Laboratory diagnosis of sexually transmitted infections in Belarus.

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Acta Derm Venereol 91
64
Letters to the Editor
© 2011 The Authors. doi: 10.2340/00015555-0982
Journal Compilation © 2011 Acta Dermato-Venereologica. ISSN 0001-5555
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
During the period September 2006 to December 2007, all
state-owned laboratories and other facilities that performed
laboratory diagnostics for STIs in Belarus were invited to
complete a questionnaire similar to that used and validated in
our earlier studies (2). To evaluate the quality of the diagnostic
assays and algorithms/strategies used in the surveyed labora-
tories, international evidence-based recommendations for STI
diagnostics and definitions of STI surveillance cases (3–5) were
used for comparison.
reSUlTS
Of the 316 state medical facilities that provided STI
services, 44% performed testing for syphilis, 82% for
gonorrhoea, 80% for trichomoniasis, 55% for genital
chlamydial infections, 24% for genital Ureaplasma and
Mycoplasma infections, 51% for Candida infections,
61% for bacterial vaginosis (BV), 16% for genital
herpes, and 4% for human papillomavirus. On average,
each laboratory provided STI diagnostic services for
approximately 30,000 inhabitants.
Screening for syphilis was performed in 140 of the
316 laboratories surveyed (44%). Of these, 130 (93%)
used locally-manufactured microprecipitation reac-
tion (MPr) tests employing cardiolipin antigen and
treponemal enzyme-linked immunoassays (elISAs).
Confirmatory treponemal ELISAs were used in only
56% of these laboratories. The Treponema pallidum
haemagglutination (TPHA) test was used by 1.3% of
the laboratories, while fluorescent treponemal antibody
absorbed (FTA-abs) and T. pallidum immobilisation
(TPI) tests were performed at seven (5%) central re-
gional serology laboratories. Thirteen percent of the
laboratories performed dark-field micro scopy for the
direct detection of T. pallidum.
More than 80% of the surveyed laboratories tested
for Neisseria gonorrhoeae and Trichomonas vaginalis
infections. Microscopic analysis of methylene blue- and/
or Gram-stained smears was the main diagnostic method
employed for the diagnosis and screening of both males
and females (used by 76% of laboratories). Culture
for N. gonorrhoeae was performed in 54 laboratories
(17%). Persons suspected of having gonorrhoea, sexual
contacts of persons with diagnosed gonorrhoea, and
persons being tested to determine whether or not they
had been cured were extensively exposed to provocation
methods (biological, chemical, mechanical, alimen-
tary and physiological) before culture was performed
(6). Only five laboratories (1.6%) utilised polymerase
chain reaction (PCr) testing for the diagnosis of go-
norrhoea, while six (1.9%) used this technique for the
detection of T. vaginalis (using reagents and equipment
manufactured in the russian Federation). Culture of T.
vaginalis was employed in three (1%) of the surveyed
laboratories.
More than half (55%) of the laboratories provided
diagnostic testing for genital C. trachomatis infections.
Of these, 45% used microscopic analysis of smears
stained by the romanovsky-Giemsa method, while 37%
used antibody detection by ELISA. Direct fluorescent
antibody (DFA) tests were utilised by 24%, PCr by only
7.4%, and culture by 1% of the laboratories surveyed.
All these test systems were manufactured in russia.
Approximately a quarter (77%) of the laboratories sur-
veyed provided STI diagnostic services for Ureaplasma spp.
and Mycoplasma hominis. Of these, 38 (49%) used culture
methods, 30 (39%) DFA tests, 13 (17%) PCr, and 3
(4%) elISA for the detection of antibodies to U. urea-
lyticum, M. hominis and M. genitalium.
DISCUSSION
It is clear that reliable data regarding STI morbidity
in Belarus are limited due to diversity in the methods
used for the diagnosis of individual infections and the
quality of the testing that is routinely available. The
majority of the diagnostic tests used in the country
are not validated against any Western quality-assured
analogues. Of the 316 participating laboratories in
Laboratory Diagnosis of Sexually Transmitted Infections in Belarus
Oleg Pankratov1, Iryna Shimanskaya1, Valentin Pankratov2, Alexandr Navrotsky2, Ronald Ballard3, Magnus Unemo4 and Marius
Domeika5*
1Belarusian State Medical Academy of Postgraduate Studies, 2Belarusian State Medical University, Minsk, Belarus, 3Division of STD Prevention, Centers for
Disease Control and Prevention (CDC), Atlanta, GA, USA, 4Department of Laboratory Medicine, Clinical Microbiology, Örebro University Hospital, Örebro,
and 5Department of Medical Sciences, Uppsala University, SE-75185 Uppsala, Sweden. *E-mail: marius.domeika@medsci.uu.se
Accepted July 1, 2010.

