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1.
  • Butylkina, Rita, et al. (author)
  • Pooling of urine specimens allows accurate and cost-effective genetic detection of Chlamydia trachomatis in Lithuania and other low-resource countries
  • 2007
  • In: Scandinavian Journal of Infectious Diseases. - : Informa UK Limited. - 0036-5548 .- 1651-1980. ; 39:3, s. 209-212
  • Journal article (peer-reviewed)abstract
    • The aims of this study were to compare performance characteristics and cost-effectiveness of pooling urine samples for screening and diagnosis of Chlamydia trachomatis using Digene Hybrid Capture II CT/NG Test (HCII), and to examine the prevalence of C. trachomatis in male military recruits in Lithuania. A total of 410 urine samples were individually tested and pooled by 5 and 10 samples, respectively. The sensitivity and specificity of diagnosis were not affected by either pooling strategy. The estimated population prevalence of C. trachomatis infection was nearly identical, i.e. 4.4%, 4.4% and 4.1% based on individually tested samples, and samples pooled by 5 and 10, respectively. For this estimation of the population prevalence, pooling 5 samples reduced the costs by 80% and pooling 10 samples reduced the costs by 90%. For diagnosis of each individual sample, the pooling strategies resulted in cost savings of 60% (5 samples per pool) and 56% (10 samples per pool). The present pooling strategies were sensitive, specific and cost-efficient for screening and diagnosis of C. trachomatis infection in male military recruits in Lithuania. The strategies would be most useful for reasonably inexpensive large-scale screening, prevalence studies and even diagnostics in Lithuania and many other low-resource countries.
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  • Domeika, Marius, et al. (author)
  • Guidelines for the laboratory diagnosis of Chlamydia trachomatis infections in East European countries
  • 2009
  • In: Journal of the European Academy of Dermatology and Venereology. - : Wiley. - 0926-9959 .- 1468-3083. ; 23:12, s. 1353-1363
  • Research review (peer-reviewed)abstract
    • The present guidelines aim to provide comprehensive information regarding the laboratory diagnosis of infections caused by Chlamydia trachomatis in East European countries. These recommendations contain important information for laboratory staff working with sexually transmitted infections (STIs) and/or STI-related issues. Individual East European countries may be required to make minor national adjustments to these guidelines as a result of lack of accessibility to some reagents or equipment, or laws in a specific country.
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8.
  • Domeika, Marius, et al. (author)
  • Guidelines for the laboratory diagnosis of genital herpes in eastern European countries
  • 2010
  • In: Eurosurveillance. - 1560-7917. ; 15:44, s. 21-27
  • Journal article (peer-reviewed)abstract
    • These guidelines aim to provide comprehensive information about sexually transmitted herpes simplex virus (HSV) infection and its laboratory diagnosis in eastern European countries. They are primarily intended for professionals testing specimens from patients at a sexual healthcare clinic but may also be helpful for community-based screening programmes. In particular, the guidelines recommend: (i) either viral culture or validated and approved nucleic acid amplification tests (NAATs) as the tests of choice for symptomatic patients, which should be promoted for laboratory confirmation of HSV infection; (ii) if culture or NAATs are not available, antigen detection - a direct immunofluorescence test or enzyme immunoassay from samples from symptomatic patients - could be employed, but HSV type determination is of importance; (iii) only type-specific serology should be used for detecting asymptomatic individuals, testing pregnant women at risk of acquiring HSV infection close to delivery, men who have sex with men and people who are HIV positive; (iv) widespread screening for HSV antibodies should be discouraged; and (v) any non-validated diagnostic tests should be validated against a recommended, approved gold standard.
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  • Domeika, Marius, et al. (author)
  • Guidelines for the laboratory diagnosis of trichomoniasis in East European countries
  • 2010
  • In: Journal of the European Academy of Dermatology and Venereology. - : Wiley. - 0926-9959 .- 1468-3083. ; 24:10, s. 1125-1134
  • Research review (peer-reviewed)abstract
    • The laboratory diagnosis of sexually transmitted infections in many Eastern European countries remains suboptimal. The main objective of the present evidence-based guidelines is to provide comprehensive information regarding the laboratory diagnosis of infections caused by Trichomonas vaginalis in East European countries. In particular, the present guidelines recommend: (i) to encourage examination of the wet mounts of vaginal exudates, instead of stained smears, at all clinical settings; (ii) nucleic acid amplification tests (NAATs) or culture could be employed if no trichomonads are detected on microscopic examination of the wet preparation and there is a strong indication of infection and (iii) the use of NAATs is encouraged in screening, using non-invasive specimens, or high volume testing situations. In the absence of internationally recognized commercial NAAT systems, tests developed in-house should be validated using obtainable international standards and quality assured strictly. Individual East European countries may be required to make minor national adjustments to these guidelines as a result of lack of accessibility to some reagents or equipment, or laws in a specific country.
