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Hadad, Ronza
Publications (10 of 20) Show all publications
Philipova, I., Hadad, R., Levterova, V., Kantardjiev, T. & Unemo, M. (2023). Mycoplasma genitalium antimicrobial (azithromycin and moxifloxacin) resistance and treatment outcome in Sofia, Bulgaria, 2018-2021 [Letter to the editor]. Journal of the European Academy of Dermatology and Venereology, 37(8), e994-e995
Open this publication in new window or tab >>Mycoplasma genitalium antimicrobial (azithromycin and moxifloxacin) resistance and treatment outcome in Sofia, Bulgaria, 2018-2021
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2023 (English)In: Journal of the European Academy of Dermatology and Venereology, ISSN 0926-9959, E-ISSN 1468-3083, Vol. 37, no 8, p. e994-e995Article in journal, Letter (Refereed) Published
Place, publisher, year, edition, pages
Wiley-Blackwell, 2023
National Category
Infectious Medicine
Identifiers
urn:nbn:se:oru:diva-105224 (URN)10.1111/jdv.19067 (DOI)000963846600001 ()36974388 (PubMedID)2-s2.0-85152049741 (Scopus ID)
Note

Funding agency:

European Fund for regional development through Operational Program Science and Education for Smart Growth 2014-2020 BG05M2OP001-1.002-0001-C04

Available from: 2023-03-30 Created: 2023-03-30 Last updated: 2023-08-11Bibliographically approved
Shipitsyna, E., Kularatne, R., Golparian, D., Müller, E. E., Vargas, S. K., Hadad, R., . . . Unemo, M. (2023). Mycoplasma genitalium prevalence, antimicrobial resistance-associated mutations, and coinfections with non-viral sexually transmitted infections in high-risk populations in Guatemala, Malta, Morocco, Peru and South Africa, 2019-2021. Frontiers in Microbiology, 14, Article ID 1130762.
Open this publication in new window or tab >>Mycoplasma genitalium prevalence, antimicrobial resistance-associated mutations, and coinfections with non-viral sexually transmitted infections in high-risk populations in Guatemala, Malta, Morocco, Peru and South Africa, 2019-2021
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2023 (English)In: Frontiers in Microbiology, E-ISSN 1664-302X, Vol. 14, article id 1130762Article in journal (Refereed) Published
Abstract [en]

The prevalence of Mycoplasma genitalium (MG) and MG antimicrobial resistance (AMR) appear to be high internationally, however, prevalence data remain lacking globally. We evaluated the prevalence of MG and MG AMR-associated mutations in men who have sex with men (MSM) in Malta and Peru and women at-risk for sexually transmitted infections in Guatemala, South Africa, and Morocco; five countries in four WHO regions mostly lacking MG prevalence and AMR data, and estimated MG coinfections with Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV). Male urine and anorectal samples, and vaginal samples were tested for MG, CT, NG, and TV (only vaginal samples) using Aptima assays (Hologic). AMR-associated mutations in the MG 23S rRNA gene and parC gene were identified using ResistancePlus MG kit (SpeeDx) or Sanger sequencing. In total, 1,425 MSM and 1,398 women at-risk were recruited. MG was detected in 14.7% of MSM (10.0% in Malta and 20.0% Peru) and in 19.1% of women at-risk (12.4% in Guatemala, 16.0% Morocco, 22.1% South Africa). The prevalence of 23S rRNA and parC mutations among MSM was 68.1 and 29.0% (Malta), and 65.9 and 5.6% (Peru), respectively. Among women at-risk, 23S rRNA and parC mutations were revealed in 4.8 and 0% (Guatemala), 11.6 and 6.7% (Morocco), and 2.4 and 3.7% (South Africa), respectively. CT was the most frequent single coinfection with MG (in 2.6% of MSM and 4.5% of women at-risk), compared to NG + MG found in 1.3 and 1.0%, respectively, and TV + MG detected in 2.8% of women at-risk. In conclusion, MG is prevalent worldwide and enhanced aetiological MG diagnosis, linked to clinical routine detection of 23S rRNA mutations, in symptomatic patients should be implemented, where feasible. Surveillance of MG AMR and treatment outcome would be exceedingly valuable, nationally and internationally. High levels of AMR in MSM support avoiding screening for and treatment of MG in asymptomatic MSM and general population. Ultimately, novel therapeutic antimicrobials and/or strategies, such as resistance-guided sequential therapy, and ideally an effective MG vaccine are essential.

