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Journal of Clinical Microbiology Jun 2024A laboratory-developed test (LDT) using analyte-specific reagents has been optimized on a commercial platform to detect macrolide resistance-associated mutations (MRM)...
UNLABELLED
A laboratory-developed test (LDT) using analyte-specific reagents has been optimized on a commercial platform to detect macrolide resistance-associated mutations (MRM) in 23S rRNA from from primary clinical specimens. In this study, MRM-LDT was applied to a multi-specimen source study set. One thousand four hundred ninety-five primary specimens testing positive for by commercial transcription-mediated amplification (TMA) were initially titered by the TMA assay using serial 10-fold dilutions to semi-quantitate target nucleic acid burden. Primary specimens were then processed for MRM detection using the MRM-LDT. Findings were stratified by gender and specimen source. The mean log target nucleic acid titer of a TMA-positive specimen was 3.51 (median 3; range 0-10). Male specimens ( = 1145) demonstrated a mean log TMA titer of 3.67; that value observed in 350 female specimens was 2.98 ( < 0.0001). The MRM-LDT detection rate (88.7%) from specimens with log TMA titers ≥ 4 was increased over specimens with log titers ≤ 1 (4.5%; < 0.0002). In females, MRM-LDT was positive from 51.3% of vaginal swab and 34.7% of urine specimens ( = 0.01). In males, MRM-LDT was positive from 65.0% of rectal swab and 55.7% of urine specimens ( = 0.002). Differences were also observed in log TMA titers as a function of specimen source. macrolide resistance rates among multiple specimen sources, as determined by MRM-LDT, are high in the United States and can be consistent with target nucleic acid burden within the primary specimen. Caveats experienced within subgroupings support MRM reflex testing on primary -positive specimens.
IMPORTANCE
First-line macrolide treatment failure is of increasing concern with in multiple settings. Recent sexually-transmitted infection treatment guidelines from the United States Centers for Disease Control and Prevention have predicated therapeutic approaches on the availability of a macrolide resistance/susceptibility result from a primary clinical specimen. In this report, we investigate potential correlation between macrolide resistance mutation detection rates (identified by a molecular amplified laboratory-developed test) and transcription-mediated amplification-based rRNA target semi-quantitation. Data reveal that rRNA semi-quantitation and laboratory-developed test detection rate differences exist as a function of gender and specimen source. These data can guide providers in proper specimen selection not only for the laboratory diagnosis of but also macrolide resistance mutation determination from primary clinical specimens.
Topics: Humans; Female; Male; Macrolides; RNA, Ribosomal, 23S; Drug Resistance, Bacterial; Sex Factors; Anti-Bacterial Agents; Mycoplasma genitalium; Molecular Diagnostic Techniques; Mutation
PubMed: 38785449
DOI: 10.1128/jcm.00485-24 -
Journal of Microbiology, Immunology,... May 2024Mycoplasma genitalium is an emerging etiology of sexually transmitted infections (STIs) with increasing resistance to antimicrobials. Surveillance on the epidemiology of...
BACKGROUND
Mycoplasma genitalium is an emerging etiology of sexually transmitted infections (STIs) with increasing resistance to antimicrobials. Surveillance on the epidemiology of M. genitalium infection and antimicrobial resistance is warranted.
METHODS
Between September 2021 and August 2023, people with HIV (PWH) and people without HIV (PWoH) at risk of STIs were screened for M. genitalium infection using a multiplex polymerase-chain-reaction assay of specimens collected from the rectum, urethra, oral cavity, and vagina. The prevalences of resistance-associated mutations (RAMs) of M. genitalium to fluoroquinolones, macrolides, and tetracycline were investigated.
