• 제목/요약/키워드: Medical test

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기능 안전 관점에서의 의료기기 소프트웨어 신뢰성 평가 방법에 관한 연구 (Study on Reliability Assessment for the Medical Device Software from the Viewpoint of Functional Safety)

  • 김성민;고병각;도경훈;김혜진;함중걸
    • 한국신뢰성학회지:신뢰성응용연구
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    • 제16권3호
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    • pp.216-223
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    • 2016
  • Purpose: This paper suggests the procedure to enhance the reliability of the software of the medical device that is to cure, treat, diagnose, and prevent a disease or an abnormal health conditions. Methods: After test requirements are classified by the software requirements specification for safety and backgrounds, reliability assessment methods are suggested. Results: Verification and validation for function and safety can be performed whether the medical device software are implemented as intended. Conclusion: Procedure on the static analysis, unit test, integration test, and system test are provided for the medical device software.

투시 검사 시 체위 변화에 따른 입사표면선량의 평가 연구 (An Evaluative Study on ESD(Entrance Surface Dose) by Posture Changes for Fluoroscopy)

  • 양해두;홍선숙;박은성;성민숙;하동윤
    • 대한디지털의료영상학회논문지
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    • 제13권4호
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    • pp.177-183
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    • 2011
  • This study intends to investigate patients' exact exposure doses by comparatively measuring ESD (Entrance Surface Dose) with the DAP meter, which excludes scattered rays, and ESD with the Xi multifunction meter, which includes scattered rays, by posture changes for Esophagography test and UGI test. The materialwere examined through Sonialvision-SafireII SPEC overtube system. ESD was measured by using the DAP meter, and as a tool to measure ESD including scattered rays on the plane of incidence of human phantom, the Xi multifunction meter was used. The average fluoroscopic time of Esophagography test was 4.192 minutes and the average number of images was 47.7, while the average fluoroscopic time of UGI test was 6.881 minutes and the average number of images was 37.8. The ratios of the incident dose of DAP meter and the ESD of Xi meter were calculated bydividing the fluoroscopic time and the number of images by each posture change. As for Esophagography test, the dose increased by 21.6~55.5% in the fluoroscopic test and by 4.8~24.7% in the spot test. In the front spot test, however, the does increased by as little as 5.3%. As for UGI test, the dose increased by 21.1~49.5% in the fluoroscopic test and by 10.1~34.9% in the spot test. It is expected that measuring doses in consideration of scattered rays by posture changes will be an important index in evaluating and managing patients' exact exposure doses for each test above. Furthermore, it is judged that this sort of study is inevitable and desirable to reduce patients' exposure doses after all.

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IgG Avidity ELISA Test for Diagnosis of Acute Toxoplasmosis in Humans

  • Rahbari, Amir Hossien;Keshavarz, Hossien;Shojaee, Saeedeh;Mohebali, Mehdi;Rezaeian, Mostafa
    • Parasites, Hosts and Diseases
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    • 제50권2호
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    • pp.99-102
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    • 2012
  • Serum samples, 100 in the total number, were collected from different laboratories in Tehran, Iran and tested for anti-Toxoplasma specific IgG and IgM antibodies using indirect immunofluorescent antibody test (IFAT). Using the IgG (chronic) and IgM (acute) positive samples, the IgG avidity test was performed by ELISA in duplicate rows of 96-well microtiter plates. One row was washed with 6 M urea and the other with PBS (pH 7.2), then the avidity index (AI) was calculated. Sixteen out of 18 (88.9%) sera with acute toxoplasmosis showed low avidity levels ($AI{\leq}50$), and 76 out of 82 (92.7%) sera in chronic phase of infection showed high avidity index (AI>60). Six sera had borderline ranges of AI. The results showed that the IgG avidity test by ELISA could distinguish the acute and chronic stages of toxoplasmosis in humans.

Brucella 양성유즙의 성질과 각종요인이 Milk Ring Test에 미치는 영향 (Characteristics of Brucella positive Milk and Effect of Some Factors Influenced Milk Ring Test)

  • 우종태
    • 대한수의사회지
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    • 제18권5호
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    • pp.54-59
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    • 1982
  • Now in Korea Brucellosis was diagnosed by individual periodic blood tests. Author hope that individual periodic blood tests was performed after Milk Ring Test, because if Cattles show negative reaction to Milk Ring Test, Periodic blood tests are needless.

