• Title/Summary/Keyword: Point-of-care diagnostic testing

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The Reliability and Validity of the Korean Version of the Cornell Assessment of Pediatric Delirium (한국어판 Cornell Assessment of Pediatric Delirium 소아 섬망 사정 도구의 검증)

  • Nam, Song Yi;Park, Ki Young;Choi, Su Jung
    • Journal of Korean Clinical Nursing Research
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    • v.26 no.2
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    • pp.254-264
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    • 2020
  • Purpose: This study was to examine the reliability and validity of the Korean version of the Cornell Assessment of Pediatric Delirium (CAPD). Methods: For testing the reliability of the Korean version of the CAPD, this study calculated the internal consistency (Cronbach's α) and the Interrater Correlation Coefficient (ICC) by comparing the independent assessment results of three nurses in Pediatric Intensive Care Unit (PICU). For testing the validity of the Korean version of the CAPD, the assessment result of the Korean version of the CAPD compared with that of the Diagnostic and Statistical Manual of Mental Disorders V (DSM-V). Receiver Operating Characteristics (ROC) analysis was used for measuring sensitivity and specificity. Results: Overall interrater reliability of the Korean version of the CAPD, ICC was .98 (95% CI .96~.99). Cronbach's α was .91 for eight items. The concordance between the Korean version of the CAPD and psychiatrist's diagnosis was 90.0%. When the Korean version of the CAPD has the cut point of 9, sensitivity was 93.8%, and specificity was 75.0%. The area under the curve indicated by the ROC analysis was .88. Conclusion: The Korean version of the CAPD showed good reliability and validity. This tool will be useful for pediatric delirium screening and management in Korean PICU.

Paper Based Point-of-Care Diagnosis for Appropriate Technology (적정기술을 위한 종이기반 현장 진단 기술)

  • Shin, Kwanwoo;Kwon, Oh-Sun
    • Journal of Appropriate Technology
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    • v.5 no.1
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    • pp.46-53
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    • 2019
  • It should be supported by the ease and economic production in terms of appropriate technology to be widely used in the real applying fields. In particular, the diagnosis of diseases is one of the most difficult areas to apply to the developing countries compared to other fields because of the high costs of professional manpower, equipment, and medial reagents. In recent years, paper, which is one of the most common materials around, has been used to fabricate the disease diagnostic chips, particularly without any special facilities or the equipment. These new technologies lead the possibility of using point-of-care testing devices that can be manufactured quickly in the field by lowering the production cost. These paperbased technologies will contribute to solve many of the deadliest medical problems in developing countries and ultimately improve the quality of human life.

Development of COVID-19 Neutralizing Antibody (NAb) Detection Kits Using the S1 RBD Protein of SARS-CoV-2 (코로나 바이러스 감염증-19의 재조합 S1 RBD 단백질을 이용한 COVID-19 바이러스의 중화항체 검사 키트의 개발)

  • Choi, Dong Ok;Lee, Kang Moon
    • Korean Journal of Clinical Laboratory Science
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    • v.53 no.3
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    • pp.257-265
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    • 2021
  • The COVID-19 virus is a β-genus virus that causes infection by mediating the angiotensin convertible enzyme 2 (ACE2) receptor, which is distributed in large numbers in the human respiratory tract. The disease requires effective post-management of antibody production by complete healers and vaccinators because there is no perfect remedy for the virus infection. This study aimed to develop recombinant proteins specifically responsive to neutralizing antibodies in clinical specimens and use them to develop a rapid diagnostic kit to diagnose neutralizing antibodies quickly and conveniently against the COVID-19 virus and confirm the possibility of commercialization through a performance evaluation. Rapid diagnostic kits using COVID-19 S1 RBD recombinant proteins can be applied to rapid diagnostic kits, with positive percentage agreement (PPA) and negative percentage agreement (NPA) of 100% and 98.3%, respectively, compared to the U.S. FDA-approved ELISA kits. If the performance of the rapid diagnostic kit is improved and neutralizing antibodies can be analyzed quantitatively using quantitative analysis equipment, it can be used as important data to predict immunity to the COVID-19 virus and determine additional vaccinations.

