Introduction
Sexually transmitted infections (STIs) are recognised as major public health
threats worldwide. However, in most of the countries of the former Soviet
Union, including Lithuania, STIs and reproductive health have received
insufficient attention, contributing to a decrease in the birth rate
and an increase in the rate of medical abortions [1]. Lithuania has a
population of 3.5 million inhabitants and comprises 10 different counties.
In 2002, the population of the counties ranged from 133 000 to 848 000
(in the country which includes the capital city, Vilnius). The estimated
incidences of non-viral STIs in Lithuania, especially genital chlamydial
infection and gonorrhoea, are comparatively low at present, and have
tended to decline during the past decade [2, 3]. However, reliable figures
for the incidences of non-viral STIs are lacking, primarily due to suboptimal
diagnostics, incomplete epidemiological surveillance, and self treatment.
Since the re-independence of Lithuania in 1991, the national healthcare
system has undergone several major changes. For example, state-controlled
mandatory hospitalisation has been replaced by a more decentralised system
based on an outpatient primary care approach, and there are many new private
STI outpatient clinics and laboratories with an anonymous care and treatment
approach. Previously, it was mandatory for local dermatovenereological
diagnostic facilities to report all diagnosed STI cases to the central
dispensary (dermatovenereological out-patient clinic). Cases must now be
reported to newly established regional public health centres, which then
report to the National Centre for Prevention and Control of Communicable
Diseases [4]. Many of these changes have contributed to distortion of the
epidemiological data.
International evidence-based recommendations regarding diagnostics [5-7]
are still mainly unknown in non-viral STI diagnostic services in Lithuania.
In many cases, the choice of diagnostic strategies and assays is consequently
based on empirical knowledge or even on the economic status of the particular
facility, which significantly affects the quality of the diagnostics. Unfortunately,
highly sensitive and specific laboratory-based diagnoses of several non-viral
STIs are quite expensive. Issues regarding laboratory quality control have
recently emerged in Lithuania but these have not yet attracted sufficient
attention on the part of healthcare administrators. Thus, there are still
no accredited clinical microbiological laboratories in Lithuania [8].
In the absence of effective vaccines, the mainstay in the prevention of
non-viral STIs is based on the availability of adequate healthcare, effective
diagnostics and treatment, and epidemiological surveillance. Consequently,
the number of physicians specialising in STIs and in counselling afflicted
patients, and the number and geographical location of adequate healthcare
institutions and laboratory facilities that can provide sensitive and specific
STI diagnostics are highly important.
The aim of the present study was to evaluate the range, quality and availability
of diagnostic services for non-viral STIs (Chlamydia trachomatis, Neisseria gonorrhoeae,
Treponema pallidum and Trichomonas vaginalis) in Lithuania
from September 2002 to December 2003.
Material and methods
Surveyed Lithuanian laboratories and demographic data
All Lithuanian laboratories and other facilities that performed diagnostic
tests for C. trachomatis, N. gonorrhoeae, T. pallidum, and T.
vaginalis from September 2002 to December 2003 were included in
the present study. Laboratories were identified from information obtained
from the Lithuanian Department of Accreditation (LDA; in Lithuanian,
the Lietuvos akreditacijos tarnyba), which is responsible for the certification
of facilities performing laboratory diagnostics. In addition, the county-level
STI management groups in all 10 Lithuanian counties [9] updated the information
received from LDA. The study questionnaire was sent to all laboratories
that had confirmed they performed non-viral STI diagnostics. Demographic
data on each of the counties in Lithuania (n=10) were obtained from the
Lithuanian Statistical Department (in Lithuanian, the Lietuvos statistikos
departamentas) [10].
Survey questionnaire and data collection procedure
The utilised questionnaire consisted of 150 questions focussing on (a)
organisation of the STI diagnostic service (type of laboratory, number
of personnel, professional qualifications of the personnel, existence
of a laboratory quality assurance system, etc.), and (b) performance
characteristics (STI agents diagnosed, number of tests performed per
month, diagnostic methods employed for the different STIs, etc.). The
laboratories provided surveillance data by email, fax, or telephone
interviews. In addition, follow up visits for validation of these data
were performed at many of the laboratories.
In the final data analysis, the laboratory diagnostics for the full minimum
range of relevant non-viral STI agents in Lithuania underwent more comprehensive
evaluation.
Adherence of Lithuanian STI diagnostics to international
evidence-based recommendations
For evaluation of the quality of the non-viral STI laboratory diagnostic
strategies and assays used at the Lithuanian laboratories, international
evidence-based recommendations for non-viral STI diagnostics and definitions
of STI surveillance cases [5-7] were used.
