Comparative effectiveness of a rapid point-of-care test for detection of<i>Chlamydia trachomatis</i>among women in a clinical setting

Huang, Wei; Gaydos, Charlotte A.; Barnes, Mathilda; Jett-Goheen, Mary; Blake, Diane R.

doi:10.1136/sextrans-2011-050355

Cited by 77 publications

(68 citation statements)

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“…A recent review of available POC tests for detection of STIs reported disappointing sensitivity for tests for Chlamydia (3). A recent cost-effectiveness study has demonstrated that implementation of POC tests meeting the ASSURED criteria can be cost-effective, compared with traditional NAATs (48). Additionally, a POC test with moderate sensitivity (65%) can help to treat more Chlamydia-positive cases than a NAAT alone when the rate of patients returning for results and treatment is lower than 65% (49).…”

Section: Discussionmentioning

confidence: 99%

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Blind Evaluation of the Microwave-Accelerated Metal-Enhanced Fluorescence Ultrarapid and Sensitive Chlamydia trachomatis Test by Use of Clinical Samples

et al. 2013

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Accurate point-of-care (POC) diagnostic tests for Chlamydia trachomatis infection are urgently needed for the rapid treatment of patients. In a blind comparative study, we evaluated microwave-accelerated metal-enhanced fluorescence (MAMEF) assays for ultrafast and sensitive detection of C. trachomatis DNA from vaginal swabs. The results of two distinct MAMEF assays were compared to those of nucleic acid amplification tests (NAATs). The first assay targeted the C. trachomatis 16S rRNA gene, and the second assay targeted the C. trachomatis cryptic plasmid. Using pure C. trachomatis, the MAMEF assays detected as few as 10 inclusion-forming units/ml of C. trachomatis in less than 9 min, including DNA extraction and detection. A total of 257 dry vaginal swabs from 245 female adolescents aged 14 to 22 years were analyzed. Swabs were eluted with water, the solutions were lysed to release and to fragment genomic DNA, and MAMEF-based DNA detection was performed. The prevalence of C. trachomatis by NAATs was 17.5%. Of the 45 samples that were C. trachomatis positive and the 212 samples that were C. trachomatis negative by NAATs, 33/45 and 197/212 were correctly identified by the MAMEF assays if both assays were required to be positive (sensitivity, 73.3%; specificity, 92.9%). Using the plasmid-based assay alone, 37/45 C. trachomatis-positive and 197/212 C. trachomatis-negative samples were detected (sensitivity, 82.2%; specificity, 92.9%). Using the 16S rRNA assay alone, 34/45 C. trachomatis-positive and 197/212 C. trachomatis-negative samples were detected (sensitivity, 75.5%; specificity, 92.9%). The overall rates of agreement with NAAT results for the individual 16S rRNA and cryptic plasmid assays were 89.5% and 91.0%, respectively. Given the sensitivity, specificity, and rapid detection of the plasmid-based assay, the plasmid-based MAMEF assay appears to be suited for clinical POC testing.

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Section: Discussionmentioning

confidence: 99%

“…The Clearview Chlamydia immunoassay test (Inverness, Princeton, NJ) has been primarily evaluated against culture, and lack of sensitivity has been reported repeatedly (48). The Chlamydia Rapid Test has shown promising results for the sensitive detection of C. trachomatis in 25 min (50).…”

Section: Discussionmentioning

confidence: 99%

Blind Evaluation of the Microwave-Accelerated Metal-Enhanced Fluorescence Ultrarapid and Sensitive Chlamydia trachomatis Test by Use of Clinical Samples

et al. 2013

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“…The hands-on time is approximately 5 min and the time for results is quick (Ͻ2 h) compared to other NAAT platforms. The ability to provide test results and treat patients before they leave the clinic or doctor's office has substantial potential to reduce complications and it might be cost-effective depending on the cost of the assay, the time patients are willing to wait, and the number of patients who might not return to a clinic for their result (3,4,24).…”

Section: Discussionmentioning

confidence: 99%

Performance of the Cepheid CT/NG Xpert Rapid PCR Test for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae

et al. 2013

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Tests for Chlamydia trachomatis and Neisseria gonorrhoeae, which can provide results rapidly to guide therapeutic decision-making, offer patient care advantages over laboratory-based tests that require several days to provide results. We compared results from the Cepheid GeneXpert CT/NG (Xpert) assay to results from two currently approved nucleic acid amplification assays in 1,722 female and 1,387 male volunteers. Results for chlamydia in females demonstrated sensitivities for endocervical, vaginal, and urine samples of 97.4%, 98.7%, and 97.6%, respectively, and for urine samples from males, a sensitivity of 97.5%, with all specificity estimates being >99.4%. Results for gonorrhea in females demonstrated sensitivities for endocervical, vaginal, and urine samples of 100.0%, 100.0%, and 95.6%, respectively, and for urine samples from males, a sensitivity of 98.0%, with all estimates of specificity being >99.8%. These results indicate that this short-turnaround-time test can be used to accurately test patients and to possibly do so at the site of care, thus potentially improving chlamydia and gonorrhea control efforts. Chlamydia trachomatis and Neisseria gonorrhoeae are the agents of the two most prevalent bacterial sexually transmitted infections (STIs) reported to the Centers for Disease Control and Prevention (CDC), accounting for Ͼ1.6 million reported infections in the United States in 2010 (1). The CDC estimates that STIs cost the health care system $1.5 billion annually. Since these infections, especially chlamydia, are most often asymptomatic, the CDC recommends yearly screening for chlamydia in all sexually active women aged 16 to 25 years. Further, since coinfections are common, most diagnostic test platforms assay for both organisms. Nucleic acid amplification tests (NAATs) are now recommended by the CDC (2) as the tests of choice; however, current NAATs are classified as being of high or moderate complexity and might take 1 to 2 days for results to become available. New assays and new platforms that provide results at the time of patient visits are urgently needed, since many patients do not return for their results when laboratory-based tests that require several days for their results are performed (3, 4).The Cepheid GeneXpert CT/NG (Xpert) assay is a rapid (Ͻ2 h to results) NAAT assay that can be performed in on-site laboratories. The assay detects the DNA of C. trachomatis and N. gonorrhoeae from endocervical, vaginal, and urine specimens of females, as well as from urine specimens of males, from both symptomatic and asymptomatic individuals. The Xpert test is performed using a modular cartridge-based platform for testing each specimen by nucleic acid amplification, and it can process from 1 to 96 specimens in Ͻ2 h with easy-to-use cartridges that minimize processing steps and contamination. This study compares the clinical performance (as measured by sensitivity, specificity, positive predictive value [PPV] and negative predictive value [NPV]) of the Xpert assay to the patient infection status (PIS)...

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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%

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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Comparative effectiveness of a rapid point-of-care test for detection ofChlamydia trachomatisamong women in a clinical setting

Cited by 77 publications

References 29 publications

Blind Evaluation of the Microwave-Accelerated Metal-Enhanced Fluorescence Ultrarapid and Sensitive Chlamydia trachomatis Test by Use of Clinical Samples

Blind Evaluation of the Microwave-Accelerated Metal-Enhanced Fluorescence Ultrarapid and Sensitive Chlamydia trachomatis Test by Use of Clinical Samples

Performance of the Cepheid CT/NG Xpert Rapid PCR Test for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae

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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