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비이식형 요실금 치료용 신경근 전기자극 의료기기 개발 (The Development of Neuromuscular Electrical Stimulation Medical Devices for The Treatment of Non-implantable Urinary Incontinence)

  • 이재용;이창두;권기진
    • 전기학회논문지P
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    • 제64권3호
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    • pp.175-181
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    • 2015
  • In this paper, the neuromuscular electrical stimulation medical devices for non-implantable incontinence treatment other than vaginal insertion type was developed and commercialized. The structure of medical devices for electrical stimulation based on the anatomy of the pelvic floor muscle designed. Then, the optimum parameters that may be effective in pelvic floor muscle electrical stimulation was set. The circuit system based on the optimum parameters were designed and manufactured. The frequency of the pulse voltage for electrical stimulation is 75[Hz], the pulse width is 300[${\mu}s$], the development of medical devices was to have seven program functions to the various treatments. The circuit system of medical devices was composed of microcontroller, comparator and converter. The performance of the developed circuit system in KTC(Korea Testing Certification) were carried out medical equipment inspection test. Test results, test specifications were satisfied with the medical device, the performance was verified to be commercialized as a medical device. The development of medical devices were validated risk assessment and product performance through a software validation. Commercialization of medical equipment was acquired to enable the certification standards of the international standard IEC 60601-1.

Human Telomerase Gene and High-Risk Human Papillomavirus Infection are Related to Cervical Intraepithelial Neoplasia

  • Zhao, Xu-Ye;Cui, Yongm;Jiang, Shu-Fang;Liu, Ke-Jun;Han, Hai-Qiong;Liu, Xiao-Su;Li, Yali
    • Asian Pacific Journal of Cancer Prevention
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    • 제16권2호
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    • pp.693-697
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    • 2015
  • Our aims were to evaluate the clinical performance of human telomerase RNA gene component (hTERC gene) amplification assay with high-risk human papillomavirus (HR-HPV) DNA test of Hybrid Capture 2 DNA test (HC2), for the detection of high grade cervical precancerous lesions and cancer (CIN 2+). In addition, the association shown between hTERC gene amplification and HPV DNA test positive in women with and without cervical neoplasia was assessed. There were 92 women who underwent cytology, HR-HPV DNA test, hTERC gene amplification test, colposcopy and biopsy. We compared the clinical performance of hTERC gene test along with HR-HPV DNA test of women with colposcopy and routine screening. The samples were histology-confirmed high-grade cervical intraepithelial neoplasia (CIN 2) or worse (CIN2+) as the positive criterion. The test of hTERC gene showed the hTERC gene amplification positivity increased with the severity of histological abnormality and cytological abnormality. The test of hTERC gene showed higher specificity than HR-HPV DNA test for high-grade lesions (84.4% versus 50%) and also higher positive predictive value (90.4% versus 76.5%). Our results predicted that hTERC gene amplification demonstrated more specific performance for predicting the risk of progression and offer a strong potential as a tool for triage in cervical cancer screening, with the limited sensitive as HR-HPV DNA test.

Antinociceptive Effects of Intrathecal Metabotropic Glutamate Receptor Compounds and Morphine in Rats

  • Choi, Jeong II;Lee, Hyung Kon;Chung, Sung Tae;Kim, Chang Mo;Bae, Hong Beom;Kim, Seok Jai;Yoon, Myung Ha;Chung, Sung Su;Jeong, Chang Young
    • The Korean Journal of Pain
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    • 제18권1호
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    • pp.1-9
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    • 2005
  • Background: Spinal metabotropic glutamate receptors (mGluRs) and opioid receptors are involved in the modulation of nociception. Although opioid receptors agonists are active for pain, the effects of the compounds for the mGluRs have not been definitely investigated at the spinal level. We examined the effects of the intrathecal mGluR compounds and morphine in the nociceptive test, and then we further clarified the role of the spinal mGluRs. In addition, the nature of the pharmacological interaction after the coadministration of mGluRs compounds with morphine was determined. Methods: Catheters were inserted into the intrathecal space of male SD rats. For the induction of pain, $50{\mu}l$ of 5% formalin solution or a thermal stimulus was applied to the hindpaw. An isobolographic analysis was used for the evaluation of the drug interaction. Results: Neither group I mGluR compounds nor group III mGluR compounds produced any antinociceptive effect in the formalin test. The group II mGluR agonist (APDC) had little effect on the formalin-induced nociception. The group II mGluR antagonist (LY 341495) caused a dose-dependent suppression of the phase 2 flinching response on the formalin test, but it did not reduce the phase 1 response of the formalin test nor did it increase the withdrawal latency of the thermal stimulus. Isobolographic analysis revealed a synergistic interaction after the intrathecal delivery of a LY 341495-morphine mixture. Conclusions: These results suggest that group II mGluRs are involved in the facilitated processing at the spinal level, and the combination of LY 341495 with morphine may be useful to manage the facilitated pain state.