Development of Neuromuscular Stimulus System using Wearable Ultra-miniature Lighting Modules and its Verification of Clinical Effectiveness (의복형 초소형 발광모듈을 이용한 신경근육 자극 시스템 개발 및 임상적 효과 검증)

  • Park, Se-Hyeong;Lee, Jong-Shill;Kim, In-Young;Kim, Sun-I.
    • Journal of Biomedical Engineering Research
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    • v.30 no.1
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    • pp.23-33
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    • 2009
  • It can be used easily to reduce rehabilitation and treatment time if diagnostic and therapeutic devices are attached to cloth or body. Therefore we developed neuromuscular wearable ultra-miniature lighting modules which can improve the neuromuscular function and verified its clinical effectiveness. The system is based on the ultra-miniature lighting treatment module and there are two types of systems. One of them is designed as an attached type and the other type is combined with clothing. The wearable ultra-miniature lighting module is composed of controller (battery, MCU, bidirectional transmitter and receiver), cable, treatment medium generating device and other peripheral devices. To verify the clinical effectiveness of this device, we observed the difference of the strength of a muscle before and after 650nm and 25mW laser irradiation on the reflex point for 1 to 4 seconds. Among 48 patients having the degenerative osteoarthritis, the muscle strength before and after irradiation of laser was $21.8{\pm}7.99$ and $27.3{\pm}8.43$. According to the result, the muscle strength after treatment was significantly increased (p<0.01). To whom having difficulty in visiting to OPD(Out-Patient Department), doctors medically examine the patients and find the therapeutic point, attachment of this wearable ultra-miniature lighting module can function as self treatment (treating instrument) and treatment assist at home. If doctor can remotely control the patient and take part in treatment, the therapeutic device could contribute to prevention and care device.

Development of Clinical Practice Guidelines in a Hospital (병원단위의 임상진료지침 개발과정)

  • Shin, Youngsoo;Kim, Chang-Yup;Oh, Byung-Hee;Han, Kyou-Sup;Yoon, Byung-Woo;Han, Joon-Koo;Khang, Young-Ho
    • Quality Improvement in Health Care
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    • v.4 no.1
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    • pp.82-103
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    • 1997
  • Background : With increased concerns about variation among physician's practice pattern and their impact on the quality of care, clinical practice guidelines have been developed by many different organizations, with differing aims and incentives. From the same point of view, there is growing interest in the development of clinical practice guidelines in Korea, but with only a few examples. As a result, there is not much exploration on the incentive and barrier to develop guidelines as well as description on the development process. The purposes of this study are to describe the process of the four different clinical practice guidelines in a hospital setting, and to identify incentives and barriers in the development of guidelines. Methods : For this research, a clinical practice guideline development committee and four clinical practice guideline development teams were organized in a university hospital which has more than 1,200 bead. Twenty eight doctors, three nurses, and one technician participated as members of development teams for eight months. Four to six meetings were held, and three to seven departments in the hospital were involved. Results : The topics which developed into clinical practice guidelines were cardiopulmonary resuscitation(CPR), blood transfusion, anticoagulation, and angiography. The main goals set by teams were education(CPR, angiography), risk management(blood transfusion), and to enhance quality of care(anticoagulation). Among four teams, only in the team for anticoagulation guideline medical record review and pilot-testing were performed. Also literature review was not carried out systematically. However, all the guidelines were developed by multidisciplinary be used as standard protocols in the practice. Conclusion : Experience and skill in developing process has to be improved to have a more valid and useful practice guideline. In particular, literature review and problem identification by examining medical record should be emphasized. Also further studies on the clinical outcomes of the guidelines application and changes in physicians' behaviors would be required.

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Comparison of Fisher's Auditory Problems Checklist (FAPC) and Scale of Auditory Behaviors (SAB) in Screening Central Auditory Processing Disorders (중추청각처리장애 선별도구로서의 Fisher's 청각행동문제 체크리스트(FAPC)와 청각행동특성척도(SAB)의 비교 연구)

  • Yoon, Min Ho;Jang, Hyun Sook
    • 재활복지
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    • v.18 no.4
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    • pp.257-277
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    • 2014
  • The purpose of this study was to observe auditory processing skills in school-age children using Fisher's Auditory Problem Checklist(FAPC; Fisher, 1976) and Scales of Auditory Behaviors(SAB; Shiffman, 1999) in order to provide a basis for clinical application in screening central auditory processing disorders(CAPD) in Korea. Korean translated version of FAPC and SAB were given to the parents or care givers of 233 students from grades 1~6. As a result of testing FAPC, the average score for all grades showed 91.87(${\pm}7.93$) points, with grade point average score falling in 90.13~93.67 range and no significant differences among grades. For SAB, the average score for all grades showed 53.44(${\pm}5.09$), with grade point average score falling in 51.78~55.44 range and also no significant differences among grades. Significant correlations between FAPC and SAB were shown in all and within grade levels. There showed to be 22 children(9.9%) in -1 SD at risk criteria, with 13 male students(12%) and 9 female students(7.8%) for both FAPC and SAB. In applying FAPC and SAB clinically to school-age children, these two tests showed to have a significant correlation, but because of different characteristics due to the small number of children in the common risk range, diagnostic testing/rehabilitation plan based on screening and auditory behavior characteristics is recommended to be conducted complementarily to one another.