Results
STI diagnostic laboratories in Lithuania and response rates
In total, 171 laboratories in Lithuania, of which 28 (16%) were private,
were LDA certified for STI diagnostics and currently performed non-viral
STI diagnostics. Consequently, the median number of inhabitants served
by one STI diagnostic laboratory in Lithuania was 20 470 (range: 10 400-30
600) in the different counties. Of the 171 laboratories identified, 153
(89%) agreed to participate in the assessment study and provided all
the surveillance data that were requested. The remaining 18 laboratories
gave various reasons for declining to participate, for example only performing
STI diagnostics occasionally, testing very few samples or not wishing
to be involved in the present study. Minor discrepancies were identified
between the data provided in the questionnaires and observations at the
site visits; however, these were associated only with incomplete filling
in of the questionnaire or occasional misunderstanding of a question.
Laboratory diagnostics for non-viral STIs in the responding
Lithuanian laboratories
Microscopy of genital samples
In all, 150/153 (98%) respondents used microscopy of genital samples
for non-viral STI diagnostics. Of note 34/153 (22%) respondents reported
microscopy of genital samples as the only method used for STI diagnostics.
In 49/153 (32%) responding laboratories, only specialists with a master’s
degree in medicine or biology, and who also specialised in laboratory
medicine, were responsible for evaluation of the genital samples. Six
respondents (6/153, 4%) reported that practicing, non-specialist physicians
performed the microscopy in their laboratories. In 31/153 (20%) of the
responding laboratories, laboratory technicians were solely responsible
for evaluating the genital samples, and in 67/153 (44%), technicians
and/or laboratory physicians performed the microscopy.
Laboratory diagnostics for the main non-viral STIs in Lithuania
No accredited clinical microbiological laboratories exist in Lithuania
and all respondents also lacked a complete and thoroughly implemented
laboratory quality assurance system; that is, one which included internal
and external quality controls, written guidelines describing the entire
procedure for processing of samples, interpretation of results, equipment
control measures, etc. Only 10% of respondents could provide diagnostics
for the full minimum range of relevant non-viral STIs in Lithuania. The
main characteristics of the diagnostics for these pathogens are summarised
in the table.
Laboratory diagnostics for C. trachomatis was available in
only six of the 10 counties in Lithuania and, in total, only in 16 (10%)
of the responding laboratories [TABLE]. Consequently, the number of samples
was much lower than for the other main non-viral STI pathogens [TABLE].
Two thirds of the analyses were performed in the largest county. Most
respondents used an enzyme immunoassay (EIA) or a direct immunofluorescence
(DIF) assay [TABLE].
For diagnosis of N. gonorrhoeae, the number of samples each month varied
dramatically among the different counties in Lithuania and ranged from
22 to 1629 for men and from 270 to 8888 for women. Almost 75 per cent
of all samples from men were tested in the two largest counties of Lithuania.
Most respondents diagnosed N. gonorrhoeae exclusively
by microscopy of stained (methylene blue or Gram stained) genital samples
[TABLE]. In seven of the 10 Lithuanian counties at least one respondent
was able to perform culture of N. gonorrhoeae, but the number
of samples was low.
Regarding the diagnostics of T. pallidum, respondents in the
larger Lithuanian counties analysed almost equal numbers of samples from
men and women, while respondents in most of the smaller counties tested
more samples collected from women. For screening purposes, the majority
(60%) of respondents performed rapid plasma reagin (RPR) tests of STI
samples, units of donated blood and plasma, pregnant women, etc. For
RPR positive samples, mainly T. pallidum haemagglutination (TPHA)
was used for subsequent specific confirmation [TABLE].
For diagnosis of T. vaginalis, the number of samples analysed
and the women/men ratio of samples tested were very similar to that of
N. gonorrhoeae [TABLE]. Almost 75% of the men tested were tested in the
two largest counties. The vast majority of the respondents diagnosed T.
vaginalis using microscopy of genital samples [TABLE]
Discussion
The present study highlights several shortcomings in the diagnostics
and management of non-viral STIs in Lithuania. A similar situation has
previously been described in one of the neighbouring Baltic countries,
Estonia [11]. In Lithuania, there is mandatory reporting of syphilis,
gonorrhoea and genital chlamydial infections [4]. Before the re-independence
of Lithuania in 1991, patients with non-viral STIs were managed exclusively
by specialists in dermatovenereology, mainly at dermatovenereological
(DV) dispensaries. Each case of syphilis and gonorrhoea was reported
by the local DV dispensary to a central dispensary. The chief dermatovenereologist
at the central DV dispensary would then be kept up to date with the progress
of each case, including partner tracing. Each primary healthcare facility
had its own dermatovenereologist who managed all the non-viral STI patients.
There were no private practices or laboratories. Following the re-independence
of Lithuania, there was no ready concept within healthcare reform for
the diagnostics and management of non-viral STIs. Many private clinics
and laboratories arose, which introduced and usually used the cheapest
available methods for STI diagnostics. There was a lack of expertise
and financial resources for controlling the STI diagnostic strategies
and the quality of the diagnostic methods used in these laboratory services.
As revealed in the present study, the 3.5 million inhabitants in Lithuania
during 2002-2003 had 171 facilities providing non-viral STI diagnostic
services, but the availability of STI diagnostic services for each inhabitant
and the number of inhabitants served by each laboratory varied significantly
between counties. Several of the responding laboratories were small and
received low number of samples for STI diagnostics. This may not be cost-effective,
there may be insufficient experience, inadequate use or even lack of
standardised controls, and it may be more difficult to implement systematic
internal and external quality assurance controls and systems.
