| Summary: | 博士 === 義守大學 === 電機工程學系 === 104 === Clinically, clinicians can diagnose knee Osteoarthritis (OA) according to the degree of degeneration of articular cartilage by examining its surface and the joint space and by detecting hyperplasia or deformation of the knee on X-ray radiographs. Although X-ray radiography is the major and the only non-invasive diagnostic method, the risk of radiation exposure still exists. In addition, the outcome of the diagnosis regarding the symptoms of early degeneration is neither unambiguous nor obvious. Instead of using the abovementioned method, the study is the first trial to develop a urine strip that able to detect the presence of the marker of articular cartilage degradation, COMP (cartilage oligomeric matrix protein) in the subjects’ urine samples. This strip provides an early diagnosis of OA and effectively decreases the expense of medication on OA. There are two parts included in this thesis, the first one including the development and mass production criteria of urine strip, including pH value, buffer solution, gold colloid and multi-clonal antibody selections. The preliminary results demonstrated that the followings are the optimal production conditions for urine strip: OD520=2, pH 7.5 boric acid buffer solution, multi-clonal antibody concentration: 0.8 mg/mL, monoclonal antibody concentration: 1.5 mg/mL and using NC membrane.
The second parts of this thesis are focused on, combining the prepared urine strip with x-ray examination and IKDC knee evaluation questionnaire, to evaluate the efficacy of this strip as an early diagnosis or monitoring tool for OA from the 110 OA patients (1 grade OA or worse) in E-DA hospital. The preliminary results indicated that this strip exhibited 86 % of accuracy from 110 urea tests. The IKDC scores 85.7±14.2 from 54 normal subjects, however, the IKDC scores 51.1±18.2 from 110 OA patients. These scores demonstrated statistical difference. In addition, we attempted to use this IKDC scores combing with urine strip to evaluate the degeneration and function of cartilage: 1. Setting the IKDC scores as OA threshold at 70, we can demonstrate that the sensitivity of urine strip is 79.1 %, specificity is 83.3 % and accuracy is 80.5 %. 2. Setting the IKDC scores as OA threshold at 80, we can demonstrate that the sensitivity of urine strip is 94.6 %, specificity is 68.5 % and accuracy is 86%. The results revealed that the urine strip together with the IKDC could be used to screen the OA and as an early diagnosis tool for OA, beyond the traditional X-ray examination.
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