scholarly journals A 30-Min Nucleic Acid Amplification Point-of-Care Test for Genital Chlamydia trachomatis Infection in Women: A Prospective, Multi-center Study of Diagnostic Accuracy

EBioMedicine ◽  
2018 ◽  
Vol 28 ◽  
pp. 120-127 ◽  
Author(s):  
E.M. Harding-Esch ◽  
E.C. Cousins ◽  
S.-L.C. Chow ◽  
L.T. Phillips ◽  
C.L. Hall ◽  
...  
Keyword(s):  
Nucleic Acid ◽  
Chlamydia Trachomatis ◽  
Diagnostic Accuracy ◽  
Point Of Care ◽  
Nucleic Acid Amplification ◽  
Chlamydia Trachomatis Infection ◽  
Point Of Care Test ◽  
Multi Center Study ◽  
Center Study

Diagnostic tests for detecting Chlamydia trachomatis and Neisseria gonorrhoeae in rectal and pharyngeal specimens

2021 ◽  
Author(s):  
Paul C. Adamson ◽  
Jeffrey D. Klausner
Keyword(s):  
Chlamydia Trachomatis ◽  
Neisseria Gonorrhoeae ◽  
Bacterial Infections ◽  
Point Of Care ◽  
High Sensitivity ◽  
Population Level ◽  
The United States ◽  
Nucleic Acid Amplification ◽  
Point Of Care Test ◽  
Control And Prevention

Chlamydia trachomatis and Neisseria gonorrhoeae are two of the most often reported bacterial infections in the United States. The rectum and oropharynx are important anatomic sites of infection and can contribute to ongoing transmission. Nucleic acid amplification tests (NAATs) are the mainstays for the detection of C. trachomatis and N. gonorrhoeae infections owing to their high sensitivity and specificity. Several NAATs have been evaluated for testing in rectal and pharyngeal infections. A few assays recently received clearance by the Food and Drug Administration, including one point-of-care test. Those assays can be used for testing in symptomatic individuals, as well as for asymptomatic screening in certain patient populations. Routine screening for C. trachomatis in pharyngeal specimens is not recommended by the Centers for Disease Control and Prevention, though is often performed due to the use of multiplex assays. While expanding the types of settings for screening and using self-collected rectal and pharyngeal specimens can help to increase access and uptake of testing, additional research is needed to determine the potential benefits and costs associated with increased screening for rectal and pharyngeal C. trachomatis and N. gonorrhoeae infections on a population level.

scholarly journals Diagnostic Accuracy of a Prototype Point-of-Care Test for Ocular Chlamydia trachomatis under Field Conditions in The Gambia and Senegal

2011 ◽  
Vol 5 (8) ◽  
pp. e1234 ◽  
Author(s):  
Emma M. Harding-Esch ◽  
Martin J. Holland ◽  
Jean-François Schémann ◽  
Sandra Molina ◽  
Isatou Sarr ◽  
...  
Keyword(s):  
Chlamydia Trachomatis ◽  
Diagnostic Accuracy ◽  
Point Of Care ◽  
The Gambia ◽  
Field Conditions ◽  
Point Of Care Test

Chlamydia trachomatis infection positivity rates determined by nucleic acid amplification test in patients of hospitals in the northeastern region of Ukraine

2017 ◽  
Vol 28 (14) ◽  
pp. 1405-1409
Author(s):  
Alexei Belozorov ◽  
Olga Fedets ◽  
Tatjana Chastii ◽  
Elena Milutina ◽  
Oksana Sokol ◽  
...  
Keyword(s):  
Nucleic Acid ◽  
Chlamydia Trachomatis ◽  
Chlamydial Infection ◽  
Age Groups ◽  
Nucleic Acid Amplification Test ◽  
Nucleic Acid Amplification ◽  
Test Results ◽  
Chlamydia Trachomatis Infection ◽  
Northeastern Region ◽  
Medical Institutions

There are no accurate data regarding the prevalence of Chlamydia trachomatis infection in Ukraine. This study aims to estimate the prevalence in the northeastern region of the country through reviewing nucleic acid amplification test results in patients of medical institutions in the Kharkov region during 2014–2016. Samples from 6920 patients (5028 women and 1892 men) aged 12–76 years were tested. The overall positivity rate was 4.5% (95% CI 4.0–5.0): 3.9% (95% CI 3.4–4.5) in women and 6.1% (95% CI 5.1–7.3) in men. The highest prevalence was found in the 16–20 (8.5%, CI 6.3–11.4) and 21–25 (8.0%, CI 6.7–9.4) year age groups. The prevalence in men was higher than in women in all investigated groups. The results show the need for more attention to the prevention, diagnosis, and treatment of chlamydial infection in these age groups of women and men in this region.

scholarly journals A 30-minute nucleic acid amplification point-of-care test for genitalChlamydia trachomatisinfection in women: a prospective, multi-centre study of diagnostic accuracy

2017 ◽  
Author(s):  
EM Harding-Esch ◽  
EC Cousins ◽  
S-LC Chow ◽  
LT Phillips ◽  
CL Hall ◽  
...  
Keyword(s):  
Nucleic Acid ◽  
Diagnostic Accuracy ◽  
Clinical Pathways ◽  
Point Of Care ◽  
Specific Treatment ◽  
Nucleic Acid Amplification ◽  
Clinical Samples ◽  
Multi Centre Study ◽  
Predictive Values ◽  
Significant Difference

ABSTRACTBackgroundRapid Point-Of-Care Tests (POCTs) forChlamydia trachomatis(CT) may reduce onward transmission and reproductive sexual health (RSH) sequelae by reducing turnaround times between diagnosis and treatment. The io®single module system (Atlas Genetics Ltd) runs clinical samples through a microfluidic CT cartridge, delivering results in 30 minutes. We evaluated its performance on female genital samples in four UK Genito-Urinary Medicine (GUM)/RSH clinics.MethodsProspective diagnostic accuracy study, using BD ProbeTec CT/GC assay as the routine clinic nucleic acid amplification test (NAAT) as the initial comparator test, and the QIAgen Artus CT assay to resolve discrepancies. In these instances, the reference standard was defined as the resolved result when two out of three assay results concurred. Female participants aged ≥16 provided additional-to-routine self-collected vulvovaginal swabs. Samples were tested fresh with the io®CT assay within 7 days of collection, or were frozen at −80°C for later testing. Participant clinical, demographic and behavioural characteristics were collected to assess risk factors associated with CT infection.ResultsOf 785 participants recruited, final analyses were conducted on 709 (90.3%). CT prevalence was 7.2% (51/709) overall. Sensitivity, specificity, positive and negative predictive values of the io®CT assay were, respectively, 96.1% (95% Confidence Interval (CI): 86.5-99.5), 97.7% (95%CI: 96.3-98.7), 76.6% (95%CI: 64.3-86.2) and 99.7% (95%CI: 98.9-100). There was no significant difference in performance measures between fresh and frozen samples, or between symptomatic and asymptomatic participants (p>0.05). The only risk factor associated with CT infection was being a sexual contact of an individual with CT.ConclusionsThe io®CT-assay is the only 30-minute, fully automated, high-performing NAAT currently CE-marked for CT diagnosis in women, making it a highly promising diagnostic to enable specific treatment, initiation of partner notification and appropriately intensive health promotion at the point of care. Future research is required to evaluate acceptability by clinicians and patients in GUM/RSH clinics, impact on clinical pathways and patient management, and cost-effectiveness.

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