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  • 1.
    Cole, Michelle Jayne
    et al.
    National Infection Service, Public Health England, London, UK.
    Davis, Grahame S.
    National Infection Service, Public Health England, London, UK.
    Fifer, Helen
    National Infection Service, Public Health England, London, UK.
    Saunders, John Michael
    National Infection Service, Public Health England, London, UK; Research Department of Infection and Population Health, University College London, London, UK.
    Unemo, Magnus
    Örebro University, School of Medical Sciences. Örebro University Hospital. WHO Collaborating Centre for Gonorrhoea and Other STIs, National Reference Laboratory for Pathogenic Neisseria, Department of Laboratory Medicine, Microbiology.
    Hadad, Ronza
    Örebro University, School of Medical Sciences.
    Roberts, David J.
    National Infection Service, Public Health England, London, UK.
    Fazal, Mohammed
    National Infection Service, Public Health England, London, UK.
    Day, Michaela Joanne
    National Infection Service, Public Health England, London, UK.
    Minshull, Jack
    National Infection Service, Public Health England, London, UK.
    Muir, Peter
    Bristol Public Health Laboratory, Public Health England, Bristol, UK.
    Horner, Paddy J.
    School of Social and Community Medicine, University of Bristol, Bristol, UK; Bristol Sexual Health Centre, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
    Gill, Noel O.
    National Infection Service, Public Health England, London, UK.
    Folkard, Kate
    National Infection Service, Public Health England, London, UK.
    No widespread dissemination of Chlamydia trachomatis diagnostic: escape variants and the impact of Neisseria gonorrhoeae positivity on the Aptima Combo 2 assay2022In: Sexually Transmitted Infections, ISSN 1368-4973, E-ISSN 1472-3263, Vol. 98, no 5, p. 366-370Article in journal (Refereed)
    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.

  • 2.
    Dahlberg, Jenny
    et al.
    Section of Clinical Bacteriology, Department of Medical Sciences, Uppsala University, Uppsala, Sweden.
    Hadad, Ronza
    Örebro University, School of Science and Technology. WHO Collaborating Centre for Gonorrhoea and other STIs, Örebro University Hospital, Örebro, Sweden.
    Elfving, Karin
    Department of Clinical Microbiology, Falu Lasarett, Falun, Sweden.
    Larsson, Inger
    Department of Clinical Microbiology, Sunderby Hospital, Luleå, Sweden.
    Isaksson, Jenny
    Section of Clinical Bacteriology, Department of Medical Sciences, Uppsala University, Uppsala, Sweden.
    Magnuson, Anders
    Fredlund, Hans
    WHO Collaborating Centre for Gonorrhoea and other STIs, Örebro University Hospital, Örebro, Sweden.
    Unemo, Magnus
    WHO Collaborating Centre for Gonorrhoea and other STIs, Örebro University Hospital, Örebro, Sweden.
    Herrmann, Bjőrn
    Section of Clinical Bacteriology, Department of Medical Sciences, Uppsala University, Uppsala, Sweden.
    Ten years transmission of the new variant of Chlamydia trachomatis in Sweden: prevalence of infections and associated complications2018In: Sexually Transmitted Infections, ISSN 1368-4973, E-ISSN 1472-3263, Vol. 94, no 2, p. 100-104Article in journal (Refereed)
    Abstract [en]

    OBJECTIVES: In 2006, a new variant of Chlamydia trachomatis (nvCT) was discovered in Sweden. It has a deletion in the plasmid resulting in failed detection by the single target systems from Abbott and Roche used at that time, whereas the third system used, from Becton Dickinson (BD), detects nvCT. The proportion of nvCT was initially up to 65% in counties using Abbott/Roche systems. This study analysed the proportion of nvCT from 2007 to 2015 in four selected counties and its impact on chlamydia-associated complications.

    METHODS: C. trachomatis-positive specimens collected from 2007 to 2015 were analysed by a specific PCR to identify nvCT cases. Genotyping was performed by multilocus sequence typing (MLST) and ompA sequencing. Ectopic pregnancy and pelvic inflammatory disease records were extracted from the national registers.

    RESULTS: In total, 5101 C. trachomatis-positive samples were analysed. The nvCT proportion significantly decreased in the two counties using Roche systems, from 56% in 2007 to 6.5% in 2015 (p<0.001). In the two counties using BD systems, a decrease was also seen, from 19% in 2007 to 5.2% in 2015 (p<0.001). Fifteen nvCT cases from 2015 and 102 cases from 2006 to 2009 had identical MLST profiles. Counties using Roche/Abbott systems showed higher mean rates of ectopic pregnancy and pelvic inflammatory disease compared with counties using BD systems.

    CONCLUSIONS: The nvCT proportion has decreased in all counties and converged to a low prevalence irrespective of previous rates. Genotyping showed that nvCT is clonal and genetically stable. Failing detection only marginally affected complication rates.

  • 3.
    Hadad, Ronza
    Örebro University, School of Medical Sciences.
    Implementation of strategies for management and prevention of sexually transmitted infections with focus on Neisseria gonorrhoeae and Chlamydia trachomatis2022Doctoral 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.

    List of papers
    1. Protection against genital tract Chlamydia trachomatis infection following intranasal immunization with a novel recombinant MOMP VS2/4 antigen
    Open this publication in new window or tab >>Protection against genital tract Chlamydia trachomatis infection following intranasal immunization with a novel recombinant MOMP VS2/4 antigen
    Show others...
    2016 (English)In: Acta Pathologica, Microbiologica et Immunologica Scandinavica (APMIS), ISSN 0903-4641, E-ISSN 1600-0463, Vol. 124, p. 1078-1086Article in journal (Refereed) Published
    Abstract [en]

    The asymptomatic nature of most Chlamydia trachomatis infections and the lack of appropriate effects by current prevention and management call for vaccine development. We evaluated a recombinant subunit vaccine candidate based on the major outer membrane protein variable segments 2 and 4 (MOMP VS2/4). To achieve maximal immunogenicity and ease of production and purification, MOMP VS2/4 was constructed by using highly immunogenic sequences of MOMP only, thereby minimizing the presence of hydrophobic regions, and spacing the immunogenic epitopes with a flexible amino acid sequence. A purification tag was also added. The MOMP VS2/4 was given intranasally, with or without intravaginal boost, with cholera toxin (CT) adjuvant to C57BL/6 mice, which were screened for immunogenicity and protection against a live challenge infection with C. trachomatis serovar D. Bacterial shedding, cell-mediated responses, and antibody responses were monitored. Immunized mice exhibited significantly less bacterial shedding and were better protected against infertility as compared to unimmunized control mice. Immunizations stimulated both systemic and local specific antibody (IgG1, IgG2c, and IgA) responses, and primed T cells that produced interferon-c and interleukins 13 and 17 upon challenge with recall antigen. Thus, MOMP VS2/4, in combination with CT adjuvant, stimulated Th1, Th2, and Th17 effector cells, and generated protective immunity associated with less pathology. We regard MOMP VS2/4 as a promising candidate for further development into a mucosal chlamydial vaccine.