Place, publisher, year, edition, pages
Frontiers Media S.A., 2023
Keywords
M. genitalium prevalence and antimicrobial resistance, Mycoplasma genitalium, antimicrobial resistance, azithromycin, men who have sex with men, moxifloxacin, prevalence, women at-risk
National Category
Infectious Medicine
Identifiers
urn:nbn:se:oru:diva-104906 (URN)10.3389/fmicb.2023.1130762 (DOI)000945517700001 ()36910203 (PubMedID)2-s2.0-85149799240 (Scopus ID)
Available from: 2023-03-14 Created: 2023-03-14 Last updated: 2024-01-17Bibliographically approved
Hadad, R., Golparian, D., Velicko, I., Ohlsson, A.-K., Lindroth, Y., Ericson, E.-L., . . . Unemo, M. (2022). First National Genomic Epidemiological Study of Neisseria gonorrhoeae Strains Spreading Across Sweden in 2016. Frontiers in Microbiology, 12, Article ID 820998.
Open this publication in new window or tab >>First National Genomic Epidemiological Study of Neisseria gonorrhoeae Strains Spreading Across Sweden in 2016
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2022 (English)In: Frontiers in Microbiology, E-ISSN 1664-302X, Vol. 12, article id 820998Article in journal (Refereed) Published
Abstract [en]

The increasing transmission and antimicrobial resistance (AMR) in Neisseria gonorrhoeae is a global health concern with worrying trends of decreasing susceptibility to also the last-line extended-spectrum cephalosporin (ESC) ceftriaxone. A dramatic increase of reported gonorrhea cases has been observed in Sweden from 2016 and onward. The aim of the present study was to comprehensively investigate the genomic epidemiology of all cultured N. gonorrhoeae isolates in Sweden during 2016, in conjunction with phenotypic AMR and clinical and epidemiological data of patients. In total, 1279 isolates were examined. Etest and whole-genome sequencing (WGS) were performed, and epidemiological data obtained from the Public Health Agency of Sweden. Overall, 51.1%, 1.7%, and 1.3% resistance to ciprofloxacin, cefixime, and azithromycin, respectively, was found. No isolates were resistant to ceftriaxone, however, 9.3% of isolates showed a decreased susceptibility to ceftriaxone and 10.5% to cefixime. In total, 44 penA alleles were found of which six were mosaic (n = 92). Using the typing schemes of MLST, NG-MAST, and NG-STAR; 133, 422, and 280 sequence types, respectively, and 93 NG-STAR clonal complexes were found. The phylogenomic analysis revealed two main lineages (A and B) with lineage A divided into two main sublineages (A1 and A2). Resistance and decreased susceptibility to ESCs and azithromycin and associated AMR determinants, such as mosaic penA and mosaic mtrD, were predominantly found in sublineage A2. Resistance to cefixime and azithromycin was more prevalent among heterosexuals and MSM, respectively, and both were predominantly spread through domestic transmission. Continuous surveillance of the spread and evolution of N. gonorrhoeae, including phenotypic AMR testing and WGS, is essential for enhanced knowledge regarding the dynamic evolution of N. gonorrhoeae and gonorrhea epidemiology.