Identification of Patients with Microscopic Hematuria who are at Greater Risk for the Presence of Bladder Tumors Using a Dedicated Questionnaire and Point of Care Urine Test - A Study by the Members of Association of Urooncology, Turkey

  • Turkeri, Levent;Mangir, Naside;Gunlusoy, Bulent;Yildirim, Asif;Baltaci, Sumer;Kaplan, Mustafa;Bozlu, Murat;Mungan, Aydin
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.15
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    • pp.6283-6286
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    • 2014
  • In patients with microscopic hematuria there is a need for better identification of those who are at greater risk of harbouring bladder tumors. The RisikoCheck(C) questionnaire has a strong correlation with the presence of urothelial carcinoma (UC) of the bladder and in combination with other available tests may help identify patients who require detailed clinical investigations due to increased risk of presence of bladder tumors. This study aimed to evaluate the efficacy of RisikoCheck(C) questionnaire together with NMP-22(R) (BladderChek(R)) as a point-of-care urine test in predicting the presence of bladder tumors in patients presenting with microscopic hematuria as the sole finding. In this multi-institutional prospective evaluation of 303 consecutive patients without a history of urothelial carcinoma (UC), RisikoCheck(C) risk group assessment, urinary tract imaging and cystourethroscopy as well as urine cytology and Nuclear Matrix Protein-22 (NMP-22 BladderChek) testing were performed where available. The sensitivity, specificity, negative predictive value (NPV), and positive predictive values (PPV) for the risk adapted approach were calculated. All patients underwent cystoscopy, and tumors were detected in 18 (5.9%). Urine cytology and NMP-22 was positive for malignancy in 9 (3.2%) and 12 (7.5%) of patients, respectively. A total of 43 (14%) patients were in the high risk group according to the RisikoCheck(C) questionnaire. The sensitivity and specificity of the questionnaire in detecting a bladder tumor was 61.5 % and 84.0 % in the high risk group. In patients with either a positive NMP-22 test or high risk category RisikoCheck(C), 23.6% had bladder tumors with a corresponding sensitivity of 54.2% and specificity of 88.6%. If both tests were negative only 3.3% of the patients had bladder tumors. The results of our study suggest that the efficacy of diagnostic evaluation of patients with microscopic hematuria may be further enhanced by combining RisikoCheck(C) questionnaire with NMP-22.

Association of chairside salivary aMMP-8 findings with periodontal risk assessment parameters in patients receiving supportive periodontal therapy

  • Schmalz, Gerhard;Kummer, Max Kristian;Kottmann, Tanja;Rinke, Sven;Haak, Rainer;Krause, Felix;Schmidt, Jana;Ziebolz, Dirk
    • Journal of Periodontal and Implant Science
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    • v.48 no.4
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    • pp.251-260
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    • 2018
  • Purpose: The aim of this retrospective cross-sectional study was to evaluate whether salivary findings of active matrix-metalloproteinase 8 (aMMP-8) chairside (point of care; POC) tests were associated with periodontal risk assessment parameters in patients receiving supportive periodontal therapy (SPT). Methods: A total of 125 patients receiving regular SPT were included, and their records were examined. The following inclusion criteria were used: a diagnosis of chronic periodontitis, at least 1 non-surgical periodontal treatment (scaling and root planning) with following regular SPT (minimum once a year), at least 6 remaining teeth, and clinical and aMMP-8 findings that were obtained at the same appointment. In addition to anamnestic factors (e.g., smoking and diabetes), oral hygiene indices (modified sulcus bleeding index [mSBI] and approximal plaque index), periodontal probing depth simultaneously with bleeding on probing, and dental findings (number of decayed, missing, and filled teeth) were recorded. Salivary aMMP-8 levels were tested using a commercial POC test system (Periomarker, Hager & Werken, Duisburg, Germany). Statistical analysis was performed using the t-test, Mann-Whitney U test, Fisher's exact test, and ${\chi}^2$ test, as appropriate (P<0.05). Results: Only the mSBI was significantly associated with positive salivary aMMP-8 findings (aMMP-8 positive: $27.8%{\pm}20.9%$ vs. aMMP-8 negative: $18.0%{\pm}14.5%$; P=0.017). No significant associations were found between aMMP-8 and smoking, diabetes, periodontal parameters, or parameters related to the maintenance interval (P>0.05). Conclusions: Salivary aMMP-8 chairside findings were not associated with common parameters used for periodontal risk assessment in patients receiving SPT. The diagnostic benefit of POC salivary aMMP-8 testing in risk assessment and maintenance interval adjustment during SPT remains unclear.