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10.
  • Domeika, Marius, et al. (author)
  • Implementation of a national electronic reporting system in Lithuania
  • 2009
  • In: Euro surveillance. - 1560-7917. ; 14:13, s. 19165-
  • Journal article (peer-reviewed)abstract
    • Electronic reporting systems improve the quality and timeliness of the surveillance of communicable diseases. The aim of this paper is to present the process of the implementation and introduction of an electronic reporting system for the surveillance of communicable diseases in Lithuania. The project which started in 2002 was performed in collaboration between Lithuania and Sweden and was facilitated by the parallel process of adapting the surveillance system to European Union (EU) standards. The Lotus-based software, SmittAdm, was acquired from the Department of Communicable Diseases Control and Prevention of Stockholm County in Sweden and adopted for Lithuania, resulting in the Lithuanian software, ULISAS. A major advantage of this program for Lithuania was the possibility to work offline. The project was initiated in the two largest counties in Lithuania where ULISAS had been installed and put in use by January 2005. The introduction was gradual, the national level was connected to the system during late 2005, and all remaining counties were included during 2006 and 2007. The reporting system remains to be evaluated concerning timeliness and completeness of the surveillance. Further development is needed, for example the inclusion of all physicians and laboratories and an alert system for outbreaks. The introduction of this case-based, timely electronic reporting system in Lithuania allows better reporting of data to the European Centre for Disease Prevention and Control (ECDC) and the World Health Organization (WHO) compared to the former reporting system with paper-based, aggregated data.
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  • Domeika, Marius, et al. (author)
  • Laboratory diagnostics for non-viral sexually transmitted infections in St. Petersburg, Russia : current situation and hallmarks for improvements
  • 2008
  • In: Journal of the European Academy of Dermatology and Venereology. - : Wiley. - 0926-9959 .- 1468-3083. ; 22:9, s. 1094-100
  • Journal article (peer-reviewed)abstract
    • BACKGROUND: The numbers and performance characteristics of laboratories providing sexually transmitted infection (STI) diagnostic services, as well as the rates of morbidity due to STIs in St. Petersburg, Russia, remain largely unknown. OBJECTIVE: The aim of the present study was to evaluate the range, quality and availability of diagnostic services for several non-viral STIs (Chlamydia trachomatis, Neisseria gonorrhoeae, Treponema pallidum and Trichomonas vaginalis) in St. Petersburg during the period September 2005 to June 2006. METHODS: Survey data focusing on organization and performance characteristics of STI diagnostic services were assessed using questionnaires, telephone interviews and site visits. RESULTS: A total of 118 laboratories providing STI diagnostic services were identified. Of the surveyed laboratories, 54% (64 of 118) diagnosed syphilis, 81% (96 of 118) gonorrhoea, 80% (94 of 118) trichomoniasis and 49% (58 of 118) chlamydial infections. Although most of the laboratories could provide a presumptive diagnosis for syphilis, most of the N. gonorrhoeae and T. vaginalis testing of women did not adhere to international recommendations. Of the laboratories with the capacity to diagnose C. trachomatis infection, 69% still used serological testing (enzyme-linked immunosorbent assay) to detect antibodies to C. trachomatis. CONCLUSIONS: Overall, the diagnostic methods used to establish a laboratory diagnosis, the system of case reporting, the training of laboratory personnel and the level of interlaboratory communication clearly require improvement. This study represents the first step in a process of evaluation of the laboratory support for STI services and the establishment of an interlaboratory network in St. Petersburg.
