Multicenter Evaluation of the BDProbeTec ET System for Detection of
            <i>Chlamydia trachomatis</i>
            and
            <i>Neisseria gonorrhoeae</i>
            in Urine Specimens, Female Endocervical Swabs, and Male Urethral Swabs

Pol, Barbara Van Der; Ferrero, D; Buck-Barrington, Linda; Hook, Edward W.; Lenderman, Connie; Quinn, Thomas C.; Gaydos, Charlotte A.; Lovchik, Judith C.; Schachter, Julius; Moncada, Jeanne; Hall, Geraldine S.; Tuohy, Marion J.; Jones, Robert B.

doi:10.1128/jcm.39.3.1008-1016.2001

Cited by 271 publications

(189 citation statements)

References 32 publications

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“…LCR and PCR are candidates to replace culture as reference tests, since they are more sensitive and better standardized and have had equivalent specificity in most studies (7,16,22,28,29). An additional advantage of using NAATs is the ability to incorporate a highly sensitive urine test into a two-test patient standard (1), thereby reducing overestimation of cervical test sensitivity and underestimation of cervical and urine test specificities that can result from use of a single-test specimen standard.…”

Section: Discussionmentioning

confidence: 99%

Head-to-Head Multicenter Comparison of DNA Probe and Nucleic Acid Amplification Tests for Chlamydia trachomatis Infection in Women Performed with an Improved Reference Standard

et al. 2002

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Few evaluations of tests for Chlamydia trachomatis have compared nucleic acid amplification tests (NAATs)with diagnostic tests other than those by culture. In a five-city study of 3,551 women, we compared the results of commercial ligase chain reaction (LCR) and PCR tests performed on cervical swabs and urine with the results of PACE 2 tests performed on cervical swabs, using independent reference standards that included both cervical swabs and urethral swab-urine specimens. Using cervical culture as a standard, the sensitivities of PACE 2, LCR, and PCR tests with cervical specimens were 78.1, 96.9, and 89.9%, respectively, and the specificities were 99.3, 97.5, and 98.2%, respectively. Using either cervical swab or urine LCR-positive tests as the standard decreased sensitivities to 60.8% for PACE 2 and to 75.8 and 74.9% for PCR with cervical swabs and urine, respectively. Specificities increased to 99.7% for PACE 2 and to 99.7 and 99.4% for PCR with cervical swabs and urine, respectively. Sensitivities with a cervical swab-urine PCR standard were 61.9% for PACE 2 and 85.5 and 80.8% for LCR with cervical swabs and urine, respectively. Specificities were 99.6% for PACE 2 and 99.0 and 98.9% for LCR with cervical swabs and urine, respectively. Cervical swab versus urine differences were significant only for PCR specificities (P ‫؍‬ 0.034). Overall, LCR sensitivity exceeded that of PCR, and sensitivities obtained with cervical swabs exceeded those obtained with urine specimens by small amounts. These data have substantiated, using a large multicenter sample and a patient standard, that LCR and PCR tests performed on endocervical swabs and urine are superior to PACE 2 tests for screening C. trachomatis infections in women. In our study, NAATs improved the detection of infected women by 17 to 38% compared to PACE 2.Chlamydia trachomatis is the most prevalent bacterial sexually transmitted infection in the United States (6). Untreated infections can have devastating consequences for the female reproductive tract by causing pelvic inflammatory disease with serious sequelae such as infertility, ectopic pregnancy, and chronic pelvic pain. Because the majority of infections, particularly in women, are unrecognized clinically, screening with laboratory tests followed by antibiotic treatment is the most important means of intervention and control. The diagnostics industry has responded to this large public health need with steady improvements in test technologies. Concomitantly, methodology used for evaluation of these newly developed tests has evolved in a parallel fashion.Historically, isolation of C. trachomatis in culture was used as the reference standard for classifying patients as infected or uninfected in new test evaluations (3). Culture was chosen for this purpose because it has nearly 100% specificity, resulting from the highly distinctive morphology of specifically stained chlamydial inclusion bodies grown in host cells, and because it was the most sensitive method available at the time. Thus, virtually all of th...

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Section: Discussionmentioning

confidence: 99%

Head-to-Head Multicenter Comparison of DNA Probe and Nucleic Acid Amplification Tests for Chlamydia trachomatis Infection in Women Performed with an Improved Reference Standard

et al. 2002

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“…The time take to process the two specimen types was very similar, but urine specimens are thought to be more difficult for inexperienced staff to process, 172 and betweencentre variation in estimated sensitivity might be greater for first catch urine specimens (range 50-100%) than for vulval swabs (range 70-100%, with only one centre less than 90%). 173 Published studies performed with women attending STD and family planning clinics have shown that vulvovaginal swabs are acceptable, but the preferred specimen was urine in three studies 167,174,175 and vulvovaginal swabs in one. 176 A small proportion of women in this study, and others, 167 said that they did not take part in screening because they did not want to take a swab specimen themselves.…”

Section: Vulvovaginal Swabs As a Non-invasive Specimen In Womenmentioning

confidence: 99%

Epidemiological, social, diagnostic and economic evaluation of population screening for genital chlamydial infection

