Highly Sensitive and Novel Point-of-Care System, aQcare Chlamydia TRF Kit for Detecting Chlamydia trachomatis by Using Europium (Eu) (III) Chelated Nanoparticles.
- Author:
Ji Yeon HAM
1
;
Jaean JUNG
;
Byung Gap HWANG
;
Won Jung KIM
;
Young Seop KIM
;
Eun Ju KIM
;
Mi Yeon CHO
;
Mi Sun HWANG
;
Dong Il WON
;
Jang Soo SUH
Author Information
- Publication Type:Evaluation Studies ; Original Article ; Research Support, Non-U.S. Gov't
- Keywords: Chlamydia trachomatis; Europium; Point-of-care systems
- MeSH: Adult; Aged; Aged, 80 and over; Chlamydia Infections/*diagnosis; Chlamydia trachomatis/*genetics/isolation & purification; DNA, Bacterial/chemistry/metabolism; Europium/*chemistry; Female; Humans; Male; Metal Nanoparticles/*chemistry; Middle Aged; Point-of-Care Systems; Reagent Kits, Diagnostic; Real-Time Polymerase Chain Reaction; Sensitivity and Specificity; Young Adult
- From:Annals of Laboratory Medicine 2015;35(1):50-56
- CountryRepublic of Korea
- Language:English
- 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.
