Multiplex PCR from Menstrual Blood: A Non-Invasive Cost-Effective Approach to Reduce Diagnostic Dilemma for Genital Tuberculosis.

AIM: Genital tuberculosis (GTB) is a potent contributor to irreversible damage to the reproductive system and infertility in females. As no gold standard diagnostic tool is yet available, clinical suspicion and relatively insensitive approaches such as histopathology, laparoscopy and hysterosalpingogram are currently critical determinants in the diagnosis of GTB. Although a polymerase chain reaction (PCR)-based assay using endometrial tissue seems promising, sampling does require an invasive procedure. OBJECTIVE: We hypothesized that menstrual blood may provide an alternate non-invasive source of samples for PCR-based GTB diagnosis. METHODS: We enrolled 195 women with primary infertility in whom GTB was suspected. We obtained ethics committee approval from our institution and written informed consent from subjects. Endometrial tissue and menstrual blood was collected from the subjects and culture, histopathology, and multiplex PCR with both sample type was performed for each subject. RESULTS: The sensitivity and specificity of multiplex PCR was, respectively, 90.2 and 86.1% for menstrual blood, 95.8 and 84.3% for endometrial tissue, and 64.8 and 93.2% for histopathology staining. CONCLUSIONS: A strong clinical suspicion aided with multiplex PCR using menstrual blood may significantly reduce the diagnostic dilemma for GTB diagnosis in a non-invasive, sensitive, rapid, and cost-effective manner.

Impact and cost-effectiveness of chlamydia testing in Scotland: a mathematical modelling study.

BACKGROUND: Chlamydia is the most common sexually transmitted bacterial infection in Scotland, and is associated with potentially serious reproductive outcomes, including pelvic inflammatory disease (PID) and tubal factor infertility (TFI) in women. Chlamydia testing in Scotland is currently targeted towards symptomatic individuals, individuals at high risk of existing undetected infection, and young people. The cost-effectiveness of testing and treatment to prevent PID and TFI in Scotland is uncertain. METHODS: A compartmental deterministic dynamic model of chlamydia infection in 15-24 year olds in Scotland was developed. The model was used to estimate the impact of a change in testing strategy from baseline (16.8% overall testing coverage; 0.4 partners notified and tested/treated per treated positive index) on PID and TFI cases. Cost-effectiveness calculations informed by best-available estimates of the quality-adjusted life years (QALYs) lost due to PID and TFI were also performed. RESULTS: Increasing overall testing coverage by 50% from baseline to 25.2% is estimated to result in 21% fewer cases in young women each year (PID: 703 fewer; TFI: 88 fewer). A 50% decrease to 8.4% would result in 20% more PID (669 additional) and TFI (84 additional) cases occurring annually. The cost per QALY gained of current testing activities compared to no testing is £40,034, which is above the £20,000-£30,000 cost-effectiveness threshold. However, calculations are hampered by lack of reliable data. Any increase in partner notification from baseline would be cost-effective (incremental cost per QALY gained for a partner notification efficacy of 1 compared to baseline: £5,119), and would increase the cost-effectiveness of current testing strategy compared to no testing, with threshold cost-effectiveness reached at a partner notification efficacy of 1.5. However, there is uncertainty in the extent to which partner notification is currently done, and hence the amount by which it could potentially be increased. CONCLUSIONS: Current chlamydia testing strategy in Scotland is not cost-effective under the conservative model assumptions applied. However, with better data enabling some of these assumptions to be relaxed, current coverage could be cost-effective. Meanwhile, increasing partner notification efficacy on its own would be a cost-effective way of preventing PID and TFI from current strategy.

Estimation of the risk of tubal factor infertility associated with genital chlamydial infection in women: a statistical modelling study.

OBJECTIVES: Using a statistical modelling approach, our study aim is to determine reliable age-related estimates of the risk of all-cause tubal factor infertility (TFI) following past or current chlamydial infection in women in Scotland. METHOD: Using data from several sources, a Markov-Chain Monte Carlo model was used to estimate the age-related risk of TFI given genital chlamydia infection at any time. The analysis is based on the probability of a woman ever having chlamydial infection, ever having TFI and ever having a previous chlamydial infection given a diagnosis of TFI. The model was programmed and evaluated using WinBugs14. RESULTS: By the age 44 years, the overall risk of a woman having at least a single chlamydial infection is estimated at 42.9% (95% credible interval 30.0, 59.0%). The risk of a woman having TFI increased from 0.5% in those aged 16-19 years to 0.8% in those aged 40-44. The overall estimated probability of TFI, based on lifetime infertility, given a past or current chlamydial infection, is relatively consistent across all five age groups from 16-44 years, being 0.9% among those aged 25-29 and 1.4% in those aged 35-39; The estimates were found to be sensitive to the definition of infertility, with the estimate increasing from 1.3% in the youngest age group to 2.8% and 4.5% for 24-month primary infertility and primary or secondary infertility, respectively. CONCLUSIONS: At the population level, the likelihood of all-cause TFI in those with past or current chlamydial infection is low. These findings have relevance both at the policy level, in the development of control programmes, and also at an individual level, particularly for clinicians supporting women undergoing testing or with a positive diagnosis.

