitivity and specificity estimates for the investigational tests in clinician-collected samples were 95.0% and 89.6%, respectively, for BV; 91.7% and 94.9% for the Candida species group; 84.7% and 99.1% for C. glabrata; and 96.5% and 95.1% for T. vaginalis. Sensitivities and specificities were similar in patient-collected samples. In a secondary analysis, clinicians’ diagnoses, in-clinic assessments, and investigational-assay results were compared to gold standard reference methods. Overall, the investigational assays had higher sensitivity and specificity than clinicians’ diagnoses and in-clinic assessments, indicating that the investigational assays were more predictive of infection than traditional diagnostic methods. These results provide clinical-efficacy evidence for two in vitro diagnostic NAATs that can detect the main causes of vaginitis.

scholarly journals Genetic Diversity and Geographical Distribution of Indigenous Soybean-Nodulating Bradyrhizobia in the United States

2013 ◽  
Vol 79 (12) ◽  
pp. 3610-3618 ◽  
Author(s):  
Sokichi Shiro ◽  
Syota Matsuura ◽  
Rina Saiki ◽  
Gilbert C. Sigua ◽  
Akihiro Yamamoto ◽  
...  
Keyword(s):  
United States ◽  
Genetic Diversity ◽  
Community Structure ◽  
Geographical Distribution ◽  
The United States ◽  
23S Rrna ◽  
Rrna Gene ◽  
Scaling Analysis ◽  
Internal Transcribed Spacer Region ◽  
Content Type

ABSTRACTWe investigated the relationship between the genetic diversity of indigenous soybean-nodulating bradyrhizobia and their geographical distribution in the United States using nine soil isolates from eight states. The bradyrhizobia were inoculated on three soybeanRjgenotypes (non-Rj,Rj2Rj3, andRj4). We analyzed their genetic diversity and community structure by means of restriction fragment length polymorphisms of PCR amplicons to target the 16S-23S rRNA gene internal transcribed spacer region, using 11 USDABradyrhizobiumstrains as reference strains. We also performed diversity analysis, multidimensional scaling analysis based on the Bray-Curtis index, and polar ordination analysis to describe the structure and geographical distribution of the soybean-nodulating bradyrhizobial community. The major clusters wereBradyrhizobium japonicumBj123, in the northern United States, andBradyrhizobium elkanii, in the middle to southern regions. Dominance of bradyrhizobia in a community was generally larger for the cluster belonging toB. elkaniithan for the cluster belonging toB. japonicum. The indigenous American soybean-nodulating bradyrhizobial community structure was strongly correlated with latitude. Our results suggest that this community varies geographically.

scholarly journals Mycoplasma genitalium Macrolide and Fluoroquinolone Resistance Detection and Clinical Implications in a Selected Cohort in New Zealand

2017 ◽  
Vol 55 (11) ◽  
pp. 3242-3248 ◽  
Author(s):  
Trevor Anderson ◽  
Edward Coughlan ◽  
Anja Werno
Keyword(s):  
Antibiotic Resistance ◽  
New Zealand ◽  
Mutation Screening ◽  
Resistance Mutation ◽  
Mycoplasma Genitalium ◽  
Fluoroquinolone Resistance ◽  
23S Rrna ◽  
Molecular Testing ◽  
Rrna Gene ◽  
Content Type

ABSTRACTMycoplasma genitaliumhas been associated with infections of the genitourinary tract, and prevalence is secondary toChlamydia trachomatis. The clinical observation of increasing treatment failure indicating antibiotic resistance, especially in cases of recurrent urethritis, has been confirmed by molecular testing. Mutations in the 23S rRNA gene can cause macrolide resistance, and topoisomerase/gyrase mutations can cause fluoroquinolone resistance. In this study, 115M. genitaliumDNA-positive samples were analyzed. Eighty-nine (77.4%) samples had a 23S rRNA mutation present, and 26 (22.6%) were wild type (no resistance mutation). Fluoroquinolone mutation screening was performed on 86 (74.8%) of the 115 samples, of which 20 (23.3%) samples had a mutation or mutations associated with increased resistance. This study shows the increasing antibiotic resistance in New Zealand and the need for appropriate guidelines to treat at-risk patients.