Place, publisher, year, edition, pages
Frontiers Media S.A., 2022
Keywords
Neisseria gonorrhoeae, Sweden, antimicrobial resistance, molecular epidemiology, whole-genome sequencing
National Category
Infectious Medicine
Identifiers
urn:nbn:se:oru:diva-97021 (URN)10.3389/fmicb.2021.820998 (DOI)000748113700001 ()35095823 (PubMedID)2-s2.0-85123806366 (Scopus ID)
Note

Funding agencies:

Örebro County Council Research Committee, Örebro, Sweden

Foundation for Medical Research at the Örebro University Hospital, Örebro, Sweden

Available from: 2022-02-01 Created: 2022-02-01 Last updated: 2024-01-17Bibliographically approved
Hadad, R. (2022). Implementation of strategies for management and prevention of sexually transmitted infections with focus on Neisseria gonorrhoeae and Chlamydia trachomatis. (Doctoral dissertation). Örebro: Örebro University
Open this publication in new window or tab >>Implementation of strategies for management and prevention of sexually transmitted infections with focus on Neisseria gonorrhoeae and Chlamydia trachomatis
2022 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Sexually transmitted infections (STIs) are a public health issue of great importance worldwide, with effects on fertility and reproduction. Chlamydia trachomatis and Neisseria gonorrhoeae, causative agents of chlamydia and gonorrhoea, respectively, are the most common bacterial STIs with an estimated 127 million new global cases of chlamydia and 87 million new gonorrhoea cases. The continued emergence of antimicrobial resistance (AMR) in N. gonorrhoeae may in the future lead to an untreatable infection. Prevention of these infections and controlling the development of AMR rely on several strategies developed by the World Health Organization (WHO). This thesis aimed to implement several of these strategies, including supporting vaccine development for C. trachomatis and N. gonorrhoeae, evaluating molecular methods for detecting N. gonorrhoeae, predicting AMR and supporting surveillance of the spread and prevalence of AMR in N. gonorrhoeae. The present studies on a C. trachomatis recombinant vaccine antigen and the investigation of similarities of N. gonorrhoeae antigen amino acid sequences to the antigens included in the meningococcal vaccine 4CMenB contributed to the field of vaccine development for STIs. The assay SpeeDx ResistancePlus® GC performed well in detecting N. gonorrhoeae and predicting ciprofloxacin resistance and could be used in AMR surveillance and individualised treatment. In 2016, the first national genomic surveillance of all N. gonorrhoeae isolates in Sweden was performed. This national surveillance study included whole-genome sequencing combined with phenotypic AMR and epidemiological data, which provides valuable information on circulating strains, epidemiology and phylogeny. Greater knowledge of gonorrhoea and gonococcal AMR epidemiology could inform decisions on guidelines and prevention. It is essential to continue to implement WHO strategies at the national and global levels to prevent and control chlamydia and gonorrhoea infections.

Place, publisher, year, edition, pages
Örebro: Örebro University, 2022. p. 104
Series
Örebro Studies in Medicine, ISSN 1652-4063 ; 267
Keywords
Neisseria gonorrhoeae, epidemiology, whole-genome sequencing, antimicrobial resistance (AMR), Chlamydia trachomatis, vaccine, strategies, management and prevention
National Category
Other Basic Medicine
Identifiers
urn:nbn:se:oru:diva-98526 (URN)9789175294407 (ISBN)
Public defence
2022-06-17, Örebro universitet, Campus USÖ, hörsal C1, Södra Grev Rosengatan 32, Örebro, 09:00 (English)
Opponent
Supervisors
Available from: 2022-04-11 Created: 2022-04-11 Last updated: 2022-06-16Bibliographically approved
Cole, M. J., Davis, G. S., Fifer, H., Saunders, J. M., Unemo, M., Hadad, R., . . . Folkard, K. (2022). No widespread dissemination of Chlamydia trachomatis diagnostic: escape variants and the impact of Neisseria gonorrhoeae positivity on the Aptima Combo 2 assay. Sexually Transmitted Infections, 98(5), 366-370
Open this publication in new window or tab >>No widespread dissemination of Chlamydia trachomatis diagnostic: escape variants and the impact of Neisseria gonorrhoeae positivity on the Aptima Combo 2 assay
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2022 (English)In: Sexually Transmitted Infections, ISSN 1368-4973, E-ISSN 1472-3263, Vol. 98, no 5, p. 366-370Article in journal (Refereed) Published
Abstract [en]