Prevalence of Chlamydia trachomatis infection in infertile women at a university hospital in Jordan.

In a prospective controlled study, we aimed to determine the prevalence of Chlamydia trachomatis infection in Jordanian women attending an infertility clinic and whether screening is useful as part of routine investigations for infertility. Two groups of patients (152 infertile patients and 146 control patients) had endocervical swab testing by polymerase chain reaction for the presence of C. trachomatis infection. A total of 6/152 patients in the infertility group tested positive for C. trachomatis (3.9%), compared with 1/146 patients in the control group (0.7%), a difference that was not statistically significant. In view of the tendency toward increased prevalence of C. trachomatis infection, screening women for chlamydial infection as part of routine investigations for infertility is recommended.

Cost-effectiveness of Chlamydia antibody tests in subfertile women.

BACKGROUND: For the evaluation of tubal function, Chlamydia antibody testing (CAT) has been introduced as a screening test. We compared six CAT screening strategies (five CAT tests and one combination of tests), with respect to their cost-effectiveness, by using IVF pregnancy rate as outcome measure. METHODS: A decision analytic model was developed based on a source population of 1715 subfertile women. The model incorporates hysterosalpingography (HSG), laparoscopy and IVF. To calculate IVF pregnancy rates, costs, effects, cost-effectiveness and incremental costs per effect of the six different CAT screening strategies were determined. RESULTS: pELISA Medac turned out to be the most cost-effective CAT screening strategy (15 075 per IVF pregnancy), followed by MIF Anilabsystems (15 108). A combination of tests (pELISA Medac and MIF Anilabsystems; 15 127) did not improve the cost-effectiveness of the single strategies. Sensitivity analyses showed that the results are robust for changes in the baseline values of the model parameters. CONCLUSIONS: Only small differences were found between the screening strategies regarding the cost-effectiveness, although pELISA Medac was the most cost-effective strategy. Before introducing a particular CAT test into clinical practice, one should consider the effects and consequences of the entire screening strategy, instead of only the diagnostic accuracy of the test used.

Overestimation of complication rates in evaluations of Chlamydia trachomatis screening programmes--implications for cost-effectiveness analyses.

BACKGROUND: Cost-effectiveness analyses of screening programmes for asymptomatic Chlamydia trachomatis infection suggest that screening at low prevalences in the population is cost-effective. However, the decision models in these studies are based on assumptions about the risk of complications, which are derived from the literature. Incorrect assumptions may lead to under- or overestimation of the effectiveness of screening. The first objective of this paper is to evaluate the assumptions about the probability of complications after an asymptomatic C. trachomatis infection. The second objective is to calculate alternative rates by using available data on the incidence of complications. METHODS: We identified cost-effectiveness studies via Medline, and evaluated these for the evidence for the quoted probabilities. In addition, the probability of complications was calculated for Amsterdam from available registration data. RESULTS: In the three studies that were identified, the assumptions for the rates of pelvic inflammatory disease (PID) (clinical and subclinical) after C. trachomatis infection varied from 15% to 80%, and for ectopic pregnancy, tubal factor infertility, and chronic pelvic pain after PID from 5-25%, 10-20%, and 18-30%, respectively. The assumptions were based on data from high-risk populations, case-control data, and data not accounting for misdiagnoses. Using data obtained from local registrations, we estimated the probability of a clinical PID (0.43%), ectopic pregnancy (0.07%), and tubal factor infertility (0.02%) for women with a current infection. These estimates were consistently lower than the estimates based on the literature. CONCLUSIONS: We argue that an overestimation of the current complication rates is likely. The effect of overestimation is potentially the greatest in populations with a low prevalence, since the currently assumed cost savings associated with screening may disappear when using more realistic estimates for complications.

Performance of five serological chlamydia antibody tests in subfertile women.