scholarly journals Characteristics of Mycoplasma genitalium Urogenital Infections in a Diverse Patient Sample from the United States: Results from the Aptima Mycoplasma genitalium Evaluation Study (AMES)

2020 ◽  
Vol 58 (7) ◽  
Author(s):  
Lisa E. Manhart ◽  
Charlotte A. Gaydos ◽  
Stephanie N. Taylor ◽  
Rebecca A. Lillis ◽  
Edward W. Hook ◽  
...  
Keyword(s):  
United States ◽  
Mycoplasma Genitalium ◽  
Evaluation Study ◽  
The United States ◽  
Nucleic Acid Amplification ◽  
Content Type ◽  
Urogenital Infections ◽  
Asymptomatic Individuals ◽  
Urogenital Symptoms

ABSTRACT Data from a large prospective multicenter clinical validation study of a nucleic acid amplification in vitro diagnostic test for Mycoplasma genitalium were analyzed to describe the prevalence of M. genitalium infection, risk factors, and disease associations in female and male patients seeking care in diverse geographic regions of the United States. Among 1,737 female and 1,563 male participants, the overall prevalence of M. genitalium infection was 10.3% and was significantly higher in persons ages 15 to 24 years than in persons ages 35 to 39 years (for females, 19.8% versus 4.7% [odds ratio {OR} = 5.05; 95% confidence interval {CI} = 3.01 to 8.46]; for males, 16.5% versus 9.4% [OR = 1.91; 95% CI = 1.20 to 3.02]). The risk for M. genitalium infection was higher in black than in white participants (for females, 12.0% versus 6.8% [OR = 1.88; 95% CI = 1.30 to 2.72]; for males, 12.9% versus 6.9% [OR = 2.02; 95% CI = 1.38 to 2.96]) and higher in non-Hispanic than in Hispanic participants (for females, 11.2% versus 6.0% [OR = 1.97; 95% CI = 1.25 to 3.10]; for males, 11.6% versus 6.8% [OR = 1.80; 95% CI = 1.14 to 2.85]). Participants reporting urogenital symptoms had a significantly elevated risk of M. genitalium infection compared to that for asymptomatic individuals (for females, OR = 1.53 [95% CI = 1.09 to 2.14]; for males, OR = 1.42 [95% CI = 1.02 to 1.99]). Women diagnosed with vaginitis and cervicitis had a higher prevalence of M. genitalium infection than women without those diagnoses, although this was statistically significant only for vaginitis (for vaginitis, OR = 1.88 [95% CI = 1.37 to 2.58]; for cervicitis, OR = 1.42 [95% CI = 0.61 to 2.96]). A diagnosis of urethritis in men was also significantly associated with M. genitalium infection (OR = 2.97; 95% CI = 2.14 to 4.13). Few characteristics distinguished asymptomatic from symptomatic M. genitalium infections. These results from persons seeking care in the United States suggest that M. genitalium infection should be considered in young persons presenting with urogenital symptoms.

scholarly journals Five-Year Summary of In Vitro Activity and Resistance Mechanisms of Linezolid against Clinically Important Gram-Positive Cocci in the United States from the LEADER Surveillance Program (2011 to 2015)

2017 ◽  
Vol 61 (7) ◽  
Author(s):  
Michael A. Pfaller ◽  
Rodrigo E. Mendes ◽  
Jennifer M. Streit ◽  
Patricia A. Hogan ◽  
Robert K. Flamm
Keyword(s):  
United States ◽  
Staphylococcus Aureus ◽  
The United States ◽  
Resistance Mechanisms ◽  
23S Rrna ◽  
Rrna Gene ◽  
Gram Positive ◽  
Content Type ◽  
Linezolid Resistance

