• 제목/요약/키워드: Diagnostic laboratory test

검색결과 252건 처리시간 0.026초

고병원성 바이러스 검사를 위한 분자진단검사실 구축 (Designing a Molecular Diagnostic Laboratory for Testing Highly Pathogenic Viruses)

  • 정태원;정재영;김성현;김영권
    • 대한임상검사과학회지
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    • 제53권2호
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    • pp.143-150
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    • 2021
  • 최근 SARS-CoV-2를 포함한 신종 및 변종 고병원성 바이러스의 확산과 이를 확진하기 위한 진단검사의 수요가 증가함에 따라 분자유전검사실 구축 시 필요한 공간별 기능을 조사하고 임상병리사의 안전성 확보를 위한 시설 지침을 마련하고자 하였다. 검사과정 중 검체 전처리 및 핵산 증폭 전실 및 후실 분리와 함께 음압설비가 필요하며, 핵산 증폭 전 공간을 분리해 단방향 작업 흐름을 고려해 공간 구성을 하여야 한다. 검사 진행과정 중 검체 전처리, 핵산 증폭 전 단계에서 실 분리와 함께 음압시설이 필요하며, 공간구성은 핵산증폭 전실 및 후실 공간을 분리하고 검사진행 방향을 단방향 검사흐름(unidirectional work flow)을 고려하여 계획하여야 한다. 안전관리 시설은 생물학적 안전 기준 2등급으로 지정하고 그에 따른 안전보호구를 배치하고, 위험물을 취급하는 경우 생물학적 안전상자 내부에서 진행해야 하며, 전염성 오염물의 폐기를 위한 멸균기가 필요하다. 국내 분자유전검사실 사례의 공통점은 검체 전처리공간을 -2.5 Pa 이하의 음압으로 유지하고 있으며, 검사과정상 전처리와 시약준비 공간에 대해서는 다른 공간에서 진행하고 있었다. 본 연구는 검사과정의 세부흐름과 공간별 기능을 분리하고 안전관리 기준 적용한 검사실 구축 방향을 제시하였고, 임시시설과 결핵검사실을 변경하여 사용하는 사례를 소개함으로써 더욱 효율적인 방향을 모색할 수 있는 자료로 의의가 있다고 하겠다.

Diagnostic Value of Fluorescence in Situ Hybridization Assay in Malignant Mesothelioma: A Meta-analysis

  • Wan, Chun;Shen, Yong-Chun;Liu, Meng-Qi;Yang, Ting;Wang, Tao;Chen, Lei;Yi, Qun;Wen, Fu-Qiang
    • Asian Pacific Journal of Cancer Prevention
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    • 제13권9호
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    • pp.4745-4749
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    • 2012
  • The diagnosis of malignant mesothelioma (MM) remains a clinical challenge and the fluorescence in situ hybridization (FISH) assay has been reported to be one promising tool. The present meta-analysis aimed to establish the overall diagnostic accuracy of FISH for diagnosing MM. After a systematic review of English language studies, the sensitivity, specificity and other measures of accuracy of FISH in the diagnosis of MM were pooled using random-effects models. Summary receiver operating characteristic curves were applied to summarize overall test performance. Nine studies met our inclusion criteria, the pooled sensitivity and specificity for FISH for diagnosing MM being 0.72 (95% CI 0.67-0.76) and 1.00 (95% CI 0.98-1.00), respectively. The positive likelihood ratio was 34.5 (95% CI 14.5-82.10), the negative likelihood ratio was 0.24 (95% CI 0.16-0.36), and the diagnostic odds ratio was 204.9 (95% CI 76.8-546.6), the area under the curve being 0.99. Our data suggest that the FISH assay is likely to be a useful diagnostic tool for confirming MM. However, considering the limited studies and patients included, further large scale studies are needed to confirm these findings.