    Place, publisher, year, edition, pages
    Hoboken, USA: Wiley-Blackwell, 2016
    Keywords
    Chlamydia trachomatis, vaccine, major outer membrane protein, mice, antibody response, T cells
    National Category
    Immunology in the medical area Microbiology in the medical area
    Research subject
    Biochemistry; Immunology; Microbiology; Infectious Diseases
    Identifiers
    urn:nbn:se:oru:diva-53554 (URN)10.1111/apm.12605 (DOI)000388265700008 ()27859689 (PubMedID)2-s2.0-84995753108 (Scopus ID)
    Projects
    Utveckling av vacciner mot sexuellt överförbara sjukdomarMolecular farming
    Funder
    Olle Engkvists stiftelse
    Note

    Funding Agencies:

    Sparbanksstiftelsen Nya

    Örebro University's Faculty for Business, Science, and Technology

    Foundation for Medical Research at Örebro University Hospital

    Available from: 2016-11-18 Created: 2016-11-18 Last updated: 2024-01-16Bibliographically approved
    2. Novel meningococcal 4CMenB vaccine antigens: prevalence and polymorphisms of the encoding genes in Neisseria gonorrhoeae
    Open this publication in new window or tab >>Novel meningococcal 4CMenB vaccine antigens: prevalence and polymorphisms of the encoding genes in Neisseria gonorrhoeae
    Show others...
    2012 (English)In: Acta Pathologica, Microbiologica et Immunologica Scandinavica (APMIS), ISSN 0903-4641, E-ISSN 1600-0463, Vol. 120, no 9, p. 750-760Article in journal (Refereed) Published
    Abstract [en]

    The first cross-protective Neisseria meningitidis vaccine (focus on serogroup B), the protein-based 4 component meningococcus serogroup B (4CMenB), includes the New Zealand outer membrane vesicle and three main genome-derived neisserial antigens (GNAs). These GNAs are fHbp (fused to GNA2091), NHBA (fused to GNA1030) and NadA. In this study, the prevalence and polymorphisms of the nucleotide and amino acid sequences of the 4CMenB antigens in a temporally and geographically diverse collection of N. gonorrhoeae isolates (n similar to=similar to 111) were investigated. All the examined GNA genes, except the nadA gene, were present in all gonococcal isolates. However, 25 isolates contained premature stop codons in the fHbp gene and/or the nhba gene, resulting in truncated proteins. Compared with the 4CMenB antigen sequences in reference strain MC58, the gonococcal strains displayed 67.095.4% and 60.994.9% identity in nucleotide sequence and amino acid sequence, respectively, in the equivalent GNA antigens. The absence of NadA, lack of universal expression of fHbp and NHBA and the uncertainty regarding the surface exposure of fHbp as well as the function of NHBA in N. gonorrhoeae will likely limit the use of the identical 4CMenB antigens in a gonococcal vaccine. However, possible cross-immunity of 4CMenB with gonococci and expression and function of the equivalent gonococcal GNAs, as well as of more appropriate GNAs for a gonococcal vaccine, need to be further examined.

    Place, publisher, year, edition, pages
    Wiley-Blackwell, 2012
    Keywords
    Neisseria gonorrhoeae, 4CMenB vaccine, genome-derived neisserial antigen (GNA)
    National Category
    Microbiology in the medical area Medical Biotechnology (with a focus on Cell Biology (including Stem Cell Biology), Molecular Biology, Microbiology, Biochemistry or Biopharmacy) Pharmacology and Toxicology Immunology in the medical area
    Identifiers
    urn:nbn:se:oru:diva-58673 (URN)10.1111/j.1600-0463.2012.02903.x (DOI)000307444600009 ()22882265 (PubMedID)2-s2.0-84865291540 (Scopus ID)
    Note

    Funding Agencies:

    Örebro County Council Research Committee  

    Foundation for Medical Research at Örebro University Hospital, Sweden  

    Novartis VD, Siena, Italy 

    Available from: 2017-07-12 Created: 2017-07-12 Last updated: 2022-06-16Bibliographically approved
    3. 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
    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
    Show others...
    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
    4. First National Genomic Epidemiological Study of Neisseria gonorrhoeae Strains Spreading Across Sweden in 2016
    Open this publication in new window or tab >>First National Genomic Epidemiological Study of Neisseria gonorrhoeae Strains Spreading Across Sweden in 2016
    Show others...
    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
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  • 4.
    Hadad, Ronza
    et al.
    Örebro University, School of Medical Sciences. WHO Collaborating Centre for Gonorrhoea and other Sexually Transmitted Infections, National Reference Laboratory for Sexually Transmitted Infections, Department of Laboratory Medicine.
    Cole, Michelle Jayne
    National Infection Service, Public Health England, London, UK.
    Ebeyan, Samantha
    SpeeDx Pty Ltd, Sydney, New South Wales, Australia.
    Jacobsson, Susanne
    Örebro University, School of Medical Sciences. Örebro University Hospital. WHO Collaborating Centre for Gonorrhoea and other Sexually Transmitted Infections, National Reference Laboratory for Sexually Transmitted Infections, Department of Laboratory Medicine.
    Tan, Lit Yeen
    SpeeDx Pty Ltd, Sydney, New South Wales, Australia.
    Golparian, Daniel
    Örebro University, School of Medical Sciences. WHO Collaborating Centre for Gonorrhoea and other Sexually Transmitted Infections, National Reference Laboratory for Sexually Transmitted Infections, Department of Laboratory Medicine.
    Erskine, Simon
    SpeeDx Pty Ltd, Sydney, New South Wales, Australia.
    Day, Michaela
    National Infection Service, Public Health England, London, UK.
    Whiley, David
    Faculty of Medicine, UQ Centre for Clinical Research, The University of Queensland, Herston, Queensland, Australia.
    Unemo, Magnus
    Örebro University, School of Medical Sciences. Örebro University Hospital. WHO Collaborating Centre for Gonorrhoea and other Sexually Transmitted Infections, National Reference Laboratory for Sexually Transmitted Infections, Department of Laboratory Medicine.
    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 gonorrhoeae2021In: Journal of Antimicrobial Chemotherapy, ISSN 0305-7453, E-ISSN 1460-2091, Vol. 76, no 1, p. 84-90Article in journal (Refereed)
    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).