RESULTS
During the 2-year study period, 1021 participants were enrolled, including 531 PWH and 490 PWoH. Overall, 83 (8.1%) and 34 (7.6%) participants had M. genitalium infection at baseline and during follow-up, respectively, with the rectum being the most common site of detection (61.5%). With the first course of antimicrobial treatment, 27 of 63 (42.9%) participants with M. genitalium infection were cured during follow-up, including 24 of 58 (41.4%) who received doxycycline monotherapy. The prevalence of RAMs to macrolides, fluoroquinolones, and tetracyclines at baseline were 24.3%, 22.4%, and 7.9%, respectively. Though PWH had more M. genitalium infection (10.2% vs 5.9%, p = 0.01), a higher rate of RAMs to macrolides (41.0% vs 14.7%, p < 0.01) was found in PWoH.
CONCLUSIONS
Among high-risk populations, the prevalence of M. genitalium infection was 8.1%. The overall genotypic resistance of M. genitalium to macrolides and fluoroquinolones was moderately high in Taiwan. Detection of M. genitalium infection and antimicrobial resistance is warranted to ensure resistance-guided antimicrobial treatments to be administered.
PubMed: 38777653
DOI: 10.1016/j.jmii.2024.05.004 -
Journal of Women's Health (2002) Jun 2024Sexually transmitted infections (STIs) continue to increase in the United States with more than 2.5 million cases of gonorrhea, chlamydia, and syphilis reported to the... (Review)
Review
Sexually transmitted infections (STIs) continue to increase in the United States with more than 2.5 million cases of gonorrhea, chlamydia, and syphilis reported to the Centers for Disease Control and Prevention in 2022. Untreated STIs in women can lead to adverse outcomes, including pelvic inflammatory disease, infertility, chronic pelvic pain, and pregnancy complications such as ectopic pregnancy, early pregnancy loss, stillbirth, and neonatal transmission. STI-related guidelines can be complex and are frequently updated, making it challenging to stay informed on current guidance. This article provides high-yield updates to support clinicians managing STIs by highlighting changes in screening, diagnosis, and treatment. One important topic includes new guidance on syphilis screening, including a clarified description of high community rates of syphilis based on Healthy People 2030 goals, defined as a case rate of primary or secondary syphilis > 4.6 per 100,000. Reproductive aged persons living in counties above this threshold should be offered syphilis screening. Additionally, American College of Obstetricians & Gynecologists now recommends syphilis screening three times during pregnancy regardless of risk-at the first prenatal visit, during the third trimester, and at delivery. In addition, new guidance to support consideration for extragenital screening for gonorrhea and chlamydia in women at sites such as the anus and pharynx is discussed. Other topics include the most recent chlamydia, gonorrhea, trichomoniasis, and pelvic inflammatory disease treatment recommendations; screening and treatment guidance for ; genital herpes screening indications and current diagnostic challenges; and the diagnosis and management of mpox in women and during pregnancy.
Topics: Humans; Female; Sexually Transmitted Diseases; Pregnancy; United States; Syphilis; Pregnancy Complications, Infectious; Mass Screening; Chlamydia Infections; Gonorrhea; Practice Guidelines as Topic; Adult
PubMed: 38770770
DOI: 10.1089/jwh.2024.0367 -
Ginekologia Polska May 2024Genitourinary tract infections in pregnant women are one of the causes of abnormal pregnancy development including miscarriages, premature labor or premature rupture of...
OBJECTIVES
Genitourinary tract infections in pregnant women are one of the causes of abnormal pregnancy development including miscarriages, premature labor or premature rupture of membranes (PPROM). Atypical bacteria responsible for reproductive tract infections include Mycoplasma genitalium, Mycoplasma hominis, Ureaplasma urealyticum and Ureaplasma parvum. Identification of pathogens and appropriately selected therapy can improve obstetric outcomes in patients with symptoms of threatened miscarriage or threatened preterm labor. The purpose of our study is to analyze the impact of reproductive tract infections with ureaplasma and mycoplasma bacteria during pregnancy.
MATERIAL AND METHODS
In the presented study, we retrospectively analyzed the cases of 201 pregnant patients hospitalized in the Obstetrics and Gynecology Department of Poznan Regional Hospital in 2019-2022, who had a swab taken from external os area of the cervix for atypical bacteria - Ureaplasma and Mycoplasma. Only patients with symptoms of threatened miscarriage or threatened preterm labor were included in the study group. Microbiological tests were performed in the hospital laboratory with the Mycoplasma IST 3 test from Biomerieux.