Only 10% of the respondents that diagnosed any STI in Lithuania were
able to provide C. trachomatis diagnostics and there were only
532 samples per 100 000 inhabitants per year. In contrast, 4726 samples
per 100 000 inhabitants are tested each year in Estonia [11]. The low
sampling size in Lithuania may partially explain why the estimated incidence
of C. trachomatis infection in Lithuania (11.08 per 100 000
inhabitants in 2004) is significantly lower than in the neighbouring
countries of Estonia [11], Belarus, Poland, Sweden, and Denmark [2].
Although Latvia has also reported a low incidence of C. trachomatis infection
[2], more information about the reliability of these figures is needed.
In Lithuania, older diagnostic assays such as EIA or DIF were most often
used, which may not give optimal sensitivity and specificity. However,
with the exception of two respondents who used serology only, the diagnostics
used by the laboratories that diagnosed C. trachomatis corresponded well
with international recommendations [5, 7], using at least one antigen
detection assay (DIF or EIA), nucleic acid detection method, or culture.
It is alarming that for N. gonorrhoeae, most respondents reported using
microscopy of stained genital samples as their sole method, because it
is cheaper to use, and only 5% of the respondents were able to culture
the bacteria. Consequently, most respondents were only able to provide
definitive diagnosis of male symptomatic gonococcal urethritis [6, 7,
12]. According to international recommendations, to provide a definitive
diagnosis, the following kinds of samples should be cultured: urethral
and cervical samples from women, samples from asymptomatic patients of
both sexes, and tests of cure, as well as all extra-genital samples [5,
6, 12]. Failing this, antigen or nucleic acid of the bacteria should
be identified [5, 7]. Culture allows subsequent identification of antimicrobial
resistance in N. gonorrhoeae and there is a complete lack of in depth
knowledge about the level of antimicrobial resistance in Lithuania.
Concerning diagnosis of syphilis in Lithuania, all respondents that performed
syphilis diagnostics could identify probable cases of primary and secondary
syphilis according to international guidelines [5, 7]. However, only
6% of the respondents reported using IgM or DFM (or another direct detection
method such as PCR) and therefore being able to provide a confirmatory
diagnosis of early primary or secondary syphilis [5, 7]. These data are
mainly in agreement with the results of our previous study in the neighbouring
country of Estonia [11].
As for N. gonorrhoeae, the sample size for T. vaginalis diagnostics
reflected the number of genital samples for microscopy from STI patients
and from women attending gynaecology clinics, which is mirrored in the
female/male sample ratio. Only 23% of the respondents used wet smear
microscopy, which is considered to be the most sensitive method for microscopic
diagnosis of the agent [13].
As mentioned previously, only 10% (n=16) of the respondents could provide
diagnostics for the full minimum range of relevant non-viral STIs in
Lithuania, and only 6% (n=9) of the respondents were able to provide
confirmatory diagnoses in accordance with international recommendations
for diagnostics [5, 7] for all the non-viral reportable STIs in Lithuania
(C. trachomatis infection, gonorrhoea, and syphilis).
The comparatively low and declining estimated incidences of non-viral
STIs in Lithuania may, in part, reflect incomplete case reporting and
epidemiological surveillance, the low number of samples for some of the
STIs, the availability of STI diagnostic services, and, in many cases,
the suboptimal diagnostics [present study, 14]. The main reason for this
situation is the low level of funding in the healthcare budget for each
non-viral STI patient, which should cover the cost of clinical investigation
and all laboratory analyses. For more thorough and complete laboratory
diagnostics the patient may have to pay for each additional assay himself/herself
[15].
In conclusion, for optimisation of non-viral STI diagnostics, epidemiological
surveillance and management of non-viral STIs in Lithuania, improved
adherence to international recommendations for diagnostics, increased
accessibility of diagnostic services, and overall improvements of reproductive
healthcare are crucial. To achieve this, we propose that: (i) national
inter-laboratory networks be established; (ii) the number of STI diagnostic
laboratories be decreased; (iii) the diagnostics of some STIs be centralised
to larger laboratories in order to ensure diagnostics in accordance with
international recommendations and quality assurance; (iv) internal and
external quality control (EQC) systems be introduced; (v) reference centres
for STIs other than HIV be established, which will be responsible for
recommendations of adequate diagnostic methodologies, coordination of
EQC systems, performance of confirmative diagnostics for smaller laboratories,
as well as guidance and education regarding STI diagnostics and quality
assurance issues; and (vi) patient insurance be introduced, to cover
expenses for thorough laboratory-based diagnostics for each STI patient.
Acknowledgements
We are grateful for the collaboration of the directors and staff of all
the laboratories surveyed in Lithuania. The present study was supported
by grants from the East Europe Committee of the Swedish Health Care Community,
Sweden.
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