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  • Domeika, Marius, et al. (author)
  • Mailed urine samples are not an effective screening approach for Chlamydia trachomatis case finding among young men
  • 2007
  • In: Journal of the European Academy of Dermatology and Venereology. - : Wiley. - 0926-9959 .- 1468-3083. ; 21:6, s. 789-794
  • Journal article (peer-reviewed)abstract
    • Background Frequency of testing is known to be low for sexually transmitted infections (STIs) in men aged 20–24 years. The use of mailed, home-obtained urine specimens could increase the uptake of young men and facilitate screening programmes for the detection of asymptomatic Chlamydia trachomatis. Objective The aim of the present study is to evaluate the home screening approach as a tool for recruitment of asymptomatic men for screening of genital C. trachomatis infections. Methods Men aged 19–24 years old (n = 1936) were invited to participate in home-based testing for genital C. trachomatis infection. Persons who agreed to be tested were provided with a testing kit. Self-collected first void urine was sent for testing to the microbiology laboratory. The test result was accessible on the study's web-page 1 week after testing. Individuals with a diagnosed infection were instructed to contact the venereal disease department. Results The response rate was 24% (462/1936). The responders' main reason for not participating was a feeling of being safe regarding STIs (87%; 159/182). The primary reason for this feeling of safety was that the responders were in a steady relationship (59%; 107/159). Having sex outside a steady relationship was reported by 36% (90/250) of the responders. The prevalence of C. trachomatis infection among the responders was 2.02% and the reported history of chlamydial infection was 36% (34/95). Out of the responders, 92% (229/249) were, to varying degrees, concerned about getting STIs; however, the majority (72%; 174/242) estimated the risk to be low. Conclusion Home screening using web-based answer management is a feasible tool for STI screening, which lowers the threshold for people at risk. In this particular population, however, the response rate was too low to be routinely introduced.
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  • Domeika, Marius, et al. (author)
  • Survey of Diagnostic Services for Genital Herpes in Fourteen Countries in Eastern Europe
  • 2011
  • In: Acta Dermato-Venereologica. - : Medical Journals Sweden AB. - 0001-5555 .- 1651-2057. ; 91:3, s. 333-336
  • Journal article (peer-reviewed)abstract
    • This paper reports survey-based data on the diagnosis and management of genital herpes simplex virus (HSV) infection in 14 countries of the Eastern European Network for Sexual and Reproductive Health (EE SRH). Only 43% of the countries could provide the number of genital HSV cases recorded at national level. Eighty-six percent of countries employed syndromic management in cases of genital ulcer disease. Most countries performed type-specific and/or non-type-specific enzyme immunoassays to detect HSV antibodies. Non-type-specific serology for diagnostic purposes should be actively discouraged. Direct detection methods for HSV, such as PCR, antigen detection and culture, are available in the region, but their usage was extremely low. Their use in Eastern European countries should be actively promoted. The availability of laboratory services must be improved, and countries in the region should implement consensus recommendations for the laboratory diagnosis of genital HSV infections in order to improve clinical practice.
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  • Glazkova, Slavyana, et al. (author)
  • Antimicrobial susceptibility/resistance and molecular epidemiological characteristics of Neisseria gonorrhoeae in 2009 in Belarus
  • 2011
  • In: Acta Pathologica, Microbiologica et Immunologica Scandinavica (APMIS). - : Wiley. - 0903-4641 .- 1600-0463. ; 119:8, s. 537-542
  • Journal article (peer-reviewed)abstract
    • Increased antimicrobial resistance (AMR) in Neisseria gonorrhoeae is a global concern, and ultimately gonorrhoea may become untreatable. Nonetheless, AMR data from East-Europe are scarce beyond Russia, and no AMR data or other characteristics of gonococci have been reported from Belarus for more than 20 years. The aim was to describe the prevalence of AMR, and report molecular epidemiological characteristics of gonococci circulating in 2009 in Belarus. In a sample of 80 isolates, resistance prevalences to antimicrobials used for gonorrhoea treatment in Belarus were: Ceftriaxone 0%, spectinomycin 0%, azithromycin 17.3%, tetracycline 25.9%, ciprofloxacin 34.6% and erythromycin 59.2%. The isolates displayed no penA mosaic alleles, 38 porB gene sequences and 35 N. gonorrhoeae multiantigen sequence types, of which 20 have not been described before worldwide. Due to the high levels of antimicrobial resistance, only ceftriaxone and spectinomycin can be recommended for empirical treatment of gonorrhoea in Belarus according to WHO recommendations. Continuous gonococcal AMR surveillance in Eastern Europe is crucial. This is now initiated in Belarus using WHO protocols.