OBJECTIVES: (NG) with the Hologic Aptima CT (ACT) assay was recommended to identify any CT variants.

METHODS: From June to October 2019, specimens with discrepant AC2/ACT CT results were submitted to Public Health England and screened for detectable CT DNA using an inhouse real-time (RT)-PCR. When enough DNA was present, partial CT 23S rRNA gene sequencing was performed. Analysis of available relative light units and interpretative data was performed.

RESULTS: A total of 317 discordant AC2/ACT specimens were collected from 315 patients. Three hundred were tested on the RT-PCR; 53.3% (n=160) were negative and 46.7% (n=140) were positive. Due to low DNA load in most specimens, sequencing was successful for only 36 specimens. The CT 23S rRNA wild-type sequence was present in 32 specimens, and two variants with C1514T or G1523A mutation were detected in four specimens from three patients. Of the discordant specimens with NG interpretation, 36.6% of NG-negative/CT-negative AC2 specimens had detectable CT DNA on the inhouse RT-PCR vs 53.3% of NG-positive/CT-negative specimens.

CONCLUSIONS: No widespread dissemination of AC2 diagnostic-escape CT variants has occurred in England. We however identified the impact of NG positivity on the discordant AC2/ACT specimens; a proportion appeared due to NG positivity and the associated NG signal, rather than any diagnostic-escape variants or low DNA load. Several patients with gonorrhoea may therefore receive false-negative AC2 CT results. Single diagnostic targets and multiplex diagnostic assays have their limitations such as providing selection pressure for escape mutants and potentially reduced sensitivity, respectively. These limitations must be considered when establishing diagnostic pathways.

Place, publisher, year, edition, pages
BMJ Publishing Group Ltd, 2022
Keywords
Chlamydia trachomatis, Neisseria gonorrhoeae, chlamydia infections, molecular diagnostic techniques, nucleic acid amplification techniques
National Category
Infectious Medicine
Identifiers
urn:nbn:se:oru:diva-94361 (URN)10.1136/sextrans-2021-054988 (DOI)000726864700001 ()34510008 (PubMedID)2-s2.0-85131350995 (Scopus ID)
Note

Funding agency:

NIHR Health Protection Research Unit in Behavioural Science and Evaluation at the University of Bristol

Available from: 2021-09-16 Created: 2021-09-16 Last updated: 2022-08-22Bibliographically approved
Hadad, R., Cole, M. J., Ebeyan, S., Jacobsson, S., Tan, L. Y., Golparian, D., . . . Unemo, M. (2021). Evaluation of the SpeeDx ResistancePlus® GC and SpeeDx GC 23S 2611 (beta) molecular assays for prediction of antimicrobial resistance/susceptibility to ciprofloxacin and azithromycin in Neisseria gonorrhoeae. Journal of Antimicrobial Chemotherapy, 76(1), 84-90
Open this publication in new window or tab >>Evaluation of the SpeeDx ResistancePlus® GC and SpeeDx GC 23S 2611 (beta) molecular assays for prediction of antimicrobial resistance/susceptibility to ciprofloxacin and azithromycin in Neisseria gonorrhoeae
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2021 (English)In: Journal of Antimicrobial Chemotherapy, ISSN 0305-7453, E-ISSN 1460-2091, Vol. 76, no 1, p. 84-90Article in journal (Refereed) Published
Abstract [en]

BACKGROUND: Accurate molecular assays for prediction of antimicrobial resistance (AMR)/susceptibility in Neisseria gonorrhoeae (Ng) can offer individualized treatment of gonorrhoea and enhanced AMR surveillance.