  • 5.
    Hadad, Ronza
    et al.
    Örebro University, School of Medical Sciences. WHO Collaborating Centre for Gonorrhoea and other Sexually Transmitted Infections; National Reference Laboratory for STIs, Department of Laboratory Medicine.
    Golparian, Daniel
    Örebro University, School of Medical Sciences. WHO Collaborating Centre for Gonorrhoea and other Sexually Transmitted Infections; National Reference Laboratory for STIs, Department of Laboratory Medicine.
    Velicko, I.
    Department of Clinical Microbiology, Karolinska University Hospital, Stockholm, Sweden.
    Lindroth, Y.
    Department of Laboratory Medicine, Medical Microbiology, Lund University, Skåne Laboratory Medicine, Lund, Sweden.
    Ohlsson, A.
    Department of Clinical Microbiology, Karolinska University Hospital, Stockholm, Sweden.
    Fredlund, H.
    WHO Collaborating Centre for Gonorrhoea and other Sexually Transmitted Infections, Örebro, Sweden; National Reference Laboratory for STIs, Department of Laboratory Medicine, Örebro, Sweden; Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
    Unemo, Magnus
    Örebro University, School of Medical Sciences. Örebro University Hospital. WHO Collaborating Centre for Gonorrhoea and other Sexually Transmitted Infections; National Reference Laboratory for STIs, Department of Laboratory Medicine.
    GENOMIC EPIDEMIOLOGY OF NEISSERIA GONORRHOEAE ISOLATES IN SWEDEN-2016 NATIONAL STUDY2021In: Sexually Transmitted Infections, ISSN 1368-4973, E-ISSN 1472-3263, Vol. 97, no Suppl. 1, p. A135-A135Article in journal (Other academic)
    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.

  • 6.
    Hadad, Ronza
    et al.
    Örebro University, School of Medical Sciences. World Health Organization Collaborating Centre for Gonorrhoea and Other Sexually Transmitted Infections, National Reference Laboratory for Sexually Transmitted Infections, Department of Laboratory Medicine.
    Golparian, Daniel
    Örebro University, School of Medical Sciences. World Health Organization Collaborating Centre for Gonorrhoea and Other Sexually Transmitted Infections, National Reference Laboratory for Sexually Transmitted Infections, Department of Laboratory Medicine.
    Velicko, Inga
    Public Health Agency of Sweden, Solna, Sweden.
    Ohlsson, Anna-Karin
    Department of Clinical Microbiology, Karolinska University Hospital, Huddinge, Sweden.
    Lindroth, Ylva
    Department of Laboratory Medicine, Medical Microbiology, Lund University, Skåne Laboratory Medicine, Lund, Sweden.
    Ericson, Eva-Lena
    Department of Clinical Microbiology, Karolinska University Hospital, Huddinge, Sweden.
    Fredlund, Hans
    World Health Organization Collaborating Centre for Gonorrhoea and Other Sexually Transmitted Infections, National Reference Laboratory for Sexually Transmitted Infections, Department of Laboratory Medicine, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
    Engstrand, Lars
    Center for Translational Microbiome Research, Department of Microbiology, Tumor and Cell Biology, Science for Life Laboratory, Karolinska Institutet, Solna, Sweden.
    Unemo, Magnus
    Örebro University, School of Medical Sciences. Örebro University Hospital. World Health Organization Collaborating Centre for Gonorrhoea and Other Sexually Transmitted Infections, National Reference Laboratory for Sexually Transmitted Infections, Department of Laboratory Medicine.
    First National Genomic Epidemiological Study of Neisseria gonorrhoeae Strains Spreading Across Sweden in 20162022In: Frontiers in Microbiology, E-ISSN 1664-302X, Vol. 12, article id 820998Article in journal (Refereed)
    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.

  • 7.
    Hadad, Ronza
    et al.
    WHO Collaborating Centre for Gonorrhoea and other STIs, National Reference Laboratory for Pathogenic Neisseria, Örebro University Hospital, Örebro, Sverige; Department of Laboratory Medicine, Microbiology, Örebro University Hospital, Örebro, Sweden.
    Jacobsson, Susanne
    Örebro University, School of Health and Medical Sciences, Örebro University, Sweden. WHO Collaborating Centre for Gonorrhoea and other STIs, National Reference Laboratory for Pathogenic Neisseria, Örebro University Hospital, Örebro, Sverige; Department of Laboratory Medicine, Microbiology, Örebro University Hospital, Örebro, Sweden.
    Pizza, Mariagrazia
    Novartis V&D, Siena, Italy.
    Rappuoli, Rino
    Novartis V&D, Siena, Italy.
    Fredlund, Hans
    WHO Collaborating Centre for Gonorrhoea and other STIs, National Reference Laboratory for Pathogenic Neisseria, Örebro University Hospital, Örebro, Sverige; Department of Laboratory Medicine, Microbiology, Örebro University Hospital, Örebro, Sweden.
    Olcén, Per
    WHO Collaborating Centre for Gonorrhoea and other STIs, National Reference Laboratory for Pathogenic Neisseria, Örebro University Hospital, Örebro, Sverige; Department of Laboratory Medicine, Microbiology, Örebro University Hospital, Örebro, Sweden.
    Unemo, Magnus
    Örebro University, School of Health and Medical Sciences, Örebro University, Sweden. WHO Collaborating Centre for Gonorrhoea and other STIs, National Reference Laboratory for Pathogenic Neisseria, Örebro University Hospital, Örebro, Sverige; Department of Laboratory Medicine, Microbiology, Örebro University Hospital, Örebro, Sweden.
    Novel meningococcal 4CMenB vaccine antigens: prevalence and polymorphisms of the encoding genes in Neisseria gonorrhoeae2012In: Acta Pathologica, Microbiologica et Immunologica Scandinavica (APMIS), ISSN 0903-4641, E-ISSN 1600-0463, Vol. 120, no 9, p. 750-760Article in journal (Refereed)
    Abstract [en]

    The first cross-protective Neisseria meningitidis vaccine (focus on serogroup B), the protein-based 4 component meningococcus serogroup B (4CMenB), includes the New Zealand outer membrane vesicle and three main genome-derived neisserial antigens (GNAs). These GNAs are fHbp (fused to GNA2091), NHBA (fused to GNA1030) and NadA. In this study, the prevalence and polymorphisms of the nucleotide and amino acid sequences of the 4CMenB antigens in a temporally and geographically diverse collection of N. gonorrhoeae isolates (n similar to=similar to 111) were investigated. All the examined GNA genes, except the nadA gene, were present in all gonococcal isolates. However, 25 isolates contained premature stop codons in the fHbp gene and/or the nhba gene, resulting in truncated proteins. Compared with the 4CMenB antigen sequences in reference strain MC58, the gonococcal strains displayed 67.095.4% and 60.994.9% identity in nucleotide sequence and amino acid sequence, respectively, in the equivalent GNA antigens. The absence of NadA, lack of universal expression of fHbp and NHBA and the uncertainty regarding the surface exposure of fHbp as well as the function of NHBA in N. gonorrhoeae will likely limit the use of the identical 4CMenB antigens in a gonococcal vaccine. However, possible cross-immunity of 4CMenB with gonococci and expression and function of the equivalent gonococcal GNAs, as well as of more appropriate GNAs for a gonococcal vaccine, need to be further examined.

