Ann Lab Med.  2015 Jan;35(1):50-56. 10.3343/alm.2015.35.1.50.

Highly Sensitive and Novel Point-of-Care System, aQcare Chlamydia TRF Kit for Detecting Chlamydia trachomatis by Using Europium (Eu) (III) Chelated Nanoparticles

Affiliations
  • 1Department of Laboratory Medicine, Kyungpook National University Hospital, Daegu, Korea. suhjs@knu.ac.kr
  • 2Medisensor Inc., Daegu, Korea.
  • 3Department of Clinical Pathology, Kyungpook National University School of Medicine, Daegu, Korea.

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.

Keyword

Chlamydia trachomatis; Europium; Point-of-care systems
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