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  • Kubanova, A., et al. (author)
  • The Russian gonococcal antimicrobial susceptibility programme (RU-GASP) - national resistance prevalence in 2007 and 2008, and trends during 2005-2008
  • 2010
  • In: Eurosurveillance. - 1025-496X. ; 15:14, s. 10-14
  • Journal article (peer-reviewed)abstract
    • Antimicrobial resistance (AMR) in Neisseria gonorrhoeae is a major problem worldwide. In the former Soviet countries including Russia, the knowledge regarding AMR has been highly limited. However, in 2004 the Russian gonococcal antimicrobial susceptibility programme (RU-GASP) was initiated. The aims of this study were to examine and describe the prevalence of N. gonorrhoeae AMR in 2007 and 2008 in Russia, and reveal trends in the period from 2005 to 2008. Gonococcal isolates (660 in 2007 and 900 in 2008) from 36 surveillance sites were examined using agar dilution method. From 2005 to 2008, the proportion of isolates resistant to spectinomycin increased from 0% to 7.2%, and remained high for those resistant to ciprofloxacin (approximately 49%). The resistance to azithromycin was 2.3% and 0.4% in 2007 and 2008, respectively. All isolates between 2005 and 2008 were susceptible to ceftriaxone. In conclusion, the AMR of N. gonorrhoeae in Russia is high, as in most countries in the European Union, and ceftriaxone should be the first line for treatment. If there is no access to ceftriaxone or in the presence of severe betalactam antimicrobial allergy, spectinomycin should be used; however, the resistance to spectinomycin has increased. Regular, quality-assured national and international surveillance of AMR in N. gonorrhoeae is crucial globally for public health.
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  • Kucinskiene, Vesta, et al. (author)
  • Home sampling and pooling of vaginal samples are effective tools for genetic screening of Chlamydia trachomatis among high school female students in Lithuania
  • 2008
  • In: Scandinavian Journal of Infectious Diseases. - London : Taylor & Francis. - 0036-5548 .- 1651-1980. ; 40:2, s. 88-93
  • Journal article (peer-reviewed)abstract
    • The aims were 1) to estimate the prevalence of C. trachomatis infection among sexually active female students in Kaunas, Lithuania; 2) to investigate the usefulness of personal invitation, self-sampling, and pooling of samples for screening; and 3) to evaluate the costs of the approaches used. A cross-sectional study inviting 795 female students (18–31 y of age) from 7 high schools and 1 college in Kaunas was performed. The response rate was 67% (533/795). Self-obtained vaginal samples were analysed, individually and pooled (n=3), using Digene Hybrid Capture II CT/NG Test. The overall prevalence of C. trachomatis infection was 5.6%. Among the sexually active female students 20–24 y of age (n=424), the prevalence was 7.1%; however, the prevalence varied from 0% to 14.2% at the different schools. For estimation of the population prevalence based solely on identification of C. trachomatis positive pools, the pooling strategy reduced the costs by 85%. For estimation of population prevalence and for diagnosis of each individual sample, pooling reduced the costs by 70%. Targeted screening, using pooling to reduce the expenses, mainly of 3rd and 4th y Lithuanian female students could be recommended. By extended personal contact and internet-based communication, increased participation rates may be attained.
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  • Kucinskiene, Vesta, et al. (author)
  • Prevalence and risk factors of genital Chlamydia trachomatis infection
  • 2006
  • In: Medicina (Kaunas). - 1010-660X .- 1648-9144. ; 42:11, s. 885-894
  • Journal article (peer-reviewed)abstract
    • The aim of the study was to provide a survey and generalization of literature data on the epidemiological situation of Chlamydia trachomatis infection in various countries, preventive screenings and risk factors of the infection. We performed a survey of articles published during 1998-2005 and selected from bibliographical medical search databases presenting data on the prevalence of Chlamydia trachomatis and the main risk factors for this sexually transmitted infection. Chlamydial infection is the most common among sexually transmitted genital infections worldwide. It has been found that the main risk factors for Chlamydia trachomatis infection are age, irregular and/or accidental sexual relationships and change of sexual partners, failure to use or erratic use of barrier contraception during intercourse, and insufficient knowledge about sexual life and care for one's sexual health. Most countries do not have national preventive screening programs or exhaustive information about the prevalence of Chlamydia trachomatis infection. The comparison of the prevalence and incidence of Chlamydia trachomatis infection among different countries is complicated due to the different diagnostic methods and sample selection techniques applied; however, in order to decrease the prevalence of chlamydial infection and its impact on the reproductive health of the society, significant attention should be paid to sexual education, preventive screening of people in high-risk groups, as well as to early diagnostics and timely treatment.