RESULTS
We found a higher incidence of preterm labor in patients with symptoms of threatened preterm labor and a genital tract infection with Ureaplasma/Mycoplasma bacteria, compared to patients not infected with Mycoplasma/Ureaplasma - 31.1% vs 20% (p = 0.098). This observation in the case of Ureaplasma/Mycoplasma monoinfection group applied to 6 patients. - 75% of the group. Pregnant patients who had co-infection with other types of bacteria (48 patients in total) gave birth before 37 weeks of pregnancy in 27.1% of cases. We obtained a significant difference (p = 0.007) when comparing groups with positive and negative cultures for Ureaplasma/Mycoplasma by the presence of monoinfection/coinfection and the week of pregnancy in which delivery occurred. We also noted the effect of atypical bacterial infection for PPROM - this complication preceded preterm delivery in 40% of ureaplasma-positive patients, compared to 20% of PPROM without infection. We found a similar rate of preterm labor and pregnancy loss in Ureaplasma/Mycoplasma-positive patients who received antibiotic therapy (35.7%) compared to a group of pregnant women who did not receive treatment (31.6%).
CONCLUSIONS
Infection of the genital tract with atypical bacteria Ureaplasma and Mycoplasma has a negative impact on the course of pregnancy. Identification of the type of microorganisms in cervical canal secretions of pregnant patients with symptoms of threatened miscarriage or preterm labor seems crucial. The impact of antibiotic therapy though, requires further analysis.
PubMed: 38717222
DOI: 10.5603/gpl.99827 -
Scientific Reports May 2024The use of self-collected specimens as an alternative to healthcare worker-collected specimens for diagnostic testing has gained increasing attention in recent years.... (Meta-Analysis)
Meta-Analysis
Accuracy of self-collected versus healthcare worker collected specimens for diagnosing sexually transmitted infections in females: an updated systematic review and meta-analysis.
The use of self-collected specimens as an alternative to healthcare worker-collected specimens for diagnostic testing has gained increasing attention in recent years. This systematic review aimed to assess the diagnostic accuracy of self-collected specimens compared to healthcare worker-collected specimens across different sexually transmitted infections (STIs) including Chlamydia trachomatis (CT), human papillomavirus (HPV), Mycoplasma genitalium (MG), Neisseria gonorrhoea (NG), Treponema pallidum and Trichomonas vaginalis (TV) in females. A rigorous process was followed to screen for studies in various electronic databases. The quality of included studies was assessed using the Quality Assessment of Diagnostic Accuracy Studies 2 tool. There were no studies on syphilis that met the criteria for inclusion in the review. A total of six studies for chlamydia, five studies for HPV, four studies for MG, and seven studies for gonorrhoea and trichomoniasis were included in the review. However, not all studies were included in the sub-group meta-analysis. The analysis revealed that self-collected specimens demonstrated comparable diagnostic accuracy to healthcare worker-collected specimens across most STIs. This indicates that the diagnostic accuracy of self-collected specimens can provide accurate results and enhance access to diagnostic testing, potentially improving healthcare service delivery. Future research should further explore the diagnostic accuracy of self-collected specimens in larger and more diverse populations.
Topics: Humans; Female; Sexually Transmitted Diseases; Specimen Handling; Health Personnel; Neisseria gonorrhoeae; Gonorrhea; Chlamydia trachomatis
PubMed: 38714714
DOI: 10.1038/s41598-024-61358-y -
Frontiers in Reproductive Health 2024In Mozambique, sexually transmitted infections (STIs) are estimated to be prevalent, but diagnosis and treatment of curable STIs rely only on syndromic management. We...
Prevalence of sexually transmitted infections (STIs), associations with sociodemographic and behavioural factors, and assessment of the syndromic management of vaginal discharge in women with urogenital complaints in Mozambique.