  • 8.
    Hadad, Ronza
    et al.
    Örebro Life Science Center, School of Science and Technology, Örebro University, Örebro, Sweden; Department of Laboratory Medicine, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
    Marks, Ellen
    Department of Medical Microbiology and Immunology, University of Gothenburg, Gothenburg, Sweden.
    Kalbina, Irina
    Örebro University, School of Science and Technology.
    Schön, Karin
    Department of Medical Microbiology and Immunology, University of Gothenburg, Gothenburg, Sweden.
    Unemo, Magnus
    Örebro University, School of Medical Sciences. Department of Laboratory Medicine.
    Lycke, Nils
    Department of Medical Microbiology and Immunology, University of Gothenburg, Gothenburg, Sweden.
    Strid, Åke
    Örebro University, School of Science and Technology. Örebro Life Science Center.
    Andersson, Sören
    Örebro University, School of Medical Sciences. Department of Laboratory Medicine.
    Protection against genital tract Chlamydia trachomatis infection following intranasal immunization with a novel recombinant MOMP VS2/4 antigen2016In: Acta Pathologica, Microbiologica et Immunologica Scandinavica (APMIS), ISSN 0903-4641, E-ISSN 1600-0463, Vol. 124, p. 1078-1086Article in journal (Refereed)
    Abstract [en]

    The asymptomatic nature of most Chlamydia trachomatis infections and the lack of appropriate effects by current prevention and management call for vaccine development. We evaluated a recombinant subunit vaccine candidate based on the major outer membrane protein variable segments 2 and 4 (MOMP VS2/4). To achieve maximal immunogenicity and ease of production and purification, MOMP VS2/4 was constructed by using highly immunogenic sequences of MOMP only, thereby minimizing the presence of hydrophobic regions, and spacing the immunogenic epitopes with a flexible amino acid sequence. A purification tag was also added. The MOMP VS2/4 was given intranasally, with or without intravaginal boost, with cholera toxin (CT) adjuvant to C57BL/6 mice, which were screened for immunogenicity and protection against a live challenge infection with C. trachomatis serovar D. Bacterial shedding, cell-mediated responses, and antibody responses were monitored. Immunized mice exhibited significantly less bacterial shedding and were better protected against infertility as compared to unimmunized control mice. Immunizations stimulated both systemic and local specific antibody (IgG1, IgG2c, and IgA) responses, and primed T cells that produced interferon-c and interleukins 13 and 17 upon challenge with recall antigen. Thus, MOMP VS2/4, in combination with CT adjuvant, stimulated Th1, Th2, and Th17 effector cells, and generated protective immunity associated with less pathology. We regard MOMP VS2/4 as a promising candidate for further development into a mucosal chlamydial vaccine.

  • 9.
    Hadad, Ronza
    et al.
    Örebro University, School of Science and Technology.
    Schön, Karin
    University of Gothenburg, Gothenburg, Sweden.
    Strid, Åke
    Örebro University, School of Science and Technology.
    Andersson, Sören
    Örebro University Hospital, Örebro, Sweden.
    Unemo, Magnus
    Örebro University Hospital, Örebro, Sweden.
    Lycke, Nils
    University of Gothenburg, Gothenburg, Sweden.
    Optimization of infection in murine model with Chlamydia trachomatis for vaccine studies2013In: Chlamydia Basic Research Society: 2013 biannual meeting, 2013Conference paper (Refereed)
    Abstract [en]

    Background and Significance: Vaccine studies for Chlamydia trachomatis (Ct) have been hampered by the lack of an ideal murine model. Ct is not ideal for infection and subsequent pathology as it is a human pathogen and C. muridarum (Cm) may not be suitable due to vaccine specificity for Ct. There is currently no standardization of chlamydial infections in murine models concerning mouse strain, infecting agent and dose.

     

    Objectives: To investigate the Ct infection in mice, using different suppliers of mice, doses and the infective agents of Ct serovars D, E and Cm.

     

    Methods: C57BL/6 mice (Taconic; Harlan; in-house breeding mice) were inoculated intravaginally with 103-105 chlamydia  elementary bodies (EB). Vaginal samples were collected at 7-8 days intervals and analyzed using MicroTrak II Chlamydia EIA kit.

     

    Results: Taconic mice inoculated with Ct D with 105 EB showed the strongest infection with 30% of mice infected at day 21 (d21) as seen in figure 1. The number of infected mice and detected antigen (not shown) decreased rapidly after the first time-point (d8). In figure 2 infective agents were analyzed. Ct E did not infect any mice despite using a tenfold increased dose. Cm infection was detectable in 80% of the mice for up to d21.

     

    Conclusions: Ct D infected the mice for a period of 2-3 weeks. There was only a small difference between the suppliers in favor for Harlan mice. Ct D 105 EB was the infectious dose with the highest number of infected mice over time, however the appropriateness of that high bacterial load must be considered. Ct E did not infect these mice and Cm, a mouse pneumonitis strain, infected all mice and had the longest duration of infection. However, for vaccine studies, Cm may not be suitable due to lack of cross reactivity and Ct may still be used however vaginal sampling must be more frequent early on to show significant differences in bacterial shedding between immunized and non-immunized mice. 

  • 10.
    Hadad, Ronza
    et al.
    Örebro University, School of Medical Sciences. WHO Collaborating Centre for Gonorrhoea and Other STIs, National Reference Laboratory for STIs, Department of Laboratory Medicine, Microbiology.
    Skov Jensen, Jørgen
    Department for Bacteria, Parasites and Fungi, Infectious Diseases Preparedness, Statens Serum Institut, Copenhagen, Denmark.
    Westh, Henrik
    Department of Clinical Microbiology, Hvidovre University Hospital, Hvidovre, Denmark.
    Grønbaek, Ida
    Department of Clinical Microbiology, Hvidovre University Hospital, Hvidovre, Denmark.
    Jessen Schwartz, Lasse
    Department for Bacteria, Parasites and Fungi, Infectious Diseases Preparedness, Statens Serum Institut, Copenhagen, Denmark.
    Nielsen, Lene
    Department of Clinical Microbiology, Copenhagen University Hospital, Herlev, Denmark.
    Müller Vang, Tobias
    Department of Clinical Microbiology, Copenhagen University Hospital, Herlev, Denmark.
    Nielsen, Rikke
    Department of Clinical Microbiology, Aalborg University Hospital, Aalborg, Denmark.
    Sandborg Weinreich, Lenette
    Department of Clinical Microbiology, Aalborg University Hospital, Aalborg, Denmark.
    Skov, Marianne N.
    Department of Clinical Microbiology, Odense University Hospital, Odense, Denmark.
    Olsen, Marlene
    Department of Clinical Microbiology, Odense University Hospital, Odense, Denmark.
    Kjølseth Møller, Jens
    Department of Clinical Microbiology, Vejle University Hospital, Vejle, Denmark.
    Kolmos, Birte
    Department of Clinical Microbiology, Vejle University Hospital, Vejle, Denmark.
    Unemo, Magnus
    Örebro University, School of Medical Sciences. Örebro University Hospital. WHO Collaborating Centre for Gonorrhoea and Other STIs, National Reference Laboratory for STIs, Department of Laboratory Medicine, Microbiology.
    Hoffmann, Steen
    Department for Bacteria, Parasites and Fungi, Infectious Diseases Preparedness, Statens Serum Institut, Copenhagen, Denmark.
    A Chlamydia trachomatis 23S rRNA G1523A variant escaping detection in the Aptima Combo 2 assay (Hologic) was widespread across Denmark in July-September 20192020In: Acta Pathologica, Microbiologica et Immunologica Scandinavica (APMIS), ISSN 0903-4641, E-ISSN 1600-0463, Vol. 128, no 6, p. 440-444Article in journal (Refereed)
    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.