Integrated RT-PCR Microdevice with an Immunochromatographic Strip for Colorimetric Influenza H1N1 virus detection

  • Heo, Hyun Young;Kim, Yong Tae;Chen, Yuchao;Choi, Jong Young;Seo, Tae Seok
    • Proceedings of the Korean Vacuum Society Conference
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    • 2013.08a
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    • pp.273-273
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    • 2013
  • Recently, Point-of-care (POC) testing microdevices enable to do the patient monitoring, drug screening, pathogen detection in the outside of hospital. Immunochromatographic strip (ICS) is one of the diagnostic technologies which are widely applied to POC detection. Relatively low cost, simplicity to use, easy interpretations of the diagnostic results and high stability under any circumstances are representative advantages of POC diagnosis. It would provide colorimetric results more conveniently, if the genetic analysis microsystem incorporates the ICS as a detector part. In this work, we develop a reverse transcriptase-polymerase chain reaction (RT-PCR) microfluidic device integrated with a ROSGENE strip for colorimetric influenza H1N1 virus detection. The integrated RT-PCR- ROSGENE device is consist of four functional units which are a pneumatic micropump for sample loading, 2 ${\mu}L$ volume RT-PCR chamber for target gene amplification, a resistance temperature detector (RTD) electrode for temperature control, and a ROSGENE strip for target gene detection. The device was fabricated by combining four layers: First wafer is for RTD microfabrication, the second wafer is for PCR chamber at the bottom and micropump channel on the top, the third is the monolithic PDMS, and the fourth is the manifold for micropump operation. The RT-PCR was performed with subtype specific forward and reverse primers which were labeled with Texas-red, serving as a fluorescent hapten. A biotin-dUTP was used to insert biotin moieties in the PCR amplicons, during the RT-PCR. The RT-PCR amplicons were loaded in the sample application area, and they were conjugated with Au NP-labeled hapten-antibody. The test band embedded with streptavidins captures the biotin labeled amplicons and we can see violet colorimetric signals if the target gene was amplified with the control line. The off-chip RT-PCR amplicons of the influenza H1N1 virus were analyzed with a ROSGENE strip in comparison with an agarose gel electrophoresis. The intensities of test line was proportional to the template quantity and the detection sensitivity of the strip was better than that of the agarose gel. The test band of the ROSGENE strip could be observed with only 10 copies of a RNA template by the naked eyes. For the on-chip RT-PCR-ROSGENE experiments, a RT-PCR cocktail was injected into the chamber from the inlet reservoir to the waste outlet by the micro-pump actuation. After filling without bubbles inside the chamber, a RT-PCR thermal cycling was executed for 2 hours with all the microvalves closed to isolate the PCR chamber. After thermal cycling, the RT-PCR product was delivered to the attached ROSGENE strip through the outlet reservoir. After dropping 40 ${\mu}L$ of an eluant buffer at the end of the strip, the violet test line was detected as a H1N1 virus indicator, while the negative experiment only revealed a control line and while the positive experiment a control and a test line was appeared.

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Evaluation of the Clinical Usefulness of the Xeniss Rapid TB kit for the Diagnosis of Tuberculosis (결핵진단에서 Xeniss Rapid TB kit의 임상적 유용성)

  • Park, Seung-Kyu;Lee, Woo-Chul;Hwang, Soo-Hee;Kwon, Eun-Si;Lee, Hung-Soon;Lee, Duk-Hyoung
    • Tuberculosis and Respiratory Diseases
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    • v.53 no.4
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    • pp.389-400
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    • 2002
  • Background : The rapid diagnostic tests for tuberculosis are needed to facilitate early treatment of tuberculosis and prevention of Mycobacterium tuberculosis transmission. The Xeniss Rapid TB kit is a rapid, card-based immunochromatographic test for the detection of antibodies directed against M. tuberculosis antigens including antigen 5(38-kDa antigen). The objective of this study was to evaluate the performance of the Xeniss Rapid TB kit for the diagnosis of active tuberculosis with serums from patients, asymptomatic healthy and close contact controls. Methods : 188 patients with active tuberculosis were tested; 177 with pulmonary tuberculosis(18 with combined pleurisy), and 11 with extrapulmonary tuberculosis. The control groups were composed of 82 close contacts and 57 healthy adults. Study subject were drawn from one national tuberculosis hospital for patients and close contacts, and another private hospital for healthy adults in Masan city, Korea. The Xeniss Rapid TB kit(Xeniss Life Science Co., Ltd., Seoul, Korea) was evaluated by using serum samples according to the instructions of the manufacturer by an investigator masked to the clinical and microbiological status of the study subjects. Results : The diagnostic sensitivity of the Xeniss Rapid TB kit was 73.9% in patients and specificities were 73.2% and 93.0% in close contact and healthy adults respectively. The positive predictive value in patients was 84.2% and the negative predictive value in controls was 85.8%. Conclusion : This study shows that the Xeniss Rapid TB test is a simple and fast method to diagnose active TB. The results of the sensitivity and specificites suggest that serodiagnosis using this point of care testing(POCT) device would be valuable and advantageous for screening tuberculosis in the clinical field.