In Mozambique, sexually transmitted infections (STIs) are estimated to be prevalent, but diagnosis and treatment of curable STIs rely only on syndromic management. We examined the prevalence of four non-viral STIs and HIV-1/2, based on etiological diagnosis, associations with sociodemographic and behavioural factors, and the STI diagnostic accuracy of the vaginal discharge syndromic management in women with urogenital complaints in Maputo, Mozambique. A cross-sectional study was performed in Maputo, Mozambique, February 2018-January 2019, enrolling 924 women of reproductive age with urogenital complaints. Endocervical/vaginal swabs were sampled and chlamydia, gonorrhoea, trichomoniasis and infections were diagnosed using a multiplex real-time PCR (AmpliSens; InterLabServices). Serological testing was performed for HIV-1/2. A structured questionnaire collected metadata. All data were analyzed in STATA/IC 12.1 using descriptive statistics, chi-square tests and logistic regression model. About 40% of the women were less than 24 years old, 50.8% were single, 62.1% had their sexual debut between 12 and 17 years of age, and the main complaint was vaginal discharge syndrome (85%). The prevalence of chlamydia was 15.5%, trichomoniasis 12.1%, gonorrhoea 4.0%, 2.1%, and HIV-1/2 22.3%. The vaginal discharge syndrome flowchart had a sensitivity of 73.0%-82.5% and a specificity of 14%-15% for the detection of any individual non-viral STI in women with urogenital complaints. In total, 19.2% of the symptomatic women with chlamydia, trichomoniasis or gonorrhoea would not be detected and accordingly treated using the vaginal discharge syndromic management (missed treatment) and 70.0% of the women would be treated despite not being infected with any of these three STIs (overtreatment). In conclusion, a high prevalence of especially chlamydia, trichomoniasis, and HIV-1/2 was found in women of childbearing age with urogenital complaints in Maputo, Mozambique. Syndromic management of vaginal discharge revealed low accuracy in the detection of STIs in symptomatic women, especially low specificity, which resulted in under-treatment of STI-positive cases and incorrect or over-treatment of women with urogenital complaints, many of whom were negative for all the non-viral STIs. Etiological diagnosis is imperative for effective management of STIs in symptomatic and asymptomatic women.
PubMed: 38706519
DOI: 10.3389/frph.2024.1323926 -
Revista Clinica Espanola 2024The global increase in sexual transmitted infections (STI) makes it necessary to seek public health strategies that facilitate rapid and minimally invasive diagnosis.... (Comparative Study)
Comparative Study
Comparative performance of vulvovaginal swab sampling versus endocervical sampling for the detection of Chlamydia, Gonorrhea, Mycoplasma genitalium, and Trichomoniasis: a cross-sectional study in Spain.
INTRODUCTION
The global increase in sexual transmitted infections (STI) makes it necessary to seek public health strategies that facilitate rapid and minimally invasive diagnosis. The objective was to evaluate the concordance between vaginal and endocervical samples for STI diagnosis.
MATERIALS AND METHODS
A retrospective cross-sectional study was carried out on vaginal and endocervical samples from women attended in our reference area with symptoms suggestive of vulvovaginitis or for STI screening during the study period.
RESULTS
A total of 130 paired samples were analyzed; fifty-seven and 59 samples were positive for vaginal and endocervical specimens (Kappa index of 0.969 (Standard error = 0.022). The sensitivity of the vaginal samples was 96.5% (IC95%: 87.2-99.4), with a specificity of 100% (IC95%: 93.0-100).
DISCUSSION
The introduction of STI screening in vaginal samples in our environment can facilitate rapid and effective diagnosis and allow early treatment of STI. Additionally, it facilitates sample collection and diagnosis in the community setting, essential for optimal screening.
