• 제목/요약/키워드: Point-of-care diagnostic testing

검색결과 20건 처리시간 0.029초

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

  • 남송이;박기영;최수정
    • 임상간호연구
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    • 제26권2호
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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.

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

  • 신관우;권오선
    • 적정기술학회지
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    • 제5권1호
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    • pp.46-53
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    • 2019
  • 적정기술이 현장에서 널리 활용되기 위한 조건 중의 하나는 그 기술을 적용하기 위한 용이함과 경제성이 뒷받침 되어야 한다. 특히 질병의 진단은 전문 인력, 장비, 그리고 시약 등의 비용이 높아, 다른 분야에 비하여 개발도상국에 적용되기 가장 어려운 분야이다. 최근, 주변에 가장 흔한 소재 중의 하나인 종이를 기반으로, 특수한 시설이나 장비가 필요 없이도, 누구나 쉽게 배워서 제작하고, 사용할 수 있는 종이 진단칩 기술이 속속 개발되고 있다. 본 기술들은 특정 질병의 진단에 현장에서 신속하게 제작이 가능한 기술로 활용 가능한 현장진단 칩으로 연구되고 있으며, 그 활용 가능성이 커지고 있다. 이 기술들의 완성도가 높아지면, 개발도상국의 가장 큰 의료문제들을 해결하여, 궁극적으로 인간의 삶의 질을 향상시키는데 활용 될 수 있을 것이다.

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

  • 최동옥;이강문
    • 대한임상검사과학회지
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    • 제53권3호
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    • pp.257-265
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    • 2021
  • 코로나바이러스감염증-19는 사람의 호흡기관에 다수로 분포하는 안지오텐신전환효소2, angiotensin converting enzyme 2 (ACE2)를 매개하여 감염을 일으키는 β-genus 바이러스이고 완치환자 및 백신 접종자의 항체생성에 대한 효율적인 사후관리가 필요한 질병을 유발하는 바이러스다. 이 논문에서는 임상 시료의 중화항체와 특이적으로 반응하는 재조합 단백질을 개발하고 이를 이용하여 COVID-19 바이러스에 대한 중화항체를 빠르고 편리하게 진단하는 신속 진단 키트를 개발하고 그것의 성능 평가를 통하여 제품화 가능성을 확인하는 것을 목표로 하였다. COVID-19 S1 RBD 재조합 단백질을 사용한 신속 진단 키트의 양성 퍼센트 일치(PPA) 및 음성 퍼센트 일치(NPA)가 미국 FDA EUA에서 승인한 ELISA 키트와 비교했을 때 각각 100% 및 98.3%인 점에서 신속 진단 키트에 적용할 수 있을 것으로 확인하였다. 향후 신속 진단 키트의 성능을 개선하고 정량 분석 장비를 통해 중화항체를 정량적으로 분석이 가능하면 제품화 통해 검체내의 중화항체 유무와 양을 확인함으로써 COVID-19 바이러스에 대한 면역성을 예측하고 추가 예방접종 여부를 판단하는 중요한 자료로 활용될 수 있을 것으로 생각한다.

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

  • 박세형;이종실;김인영;김선일
    • 대한의용생체공학회:의공학회지
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    • 제30권1호
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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.

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

  • 신영수;김창엽;오병희;한규섭;윤병우;한준구;강영호
    • 한국의료질향상학회지
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    • 제4권1호
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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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중추청각처리장애 선별도구로서의 Fisher's 청각행동문제 체크리스트(FAPC)와 청각행동특성척도(SAB)의 비교 연구 (Comparison of Fisher's Auditory Problems Checklist (FAPC) and Scale of Auditory Behaviors (SAB) in Screening Central Auditory Processing Disorders)