Prospective evaluation of the clinical utility of whole-exome sequencing using buccal swabbing for undiagnosed rare diseases

  • Chong Kun Cheon;Yong Beom Shin;Soo-Yeon Kim;Go Hun Seo;Hane Lee;Changwon Keum;Seung Hwan Oh
    • Journal of Genetic Medicine
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    • 제19권2호
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    • pp.76-84
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    • 2022
  • Purpose: Whole-exome sequencing (WES) has been a useful tool for novel gene discovery of various disease categories, further increasing the diagnostic yield. This study aimed to investigate the clinical utility of WES prospectively in undiagnosed genetic diseases. Materials and Methods: WES tests were performed on 110 patients (age range, 0-28 years) with suspected rare genetic diseases. WES tests were performed at a single reference laboratory and the variants reported were reviewed by clinical geneticists, pediatricians, neurologists, and laboratory physicians. Results: The patients' symptoms varied with abnormalities in the head or neck, including facial dysmorphism, being the most common, identified in 85.4% of patients, followed by abnormalities in the nervous system (83.6%). The average number of systems manifesting phenotypic abnormalities per patient was 3.9±1.7. The age at presentation was 2.1±2.7 years old (range, 0-15 years), and the age at WES testing was 6.7±5.3 years (range, 0-28 years). In total, WES test reported 100 pathogenic/likely pathogenic variants or variants of uncertain significance for 79 out of 110 probands (71.8%). Of the 79 patients with positive or inconclusive calls, 55 (50.0%) patients were determined to have good genotype-phenotype correlations after careful review. Further clinical reassessment and family member testing determined 45 (40.9%) patients to have been identified with a molecular diagnosis. Conclusion: This study showed a 40.9% diagnostic yield for WES test for a heterogeneous patient cohort with suspected rare genetic diseases. WES could be the feasible genetic test modality to overcome the diversity and complexity of rare disease diagnostics.

Diagnostic/prognostic health monitoring system and evaluation of a composite bridge

  • Mosallam, A.;Miraj, R.;Abdi, F.
    • Smart Structures and Systems
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    • 제5권4호
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    • pp.397-413
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    • 2009
  • Composite bridges offer many advantages compared to current steel and aluminum bridges. This paper presents the results of a comprehensive on-going research program to develop innovative Diagnostic Prognostic System (DPS) and a structural evaluation of Composite Army Bridge (CAB) system. The DPS is founded on three technologies: optical fiber sensing, remote data transmission, and virtual testing. In developing this system, both laboratory and virtual test were used in different damage scenarios. Health monitoring with DPS entailed comparing live strain data to archived strained data in various bridge locations. For field repairs, a family of composite chords was subjected to simple ramp loads in search of ultimate strength. As such, composite bridge specimens showcased their strengths, heralded the viability of virtual testing, highlighted the efficacy of field repair, and confirmed the merits of health monitoring.

발전기 고정자 권선의 가속열화 특성 (Characteristics of Accelerated Aging in Generator Stator Windings)

  • 김희동;공태식;주영호
    • 한국전기전자재료학회:학술대회논문집
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    • 한국전기전자재료학회 2008년도 하계학술대회 논문집 Vol.9
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    • pp.279-280
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    • 2008
  • Accelerated aging tests were conducted under laboratory conditions on two generator stator bars. Electrical stress is applied in No. 1 model stator bar. Electrical and thermal stresses are applied in No. 2 model stator bar. As aging times increased from 0 to 4780h, diagnostic tests were performed on No. 1 and No. 2 model stator bars. Diagnostic tests included AC current, dissipation factor(tan$\delta$) and partial discharge magnitude. The ${\Delta}tan{\delta}$ and $\Deta$I of No. 1 and No. 2 model stator bars increased with increased in aging time.

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혈액암 인자 유효성 검증과 분류를 위한 진단 예측 알고리즘 성능 비교 분석 (Comparative Analysis of Diagnostic Prediction Algorithm Performance for Blood Cancer Factor Validation and Classification)

  • 정재승;주현수;조치현
    • 한국멀티미디어학회논문지
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    • 제25권10호
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    • pp.1512-1523
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    • 2022
  • Artificial intelligence application in digital health care has been increasing with its development of artificial intelligence. The convergence of the healthcare industry and information and communication technology makes the diagnosis of diseases more simple and comprehensible. From the perspective of medical services, its practice as an initial test and a reference indicator may become widely applicable. Therefore, analyzing the factors that are the basis for existing diagnosis protocols also helps suggest directions using artificial intelligence beyond previous regression and statistical analyses. This paper conducts essential diagnostic prediction learning based on the analysis of blood cancer factors reported previously. Blood cancer diagnosis predictions based on artificial intelligence contribute to successfully achieve more than 90% accuracy and validation of blood cancer factors as an alternative auxiliary approach.