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  • Lebedzeu, Fiodar, et al. (author)
  • Antimicrobial susceptibility/resistance and NG-MAST characterisation of Neisseria gonorrhoeae in Belarus, Eastern Europe, 2010-2013
  • 2015
  • In: BMC Infectious Diseases. - : BioMed Central. - 1471-2334. ; 15
  • Journal article (peer-reviewed)abstract
    • Background: Gonorrhoea and widely spread antimicrobial resistance (AMR) in its etiological agent Neisseria gonorrhoeae are major public health concerns worldwide. Gonococcal AMR surveillance nationally and internationally, to identify emerging resistance and inform treatment guidelines, is imperative for public health purposes. In 2009, AMR surveillance was initiated in Belarus, Eastern Europe because no gonococcal AMR data had been available for at least two decades. Herein, the prevalence and trends of gonococcal AMR and molecular epidemiological characteristics of N. gonorrhoeae strains from 2010 to 2013 in Belarus, are described. Methods: N. gonorrhoeae isolates (n = 193) obtained in the Mogilev (n = 142), Minsk (n = 36) and Vitebsk (n = 15) regions of Belarus in 2010 (n = 72), 2011 (n = 6), 2012 (n = 75) and 2013 (n = 40) were analyzed in regards to AMR using the Etest method and for molecular epidemiology with N. gonorrhoeae multi-antigen sequence typing (NG-MAST). Results: During 2010-2013, the proportions of resistant N. gonorrhoeae isolates were as follows: tetracycline 36%, ciprofloxacin 28%, penicillin G 9%, azithromycin 5%, and cefixime 0.5%. Only one (0.5%) beta-lactamase producing isolate was detected. No isolates resistant to ceftriaxone and spectinomycin were identified. Overall, the resistance levels to tetracycline, ciprofloxacin and penicillin G were relatively stable. Interestingly, the level of resistance to azithromycin declined from 12% in 2010 to 0% in 2013 (P < 0.05). In total, 70 NG-MAST STs were identified. The predominant STs were ST1993 (n = 53), ST807 (n = 13), ST285 (n = 8) and ST9735 (n = 8). Many novel STs (n = 43, 61%), representing 41% of all isolates, were found. Conclusions: During 2010-2013, the N. gonorrhoeae population in Belarus displayed high and relatively stable resistance levels to tetracycline, ciprofloxacin, and penicillin G, while the resistance to azithromycin declined. One isolate was resistant to cefixime, but no resistance to ceftriaxone or spectinomycin was found. The results of the present surveillance initiated in 2009 were also used to replace penicillin G with ceftriaxone (1 g single dose intramuscularly) as the first-line drug for empiric treatment of gonorrhoea in the national treatment guidelines in Belarus in late 2009. It is essential to further strengthen the surveillance of gonococcal AMR and ideally survey also treatment failures and molecular epidemiological genotypes in Belarus.
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  • Mlynarczyk-Bonikowska, Beata, et al. (author)
  • Antimicrobial susceptibility/resistance and genetic characteristics of Neisseria gonorrhoeae isolates from Poland, 2010-2012
  • 2014
  • In: BMC Infectious Diseases. - : BioMed Central. - 1471-2334. ; 14
  • Journal article (peer-reviewed)abstract
    • Background: In Poland, gonorrhoea has been a mandatorily reported infection since 1948, however, the reported incidences are likely underestimated. No antimicrobial resistance (AMR) data for Neisseria gonorrhoeae has been internationally reported in nearly four decades, and data concerning genetic characteristics of N. gonorrhoeae are totally lacking. The aims of this study were to investigate the AMR to previously and currently recommended gonorrhoea treatment options, the main genetic resistance determinant (penA) for extended-spectrum cephalosporins (ESCs), and genotypic distribution of N. gonorrhoeae isolates in Poland in 2010-2012.Methods: N. gonorrhoeae isolates cultured in 2010 (n = 28), 2011 (n = 92) and 2012 (n = 108) in Warsaw and Bialystok, Poland, were examined using antimicrobial susceptibility testing (Etest), pyrosequencing of penA and N. gonorrhoeae multi-antigen sequence typing (NG-MAST).Results: The proportions of N. gonorrhoeae isolates showing resistance were as follows: ciprofloxacin 61%, tetracycline 43%, penicillin G 22%, and azithromycin 8.8%. No isolates resistant to ceftriaxone, cefixime or spectinomycin were found. However, the proportion of isolates with an ESC MIC = 0.125 mg/L, i.e. at the resistance breakpoint, increased significantly from none in 2010 to 9.3% and 19% in 2012 for ceftriaxone and cefixime, respectively. Furthermore, 3.1% of the isolates showed multidrug resistance, i.e., resistance to ciprofloxacin, penicillin G, azithromycin, and decreased susceptibility to cefixime (MIC = 0.125 mg/L). Seventy-six isolates (33%) possessed a penA mosaic allele and 14 isolates (6.1%) contained an A501V/T alteration in penicillin-binding protein 2. NG-MAST ST1407 (n = 58, 25% of isolates) was the most prevalent ST, which significantly increased from 2010 (n = 0) to 2012 (n = 46; 43%).Conclusions: In Poland, the diversified gonococcal population displayed a high resistance to most antimicrobials internationally previously recommended for gonorrhoea treatment and decreasing susceptibility to the currently recommended ESCs. The decreasing susceptibility to ESCs was mostly due to the introduction of the internationally spread multidrug-resistant NG-MAST ST1407 in 2011. It is essential to promptly revise the gonorrhoea treatment guidelines, improve the gonorrhoea laboratory diagnostics, and implement quality assured surveillance of gonococcal AMR (ideally also treatment failures) in Poland.
