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Acta Dermato-venereologica | 2010

Guidelines for the Laboratory Diagnosis of Mycoplasma genitalium Infections in East European Countries

Elena Shipitsyna; Alevtina Savicheva; Evgenij Sokolovskiy; R. Ballard; Marius Domeika; Magnus Unemo; Jørgen Skov Jensen

The present guidelines aim to provide comprehensive information regarding laboratory diagnosis of Mycoplasma 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 (EE SRH) 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.


Journal of The European Academy of Dermatology and Venereology | 2010

Guidelines for the laboratory diagnosis of trichomoniasis in East European countries

Marius Domeika; L. Zhurauskaya; Alevtina Savicheva; N. Frigo; E. Sokolovskiy; Anders Hallén; Magnus Unemo; R. Ballard

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.


Journal of The European Academy of Dermatology and Venereology | 2009

Guidelines for the laboratory diagnosis of syphilis in East European countries

E Sokolovskiy; N Frigo; S Rotanov; Alevtina Savicheva; O Dolia; N Kitajeva; Anders Hallén; Magnus Unemo; Marius Domeika; R. Ballard

The present guidelines aim to provide comprehensive and precise information regarding the laboratory diagnosis of the sexually transmitted infection (STI) syphilis in East European countries. These recommendations contain important information for laboratory staff working with 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.


Journal of The European Academy of Dermatology and Venereology | 2008

Laboratory diagnostics for non-viral sexually transmitted infections in St. Petersburg, Russia : current situation and hallmarks for improvements

Marius Domeika; I. Litvinenko; T. Smirnova; O. Gaivaronskaya; Alevtina Savicheva; E. Sokolovskiy; R. Ballard; Magnus Unemo

Backgroundu2003 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.


Journal of The European Academy of Dermatology and Venereology | 2013

Evaluation of polymerase chain reaction assays for the diagnosis of Trichomonas vaginalis infection in Russia

Elena Shipitsyna; E. Zolotoverkhaya; Cheng-Yen Chen; K. H. Chi; A. Grigoryev; Alevtina Savicheva; R. Ballard; Marius Domeika; Magnus Unemo

Backgroundu2002 In Russia, the microscopy‐ and culture‐based diagnostics of trichomoniasis is mainly suboptimal. Recent years, domestically produced diagnostic PCR assays have been implemented; however, any evaluation of these PCRs has never been internationally reported.


Journal of The European Academy of Dermatology and Venereology | 2009

Guidelines for the laboratory diagnosis of Chlamydia trachomatis infections in East European countries

Marius Domeika; Alevtina Savicheva; E. Sokolovskiy; N. Frigo; T. Brilene; Anders Hallén; Magnus Unemo; R. Ballard; M. Ward

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.


International Journal of Std & Aids | 2009

Quality enhancements and quality assurance of laboratory diagnosis of sexually transmitted infections in Eastern Europe.

Marius Domeika; Alevtina Savicheva; E. Sokolovskiy; R. Ballard; Magnus Unemo

Quality enhancements and quality assurance of laboratory diagnosis of sexually transmitted infections in Eastern Europe


Journal of The European Academy of Dermatology and Venereology | 2015

Analytical evaluation of nine serological assays for diagnosis of syphilis

Kerstin Malm; Sören Andersson; Hans Fredlund; Hans Norrgren; Antonio Biague; Fredrik Månsson; R. Ballard; Magnus Unemo

The diagnosis of syphilis is most frequently dependent on antibody detection with serological assays. Assays for both treponemal and non‐treponemal antibodies are needed to provide a sensitive and specific diagnosis. For decades, a first screening has been done with non‐treponemal assays, followed by treponemal. However, in recent years, following laboratory automation, the reverse sequence screening algorithms have been developed, using a treponemal assay as the initial screening test.


Acta Dermato-venereologica | 2011

Evaluation of three serological tests manufactured in Belarus for the diagnosis of syphilis.

Iryna Shimanskaya; Larisa Zhurauskaya; Oleg Pankratov; Magnus Unemo; R. Ballard; Marius Domeika

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.


Acta Dermato-venereologica | 2011

Laboratory Diagnosis of Sexually Transmitted Infections in Belarus

Oleg Pankratov; Iryna Shimanskaya; Valentin Pankratov; Alexandr Navrotsky; R. Ballard; Magnus Unemo; Marius Domeika

Following the collapse of the Soviet Union, the manage-ment of sexually transmitted infections (STIs) became fragmented, with a consequent increase in STI morbidity. In Belarus, reliable data are generally lacking as a result of poor access to effective diagnostic facilities, while the quality of laboratory testing for STIs in recognised centres is questionable. As part of the Belarusian-Swedish project “Optimization of the prevention and control of STI/HIV in Belarus” (1) we surveyed STI diagnostic facilities for the methods they used (including their range, availability and quality) and their adherence to international evidence-based guidelines. MATerIAlS AND MeTHODS

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Anders Hallén

Uppsala University Hospital

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