  • 윤민호;장현숙
    • 재활복지
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    • 제18권4호
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    • pp.257-277
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    • 2014
  • 본 연구의 목적은 국외에서 중추청각처리장애의 선별도구로 널리 사용되고 있는 Fisher's 청각행동문제 체크리스트(Fisher's auditory problems checklist, FAPC)와 청각행동특성척도(Scale of Auditory Behaviors, SAB)를 한국어로 번역하여 학령기 아동을 대상으로 실시하므로 국내의 학령기 아동의 청각행동특성을 파악하고, 두 검사 간의 특성을 비교하므로 국내에서 중추청각처리장애 선별을 위한 기초 자료를 제공하는데 있다. 한국어로 번역된 FAPC와 SAB 검사도구를 1~6학년 223명의 학생의 부모나 양육자에게 실시한 결과, FAPC와 SAB 검사 도구는 모두 학년별로 유의미한 점수 차이를 보이지 않았고, 학년 증감에 따른 수행 점수 간에 특정 유형이 관찰되지 않았으므로 본 설문지들은 학년에 상관없이 사용하여도 무방하다고 여겨진다. 그러나 두 검사의 유의미한 상관관계에도 불구하고 공통위험군 범위의 아동 수가 적어 서로 다른 특성을 포함하고 있으므로 선별검사 및 청각행동특성을 기초로 한 진단검사의 선정 및 재활 계획 수립시 서로 보완적으로 사용하는 것이 바람직하다고 여겨진다. 더하여 두 검사의 중추청각처리장애와의 관련성 검증과 표본 집단을 확대한 규준 제시를 통한 후속 표준화 연구가 요구된다.

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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    • 제15권15호
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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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    • 제48권4호
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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
    • 한국진공학회:학술대회논문집
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    • 한국진공학회 2013년도 제45회 하계 정기학술대회 초록집
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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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결핵진단에서 Xeniss Rapid TB kit의 임상적 유용성 (Evaluation of the Clinical Usefulness of the Xeniss Rapid TB kit for the Diagnosis of Tuberculosis)

  • 박승규;이우철;황수희;권은시;이흥순;이덕형
    • Tuberculosis and Respiratory Diseases
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    • 제53권4호
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    • pp.389-400
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    • 2002
  • 배 경 :결핵의 조기치료와 전염방지를 위해서 신속하고 간편한 결핵진단법의 개발이 요구되고 있는 실정에서 결핵균에 특이한 38-kDa단백을 포함하여 금 콘쥬게이트에 결합된 유전자재조합 항원을 혈청과 반응시켜 항결핵 항체를 발견하도록 고안된 카드형태의 혈청학적 진단기법인 Xeniss Rapid TB kit가 결핵의 진단에 유용하게 이용될 수 있는 지를 알아보고자 하였다.방 법 :188명의 결핵환자(폐결핵 177명, 폐외결핵 11명)와 82명의 접촉자, 그리고 57명의 건강한 성인을 대상으로 하였으며, 연구대상자의 혈청을 이용하여 Xeniss Rapid TB kit의 민감도, 특이도, 양성예측율, 그리고 음성예측율을 조사하였다. 결 과 : 전체적인 민감도는 73.9%, 특이도 81.3%, 양상예측율 84.2%, 그리고 음성예측율은 85.8%였다. 진단시점부터 검사시점간의 시간간격에 따라서는 1개월 이내에서 61.5%로 가장 낮고 점차 증가하여 4-6개월 시점에 94.4%로 가장 높았으며 이후 점차 감소하여 12개월 이상 경과한 시점에서는 67.4%의 양성반응율을 보였다. 페외결핵 환자(90.9%)에서는 폐결핵 환자(72.8%)보다 양성반응율이 높았다. 객담도말양성 (76.2 대 68.4%), 방사선 사진상 중증 (79.3 대 63.3%), 공동성 병소(75.7 대 70.0%), 과거 치료력 (76.3 대 73.3%)이 있는 환자군에서 상대적으로 높은 양성반응율을 보였으며, 당뇨병을 동반한 환자군(69.0 대 74.8%)과 노인환자군(68.l 대 100%)에서는 상대적으로 낮은 양성반응율을 보였다. 건강성인군 7.0%, 환자가족군 17.5%에 비해 병원직원군에서 57.9%의 양성반응율을 보여 활동성 결핵환자와 장기간 지속적으로 접촉한 군에서 높은 양성반응율을 보였다. 결 론 : Xeniss Rapid TB kit는 신속하고 간편하며, 민감도와 특이도가 비교적 높고 특히, 폐외결핵에서는 높은 양성반응율을 보여 폐결핵, 폐외결핵, 그리고 감염자의 진단에 보조적 검사법으로 유용하게 이용될 수 있을 것으로 생각된다.