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  • Shalepo, Kira, et al. (author)
  • Diagnosis of Chlamydia trachomatis in Russia--in-house PCR assays may be effective but overall optimization and quality assurance are urgently needed
  • 2006
  • In: Acta Pathologica, Microbiologica et Immunologica Scandinavica (APMIS). - : Wiley. - 0903-4641 .- 1600-0463. ; 114:7-8, s. 500-507
  • Journal article (peer-reviewed)abstract
    • In the present study, the performance of the cell culture method, two non-Russian direct immunofluorescence (DIF) assays, and three different in-house polymerase chain reaction (PCR) tests used in St. Petersburg, Russia, for detection of Chlamydia trachomatis in urogenital specimens was evaluated. A total of 650 patients were examined and it was most disquieting that previous C. trachomatis positivity with Russian DIF assays could - 7 days later - be confirmed only in 26% of the women and 30% of the men. Overall, the highest diagnostic sensitivity was obtained using PCR analysis. However, the sensitivity varied significantly: from 79% to 100% between the different PCR assays, sex of the patients, and type of samples. The highest sensitivity was obtained for female vaginal and male urine samples (100%). The specificity of the PCR assays varied from 97% to 100%. The sensitivity of cell culture and both the examined DIF assays was low, i.e. it varied from 46% to 56% and 55% to 75%, respectively. Meanwhile, cell culture was 100% specific and the DIFs showed a specificity varying from 99% to 100%. In conclusion, in a Russian perspective, adequate in-house PCR methods may be used quite effectively for detection of C. trachomatis in invasive as well as non-invasive clinical material. Simultaneous analysis of two different specimens from women resulted in a significantly increased detection rate of C. trachomatis. Nevertheless, in Russia the need for optimization and quality assurance of diagnostic methods for C. trachomatis, especially Russian DIF assays, has to be emphasized.
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  • Shimanskaya, Iryna, et al. (author)
  • Evaluation of Three Serological Tests Manufactured in Belarus for the Diagnosis of Syphilis
  • 2011
  • In: Acta Dermato-Venereologica. - : Medical Journals Sweden AB. - 0001-5555 .- 1651-2057. ; 91:3, s. 299-302
  • Journal article (peer-reviewed)abstract
    • The performance of three serological tests manufactured in Belarus for the diagnosis of syphilis, i.e. a microprecipitation reaction (MPR) and two enzyme-linked immunosorbent assays (ELISAs) were compared with internationally recognized assays, namely the rapid plasma reagin test and the Treponema pallidum passive particle agglutination assay (TPPA). Sera from 392 consecutive patients attending Brest (Belarus) regional dermatovenereological dispensaries were tested. The sensitivity of the MPR test was low (77.3%) compared with the rapid plasma reagin test, while the specificity was high (100%). In contrast, both Belarusian ELISAs performed well when compared with the TPPA (sensitivities of 99.2% and 100%, specificities of 98.7% and 99.0%, respectively). There is a clear need to improve the sensitivity of the existing Belarusian MPR test or to use a more sensitive screening test in order to improve diagnosis of the disease in Belarus.
