Abstract
BackgroundScreening women for Chlamydia trachomatis infection in developing countries is highly desirable because of asymptomatic infection. The existing diagnostic methods in developing countries are not effective and their sensitivity fall below 45.0% which leads to further spread of infection. There is an urgent need for improved and cost effective diagnostic tests that will reduce the burden of sexually transmitted infections in the developing world.MethodsPrevalence of C. trachomatis infection among women visiting gynaecology department of Hindu Rao hospital in Delhi, India was determined using Roche Amplicor Multi Well Plate kit (MWP) as well as using in-house PCR assay. We used 593 endocervical swabs for clinical evaluation of the in-house developed assay against Direct Fluorescence Assay (DFA; Group I n = 274) and Roche Amplicor MWP kit (Group II, n = 319 samples) and determined the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) of the in-house developed assay.ResultsWe detected 23.0% positive cases and there was a higher representation of women aged 18-33 in this group. An in-house PCR assay was developed and evaluated by targeting unique sequence within the gyrA gene of C. trachomatis. Specificity of the reaction was confirmed by using genomic DNA of human and other STI related microorganisms as template. Assay is highly sensitive and can detect as low as 10 fg of C. trachomatis DNA. The resolved sensitivity of in-house PCR was 94.5% compared with 88.0% of DFA assay. The high specificity (98.4%) and sensitivity (97.1%) of the in-house assay against Roche kit and availability of test results within 3 hours allowed for immediate treatment and reduced the risk of potential onward transmission.ConclusionsThe in-house PCR method is cost effective (~ 20.0% of Roche assay) and hence could be a better alternative for routine diagnosis of genital infection by C. trachomatis to facilitate improved screening and treatment management.
Highlights
Screening women for Chlamydia trachomatis infection in developing countries is highly desirable because of asymptomatic infection
Sensitivity and specificity so that it can be used for diagnosis of C. trachomatis infection
The existing diagnostic methods in developing countries are not effective and their sensitivity fall below 45.0% which leads to further spread of infection [49]
Summary
Screening women for Chlamydia trachomatis infection in developing countries is highly desirable because of asymptomatic infection. The existing diagnostic methods in developing countries are not effective and their sensitivity fall below 45.0% which leads to further spread of infection. There is an urgent need for improved and cost effective diagnostic tests that will reduce the burden of sexually transmitted infections in the developing world. Genital infection due to Chlamydia trachomatis is one of the most common sexually transmitted infections. The developing countries have a high incidence of new chlamydial infection, with the exception of sporadic testing, screening for Chlamydia is rare. Using various diagnostic tests with different performance characteristics, the prevalence of chlamydial infection among women in developing countries sex workers varies from 8.5% to 37.0% [7,8,9,10]. The prevalence among female sex workers ranged from 27.0-36.0% in Philippines [11,12] while it is 24.0% in Indonesia [7]
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