Topics: Humans; Female; Cross-Sectional Studies; Retrospective Studies; Adult; Spain; Gonorrhea; Chlamydia Infections; Mycoplasma genitalium; Specimen Handling; Young Adult; Mycoplasma Infections; Sensitivity and Specificity; Cervix Uteri; Vaginal Smears; Vagina; Middle Aged; Trichomonas Infections; Adolescent; Sexually Transmitted Diseases
PubMed: 38701969
DOI: 10.1016/j.rceng.2024.04.015 -
BMJ Open May 2024A prototype lateral flow device detecting cytokine biomarkers interleukin (IL)-1α and IL-1β has been developed as a point-of-care test-called the Genital InFlammation... (Observational Study)
Observational Study
Novel point-of-care cytokine biomarker lateral flow test for the screening for sexually transmitted infections and bacterial vaginosis: study protocol of a multicentre multidisciplinary prospective observational clinical study to evaluate the performance and feasibility of the Genital InFlammation...
INTRODUCTION
A prototype lateral flow device detecting cytokine biomarkers interleukin (IL)-1α and IL-1β has been developed as a point-of-care test-called the Genital InFlammation Test (GIFT)-for detecting genital inflammation associated with sexually transmitted infections (STIs) and/or bacterial vaginosis (BV) in women. In this paper, we describe the rationale and design for studies that will be conducted in South Africa, Zimbabwe and Madagascar to evaluate the performance of GIFT and how it could be integrated into routine care.
METHODS AND ANALYSIS
We will conduct a prospective, multidisciplinary, multicentre, cross-sectional and observational clinical study comprising two distinct components: a biomedical ('diagnostic study') and a qualitative, modelling and economic ('an integration into care study') part. The diagnostic study aims to evaluate GIFT's performance in identifying asymptomatic women with discharge-causing STIs ( (CT), (NG), (TV) and (MG)) and BV. Study participants will be recruited from women attending research sites and family planning services. Several vaginal swabs will be collected for the evaluation of cytokine concentrations (ELISA), STIs (nucleic acid amplification tests), BV (Nugent score) and vaginal microbiome characteristics (16S rRNA gene sequencing). The first collected vaginal swab will be used for the GIFT assay which will be performed in parallel by a healthcare worker in the clinic near the participant, and by a technician in the laboratory. The integration into care study aims to explore how GIFT could be integrated into routine care. Four activities will be conducted: user experiences and/or perceptions of the GIFT device involving qualitative focus group discussions and in-depth interviews with key stakeholders; discrete choice experiments; development of a decision tree classification algorithm; and economic evaluation of defined management algorithms.
ETHICS AND DISSEMINATION
Findings will be reported to participants, collaborators and local government for the three sites, presented at national and international conferences, and disseminated in peer-reviewed publications.The protocol and all study documents such as informed consent forms were reviewed and approved by the University of Cape Town Human Research Ethics Committee (HREC reference 366/2022), Medical Research Council of Zimbabwe (MRCZ/A/2966), Comité d'Ethique pour la Recherche Biomédicale de Madagascar (N° 143 MNSAP/SG/AMM/CERBM) and the London School of Hygiene and Tropical Medicine ethics committee (LSHTM reference 28046).Before the start, this study was submitted to the Clinicaltrials.gov public registry (NCT05723484).
TRIAL REGISTRATION NUMBER
NCT05723484.
Topics: Humans; Female; Vaginosis, Bacterial; Prospective Studies; Biomarkers; Sexually Transmitted Diseases; Cross-Sectional Studies; Point-of-Care Testing; Feasibility Studies; Interleukin-1alpha; Interleukin-1beta; Adult; Cytokines; South Africa; Zimbabwe; Observational Studies as Topic; Multicenter Studies as Topic
PubMed: 38692732
DOI: 10.1136/bmjopen-2024-084918 -
Genes Apr 2024() poses a significant public health challenge due to its association with non-gonococcal urethritis (particularly in men) and antimicrobial resistance. However,...