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  • Shipitsyna, Elena, et al. (author)
  • Comparison of microscopy, culture and in-house PCR and NASBA assays for diagnosis of Neisseria gonorrhoeae in Russia
  • 2008
  • In: Acta Pathologica, Microbiologica et Immunologica Scandinavica (APMIS). - Oxford : Blackwell. - 0903-4641 .- 1600-0463. ; 116:2, s. 133-138
  • Journal article (peer-reviewed)abstract
    • This study aimed to assess the laboratory diagnosis of Neisseria gonorrhoeae in St. Petersburg, Russia. In total, 334 consecutive symptomatic patients were enrolled. Cervical and urethral specimens from women (nΩ286) and urethral specimens from men (nΩ48) were analyzed by microscopy, culture and two in-house NAATs, i.e. polymerase chain reaction (PCR) and nucleic acid sequence-based amplification (NASBA), developed in Russia. All N. gonorrhoeae-positive samples were confirmed using porA pseudogene and 16S rRNA gene sequencing. All methods displayed 100% specificity, i.e. positive predictive values of 100%. Compared to the PCR (most sensitive method in the present study), in women the sensitivity of both microscopy and culture was 31.8%, and that of NASBA was 90.9%. In men, microscopy, culture and NASBA displayed a sensitivity of 75%, 50% and 100%, respectively. The negative predictive values of microscopy, culture, and NASBA were 97.3%, 97.3%, and 99.6% in women, and 97.8%, 95.7%, and 100% in men, respectively. According to the PCR, the prevalences of N. gonorrhoeae were 4.5% (women) and 8.3% (men). In conclusion, both the investigated Russian NAATs displayed a high sensitivity and specificity. However, in general the diagnosis of gonorrhoea in Russia is suboptimal and crucially requires validation, improvements and quality assurance.
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  • Shipitsyna, Elena, et al. (author)
  • First evaluation of six nucleic acid amplification tests widely used in the diagnosis of Chlamydia trachomatis in Russia
  • 2009
  • In: Journal of the European Academy of Dermatology and Venereology. - : Wiley. - 0926-9959 .- 1468-3083. ; 23:3, s. 268-276
  • Journal article (peer-reviewed)abstract
    • Abstract Background In Russia, nationally developed nucleic acid amplification tests (NAATs), which have never been validated to international commercially available NAATs, are mainly used in the diagnosis of Chlamydia trachomatis infection. Objective To evaluate the performance characteristics of six NAATs widely used to diagnose C. trachomatis infection in Russia. Materials and methods In total, 446 consecutive symptomatic patients (319 females and 127 males) were included. Five polymerase chain reaction (PCR) assays and one real-time nucleic acid sequence-based amplification (NASBA) assay were evaluated on cervical and vaginal samples from females and on urethral and first voided urine samples from males. As reference methods, the Cobas Amplicor PCR, as the main 'gold standard' method, and LightMix 480HT PCR were used. Results The overall prevalence of C. trachomatis infection was 12.6%. The Russian NAATs and the reference methods displayed a high level of concordance (97.9% to 99.2%). In comparison with the reference methods, the sensitivities, specificities, positive predictive values and negative predictive values of the Russian tests in different specimens ranged from 86.1% to 100%, 99.1% to 100%, 92.3% to 100% and 98.2% to 100%, respectively. Conclusions According to the reference methods, C. trachomatis NAATs developed and used in Russia have relatively good performance characteristics for both invasive and non-invasive samples. However, larger studies that include symptomatic and asymptomatic patients as well as genital and extra-genital samples, and in comparison with other internationally well-recognized, validated, and ideally Food and Drug Administration-approved C. trachomatis NAATs performed strictly according to the manufacturer's instructions, need to be conducted. Conflicts of interest None declared.
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  • Shipitsyna, Elena, et al. (author)
  • Guidelines for the Laboratory Diagnosis of Mycoplasma genitalium Infections in East European Countries
  • 2010
  • In: Acta Dermato-Venereologica. - : Medical Journals Sweden AB. - 0001-5555 .- 1651-2057. ; 90:5, s. 461-467
  • Journal article (peer-reviewed)abstract
    • The present guidelines aim to provide comprehensive information regarding laboratory diagnosis of Myeoplasma genitalium infections in East European countries. These guidelines are intended primarily for laboratory professionals testing specimens from patients at sexual health care clinics, but may also be useful for community-based screening programmes. Diagnosis of M. genitalium infection is performed exclusively using nucleic acid amplification tests (NAATs), owing to the poor and slow growth of the bacterium in culture. Because no internationally validated and approved commercial NAAT for M. genitalium detection is presently available, it is necessary that laboratories performing M. genitalium diagnostics not only carefully evaluate and validate their in-house PCRs before using them routinely, but also use comprehensive internal controls and take part in external quality assessment programmes. The guidelines were elaborated as a consensus document of the Eastern European Sexual and Reproductive Health Network, and comprise one element of a series of guidelines aimed at optimizing, standardizing, and providing guidance on quality laboratory testing for reproductive tract infections.
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32.