  • 11.
    Hadfield, James
    et al.
    Pathogen Genomics, The Wellcome Trust Sanger Institute, Wellcome Trust Genome Campus, Hinxton, United Kingdom.
    Harris, Simon R
    Pathogen Genomics, The Wellcome Trust Sanger Institute, Wellcome Trust Genome Campus, Hinxton, United Kingdom.
    Seth-Smith, Helena M B
    Pathogen Genomics, The Wellcome Trust Sanger Institute, Wellcome Trust Genome Campus, Hinxton, United Kingdom; Applied Microbiology Research, Department of Biomedicine, University of Basel, Basel, Switzerland; Clinical Microbiology, University Hospital Basel, Basel, Switzerland.
    Parmar, Surendra
    Public Health England, Public Health Laboratory Cambridge, Addenbrooke's Hospital, Cambridge, United Kingdom.
    Andersson, Patiyan
    Menzies School of Health Research, Darwin NT, Australia.
    Giffard, Philip M.
    Menzies School of Health Research, Darwin NT, Australia; School of Psychological and Clinical Sciences, Charles Darwin University, Darwin, Australia.
    Schachter, Julius
    Department of Laboratory Medicine, University of California, San Francisco CA, USA.
    Moncada, Jeanne
    Department of Laboratory Medicine, University of Californiao, San Francisco CA, USA.
    Ellison, Louise
    Pathogen Genomics, The Wellcome Trust Sanger Institute, Wellcome Trust Genome Campus, Hinxton, United Kingdom.
    Vaulet, María Lucía Gallo
    Facultad de Farmacia y Bioquímica, Departamento de Bioquímica Clínica, Microbiología Clínica, Universidad de Buenos Aires, Buenos Aires, Argentina.
    Fermepin, Marcelo Rodríguez
    Facultad de Farmacia y Bioquímica, Departamento de Bioquímica Clínica, Microbiología Clínica, Universidad de Buenos Aires, Buenos Aires, Argentina.
    Radebe, Frans
    Centre for HIV and Sexually Transmitted Infections, National Institute for Communicable Diseases, National Health Laboratory Service, Johannesburg, South Africa.
    Mendoza, Suyapa
    Jefe Laboratorio de ITS, Laboratorio Nacional de Vigilancia, Honduras.
    Ouburg, Sander
    Department of Medical Microbiology and Infection Control, Laboratory of Immunogenetics, Vrije University Medical Center, Amsterdam, The Netherlands.
    Morré, Servaas A
    Department of Medical Microbiology and Infection Control, Laboratory of Immunogenetics, Vrije University Medical Center, Amsterdam, The Netherlands; Department of Genetics and Cell Biology, Institute of Public Health Genomics, School for Oncology & Developmental Biology (GROW), Faculty of Health, Medicine and Life Sciences, University of Maastricht, Maastricht, The Netherlands.
    Sachse, Konrad
    Institute of Molecular Pathogenesis, Friedrich-Loeffler-Institut (Federal Research Institute for Animal Health), Jena, Germany.
    Puolakkainen, Mirja
    Department of Virology, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.
    Korhonen, Suvi J
    Department of Virology, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.
    Sonnex, Chris
    Public Health England, Public Health Laboratory Cambridge, Addenbrooke's Hospital, Cambridge, United Kingdom.
    Wiggins, Rebecca
    Department of Biology, University of York, York, United Kingdom.
    Jalal, Hamid
    Public Health England, Public Health Laboratory Cambridge, Addenbrooke's Hospital, Cambridge, United Kingdom.
    Brunelli, Tamara
    Clinical Chemistry and Microbiology Laboratory, Santo Stefano Hospital, Prato, Italy.
    Casprini, Patrizia
    Clinical Chemistry and Microbiology Laboratory, Santo Stefano Hospital, Prato, Italy.
    Pitt, Rachel
    Sexually Transmitted Bacteria Reference Unit, Microbiological Services, Public Health England, London, United Kingdom.
    Ison, Cathy
    Sexually Transmitted Bacteria Reference Unit, Microbiological Services, Public Health England, London, United Kingdom.
    Savicheva, Alevtina
    Laboratory of Microbiology, D.O. Ott Research Institute of Obstetrics and Gynecology, St. Petersburg, Russia.
    Shipitsyna, Elena
    Laboratory of Microbiology, D.O. Ott Research Institute of Obstetrics and Gynecology, St. Petersburg, Russia; WHO Collaborating Centre for Gonorrhoea and other STIs, Faculty of Medicine and Health, Örebro University Hospital, Örebro, Sweden.
    Hadad, Ronza
    Örebro University, School of Science and Technology. WHO Collaborating Centre for Gonorrhoea and other STIs, Örebro University Hospital, Örebro, Sweden.
    Kari, Laszlo
    Laboratory of Intracellular Parasites, Rocky Mountain Laboratories, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Hamilton Montana, USA.
    Burton, Matthew J
    Clinical Research Department, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, United Kingdom.
    Mabey, David
    Centre for Infectious Diseases and Microbiology, Sydney, Australia; Marie Bashir Institute for Infectious Diseases and Biosecurity, Westmead Clinical School, University of Sydney, Sydney, Australia.
    Solomon, Anthony W
    Centre for Infectious Diseases and Microbiology, Sydney, Australia; Marie Bashir Institute for Infectious Diseases and Biosecurity, Westmead Clinical School, University of Sydney, Sydney, Australia.
    Lewis, David
    Centre for HIV and Sexually Transmitted Infections, National Institute for Communicable Diseases, National Health Laboratory Service, Johannesburg, South Africa; Centre for Infectious Diseases and Microbiology, Sydney, Australia; Marie Bashir Institute for Infectious Diseases and Biosecurity, Westmead Clinical School, University of Sydney, Sydney, Australia.
    Marsh, Peter
    Public Health England, Public Health Laboratory Southampton, Southampton General Hospital, Southampton, United Kingdom.
    Unemo, Magnus
    Örebro University, School of Medical Sciences; WHO Collaborating Centre for Gonorrhoea and other STIs, Örebro University Hospital, Örebro, Sweden.
    Clarke, Ian N
    Molecular Microbiology Group, University Medical School, Southampton General Hospital, Southampton, United Kingdom.
    Parkhill, Julian
    Pathogen Genomics, The Wellcome Trust Sanger Institute, Wellcome Trust Genome Campus, Hinxton, United Kingdom.
    Thomson, Nicholas R.
    Pathogen Genomics, The Wellcome Trust Sanger Institute, Wellcome Trust Genome Campus, Hinxton, United Kingdom; Department of Pathogen Molecular Biology, The London School of Hygiene and Tropical Medicine, London, United Kingdom.
    Comprehensive global genome dynamics of Chlamydia trachomatis show ancient diversification followed by contemporary mixing and recent lineage expansion2017In: Genome Research, ISSN 1088-9051, E-ISSN 1549-5469, Vol. 27, no 7, p. 1220-1229Article in journal (Refereed)
    Abstract [en]

    Chlamydia trachomatis is the world's most prevalent bacterial sexually transmitted infection and leading infectious cause of blindness, yet it is one of the least understood human pathogens, in part due to the difficulties of in vitro culturing and the lack of available tools for genetic manipulation. Genome sequencing has reinvigorated this field, shedding light on the contemporary history of this pathogen. Here, we analyze 563 full genomes, 455 of which are novel, to show that the history of the species comprises two phases, and conclude that the currently circulating lineages are the result of evolution in different genomic ecotypes. Temporal analysis indicates these lineages have recently expanded in the space of thousands of years, rather than the millions of years as previously thought, a finding that dramatically changes our understanding of this pathogen's history. Finally, at a time when almost every pathogen is becoming increasingly resistant to antimicrobials, we show that there is no evidence of circulating genomic resistance in C. trachomatis.