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65
Letters to the Editor
the present study, only 73 (23%) were able to provide
comprehensive diagnostic services for the four main
treatable non-viral STIs, namely T. pallidum, N. go-
norrhoeae, T. vaginalis and C. trachomatis. Many tests
used in STI diagnostics in Belarus are manufactured
in russia. Clinical evaluation of these tests should
prove valuable when choosing the most appropriate
test systems for use in Belarus (7–10).
The findings of the present study clearly emphasise
that many of the tests used in laboratory diagnosis are
inadequate, resulting in poor case-reporting of STIs in
Belarus. representatives from Belarus have actively
taken part in the european Network for Sexual and
reproductive Health (ee SrH)’s (11) development of
regional consensus guidelines for the diagnosis of seve-
ral STIs. These guidelines have subsequently been adap-
ted to local conditions and adopted by the Ministry of
Health of Belarus as the national standard for diagnosis
of these infections. The need for quality testing has been
recognised and the International Organization for Stan-
dardization (ISO) 15189 (international laboratory quality
management standard) has been adopted nationally.
recommendations regarding preparation for laboratory
accreditation have been accepted and published, and a
training programme for laboratory professionals has
been designed in collaboration with the Belarus Medical
Academy for Postgraduate education (BelMAPS). The
formation of a Belarus national STI reference laboratory
is currently under consideration. Studies to determine
the performance characteristics of tests manufactured in
Belarus are currently in progress.
reFereNCeS
STIGUP (Sexually Transmitted Infections Uppsala Group).
Spring marathon of the Belarus STI project. In: Domeika
M, Shimanskaya I, editors. STIGUP Newsletter, 2008, No.
9, p. 4. Available from: http://www.medsci.uu.se/klinbakt/
stigup/Newsletter.htm.
Naaber P, Uusküla A, Naaber J, Põder A, Hjelm e, Hallén
A, et al. laboratory diagnosis of sexually transmitted infec-
1.
2.
tions in estonia in 2001–2002: shortcomings with impact on
diagnostic quality and surveillance. Sex Transm Dis 2005;
32: 759–764.
European Branch of the IUSTI and European Office of
WHO. european guidelines for the management of sexually
transmitted diseases. Int J STD AIDS 2001; 12 (Suppl 3):
1–102.
european Community. Commission Decision No 2002/253/
EC of 19 March 2002 laying down case definitions for re-
porting communicable diseases to the community network
under Decision No 2119/98/eC of the european Parliament
and of the Council. Off J eur Comm 2002; 86: 46–62.
Centers for Disease Control and Prevention. Sexually trans-
mitted diseases treatment guidelines. Available from: http://
www.cdc.gov/std/treatment.
renton A, Filatova e, Ison C, Meheus A, Dmitriev G,
Akovbian V, et al. A trial of the validity of genital smears
and cultures with gonococcal vaccine provocation in diag-
nosing genital gonorrhoea in women. Int J STD AIDS 2009;
20: 24–29.
Unemo M, Savicheva A, Budilovskaya O, Sokolovsky e,
larsson M, Domeika M. laboratory diagnosis of Neisseria
gonorrhoeae in St Petersburg, russia: inventory, performance
characteristics and recommended optimisations. Sex Transm
Infect 2006; 82: 41–44.
Shipitsyna e, Zolotoverkhaya e, Krysanova A, Benkovich A,
Dohn B, Savicheva A, et al. First evaluation of polymerase
chain reaction assays used for diagnosis of Mycoplasma
genitalium in russia. J eur Acad Dermatol Venereol 2009;
23: 1164–1172.
Shipitsyna e, Zolotoverkhaya e, Hjelmevoll SO, Benkovich
A, Krysanova A, Savicheva A, et al. evaluation of six nu-
cleic acid amplification tests used for diagnosis of Neisseria
gonorrhoeae in russia compared with an international
strictly validated real-time porA pseudogene polymerase
chain reaction. J eur Acad Dermatol Venereol 2009; 23:
1246–1253.
Shipitsyna e, Zolotoverkhaya e, Agné-Stadling I, Krysanova
A, Savicheva A, Sokolovsky e, et al. First evaluation of six
nucleic acid amplification tests widely used in the diagnosis
of Сhlamydia trachomatis in Russia. J Eur Acad Dermatol
Venereol 2009; 23: 268–276.
Domeika M, Savicheva A, Sokolovskiy e, Ballard r, Unemo
M. eastern european Network for Sexual and reproduc-
tive Health (ee SrH Network). Quality enhancements
and quality assurance of laboratory diagnosis of sexually
transmitted infections in eastern europe. Int J STD AIDS
2009; 20: 365–367.
3.
4.
5.
6.
7.
8.
9.
10.
11.
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