BACKGROUND: Micro-immunofluorescence (MIF) is widely used for chlamydia antibody testing (CAT). Recently a species-specific MIF and three enzyme-linked immunosorbent assay (ELISA) tests have been introduced. We compared five commercially available CAT tests, using laparoscopy as a reference, and evaluated whether combinations of tests could improve the predictive value of CAT. METHODS: In a consecutive cohort of 315 subfertile women, results of the five CAT tests were correlated to findings at laparoscopy. Likelihood and odds ratios (OR) were calculated for single tests and for combinations of tests. RESULTS: Of the tests evaluated, MIF Labsystems had the best diagnostic performance (OR 15.7), while pELISA Medac (OR 8.2) was the best of the three ELISA tests. Stepwise logistic regression analysis showed that performance of MIF Labsystems could not be improved by adding a second test. Significant cross-reactivity with C. pneumoniae antibodies was found in all tests evaluated, except in pELISA Medac. CONCLUSIONS: In screening for tubal factor subfertility, MIF Labsystems was superior to the ELISA tests evaluated, and combining two CAT tests did not improve its predictive value. Economic analysis will show whether serial testing by pELISA Medac, and retesting positive samples by MIF Labsystems, is most cost-effective. In CAT, cross-reactivity with C. pneumoniae antibodies is still a major concern.

[Sexually transmitted diseases and female sterility at the University Hospital Center of Dakar: management and prevention]. / Maladies sexuellement transmissibles et stérilité féminine au CHU de Dakar: prise en charge et moyens de prévention.

It is a retrospective study supporting 82 cases continued series of feminine sterility and which objective is to evaluate the nursing management quality of genital infection in exploration and treatment of sterility. Women mean age is 26 years old, sterility is most primary frequently (68%) and from fallopian origin (80%). Followers examinations have been asked: vaginal taking (100%), urines cytobacteriology examination (56%), syphilis serology (23%), chlamydia serology (57%), mycoplasma serology (03%). Genital infection have been diagnosed in 75% of cases, in 33% of cases positive Chlamydia serology was found. Three molecules have been used principally in treatment: cyclines 50%, imidazoles derived 47%, lactamines 15%. The upper cost of diagnostic and treatments produce a wishest of prevention which based is the tracking and the precocious treatment of STD.

[The assessment of the clinical and microbiological status of the lower genital tract in women with sterility]. / Otsenka na klinichniia i mikrobiologichniia status na dolniia genitalen trakt pri zheni sus sterilitet.

The study was carried out on 40 randomly selected patients with sterility, in whom microbiological examination of the lower genital tract was performed. Pathogenic microorganisms were isolated in the vaginal secretion of 10 out of 26 patients with primary sterility, but in the cervical secretion in 8 out of 26 women. Similar finding was found in 5 patients out of 14 patients with secondary sterility. The obtained results were compared with the complaints of women and their gynecological examination. Attention is paid again to the necessity of complex evaluation on the character of microbiological flora in view of the frequent usage of invasive methods in diagnosis and treatment of sterility.

Chlamydia trachomatis: the prevalence, trend and importance in initial infertility management.

One thousand and five women, and 354 of their partners, attending an infertility clinic have been assessed for the presence of Chlamydia trachomatis antibodies in their serum. The overall prevalence in women was 12.4% (125/1,005) but appeared to have increased over a 2-year period. A similar trend was not apparent for men and the prevalence was only 4.2% (15/354). Of the 125 seropositive women 81 had their pelvis examined for the first time by laparoscopy. Fifty seven had tubal disease of varying severity, but only 16 had had an ectopic pregnancy or admitted to a previous history of pelvic inflammatory disease or nonspecific urethritis. These findings suggest that laboratory testing for chlamydial antibodies should be routine in the initial investigation of an infertile couple and that early laparoscopy is indicated in seropositive women.

Guinea-pig inoculation and culture for Mycobacterium tuberculosis in infertile women. A study of cost-effectiveness.

Endometrial biopsy (EB) specimens obtained from infertile women at Natalspruit Hospital are routinely subjected to histological examination, culture for tubercle bacilli and guinea-pig inoculation (GPI). A retrospective analysis of 103 EB specimens from Natalspruit Hospital and 255 specimens from private patients (in the Greater Johannesburg area) examined during January 1981 - August 1983 revealed a 1,96% overall incidence of endometrial tuberculosis (TB). The incidence of endometrial TB in infertile Black women attending Natalspruit Hospital during this period was 4,85%. Confirmed cases of endometrial TB yielded positive cultures in 57% of cases; GPIs were positive in 71% of cases and histological findings were positive in 42% of cases. Statistical comparison of culture and GPI was difficult because of the small number of cases involved. Cost analysis of culture and GPI suggested that culture of EB specimens as a routine screening procedure for infertile patients is more cost-effective and that GPI tests should be reserved for cases in which TB is highly probable. The literature on symptoms, pathology and diagnostic investigation of pelvic TB is briefly reviewed.