Evaluation of a Novel Electrochemical Detection Method for Chlamydia trachomatis : Application for Point-of-Care Diagnostics

Pearce, David; Shenton, Daniel P.; Holden, Jeffrey P.; Gaydos, Charlotte A.

doi:10.1109/tbme.2010.2095851

Cited by 35 publications

(24 citation statements)

References 5 publications

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“…1516 Sadly, we have few good Federal Drug Administration-approved POC tests, 17 other than for HIV and trichomonas in the USA, 18 but several promising ones are in development. 1920 …”

Section: Diagnosis and Treatment Issuesmentioning

confidence: 99%

STI management and control in North America IUSTI region

Gaydos

2011

Sex Transm Infect

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“…1516 Sadly, we have few good Federal Drug Administration-approved POC tests, 17 other than for HIV and trichomonas in the USA, 18 but several promising ones are in development. 1920 …”

Section: Diagnosis and Treatment Issuesmentioning

confidence: 99%

STI management and control in North America IUSTI region

Gaydos

2011

Sex Transm Infect

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“…However, the GeneXpert platform fails to fulfil the ASSURED criteria (affordable, sensitive, specific, user-friendly, rapid, equipment-free, delivered to those who need it),13 stated by WHO, for rapid POC tests, for example, because the assays take around 90 min from sample to result, needs a source of electricity and is costly. Most recently, a rapid molecular POC test for C. trachomatis was approved in Europe (Atlas Genetics io),14 with a 30 min turnaround time, and many additional rapid molecular POC tests for non-viral STIs are in the pipeline.…”

Section: Introductionmentioning

confidence: 99%

Rapid accurate point-of-care tests combining diagnostics and antimicrobial resistance prediction forNeisseria gonorrhoeaeandMycoplasma genitalium

2017

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In addition to inadequate access to early diagnosis and treatment with antimicrobial agents for patients and sexual contacts, management and control of STIs is significantly challenged by emergence and spread of antimicrobial resistance (AMR), particularly for STIs such as and This is further compounded by use of nucleic acid amplification techniques for diagnosis, resulting in reduced phenotypic AMR testing for and absence or suboptimal AMR surveillance for guiding treatment of both STIs in many settings. Rapid accurate point-of-care (POC) tests for diagnosis of all STIs would be valuable but to significantly impact treatment precision and management of and infections, combinations of rapid POC diagnostic and AMR testing (POC-AMR) will likely be required. This strategy would combat STI burden and AMR emergence and spread by enabling diagnosis and individualised treatment at the first healthcare visit, potentially reducing selection pressure on recommended antimicrobials, reducing transmission of resistant strains and providing means for AMR surveillance. Microfluidic and nanotechnology platforms under development for rapid detection of STIs provide a basis to also develop molecular rapid POC-AMR prediction. A number of prototypic devices are in the pipeline but none as yet approved for routine use. However, particularly for, more knowledge is required to assess which antimicrobials lend themselves to a genotypic POC-AMR approach, in relation to genotypic-phenotypic associations and potential impact clinically and epidemiologically. Key for successful deployment will include also understanding cost-effectiveness, cost-consequences and acceptability for key stakeholders.

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“…Since the previous literature review [7], 4 studies have been published on the performance of investigational CT POC tests [64][65][66][67]. Hesse et al evaluated the performance of 4 novel CT POC prototypes in succession, each modified based on communication with the manufacturer, on vaginal and cervical swabs compared with SDA [64].…”

Section: Discussionmentioning

confidence: 99%

“…Dean et al evaluated the performance of a novel microfluidic multiplex PCR POC test on cervical swabs compared with the Roche Amplicor NAAT (PCR) and found that the sensitivity and specificity for the multiplex assay was 91.5% and 100% vs 62.4% and 95.9% for NAAT; discordant results between the multiplex assay and NAAT were evaluated using microfluidic Sanger sequencing [66]. Pearce et al evaluated the performance of a novel CT POC test using an electrochemical detection method on 306 samples previously pretyped as either CT positive (n = 107) or CT negative (n = 199) by TMA or PCR and found that the sensitivity and specificity for the novel POC test were 98.1% and 98.0%, respectively [67].…”