OBJECTIVES: We evaluated the new ResistancePlus® GC assay and the GC 23S 2611 (beta) assay (SpeeDx), for prediction of resistance/susceptibility to ciprofloxacin and azithromycin, respectively.

METHODS: Nine hundred and sixty-seven whole-genome-sequenced Ng isolates from 20 European countries, 143 Ng-positive (37 with paired Ng isolates) and 167 Ng-negative clinical Aptima Combo 2 (AC2) samples, and 143 non-gonococcal Neisseria isolates and closely related species were examined with both SpeeDx assays.

RESULTS: The sensitivity and specificity of the ResistancePlus® GC assay to detect Ng in AC2 samples were 98.6% and 100%, respectively. ResistancePlus® GC showed 100% sensitivity and specificity for GyrA S91 WT/S91F detection and 99.8% sensitivity and specificity in predicting phenotypic ciprofloxacin resistance. The sensitivity and specificity of the GC 23S 2611 (beta) assay for Ng detection in AC2 samples were 95.8% and 100%, respectively. GC 23S 2611 (beta) showed 100% sensitivity and 99.9% specificity for 23S rRNA C2611 WT/C2611T detection and 64.3% sensitivity and 99.9% specificity for predicting phenotypic azithromycin resistance. Cross-reactions with non-gonococcal Neisseria species were observed with both assays, but the analysis software solved most cross-reactions.

CONCLUSIONS: The new SpeeDx ResistancePlus® GC assay performed well in the detection of Ng and AMR determinants, especially in urogenital samples. The GC 23S 2611 (beta) assay performed relatively well, but its sensitivity, especially for predicting phenotypic azithromycin resistance, was suboptimal and further optimizations are required, including detection of additional macrolide resistance determinant(s).

Place, publisher, year, edition, pages
Oxford University Press, 2021
National Category
Infectious Medicine
Identifiers
urn:nbn:se:oru:diva-85867 (URN)10.1093/jac/dkaa381 (DOI)000620811500010 ()32929456 (PubMedID)2-s2.0-85098461440 (Scopus ID)
Note

Funding Agencies:

Örebro County Council Research Committee  

Foundation for Medical Research at Örebro University Hospital, Örebro, Sweden  

Available from: 2020-09-23 Created: 2020-09-23 Last updated: 2022-05-23Bibliographically approved
Hadad, R., Golparian, D., Velicko, I., Lindroth, Y., Ohlsson, A., Fredlund, H. & Unemo, M. (2021). GENOMIC EPIDEMIOLOGY OF NEISSERIA GONORRHOEAE ISOLATES IN SWEDEN-2016 NATIONAL STUDY. Paper presented at STI & HIV World Congress, July 14–17, 2021. Sexually Transmitted Infections, 97(Suppl. 1), A135-A135
Open this publication in new window or tab >>GENOMIC EPIDEMIOLOGY OF NEISSERIA GONORRHOEAE ISOLATES IN SWEDEN-2016 NATIONAL STUDY
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2021 (English)In: Sexually Transmitted Infections, ISSN 1368-4973, E-ISSN 1472-3263, Vol. 97, no Suppl. 1, p. A135-A135Article in journal, Meeting abstract (Other academic) Published
Abstract [en]

Background: The number of reported cases of gonorrhoea in Sweden continuously increased from an incidence of 7.8 per 100 000 inhabitants in 2009 to 31.4 in 2019. The largest increase in incidence was observed during 2016–2017. No national molecular epidemiological study investigating the population of N. gonorrhoeae circulating in Sweden has been performed in the last two decades. Our aim was to examine the antimicrobial resistance (AMR) and genome-based epidemiology, in conjunction to patient epidemiological data, of all gonococcal isolates (n=1279; one isolate per case) from gonorrhoea cases in Sweden during 2016.