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    Comprehensive global genome dynamics of Chlamydia trachomatis show ancient diversification followed by contemporary mixing and recent lineage expansion
  • 12.
    Herrmann, Björn
    et al.
    Section of Clinical Bacteriology, Department of Medical Sciences, Uppsala University, Uppsala, Sweden.
    Eden, Desiree
    Section of Clinical Bacteriology, Department of Medical Sciences, Uppsala University, Uppsala, Sweden.
    Hadad, Ronza
    WHO Collaborating Centre for Gonorrhoea and Other STIs, Örebro University Hospital, Örebro, Sweden.
    Christerson, Linus
    Section of Clinical Bacteriology, Department of Medical Sciences, Uppsala University, Uppsala, Sweden.
    Loré, Britta
    Department of Clinical Microbiology, Falu Lasarett, Falun, Sweden.
    Österlund, Anders
    Communicable Disease Prevention and Control, Sunderby Hospital, Luleå, Sweden.
    Larsson, Inger
    Department of Clinical Microbiology, Sunderby Hospital, Luleå, Sweden.
    Sylvan, Staffan
    Department of Communicable Diseases Control and Prevention, Uppsala County Council, Uppsala, Sweden.
    Fredlund, Hans
    Örebro University Hospital. WHO Collaborating Centre for Gonorrhoea and Other STIs , Örebro University Hospital, Örebro, Sweden.
    Unemo, Magnus
    Örebro University Hospital. WHO Collaborating Centre for Gonorrhoea and Other STIs, Örebro University Hospital, Örebro, Sweden.
    Prevalence Trends of the New Variant of Chlamydia trachomatis in Four Counties of Sweden in 2007-20112012In: Sexually Transmitted Diseases, ISSN 0148-5717, E-ISSN 1537-4521, Vol. 39, no 8, p. 648-650Article in journal (Refereed)
    Abstract [en]

    A new variant of Chlamydia trachomatis (nvCT) was discovered in Sweden in 2006, and it could not be detected by diagnostic systems from Abbott and Roche, whereas the third system used, from Becton Dickinson (BD), detects nvCT. We analyzed 3648 samples from 2 counties that used Roche and 2 counties that used BD methods from 2007 to 2011. After implementation of a Roche method that detects nvCT, its proportion has decreased and converged in the 4 counties but are still at different levels in Roche and BD counties. Future studies are needed to see if nvCT will decline further.

  • 13.
    Hilmarsdóttir, Ingibjörg
    et al.
    Department of Microbiology, Landspítali-The University Hospital of Iceland, Reykjavík, Iceland ; Faculty of Medicine, University of Iceland, Reykjavík, Iceland.
    Arnardóttir, Eva Mjöll
    Department of Microbiology, Landspítali-The University Hospital of Iceland, Reykjavík, Iceland; Faculty of Medicine, University of Iceland, Reykjavík, Iceland.
    Jóhannesdóttir, Elísabet Reykdal
    Department of Sexually Transmitted Diseases, Landspítali-The University Hospital of Iceland, Reykjavík, Iceland.
    Valsdóttir, Freyja
    Department of Microbiology, Landspítali-The University Hospital of Iceland, Reykjavík, Iceland.
    Golparian, Daniel
    Örebro University, School of Medical Sciences. WHO Collaborating Centre for Gonorrhoea and other Sexually Transmitted Infections, Department of Laboratory Medicine.
    Hadad, Ronza
    Örebro University, School of Medical Sciences. WHO Collaborating Centre for Gonorrhoea and other Sexually Transmitted Infections, Department of Laboratory Medicine.
    Vigfússon, Hannes Bjarki
    Department of Microbiology, Landspítali-The University Hospital of Iceland, Reykjavík, Iceland.
    Unemo, Magnus
    Örebro University, School of Medical Sciences. Örebro University Hospital. WHO Collaborating Centre for Gonorrhoea and other Sexually Transmitted Infections, Department of Laboratory Medicine.
    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 diagnosis2020In: Journal of Clinical Microbiology, ISSN 0095-1137, E-ISSN 1098-660X, Vol. 58, no 9, article id e01084-20Article in journal (Refereed)
    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.

  • 14.
    Johansen, Tone Bjordal
    et al.
    Norwegian Institute of Public Health, Oslo, Norway; European Public Health Microbiology Training Programme (EUPHEM), European Centre for Disease Prevention and Control (ECDC), Stockholm, Sweden.
    Kløvstad, Hilde
    Norwegian Institute of Public Health, Oslo, Norway.
    Rykkvin, Rikard
    Norwegian Institute of Public Health, Oslo, Norway.
    Herrfurth-Erichsen, Einar Bredo
    Fürst Medical Laboratory, Oslo, Norway.
    Sorthe, Joakim
    Fürst Medical Laboratory, Oslo, Norway.
    Njølstad, Gro
    Haukeland University Hospital, Bergen, Norway.
    Ebbesen, Marit Helen
    Haukeland University Hospital, Bergen, Norway.
    Nygaard, Randi Monsen
    Haukeland University Hospital, Bergen, Norway.
    Sandmoen, Ellen Kristin
    Tønsberg Hospital Trust, Department of Medical Microbiology, Tønsberg, Norway.
    Thilesen, Carina
    Unilabs Laboratory Medicine, Department of Medical Microbiology, Skien, Norway.
    Onken, Annette
    Vestre Viken Hospital Trust, Department of Microbiology, Drammen, Norway.
    Liljedal, Inger
    Levanger Hospital, Department for Laboratory Medicine, Levanger, Norway.
    Hadad, Ronza
    Örebro University, School of Medical Sciences. WHO Collaborating Centre for Gonorrhoea and other STIs, National Reference Laboratory for STIs, Department of Laboratory Medicine.
    Unemo, Magnus
    Örebro University, School of Medical Sciences. Örebro University Hospital. WHO Collaborating Centre for Gonorrhoea and other STIs, National Reference Laboratory for STIs, Department of Laboratory Medicine.
    The 'Finnish new variant of Chlamydia trachomatis' escaping detection in the Aptima Combo 2 assay is widespread across Norway, June to August 20192019In: Eurosurveillance, ISSN 1025-496X, E-ISSN 1560-7917, Vol. 24, no 42, p. 2-6Article in journal (Refereed)
    Abstract [en]

    The 'Finnish new variant of Chlamydia trachomatis' (FI-nvCT), escaping detection in the Aptima Combo 2 assay (AC2), is widespread across Norway. From June to August 2019, 84% (81/97) of available AC2/Aptima CT discordant samples from five laboratories were confirmed as FI-nvCT. Two additional CT variants (CT 23S rRNA C1514T and G1523A) also escaped AC2 detection. The high FI-nvCT proportion might indicate a long-term national spread and it cannot be excluded that FI-nvCT emerged in Norway.