ABSTRACT This report describes linezolid susceptibility testing results for 6,741 Gram-positive pathogens from 60 U.S. sites collected during 2015 for the LEADER Program. In addition, the report summarizes linezolid in vitro activity, resistance mechanisms, and molecular typing obtained for 2011 to 2015. During 2015, linezolid showed potent activity in testing against Staphylococcus aureus, inhibiting >99.9% of 3,031 isolates at ≤2 µg/ml. Similarly, linezolid showed coverage against 99.2% of coagulase-negative staphylococci, 99.7% of enterococci, and 100.0% of Streptococcus pneumoniae, virdans group, and beta-hemolytic streptococcus isolates tested. The overall linezolid resistance rate remained a modest <1% from 2011 to 2015. Staphylococci, especially Staphylococcus epidermidis, showed a range of linezolid resistance mechanisms. Increased annual trends for the presence of cfr among Staphylococcus aureus isolates were not observed, but 64.3% (9/14) of the isolates with decreased susceptibility (MIC, ≥4 µg/ml) to linezolid carried this transferrable gene (2011 to 2015). The cfr gene was detected in 21.9% (7/32) of linezolid-resistant staphylococci other than S. aureus from 2011 to 2015. The optrA gene was noted in half (2/4) of the population of linezolid-nonsusceptible Enterococcus faecalis isolates from 2011 to 2015, while linezolid-nonsusceptible Enterococcus faecium isolates showed alterations predominantly (16/16) in the 23S rRNA gene (G2576T). This report confirms a long record of linezolid activity against Gram-positive isolates in the United States since regulatory approval in 2000 and reports the oxazolidinones evolving resistance mechanisms.

scholarly journals Detection of a Newcfr-Like Gene,cfr(B), in Enterococcus faecium Isolates Recovered from Human Specimens in the United States as Part of the SENTRY Antimicrobial Surveillance Program

2015 ◽  
Vol 59 (10) ◽  
pp. 6256-6261 ◽  
Author(s):  
Lalitagauri M. Deshpande ◽  
Deborah S. Ashcraft ◽  
Heather P. Kahn ◽  
George Pankey ◽  
Ronald N. Jones ◽  
...  
Keyword(s):  
United States ◽  
Enterococcus Faecium ◽  
Ribosomal Proteins ◽  
Medical Center ◽  
The United States ◽  
Gene Location ◽  
Rrna Genes ◽  
23S Rrna ◽  
Surveillance Program ◽  
Content Type

ABSTRACTTwo linezolid-resistantEnterococcus faeciumisolates (MICs, 8 μg/ml) from unique patients of a medical center in New Orleans were included in this study. Isolates were initially investigated for the presence of mutations in the V domain of 23S rRNA genes and L3, L4, and L22 ribosomal proteins, as well ascfr. Isolates were subjected to pulsed-field gel electrophoresis (just one band difference), and one representative strain was submitted to whole-genome sequencing. Gene location was also determined by hybridization, andcfrgenes were cloned and expressed in aStaphylococcus aureusbackground. The two isolates had one out of six 23S rRNA alleles mutated (G2576T), had wild-type L3, L4, and L22 sequences, and were positive for acfr-like gene. The sequence of the protein encoded by thecfr-like gene was most similar (99.7%) to that found inPeptoclostridium difficile, which shared only 74.9% amino acid identity with the proteins encoded by genes previously identified in staphylococci and non-faeciumenterococci and was, therefore, denominated Cfr(B). When expressed inS. aureus, the protein conferred a resistance profile similar to that of Cfr. Two copies ofcfr(B) were chromosomally located and embedded in a Tn6218similar to thecfr-carrying transposon described inP. difficile.This study reports the first detection ofcfrgenes inE. faeciumclinical isolates in the United States and characterization of a newcfrvariant,cfr(B).cfr(B) has been observed in mobile genetic elements inE. faeciumandP. difficile, suggesting potential for dissemination. However, further analysis is necessary to access the resistance levels conferred bycfr(B) when expressed in enterococci.

Sign in / Sign up

Export Citation Format

Share Document