Methods: AMR testing was performed using Etest, and MICs were interpreted using current clinical resistance breakpoints from EUCAST. All isolates were whole genome sequenced using Illumina HiSeq X platform. Patient epidemiological data was obtained from the Public Health Agency of Sweden.

Results: The gonorrhoea patients consisted of 252 (19.7%) women and 1027 men (80.3%). The medium age of the women was 27.4 years and of the men 32.1 years. Regarding sexual orientation, 619 (48.4%) reported homosexual, 605 (47.3%) heterosexual, 31 (2.4%) bisexual, and 24 (1.9%) did not report. Most prevalent countries of infection were Sweden (n=875, 68.4%), followed by Thailand (n=70, 5.5%) and Germany (n=32, 2.5%).

Overall, the phenotypic AMR was as follows: ceftriaxone and spectinomycin (0%), cefixime (1.7%), azithromycin (1.3%) and ciprofloxacin (51.1%). A high concordance between phenotypic AMR and molecular AMR determinants was found. Results from the genome-based epidemiology are currently in final analysis.

Conclusions: AMR in N. gonorrhoeae in Sweden remains low, in particular to ceftriaxone and azithromycin that is recommended internationally for dual therapy. The incidence increases in Sweden appear to be driven by increased spread among men-who-have-sex-with-men but also younger heterosexuals of both genders. This is the first national genome-based epidemiological study for N. gonorrhoeae in Sweden and final genomic results are pending.

Place, publisher, year, edition, pages
BMJ Publishing Group Ltd, 2021
National Category
Infectious Medicine
Identifiers
urn:nbn:se:oru:diva-95229 (URN)10.1136/sextrans-2021-sti.353 (DOI)000704729500241 ()
Conference
STI & HIV World Congress, July 14–17, 2021
Available from: 2021-10-27 Created: 2021-10-27 Last updated: 2021-10-27Bibliographically approved
Hadad, R., Skov Jensen, J., Westh, H., Grønbaek, I., Jessen Schwartz, L., Nielsen, L., . . . Hoffmann, S. (2020). A Chlamydia trachomatis 23S rRNA G1523A variant escaping detection in the Aptima Combo 2 assay (Hologic) was widespread across Denmark in July-September 2019. Acta Pathologica, Microbiologica et Immunologica Scandinavica (APMIS), 128(6), 440-444
Open this publication in new window or tab >>A Chlamydia trachomatis 23S rRNA G1523A variant escaping detection in the Aptima Combo 2 assay (Hologic) was widespread across Denmark in July-September 2019
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2020 (English)In: Acta Pathologica, Microbiologica et Immunologica Scandinavica (APMIS), ISSN 0903-4641, E-ISSN 1600-0463, Vol. 128, no 6, p. 440-444Article in journal (Refereed) Published
Abstract [en]

Chlamydia trachomatis infection is the most common bacterial sexually transmitted infection globally, and nucleic acid amplification tests (NAATs) are recommended for highly sensitive and specific diagnosis. In early 2019, the Finnish new variant of Chlamydia trachomatis (FI-nvCT) was identified. The FI-nvCT has a C1515T mutation in the 23S rRNA gene, making it escaping detection in the Aptima Combo 2 (AC2; Hologic) NAAT, and the FI-nvCT has been subsequently reported in Sweden and Norway. In the present study, we investigated the presence of the FI-nvCT and other AC2 diagnostic-escape CT mutants in July-September 2019 in Denmark. The FI-nvCT was present but rare in Denmark. However, another AC2 diagnostic-escape CT mutant (with a 23S rRNA G1523A mutation) was found to be widespread across Denmark, accounting for 95% (76/80) of AC2 diagnostic-escape nvCT samples from five Danish CT-diagnostic laboratories. This nvCT-G1523A has previously only been detected in one single sample in the United Kingdom and Norway, respectively. It is vital to monitor the continued stability of the NAAT targets in local, national and international settings and monitor as well as appropriately analyse incidence, unexplained shifts in diagnostics rates, and/or annual collections of samples diagnosed as negative/equivocal using NAATs with different target(s). Furthermore, diagnostic CT NAATs with dual target sequences are crucial and fortunately, an updated Hologic AC2 assay including one additional target sequence is in advanced development.

