Highly sensitive and novel point-of-care system, aQcare Chlamydia TRF kit for detecting Chlamydia trachomatis by using europium (Eu) (III) chelated nanoparticles.

Abstract:

BACKGROUND:The bacterium Chlamydia trachomatis is one of the leading causes of sexually transmitted diseases worldwide. Since no simple and effective tool exists to diagnose C. trachomatis infections, we evaluated a novel point-of-care (POC) test, aQcare Chlamydia TRF kit, which uses europium-chelated nanoparticles and a time-resolved fluorescence reader. METHODS:The test performance was evaluated by comparing the results obtained using the novel POC testing kit with those obtained using a nucleic acid amplification test (NAAT), using 114 NAAT-positive and 327 NAAT-negative samples. RESULTS:The cut-off value of the novel test was 20.8 with a detection limit of 0.27 ng/mL. No interference or cross-reactivity was observed. Diagnostic accuracy showed an overall sensitivity of 93.0% (106/114), specificity of 96.3% (315/327), positive predictive value (PPV) of 89.8% (106/118), and negative predictive value (NPV) of 97.5% (315/323). The sensitivity of the novel test was much higher than that of currently available POC tests. Furthermore, the relative ease and short turnaround time (30 min) of this assay enables C. trachomatis-infected individuals to be treated without a diagnostic delay. CONCLUSIONS:This simple and novel test is a potential tool to screen a larger population, especially those in areas with limited resources.

journal_name

Ann Lab Med

authors

Ham JY,Jung J,Hwang BG,Kim WJ,Kim YS,Kim EJ,Cho MY,Hwang MS,Won DI,Suh JS

doi

10.3343/alm.2015.35.1.50

subject

Has Abstract

pub_date

2015-01-01 00:00:00

pages

50-6

issue

1

eissn

2234-3806

issn

2234-3814

journal_volume

35

pub_type

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