Section: Discussionmentioning

confidence: 99%

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Diagnosis and Management of UncomplicatedChlamydia trachomatisInfections in Adolescents and Adults: Summary of Evidence Reviewed for the 2015 Centers for Disease Control and Prevention Sexually Transmitted Diseases Treatment Guidelines

Geisler

2015

Clin Infect Dis.

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In preparation for the 2015 Centers for Disease Control and Prevention (CDC) Sexually Transmitted Diseases (STD) Treatment Guidelines, the CDC convened an advisory group in 2013 to examine recent abstracts and published literature addressing the epidemiology, diagnosis, and management of STDs. This article summarizes the key questions, evidence, and recommendations for the diagnosis and management of uncomplicated Chlamydia trachomatis (CT) infection in adolescents and adults that were considered in development of the 2015 CDC STD Treatment Guidelines. The evidence reviewed primarily focused on CT infection risk factors in women, clinical significance of oropharyngeal CT detection, acceptability and performance of CT testing on self-collected specimens in men, performance of CT point-of-care tests, efficacy of recommended and investigational CT infection treatments, and timing of test of cure following CT infection treatment in pregnant women.Keywords. chlamydia; diagnosis; management; CDC; guidelines.Chlamydia trachomatis (CT) infection is the most frequently reported bacterial sexually transmitted infection in the United States and remains highly prevalent, with >1.4 million cases reported to the Centers for Disease Control and Prevention (CDC) annually [1]. Young age is a strong predictor of CT infection, with the highest CT infection prevalence in persons <25 years of age [1]. Because the majority of CT infections are asymptomatic, detection of infection often relies on screening. The 2010 CDC Sexually Transmitted Diseases (STD) Treatment Guidelines recommends annual CT screening in all sexually active women 25 years of age or younger and also older women with risk factors (eg, those who have a new sex partner or multiple sex partners) [2]. Benefits of CT screening in women have been demonstrated in areas where screening programs have reduced rates of pelvic inflammatory disease (PID) [3,4], a precursor of infertility, and recent literature suggests a continued decline in PID rates in the United States [5].The approach to the diagnosis and management of uncomplicated CT infection in adolescents and adults includes (1) CT testing using nucleic acid amplification tests (NAATs); (2) treatment with CDC-recommended therapy to reduce complications and prevent transmission to others; (3) treatment of sexual partners to prevent reinfection of patients and complications in patients and partners; (4) risk-reduction counseling; (5) repeat CT testing a few months following treatment to identify repeat infection; and (6) in pregnant women at a minimum of 3 weeks following treatment to identify persisting or repeat infection so that repeat treatment can be provided promptly to reduce risk for maternal and neonatal morbidity.Following release of the 2010 CDC STD Treatment Guidelines [2], unanswered questions and topics requiring further study on the epidemiology, diagnosis, and management of uncomplicated CT infection remained. In preparation for the 2015 CDC STD Treatment Guidelines, the CDC convened an advisory group in...

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Evaluation of a Novel Electrochemical Detection Method for Chlamydia trachomatis : Application for Point-of-Care Diagnostics

Cited by 35 publications

References 5 publications

STI management and control in North America IUSTI region

STI management and control in North America IUSTI region

Rapid accurate point-of-care tests combining diagnostics and antimicrobial resistance prediction forNeisseria gonorrhoeaeandMycoplasma genitalium

Diagnosis and Management of UncomplicatedChlamydia trachomatisInfections in Adolescents and Adults: Summary of Evidence Reviewed for the 2015 Centers for Disease Control and Prevention Sexually Transmitted Diseases Treatment Guidelines

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