  • 15.
    Lindh, Ingrid
    et al.
    Örebro University, School of Science and Technology. Örebro Life Sci Ctr, Univ Örebro, Örebro, Sweden; Sch Sci & Technol, Univ Örebro, Örebro, Sweden.
    Bråve, Andreas
    Swedish Institute for Communicable Disease Control (SMI), Stockholm, Sweden.
    Hallengärd, David
    Dept Microbiol Tumor & Cell Biol, Karolinska Inst, Stockholm, Sweden.
    Hadad, Ronza
    Örebro University, School of Science and Technology. Örebro Life Sci Ctr, Univ Örebro, Örebro, Sweden.
    Kalbina, Irina
    Örebro University, School of Science and Technology. Örebro Life Sci Ctr, Univ Örebro, Örebro, Sweden.
    Strid, Åke
    Örebro University, School of Science and Technology. Örebro Life Sci Ctr, Univ Örebro, Örebro, Sweden.
    Andersson, Sören
    Örebro University Hospital. Örebro Life Sci Ctr, Univ Örebro, Örebro, Sweden; Örebro University Hospital, Örebro, Sweden.
    Oral delivery of plant-derived HIV-1 p24 antigen in low doses shows a superior priming effect in mice compared to high doses2014In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 32, no 20, p. 2288-2293Article in journal (Refereed)
    Abstract [en]

    During early infection with human immunodeficiency virus type 1 (HIV-1), there is a rapid depletion of CD4+ T-cells in the gut-associated lymphoid tissue (GALT) in the gastrointestinal tract. Therefore, immediate protection at these surfaces is of high priority for the development of an HIV-1 vaccine. Thus, transgenic plants expressing HIV-1 antigens, which are exposed to immune competent cells in the GALT during oral administration, can be interesting as potential vaccine candidates. In the present study, we used two HIV-1 p24 antigen-expressing transgenic plant systems, Arabidopsis thaliana and Daucus carota, in oral immunization experiments. Both transgenic plant systems showed a priming effect in mice and induced humoral immune responses, which could be detected as anti-p24-specific IgG in sera after an intramuscular p24 protein boost. Dose-dependent antigen analyses using transgenic Arabidopsis thaliana indicated that low p24 antigen doses were superior to high p24 antigen doses

  • 16.
    Lindh, Ingrid
    et al.
    Örebro University, School of Science and Technology.
    Bråve, Andreas
    Swedish Institute for Communicable Disease Control, The Public Health Agency of Sweden, Stockholm, Sweden.
    Hallengärd, David
    Swedish Institute for Communicable Disease Control, The Public Health Agency of Sweden, Stockholm, Sweden.
    Hadad, Ronza
    Örebro University, School of Science and Technology.
    Strid, Åke
    Örebro University, School of Science and Technology.
    Andersson, Sören
    Örebro University Hospital, Örebro, Sweden.
    Oral delivery of transgenic plant-derived HIV-1 p24 antigen in low doses shows a superior priming effect in mice compared to higher doses2012In: Retrovirology, E-ISSN 1742-4690, Vol. 9, no Suppl. 2, article id P336Article in journal (Refereed)
    Abstract [en]

    Background

    The gut associated lymphoid tissue (GALT) includes around two thirds of the total lymphoid system. CD4+ T-cells in the GALT are a main target for HIV during primary infection. Thus, immunization targetting GALT is likely to be of importance for an effective vaccine strategy. Transgenic plants expressing HIV antigens can reach GALT conveniently. This system allows multiple boosts, has simple logistics (no cold chain, no injections) and large production capacity.

    Methods

    Three groups of mice were given extract from plant lines expressing HIV-1 p24 at (A) low level (20 ng/feeding); (B) high level (460 ng/feeding); (C) control (wild type, 0 ng). No adjuvant was included. The extracts were administered by gastric tube day 0, 14 and 28. On day 55 all mice were given an intramuscular (i.m.) boost with 10 micrograms of purified p24 antigen. Immune responses were determined by measurement of p24-antibodies in serum by ELISA.

    Results

    The mice immunized by the low dose plant line (A) showed a higher systemic immune response after i.m. boost compared to the high dose group (B). The w.t. controls (C) had undetectable p24-responses. The responses in group A were 3 to 10 times higher (ELISA OD values) than in group B. Pre-boost antibody responses were at background levels in all groups. Preliminary analyses indicate a predomninant Th1-type response (antigen-specific IgG2a higher than IgG1).

    Conclusion

    Simple and inexpensive means of vaccination are important in order to reach large numbers of people with effective vaccine regimens. The HIV-1 p24 low dose transgenic plant extracts given orally showed a superior priming effect in mice compared to the p24 high dose extracts. This could be an immunization method and route worth exploring further.