() poses a significant public health challenge due to its association with non-gonococcal urethritis (particularly in men) and antimicrobial resistance. However, despite the prevalence of infections and the rise in resistance rates, routine testing and surveillance remain limited. This is the first study from Croatia that aimed to assess the prevalence and trends of resistance in strains isolated from male individuals by detecting macrolide and fluoroquinolone resistance genes. The study also aimed to explore the factors associated with resistance and changes in resistance patterns over time. Urine samples collected from male individuals in the Zagreb County and northwest region of Croatia between 2018 and 2023 were tested for with the use of molecular methods. Positive samples were subjected to DNA extraction and multiplex tandem polymerase chain reaction (MT-PCR) targeting genetic mutations associated with macrolide ( gene) and fluoroquinolone ( gene) resistance. Of the 8073 urine samples tested from 6480 male individuals (and following the exclusion of repeated specimens), we found that the prevalence of infection was 2.2%. Macrolide resistance was observed in 60.4% of strains, while fluoroquinolone resistance was found in 19.2%. Co-resistance to both antibiotics was present in 18.2% of cases. A statistically significant increase in fluoroquinolone resistance was noted over the study period ( = 0.010), but this was not evident for azithromycin resistance ( = 0.165). There were no statistically significant differences in resistance patterns between age groups, whereas re-testing of patients revealed dynamic changes in resistance profiles over time. The high burden of macrolide resistance and increasing fluoroquinolone resistance underscore the urgent need for comprehensive resistance testing and surveillance programs. The implementation of resistance-guided treatment strategies, along with enhanced access to molecular diagnostics, is pivotal for effectively managing infections.
Topics: Mycoplasma genitalium; Humans; Male; Fluoroquinolones; Croatia; Macrolides; Adult; Mycoplasma Infections; Anti-Bacterial Agents; Drug Resistance, Bacterial; Middle Aged; Young Adult; RNA, Ribosomal, 23S; Adolescent; Urethritis; Microbial Sensitivity Tests
PubMed: 38674404
DOI: 10.3390/genes15040470 -
International Journal of Environmental... Apr 2024Sexually transmitted infections (STIs) can be caused by a number of microorganisms that vary greatly in size, life cycle, clinical manifestations, and sensitivity to...
INTRODUCTION
Sexually transmitted infections (STIs) can be caused by a number of microorganisms that vary greatly in size, life cycle, clinical manifestations, and sensitivity to available treatments. Transmission of STIs can occur during unprotected (or condomless) sexual contact and through the exchange of body fluids during any type of activity. The prevalence of sexually transmitted diseases remains high in the world, despite diagnostic and therapeutic improvements for these infectious diseases that rapidly eliminate the contagiousness of patients. Our study determines the prevalence of STI pathogens in adolescents and young adults in the population of the Province of Macerata (Italy). We will analyze data in correspondence to age and gender, and we will compare our results to international studies.
MATERIALS AND METHOD
We analyzed STI test results from the entire database of a Provincial Health Authority for the period 2021-2022. The samples came from the following age groups: 0-12, 13-18, 19-25, and 26-35 from 2021 to 2022. The results came from vaginal and cervical swabs (for females); urethral, rectal, and pharyngeal swabs (for males and females); and seminal fluid (for males) for the following infections: HPV, , , , , , , and . The results also came from blood tests for HIV, hepatitis C, hepatitis B, and (TPHA, VDRL). In addition, we examined results from urine tests for chlamydia, , trichomonas, and .
CONCLUSIONS
The literature for other countries reports the need for comprehensive, culturally and developmentally sensitive care to address sexuality-related issues in adolescents and young adults, a need that also applies to Italy. These data will be of great importance in adopting evidence-based STI control programs in Marche Region. This study could, indeed, represent a landmark for public health officials and professionals, with the aim of promoting adolescents' access to sexual health services to receive useful information, strengthening preventive measures in younger age groups, and designing sexual education programs.
Topics: Humans; Adolescent; Sexually Transmitted Diseases; Male; Female; Young Adult; Italy; Adult; Prevalence; Public Health; Child; Child, Preschool; Infant; Cross-Sectional Studies; Infant, Newborn
PubMed: 38673412
DOI: 10.3390/ijerph21040501