Place, publisher, year, edition, pages
Wiley-Blackwell Publishing Inc., 2020
Keywords
Chlamydia trachomatis, 23S rRNA, Aptima Combo 2 assay, C1515T, Denmark, FI-nvCT, G1523A, New variant
National Category
Infectious Medicine
Identifiers
urn:nbn:se:oru:diva-80835 (URN)10.1111/apm.13043 (DOI)000530420800001 ()32202687 (PubMedID)2-s2.0-85085151002 (Scopus ID)
Available from: 2020-03-25 Created: 2020-03-25 Last updated: 2020-12-01Bibliographically approved
Hilmarsdóttir, I., Arnardóttir, E. M., Jóhannesdóttir, E. R., Valsdóttir, F., Golparian, D., Hadad, R., . . . Unemo, M. (2020). Prevalence of Mycoplasma genitalium and antibiotic resistance-associated mutations in an Icelandic STI population, and comparison of the S-DiaMGTV and Aptima Mycoplasma genitalium assays for diagnosis. Journal of Clinical Microbiology, 58(9), Article ID e01084-20.
Open this publication in new window or tab >>Prevalence of Mycoplasma genitalium and antibiotic resistance-associated mutations in an Icelandic STI population, and comparison of the S-DiaMGTV and Aptima Mycoplasma genitalium assays for diagnosis
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2020 (English)In: Journal of Clinical Microbiology, ISSN 0095-1137, E-ISSN 1098-660X, Vol. 58, no 9, article id e01084-20Article in journal (Refereed) Published
Abstract [en]

Objectives: Mycoplasma genitalium (MG) is prevalent among attendees in sexually transmitted infections (STI) clinics and therapy is hampered by rapidly rising levels of resistance to azithromycin and moxifloxacin. In this study we evaluated, for the first time in Iceland, the prevalence of MG and azithromycin and moxifloxacin resistance-associated mutations, and assessed the diagnostic performance of the CE/IVD-marked S-DiaMGTV (Diagenode Diagnostics) versus the US FDA/CE/IVD-approved Aptima MG (AMG; Hologic) for MG detection.

Methods: From October 2018 to January 2019, urine and vaginal swabs were provided by male and female attendees at Iceland's only STI clinic. Specimens were tested with S-DiaMGTV and AMG, and resistance-associated mutations were determined by 23S rRNA gene and parC sequencing. Demographic and clinical data were collected from patient records.

Results: MG prevalence was 9.3% overall; 7.7% (38/491) among male and 10.9% (53/487) among female participants. Azithromycin and moxifloxacin resistance-associated mutations were found in 57.0% (45/79) and 0.0% (0/80) of evaluable specimens, respectively. Sensitivity was 72.5% and 100%, and specificity was 99.9% and 100% for S-DiaMGTV and AMG, respectively. No association was found between MG and symptoms of urethritis in men.

Conclusions: Prevalence rates for MG and azithromycin resistance-associated genes in Iceland are among the highest reported in Europe. The significantly higher sensitivity of AMG over that of S-DiaMGTV can have important clinical implications. More information is urgently needed to clarify the significance of false-negative results obtained with S-DiaMGTV and other similarly performing, widely used real-time PCR methods for diagnosis and management of this sexually transmitted infection.