Detection of MicroRNA-21 Expression as a Potential Screening Biomarker for Colorectal Cancer: a Meta-analysis

  • Jiang, Jian-Xin;Zhang, Na;Liu, Zhong-Min;Wang, Yan-Ying
    • Asian Pacific Journal of Cancer Prevention
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    • 제15권18호
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    • pp.7583-7588
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    • 2014
  • Background: Colorectal cancer (CRC) is a major cause of cancer-related death and cancer-related incidence worldwide. The potential of microRNA-21 (miR-21) as a biomarker for CRC detection has been studied in several studies. However, the results were inconsistent. Therefore, we conducted the present meta-analysis to systematically assess the diagnostic value of miR-21 for CRC. Materials and Methods: Using a random-effect model, the pooled sensitivity (SEN), specificity (SPE), positive likelihood ratio (PLR), negative likelihood ratio (NLR), and diagnostic odds ratio (DOR) were calculated to evaluate the diagnostic performance of miR-21 for CRC. A summary receiver operating characteristic (SROC) curve and an area under the curve (AUC) were also generated to assess the diagnosis accuracy of miR-21 for CRC. Q test and I2 statistics were used to assess between-study heterogeneity. Publication bias was evaluated by the Deeks' funnel plot asymmetry test. Results: A total of 986 CRC patients and 702 matched healthy controls from 8 studies were involved in the meta-analysis. The pooled results for SEN, SPE, PLR, NLR, DOR, and AUC were 57% (95%CI: 39%-74%), 87% (95%CI: 78%-93%), 4.4 (95%CI: 2.4-8.0), 0.49 (95%CI: 0.32-0.74), 9 (95%CI: 4-22), and 0.83 (95%CI: 0.79-0.86), respectively. Subgroup analyses further suggested that blood-based studies showed a better diagnostic accuracy compared with feces-based studies, indicating that blood may be a better matrix for miR-21 assay and CRC detection. Conclusions: Our findings suggest that miR-21 has a potential diagnostic value for CRC with a moderate level of overall diagnostic accuracy. Hence, it could be used as auxiliary means for the initial screening of CRC and avoid unnecessary colonoscopy, which is an invasive and expensive procedure.

Performance Evaluation of the Automated Fluorescent Immunoassay System Rotavirus Assay in Clinical Samples

  • Kim, Jae-Seok;Lee, Su-Kyung;Ko, Dae-Hyun;Hyun, Jungwon;Kim, Hyun Soo
    • Annals of Laboratory Medicine
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    • 제39권1호
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    • pp.50-57
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    • 2019
  • Background: The Automated Fluorescent Immunoassay System (AFIAS) rotavirus assay (Boditech Med Inc., Chuncheon, Korea) is a new rapid antigen test for rotavirus detection. We evaluated the performance of this assay for detecting rotaviruses and their specific genotypes in clinical stool samples. Methods: AFIAS rotavirus assay was performed in 103 rotavirus-positive and 103 rotavirus-negative stool samples (confirmed by both PCR and ELISA), and its results were compared with those of PCR, ELISA, and immunochromatographic assay (ICA). We evaluated diagnostic sensitivity/specificity, the detectability of rotavirus subtypes, lower limit of detection (LLOD), reproducibility, cross-reactivity, and interference of AFIAS rotavirus assay. Results: Based on PCR and ELISA results, diagnostic sensitivity and specificity of the AFIAS rotavirus assay were both 99.0%. LLOD results showed that the AFIAS assay had sensitivity similar to or greater than ICA and ELISA. High reproducibility was confirmed, and no cross-reactivity or interference was detected. This assay could detect genotypes G1P[8], G2P[4], G3P[8], G4P[6], G4P[8], G8P[4], G8P[8], G9P[4], and G9P[8]. Conclusions: The AFIAS rotavirus assay showed high reproducibility, sensitivity, and specificity as well as excellent agreement with ELISA, PCR, and ICA. It detected the most common as well as unusual genotypes of rotavirus prevalent in Korea. It could be a useful onsite assay for rapid, convenient, and cost-effective detection of rotavirus infection.