오공약침(蜈蚣藥針)을 이용한 요추간판탈출증(腰椎間板脫出症) 치료(治療)의 임상적(臨床的) 연구(硏究) (Clinical study on treatment of HIVD of lumbar spine using Scolopendrid herbal acupuncture)

  • 고강훈;박소영;최회강;소기숙;황우준;이건목;김성철
    • Journal of Acupuncture Research
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    • 제19권3호
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    • pp.192-206
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    • 2002
  • Objective : This study is performed for the purpose of examining into the efficacy of the scolopendrid(Scolopendra morsitans L) which has been used among the Korean people for the H.I.V.D of lumbar spine. Methods & Results : Using the herbal acupuncture made of scolopendrid(Scolopendra morsitans L), we treated the 20 H.I.V.D patients for 1 week and operated 4 pre and post treatment test ; D.I.T.I, 6 kinds of physical test, Oswestry disability index, and self-conscious pain rate. Trough the test, we saw 43-95% of efficacy rate in each test. And all of the 7 acupuncture point in D.I.T.I, Oswestry disability index and self-conscious pain rate test showed statistically valuable change. Conclusion : We brought to the conclusion that the scolopendrid herbal acupuncture has possibility to be efficient to cure the H.I.V.D patients. So we suggest the possibility to use this new remedy for the H.I.V.D.

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Diagnostic Value of Immunoglobulin G Anti-Deamidated Gliadin Peptide Antibody for Diagnosis of Pediatric Celiac Disease: A Study from Shiraz, Iran

  • Anbardar, Mohammad Hossein;Haghighi, Fatemeh Golbon;Honar, Naser;Zahmatkeshan, Mozhgan
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • 제25권4호
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    • pp.312-320
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    • 2022
  • Purpose: Screening serologic tests are important tools for the diagnosis of celiac disease (CD). Immunoglobulin (Ig)G anti-deamidated gliadin peptide (anti-DGP) is a relatively new autoantibody thought to have good diagnostic accuracy, comparable to that of anti-tissue transglutaminase (anti-tTG) antibody. Methods: Pediatric patients (n=86) with a clinical suspicion of CD were included. Duodenal biopsy, anti-tTG, and IgG anti-DGP antibody tests were performed. The patients were divided into CD and control groups based on the pathological evaluation of duodenal biopsies. The diagnostic accuracy of serological tests was determined. Results: IgA anti-tTG and IgG anti-DGP antibodies were positive in 86.3% and 95.4% of patients, respectively. The sensitivity, specificity, and diagnostic accuracy of the IgA anti-tTG test were 86.3%, 50.0%, and 68.6%, respectively, and those of the IgG anti-DGP test were 95.4%, 85.7%, and 90.7%, respectively. The area under the receiver operating characteristic (ROC) curve was 0.84 (95% confidence interval [CI], 0.74-0.91) for IgA anti-tTG test and 0.93 (95% CI, 0.86-0.97) for IgG anti-DGP test. The comparison of IgA anti-tTG and IgG anti-DGP ROC curves showed a higher sensitivity and specificity of the IgG anti-DGP test. Conclusion: IgG anti-DGP is a reliable serological test for CD diagnosis in children. High tTG and DGP titers in the serum are suggestive of severe duodenal atrophy. The combined use of IgA anti-tTG and IgG anti-DGP tests for the initial screening of CD can improve diagnostic sensitivity.