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

다국어 초록 (Multilingual 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.

참고문헌 (Reference)

1 이임순, "특집/성매개 질환 발생에 관한 시대적 변천과 현황" 대한의사협회 51 (51): 868-874, 2008

2 Korenromp EL, "What proportion of episodes of gonorrhoea and Chlamydia becomes symptomatic?" 13 : 91-101, 2002

3 CLSI, "User protocol for evaluation of qualitative test performance; approved guideline-second edition. CLSI document EP12-2A"

4 Watson EJ, "The accuracy and efficacy of screening tests for Chlamydia trachomatis: a systematic review" 51 : 1021-1031, 2002

5 Wang Q, "Stable and highly fluorescent europium (III) chelates for time-resolved immunoassays" 52 : 8461-8466, 2013

6 Järvenpää ML, "Rapid and sensitive cardiac troponin I immunoassay based on fluorescent europium (III)-chelate-dyed nanoparticles" 414 : 70-75, 2012

7 CLSI, "Protocols for determination of limits of detection and limits of quantitation; approved guideline-second edition. CLSI document EP17"

8 Saison F, "Prevalence of Chlamydia trachomatis infection among low- and high-risk Filipino women and performance of Chlamydia rapid tests in resource-limited settings" 45 : 4011-4017, 2007

9 Patel AL, "Prevalence of Chlamydia infection among women visiting a gynaecology outpatient department: evaluation of an in-house PCR assay for detection of Chlamydia trachomatis" 9 : 24-, 2010

10 van der Helm JJ, "Point-of-care test for detection of urogenital Chlamydia in women shows low sensitivity. A performance evaluation study in two clinics in Suriname" 7 : e32122-, 2012

11 Michel CE, "Pitfalls of internet-accessible diagnostic tests: inadequate performance of a CE-marked Chlamydia test for home use" 85 : 187-189, 2009

12 Juntunen E, "Performance of fluorescent europium (III) nanoparticles and colloidal gold reporters in lateral flow bioaffinity assay" 428 : 31-38, 2012

13 Nadala EC, "Performance evaluation of a new rapid urine test for Chlamydia in men: prospective cohort study" 339 : b2655-, 2009

14 Mahilum-Tapay L, "New point of care Chlamydia Rapid Test--bridging the gap between diagnosis and treatment: performance evaluation study" 335 : 1190-1194, 2007

15 Xia X, "Lateral flow immunoassay using europium chelate–loaded silica nanoparticles as labels" 55 : 179-182, 2009

16 CLSI, "Interference testing in clinical chemistry; approved guideline-second edition. CLSI document EP07-A2"

17 Moi H, "Handilab C Chlamydia for home testing is not what it claims" 127 : 2083-2085, 2007

18 Knox J, "Evaluation of self-collected samples in contrast to practitioner-collected samples for detection of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis by polymerase chain reaction among women living in remote areas" 29 : 647-654, 2002

19 Sachdeva P, "Comparison of an in-house PCR assay, direct fluorescence assay and the Roche AMPLICOR Chlamydia trachomatis kit for detection of C. trachomatis" 58 : 867-873, 2009

20 Huang W, "Comparative effectiveness of a rapid point-of-care test for detection of Chlamydia trachomatis among women in a clinical setting" 89 : 108-114, 2013

21 Hajikhani B, "Classical and molecular methods for evaluation of Chlamydia trachomatis infection in women with tubal factor infertility" 14 : 29-33, 2013

22 Torrone EA, "Chlamydia trachomatis infection among women 26 to 39 yr of age in the United States, 1999 to 2010" 40 : 335-337, 2013

23 Zhou Y, "Application of europium (III) chelates-bonded silica nanoparticle in time-resolved immunofluorometric detection assay for human thyroid stimulating hormone" 722 : 95-99, 2012

24 van Dommelen L, "Alarmingly poor performance in Chlamydia trachomatis point-of-care testing" 86 : 355-359, 2010

25 Xia X, "A highly sensitive europium nanoparticle-based lateral flow immunoassay for detection of chloramphenicol residue" 405 : 7541-7544, 2013

26 von Lode P, "A europium chelate for quantitative point-of-care immunoassays using direct surface measurement" 75 : 3193-3201, 2003