Low

McCarthy²,

Macleod³

et al. 2007

Health Technol Assess

134

179

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Non-UK purchasers will have to pay a small fee for post and packing. For European countries the cost is £2 per monograph and for the rest of the world £3 per monograph.You can order HTA monographs from our Despatch Agents:-fax (with credit card or official purchase order) -post (with credit card or official purchase order or cheque) -phone during office hours (credit card only).Additionally the HTA website allows you either to pay securely by credit card or to print out your order and then post or fax it. NHS libraries can subscribe free of charge. Public libraries can subscribe at a very reduced cost of £100 for each volume (normally comprising 30-40 titles). The commercial subscription rate is £300 per volume. Please see our website for details. Subscriptions can only be purchased for the current or forthcoming volume. Contact details are as follows: Payment methods Paying by chequeIf you pay by cheque, the cheque must be in pounds sterling, made payable to Direct Mail Works Ltd and drawn on a bank with a UK address. Paying by credit cardThe following cards are accepted by phone, fax, post or via the website ordering pages: Delta, Eurocard, Mastercard, Solo, Switch and Visa. We advise against sending credit card details in a plain email. Paying by official purchase orderYou can post or fax these, but they must be from public bodies (i.e. NHS or universities) within the UK. We cannot at present accept purchase orders from commercial companies or from outside the UK. How do I get a copy of HTA on CD?Please use the form on the HTA website (www.hta.ac.uk/htacd.htm). Or contact Direct Mail Works (see contact details above) by email, post, fax or phone. HTA on CD is currently free of charge worldwide.The website also provides information about the HTA Programme and lists the membership of the various committees. HTA NIHR Health Technology Assessment ProgrammeT he Health Technology Assessment (HTA) programme, now part of the National Institute for Health Research (NIHR), was set up in 1993. It produces high-quality research information on the costs, effectiveness and broader impact of health technologies for those who use, manage and provide care in the NHS. 'Health technologies' are broadly defined to include all interventions used to promote health, prevent and treat disease, and improve rehabilitation and long-term care, rather than settings of care. The research findings from the HTA Programme directly influence decision-making bodies such as the National Institute for Health and Clinical Excellence (NICE) and the National Screening Committee (NSC). HTA findings also help to improve the quality of clinical practice in the NHS indirectly in that they form a key component of the 'National Knowledge Service'. The HTA Programme is needs-led in that it fills gaps in the evidence needed by the NHS. There are three routes to the start of projects. First is the commissioned route. Suggestions for research are actively sought from people working in the NHS, the public and consumer groups and professional bodies such as r...

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“…The BD ProbeTec TM ET System enables the user to characterize and quantify in real-time of up to 564 samples in eight hours [135]. Its usefulness has been shown in clinical setups especially for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae and other pathogens [136][137][138][139][140][141]. The technology is utilized to generate billions of copies of target molecules from a single DNA or RNA template in the one-hour assay time [142].…”

Section: Sda: Strand Displacement Amplificationmentioning

confidence: 99%

Isothermal Amplification and Quantification of Nucleic Acids and its Use in Microsystems

Tröger¹,

Niemann²,

Gärtig³

et al. 2015

J Nanomed Nanotechnol

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Nucleic acid amplification technologies (NAATs) offer the most sensitive tests in the clinical laboratory. These techniques are used as a powerful tool for screening and diagnosis of infectious diseases. Isothermal methods, as an alternative to polymerase chain reaction (PCR), require no thermocycling machine and can mostly be performed with reduced time, high throughput, and accurate and reliable results.However, current molecular diagnostic approaches generally need manual analysis by qualified and experienced personal which is a highly complex, time-consuming and labor-intensive task. Thus, the demand for simpler, miniaturized systems and assays for pathogen detection is steadily increasing. Microfluidic platforms and lab-on-a-chip devices have many advantages such as small sample volume, portability and rapid detection time and enable point-of-care diagnosis.In this article, we review several isothermal amplification methods and their implementation in microsystems in relation to quantification of nucleic acids. miniaturized systems can be diverse. The majority of publications are focussed on clinical diagnostics including foodborne organisms for environmental monitoring [10][11][12]. In case of an infectious disease, cultivation and phenotypic characterization are still the standard methods of microbiologists which need days up to weeks to obtain a diagnostic result. Hence, scientists started to make use of nucleic acid amplification methods to accelerate the analysis. The most widespread and well known technique for this purpose is the polymerase chain reaction (PCR) [10,13], which exploits the activity of the DNA polymerase. The method is based on a thermal cycling process consisting of repeated cycles of heating and cooling steps allowing for DNA melting, sequence specific primer binding and enzymatic amplification of the target nucleic acid. The quantitative assessment of target copies is possible by using a real-time PCR approach, where a concentration dependent signal (e.g. fluorescence) increases over time [14]. The latter enables the user to easily assess the pathogen load of patient samples [15][16][17][18]. Since the first example of a PCR on a miniaturized system in 1994 [19,20], numerous devices were presented, which integrate not just the amplification, but also sample preparation and detection steps [9,[21][22][23][24][25][26][27][28]. Just a few of those microsystems have reached the market so far, but some have shown a fascinating potential to replace the classical laboratory-oriented state-of-the art [29][30][31][32][33]. setups has been shown to obtain a similar result [34]. A smaller heat capacity allows for rapid changes in temperature beneficial for the PCR time as well as a higher parallelism of multiple genetic samples [34].However, a major drawback of the integration of PCR to microsystems is the necessity of sophisticated instrumentation. The reaction requires a thermal cycling instrumentation, space and considerable expertise [35]. Therefore, isothermal reactions for the ta...

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Multicenter Evaluation of the BDProbeTec ET System for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae in Urine Specimens, Female Endocervical Swabs, and Male Urethral Swabs

Cited by 271 publications

References 32 publications

Head-to-Head Multicenter Comparison of DNA Probe and Nucleic Acid Amplification Tests for Chlamydia trachomatis Infection in Women Performed with an Improved Reference Standard

Head-to-Head Multicenter Comparison of DNA Probe and Nucleic Acid Amplification Tests for Chlamydia trachomatis Infection in Women Performed with an Improved Reference Standard

Epidemiological, social, diagnostic and economic evaluation of population screening for genital chlamydial infection

Isothermal Amplification and Quantification of Nucleic Acids and its Use in Microsystems

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