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      Detection of Chlamydia trachomatis infections by polymerase chain reaction in asymptomatic pregnant women with special reference to the utility of the pooling of urine specimens

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          Abstract

          Background & objectives:

          Genital Chlamydia trachomatis (CT) infections are one of the most prevalent sexually transmitted infections across the world. In pregnant women, if not detected and treated early, these may result in poor pregnancy outcomes and complications. The present study was aimed to screen CT infections from first void urine (FVU) samples of asymptomatic pregnant women using molecular methods. The secondary objective was to evaluate cost-effectiveness in pooling FVU samples for their diagnostic application.

          Methods:

          FVU samples were collected from 1000 asymptomatic pregnant women over a period of three years. Pooling was done by including five specimens in one pool in the amount of 10 µl and subjected to polymerase chain reaction (PCR) and further confirmed by direct fluorescent antibody assay (DFA).

          Results:

          The age of study participants ranged from 18 to 43 yr with the median±standard deviation of 26±3.84 yr. Majority of positive participants were younger than 25 years. A total of 200 pools were prepared and 20 of these were PCR positive. When individual specimen in 20 positive pools was tested, 20 PCR-positive specimens were identified from 19 pools, of which 16 were positive by DFA. Thus, CT was detected in 1.6 per cent asymptomatic pregnant women in India and pooling strategy resulted in 70 per cent reduction in a number of tests performed.

          Interpretation & conclusions:

          Our study detected C. trachomatis infection in 1.6 per cent asymptomatic pregnant women, and pooling of FVU specimens for PCR testing was found to be a cost-saving strategy in comparison to testing individual samples. Further evaluation and studies on the bigger sample size are warranted to validate these results.

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          Most cited references25

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          Sexually transmitted infections in pregnancy: prevalence, impact on pregnancy outcomes, and approach to treatment in developing countries.

          Sexually transmitted infections (STIs) are common in the developing world. Management of STIs in pregnancy in many developing countries has, however, been complicated by the lack of simple and affordable diagnostic tests. This review examines the prevalence and impact on pregnancy outcome of STIs in developing countries and recommends approaches to management of STIs in pregnancy for resource poor settings.
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            Cost effectiveness of screening for Chlamydia trachomatis: a review of published studies.

            Screening for Chlamydia trachomatis in the lower genital tract may contribute to the prevention of pelvic inflammatory disease in women. The purpose of this review was to critically appraise, and summarise studies of the cost effectiveness of screening for C trachomatis. A literature search was conducted on Medline and in Health Star from 1990-2000. Keywords were C trachomatis, screening, cost effectiveness. Bibliographies of reviewed articles were also searched. The population studied was asymptomatic sexually active women under 30 years of age in a primary care setting. The intervention assessed was screening for lower genital tract infection with C trachomatis and the outcomes studied were cases of C trachomatis detected, cases of PID prevented, and associated costs. Studies were assessed using the Drummond criteria for economic evaluations. They were assessed qualitatively as they were too heterogeneous to allow quantitative analysis. 10 studies were included. All were modelled scenarios and all found screening to be more cost effective than simply testing symptomatic women, although all were based on probabilities that were assumed. Six of the studies focused on DNA based testing, three of them using urine. The models showed screening to be cost effective at prevalences of 3.1-10.0%, and cost saving (overtesting symptomatic women) at a prevalence as low as 1.1%, if age was used as a selection factor and DNA based tests were used in urine samples. At the prevalence of infection expected in the target population, all studies suggest screening is cost effective. However, the assumptions used in the models have been difficult to confirm and there is a need for more data, particularly on the risk of complications in women with asymptomatic lower tract infection.
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              Head-to-head comparison of second-generation nucleic acid amplification tests for detection of Chlamydia trachomatis and Neisseria gonorrhoeae on urine samples from female subjects and self-collected vaginal swabs.

              In a comparison of 4 second-generation nucleic acid amplification tests performed with self-collected vaginal swab (SCVS) and first-void urine (FVU) specimens from 575 women, SCVS specimens indicated more infections than did FVU specimens in all assays. The prevalence rates were 9% (53/575 patients) for Chlamydia trachomatis and 2% (11/575 patients) for Neisseria gonorrhoeae. The clinical sensitivities for testing SCVS specimens for C. trachomatis were 98.1% on a Tigris system and 96.2% on a Panther system for the Aptima Combo 2 assay (Hologic Gen-Probe), 98.0% for the RealTime CT/NG assay on an m2000 instrument (Abbott), 90.6% for the ProbeTec CT/GC Q(x) assay on the Viper system (Becton Dickinson), and 84.6% for the cobas CT/NG assay on the cobas 4800 platform (Roche). Clinical sensitivities for C. trachomatis in FVU specimens were 88.7% (Tigris) and 88.0% (Panther) for the Aptima Combo 2 assay, 76.9% for the RealTime CT/NG assay, 75.5% for the ProbeTec CT/GC Q(x) assay, and 81.1% for the cobas CT/NG assay. Clinical sensitivities of the assays for N. gonorrhoeae, with limited positive results, ranged from 63.6% to 100%. Specificities for both infections ranged from 98.4 to 100%. Differences in analytical sensitivities and levels of molecular targets in clinical samples but not inhibitors of amplification may explain the differences in clinical sensitivities.
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                Author and article information

                Journal
                Indian J Med Res
                Indian J. Med. Res
                IJMR
                The Indian Journal of Medical Research
                Medknow Publications & Media Pvt Ltd (India )
                0971-5916
                July 2017
                : 146
                : Suppl 1
                : S59-S63
                Affiliations
                [1 ] Department of Medical Microbiology, Postgraduate Institute of Medical Education & Research, Chandigarh, India
                [2 ] Department of Obstetrics & Gynaecology, Postgraduate Institute of Medical Education & Research, Chandigarh, India
                Author notes
                Reprint requests: Dr. Sunil Sethi, Department of Medical Microbiology, Postgraduate Institute of Medical Education and Research, Chandigarh 160 012, India e-mail: sunilsethi10@ 123456hotmail.com
                Article
                IJMR-146-59
                10.4103/ijmr.IJMR_981_15
                5735572
                29205197
                b38803eb-642b-4ecb-a926-ceed8323190b
                Copyright: © 2017 Indian Journal of Medical Research

                This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms.

                History
                : 05 July 2015
                Categories
                Original Article

                Medicine
                asymptomatic pregnant,chlamydia trachomatis infection,direct fluorescent antibody assay,first void urine,north india,polymerase chain reaction,pooling,prevalence

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