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  • 17.
    Philipova, I.
    et al.
    Department of Microbiology, National Center of Infectious and Parasitic Diseases, Sofia, Bulgaria.
    Hadad, Ronza
    Örebro University, School of Medical Sciences. Örebro University Hospital. WHO Collaborating Centre for Gonorrhoea and other Sexually Transmitted Infections, National Reference Laboratory for Sexually Transmitted Infections, Department of Laboratory Medicine.
    Levterova, V.
    Department of Microbiology, National Center of Infectious and Parasitic Diseases, Sofia, Bulgaria.
    Kantardjiev, T.
    Department of Microbiology, National Center of Infectious and Parasitic Diseases, Sofia, Bulgaria.
    Unemo, Magnus
    Örebro University, School of Medical Sciences. Örebro University Hospital. WHO Collaborating Centre for Gonorrhoea and other Sexually Transmitted Infections, National Reference Laboratory for Sexually Transmitted Infections, Department of Laboratory Medicine, Örebro University, Örebro, Sweden; University College London (UCL), London, UK.
    Mycoplasma genitalium antimicrobial (azithromycin and moxifloxacin) resistance and treatment outcome in Sofia, Bulgaria, 2018-20212023In: 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 (Refereed)
  • 18.
    Shipitsyna, Elena
    et al.
    World Health Organization Collaborating Centre for Gonorrhoea and Other STIs, Department of Laboratory Medicine, Microbiology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden; Department of Medical Microbiology, D.O. Ott Research Institute of Obstetrics, Gynecology and Reproductology, St. Petersburg, Russia.
    Kularatne, Ranmini
    Labtests Laboratory and Head Office, Mt Wellington, Auckland, New Zealand; Department of Clinical Microbiology & Infectious Diseases, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
    Golparian, Daniel
    Örebro University, School of Medical Sciences. World Health Organization Collaborating Centre for Gonorrhoea and Other STIs, Department of Laboratory Medicine, Microbiology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
    Müller, Etienne E.
    Centre for HIV and STIs, National Institute for Communicable Diseases, National Health Laboratory Service, Johannesburg, South Africa.
    Vargas, Silver K.
    School of Public Health and Administration, Centre for Interdisciplinary Investigation in Sexuality, AIDS, Society and Laboratory of Sexual Health, Universidad Peruana Cayetano Heredia, Universidad Peruana Cayetano Heredia, Lima, Peru.
    Hadad, Ronza
    Örebro University, School of Medical Sciences. Örebro University Hospital. World Health Organization Collaborating Centre for Gonorrhoea and Other STIs, Department of Laboratory Medicine, Microbiology.
    Padovese, Valeska
    Genitourinary Clinic, Department of Dermatology and Venereology, Mater Dei Hospital, Msida, Malta.
    Hancali, Amina
    STIs Laboratory, National Institute of Hygiene, Ministry of Health, Rabat, Morocco.
    Alvarez, Christian S.
    Sida y Sociedad ONG (SISO), Escuintla, Guatemala.
    Oumzil, Hicham
    STIs Laboratory, National Institute of Hygiene, Ministry of Health, Rabat, Morocco; Faculty of Medicine and Pharmacy, University Mohamed V, Rabat, Morocco.
    Camey, Elsy
    Sida y Sociedad ONG (SISO), Escuintla, Guatemala.
    Blondeel, Karel
    Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland; Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.
    Toskin, Igor
    Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland.
    Unemo, Magnus
    Örebro University, School of Medical Sciences. Örebro University Hospital. World Health Organization Collaborating Centre for Gonorrhoea and Other STIs, Department of Laboratory Medicine, Microbiology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden; Institute for Global Health, University College London (UCL), London, United Kingdom.
    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, 2019-20212023In: Frontiers in Microbiology, E-ISSN 1664-302X, Vol. 14, article id 1130762Article in journal (Refereed)
    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.

  • 19.
    Unemo, Magnus
    et al.
    Örebro University, School of Medical Sciences. Örebro University Hospital. World Health Organization, Collaborating Centre for Gonorrhoea and Other Sexually Transmitted Infections (STIs), National Reference Laboratory for STIs, Department of Laboratory Medicine, Clinical Microbiology.
    Hansen, Marit
    World Health Organization, Collaborating Centre for Gonorrhoea and Other Sexually Transmitted Infections (STIs), National Reference Laboratory for STIs, Department of Laboratory Medicine, Clinical Microbiology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
    Hadad, Ronza
    Örebro University, School of Medical Sciences. World Health Organization, Collaborating Centre for Gonorrhoea and Other Sexually Transmitted Infections (STIs), National Reference Laboratory for STIs, Department of Laboratory Medicine, Clinical Microbiology.
    Puolakkainen, Mirja
    Department of Virology and Immunology, University of Helsinki, Helsinki University Hospital, HUSLAB, Helsinki, Finland.
    Westh, Henrik
    Department of Clinical Medicine, Faculty of Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Department of Clinical Microbiology, Hvidovre University Hospital, Hvidovre, Denmark.
    Rantakokko-Jalava, Kaisu
    Department of Clinical Microbiology, Turku University Hospital, Turku, Finland.
    Thilesen, Carina
    Department of Microbiology, Unilabs Laboratory Medicine, Skien, Norway.
    Cole, Michelle J.
    National Infection Service, Public Health England, London, United Kingdom.
    Boiko, Iryna
    World Health Organization, Collaborating Centre for Gonorrhoea and Other Sexually Transmitted Infections (STIs), National Reference Laboratory for STIs, Department of Laboratory Medicine, Clinical Microbiology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden; Department of Functional and Laboratory Diagnostics, I. Horbachevsky Ternopil National Medical University, Ternopil, Ukraine.
    Lan, Pham T.
    Hanoi Medical University, National Hospital of Dermatology and Venereology, Hanoi, Viet Nam.
    Golparian, Daniel
    Örebro University, School of Medical Sciences. World Health Organization, Collaborating Centre for Gonorrhoea and Other Sexually Transmitted Infections (STIs), National Reference Laboratory for STIs, Department of Laboratory Medicine, Clinical Microbiology.
    Ito, Shin
    iClinic, Sendai, Miyagi, Japan.
    Sundqvist, Martin
    Örebro University, School of Medical Sciences. Örebro University Hospital. World Health Organization, Collaborating Centre for Gonorrhoea and Other Sexually Transmitted Infections (STIs), National Reference Laboratory for STIs, Department of Laboratory Medicine, Clinical Microbiology.
    Sensitivity, specificity, inclusivity and exclusivity of the updated Aptima Combo 2 assay, which provides detection coverage of the new diagnostic-escape Chlamydia trachomatis variants2020In: BMC Infectious Diseases, E-ISSN 1471-2334, Vol. 20, no 1, article id 419Article in journal (Refereed)
    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.

  • 20.
    Weinbaum, Barbara
    et al.
    Research and Development, Hologic Inc., San Diego, United States.
    Williams, Analee
    Research and Development, Hologic Inc., San Diego, United States.
    Hadad, Ronza
    Örebro University, School of Medical Sciences. World Health Organization Collaborating Centre for Gonorrhoea and Other Sexually Transmitted Infections (STIs), National Reference Laboratory for STIs, Department of Laboratory Medicine.
    Vinluan, Bryan
    Research and Development, Hologic Inc., San Diego, United States.
    Puolakkainen, Mirja
    Department of Virology and Immunology, University of Helsinki and Helsinki University Hospital, HUSLAB, Helsinki, Finland.
    Unemo, Magnus
    Örebro University, School of Medical Sciences. Örebro University Hospital. World Health Organization Collaborating Centre for Gonorrhoea and Other Sexually Transmitted Infections (STIs), National Reference Laboratory for STIs, Department of Laboratory Medicine.
    Getman, Damon
    Research and Development, Hologic Inc., San Diego, United States.
    Validation of an Aptima-format Finnish new variant of Chlamydia trachomatis (FI-nvCT) surveillance assay, 20192020In: Eurosurveillance, ISSN 1025-496X, E-ISSN 1560-7917, Vol. 25, no 5, p. 16-22, article id 2000038Article in journal (Refereed)
    Abstract [en]

    The Finnish new variant of Chlamydia trachomatis (FI-nvCT) is escaping diagnostics in Finland, Norway and Sweden. We have developed and validated an Aptima-format nucleic acid amplification test (NAAT) designed specifically to detect the FI-nvCT. This NAAT has high sensitivity (100%) and specificity (100%) for the FI-nvCT strain, enabling further investigation of the geographic distribution, prevalence and transmission of this diagnostic-escape mutant in screening populations in Europe.

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