  • Shipitsyna, Elena, et al. (author)
  • Pooling samples : the key to sensitive, specific and cost-effective genetic diagnosis of Chlamydia trachomatis in low-resource countries
  • 2007
  • In: Acta Dermato-Venereologica. - : Medical Journals Sweden AB. - 0001-5555 .- 1651-2057. ; 87:2, s. 140-143
  • Journal article (peer-reviewed)abstract
    • The aims of this study were to compare the performance characteristics and cost-effectiveness of pooling endocervical samples for screening and diagnosis of Chlamydia trachomatis, and to investigate the prevalence of C. trachomatis infection in women in Leningrad Oblast, Russia. A total of 1500 endocervical samples were tested individually and when pooled in groups of 5 and 10 samples, respectively. A previously evaluated in-house diagnostic polymerase chain reaction (PCR) assay was utilized. The sensitivity and specificity of the PCR were not affected by either pooling strategy. The estimated prevalence of genital C. trachomatis infection was 6.6%, 6.1% and 6.0% based on individually tested samples, and pools of 5 and 10, respectively. For diagnosis of individual samples, the pooling strategies resulted in cost savings of 53.3% (5 samples per pool) and 44.0% (10 samples per pool). Pooling samples for PCR detection of C. trachomatis is an accurate and cost-saving approach for diagnosis and large-scale prevalence studies in St Petersburg, Russia.
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33.
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34.
  • Unemo, Magnus, et al. (author)
  • Gonorrhoea surveillance, laboratory diagnosis and antimicrobial susceptibility testing of Neisseria gonorrhoeae in 11 countries of the eastern part of the WHO European region
  • 2011
  • In: Acta Pathologica, Microbiologica et Immunologica Scandinavica (APMIS). - : Wiley. - 0903-4641 .- 1600-0463. ; 119:9, s. 643-649
  • Journal article (peer-reviewed)abstract
    • Quality-assured worldwide surveillance of antimicrobial resistance (AMR) in Neisseria gonorrhoeae is crucial for public health purposes. In the countries of the eastern part of the WHO European region the knowledge regarding gonococcal AMR is limited, and antimicrobials of many different types, sources and quality are used for gonorrhoea treatment. This study surveyed gonorrhoea incidence, laboratory diagnosis and gonococcal AMR testing in 11 independent countries of the former Soviet Union. The national gonorrhoea incidences remain mainly high. In general, gonococcal culture and AMR testing were rarely performed, poorly standardized and rarely quality assured. To establish a gonococcal AMR surveillance programme in Eastern Europe, i.e. the geographical area of the former Soviet Union, several actions have recently been undertaken by the Eastern European Sexual and Reproductive Health (EE SRH) Network and the WHO. The information provided herein will be useful in this respect.
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35.
  • Unemo, M., et al. (author)
  • Recommended antimicrobial treatment of uncomplicated gonorrhoea in 2009 in 11 East European countries : implementation of a Neisseria gonorrhoeae antimicrobial susceptibility programme in this region is crucial
  • 2010
  • In: Sexually Transmitted Infections. - : BMJ. - 1368-4973 .- 1472-3263. ; 86:6, s. 442-444
  • Journal article (peer-reviewed)abstract
    • Background Antimicrobial resistance (AMR) in Neisseria gonorrhoeae (gonococcus) is a major problem worldwide. Quality-assured and quality-controlled AMR surveillance data on gonococci globally are crucial for public health purposes. In East European countries, knowledge regarding gonococcal AMR and its prevalence is limited. Objectives To ascertain the recommendations for antimicrobial treatment of uncomplicated gonorrhoea in 11 East European countries, valuable information for introducing an international gonococcal AMR surveillance programme. Methods A questionnaire was used to collect information regarding the types, doses and manufacturers of the antimicrobials recommended for gonorrhoea treatment in all countries. Results Ceftriaxone (250-1000 mg, intramuscularly (IM)x 1) was reported as a first-line antimicrobial in all countries (n=11). Many of the second-line and alternative treatments seemed suboptimal for empirical treatment. Regionally manufactured antimicrobials were predominantly used and easily available, and some may be of suboptimal quality. This generates effective prerequisites for emergence, and rapid spread of gonococcal AMR and gonorrhoea. Conclusion Ceftriaxone was first-line antimicrobial in all the 11 East European countries, which is an appropriate choice also in a global perspective. However, the adherence, especially among private physicians, to these public sector recommendations is questionable. Implementation of national and international gonococcal AMR surveillance in this region is crucial; to provide evidence-based data for regular and timely updating of treatment guidelines, to identify emerging resistance, and to assist in the prevention, control and containment of gonococcal AMR and gonorrhoea.
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