Comparison of the Three Molecular Diagnostic Assays for Molecular Identification of Mycobacterium tuberculosis and Nontuberculous Mycobacteria Species in Sputum Samples

  • Bae, Jinyoung;Park, Sung-Bae;Kim, Ji-Hoi;Kang, Mi Ran;Lee, Kyung Eun;Kim, Sunghyun;Jin, Hyunwoo
    • 대한의생명과학회지
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    • 제26권3호
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    • pp.170-178
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    • 2020
  • Mycobacterium tuberculosis (MTB) continues to be one of the main causative agents of tuberculosis (TB); moreover, the incidence of nontuberculous mycobacteria (NTM) infections has been rising gradually in both immunocompromised and immunocompetent patients. Precise and rapid detection and identification of MTB and NTM in respiratory specimens are thus important for MTB infection control. Molecular diagnostic methods based on the nucleic acid amplification test (NAAT) are known to be rapid, sensitive, and specific compared to the conventional acid-fast bacilli (AFB) smear and mycobacterial culture methods. In the present study, the clinical performances of three commercial molecular diagnostic assays, namely TB/NTM PCR (Biocore), MolecuTech Real MTB-ID® (YD Diagnostics), and REBA Myco-ID® (YD Diagnostics), were evaluated with a total of 92 respiratory specimens (22 AFB smear positives and 67 AFB smear negatives). The sensitivity and specificity of TB/NTM PCR were 100% and 75.81%, respectively. The corresponding values of MolecuTech Real MTB-ID® and REBA Myco-ID® were 56.52% and 90.32%, and 56.52% and 82.26%, respectively. TB/NTM PCR showed the highest sensitivity; however, the concordant rate was 10% compared with sequence analysis. Although MolecuTech Real MTB-ID® showed lower sensitivity, its specificity was the highest among the three methods. REBA Myco-ID® allowed accurate classification of NTM species; therefore, it was the most specific diagnostic method. Of the three PCR-based methods, MolecuTech Real MTB-ID® showed the best performance. This method is expected to enable rapid and accurate identification of MTB and NTM.

주의력결핍 과잉행동장애의 진단 보조도구로 뉴로가이드와 IVA + Plus의 유용성에 관한 예비연구 (A Preliminary Evaluation of NeuroGuide and IVA + Plus as Diagnostic Tools for Attention-Deficit Hyperactivity Disorder)

  • 양정인;김소율;김영성;이재원
    • 생물정신의학
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    • 제19권1호
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    • pp.45-52
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    • 2012
  • Objectives : This study was designed to investigate the usability of IVA + Plus (Continuous Performance Test) and Neuro-Guide [Quantitative electroencephalography (EEG) normative database] as an auxiliary diagnostic tools for attention-deficit hyperactivity disorder (ADHD). Methods : The scores of IVA + Plus and resting EEG were obtained from 34 elementary school-aged children. Also, the Korean ADHD Rating Scale (K-ARS) and the Diagnostic Interview Schedule for Children version IV (DISC-IV) was done for the parent of them. From the result of the DISC-IV, we divided them into three groups, ADHD Not Otherwise Specified (NOS), and Normal Control (NC). Using NeuroGuide, the z-scores of relative power for delta (1-4 Hz), theta (4-8 Hz), alpha (8-12 Hz), and beta (12-25 Hz) were calculated. Then the correlation and variance analysis were done to investigate the differences between three groups. Results : The scores of IVA + Plus were negatively correlated with the K-ARS. IVA + Plus have successfully discriminated the ADHD from NC and NOS. The z-scores of relative power of delta and theta were positively correlated with the K-ARS. The z-scores of relative power of alpha and beta were negatively correlated with the K-ARS. Conclusions : The IVA + Plus and NeuroGuide QEEG test are expected to be used as the valuable tools for diagnosing ADHD accurately.