Place, publisher, year, edition, pages
American Society for Microbiology, 2020
Keywords
23S rRNA: Iceland: antimicrobial resistance: azithromycin: moxifloxacin parC: urethritis
National Category
Infectious Medicine
Identifiers
urn:nbn:se:oru:diva-84690 (URN)10.1128/JCM.01084-20 (DOI)000575116900052 ()32611793 (PubMedID)2-s2.0-85089922558 (Scopus ID)
Note

Funding Agencies:

Landspitali University Hospital  

Örebro County Council Research Committee  

Foundation for Medical Research at Örebro University Hospital  

Scandinavian Society for Antimicrobial Chemotherapy Foundation  

Available from: 2020-08-26 Created: 2020-08-26 Last updated: 2020-12-01Bibliographically approved
Unemo, M., Hansen, M., Hadad, R., Puolakkainen, M., Westh, H., Rantakokko-Jalava, K., . . . Sundqvist, M. (2020). Sensitivity, specificity, inclusivity and exclusivity of the updated Aptima Combo 2 assay, which provides detection coverage of the new diagnostic-escape Chlamydia trachomatis variants. BMC Infectious Diseases, 20(1), Article ID 419.
Open this publication in new window or tab >>Sensitivity, specificity, inclusivity and exclusivity of the updated Aptima Combo 2 assay, which provides detection coverage of the new diagnostic-escape Chlamydia trachomatis variants
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2020 (English)In: BMC Infectious Diseases, E-ISSN 1471-2334, Vol. 20, no 1, article id 419Article in journal (Refereed) Published
Abstract [en]

Background: Four new variants of Chlamydia trachomatis (nvCTs), detected in several countries, cause false-negative or equivocal results using the Aptima Combo 2 assay (AC2; Hologic). We evaluated the clinical sensitivity and specificity, as well as the analytical inclusivity and exclusivity of the updated AC2 for the detection of CT and Neisseria gonorrhoeae (NG) on the automated Panther system (Hologic).

Methods: We examined 1004 clinical AC2 samples and 225 analytical samples spiked with phenotypically and/or genetically diverse NG and CT strains, and other potentially cross-reacting microbial species. The clinical AC2 samples included CT wild type (WT)-positive (n = 488), all four described AC2 diagnostic-escape nvCTs (n = 170), NG-positive (n = 214), and CT/NG-negative (n = 202) specimens.

Results: All nvCT-positive samples (100%) and 486 (99.6%) of the CT WT-positive samples were positive in the updated AC2. All NG-positive, CT/NG-negative, Trichomonas vaginalis (TV)-positive, bacterial vaginosis-positive, andCandida-positive AC2 specimens gave correct results. The clinical sensitivity and specificity of the updated AC2 for CT detection was 99.7 and 100%, respectively, and for NG detection was 100% for both. Examining spiked samples, the analytical inclusivity and exclusivity were 100%, i.e., in clinically relevant concentrations of spiked microbe.

Conclusions: The updated AC2, including two CT targets and one NG target, showed a high sensitivity, specificity, inclusivity and exclusivity for the detection of CT WT, nvCTs, and NG. The updated AC2 on the fully automated Panther system offers a simple, rapid, high-throughput, sensitive, and specific diagnosis of CT and NG, which can easily be combined with detection of Mycoplasma genitalium and TV.

Place, publisher, year, edition, pages
BioMed Central, 2020
Keywords
Finnish new variant, Chlamydia trachomatis, Aptima combo 2, 23S rRNA, Validation, Surveillance
National Category
Infectious Medicine
Identifiers
urn:nbn:se:oru:diva-84850 (URN)10.1186/s12879-020-05148-7 (DOI)000542951400002 ()32546213 (PubMedID)2-s2.0-85086686721 (Scopus ID)
Note

Funding Agencies:

Örebro County Council Research Committee  

Foundation for Medical Research at Örebro University Hospital, Örebro, Sweden 

Available from: 2020-08-17 Created: 2020-08-17 Last updated: 2024-01-17Bibliographically approved
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