• Title/Summary/Keyword: diagnostic tests

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Diagnostic Methods of Respiratory Virus Infections and Infection Control (호흡기 바이러스 감염의 진단법과 감염관리)

  • Park, Chang-Eun
    • Korean Journal of Clinical Laboratory Science
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    • v.53 no.1
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    • pp.11-18
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    • 2021
  • Respiratory viruses (RVs) cause infections in hospital environments through direct contact with infected visitors. In infection control, it causes major problems of acquired infections in hospitals by respiratory viruses. The surveillance data derived from clinical laboratories are often used to properly allocate medical resources to hospitals and communities for treatment, consumables, and diagnostic product purchases in the institutions and public health sectors that provide health care. An early diagnosis is essential in infection with respiratory viruses, and methods that can be used in diagnostic methods using respiratory samples include virus culture, molecular diagnosis, and analysis. A microchip provides a new strategy for developing a more diverse and powerful technology called point-of-care testing. The importance of the respiratory system should be applied strictly to the infection control guidelines to ensure the occupational health and safety of health care workers. Evidence of clinical efficacy, including this study, is challenging the long-standing paradigm for infection propagation. Additional assistance will be needed for frequent tests to detect respiratory viruses in inpatients who have begun to show new respiratory symptoms indicating infections requiring efforts to control the infection.

Key Principles of Clinical Validation, Device Approval, and Insurance Coverage Decisions of Artificial Intelligence

  • Seong Ho Park;Jaesoon Choi;Jeong-Sik Byeon
    • Korean Journal of Radiology
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    • v.22 no.3
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    • pp.442-453
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    • 2021
  • Artificial intelligence (AI) will likely affect various fields of medicine. This article aims to explain the fundamental principles of clinical validation, device approval, and insurance coverage decisions of AI algorithms for medical diagnosis and prediction. Discrimination accuracy of AI algorithms is often evaluated with the Dice similarity coefficient, sensitivity, specificity, and traditional or free-response receiver operating characteristic curves. Calibration accuracy should also be assessed, especially for algorithms that provide probabilities to users. As current AI algorithms have limited generalizability to real-world practice, clinical validation of AI should put it to proper external testing and assisting roles. External testing could adopt diagnostic case-control or diagnostic cohort designs. A diagnostic case-control study evaluates the technical validity/accuracy of AI while the latter tests the clinical validity/accuracy of AI in samples representing target patients in real-world clinical scenarios. Ultimate clinical validation of AI requires evaluations of its impact on patient outcomes, referred to as clinical utility, and for which randomized clinical trials are ideal. Device approval of AI is typically granted with proof of technical validity/accuracy and thus does not intend to directly indicate if AI is beneficial for patient care or if it improves patient outcomes. Neither can it categorically address the issue of limited generalizability of AI. After achieving device approval, it is up to medical professionals to determine if the approved AI algorithms are beneficial for real-world patient care. Insurance coverage decisions generally require a demonstration of clinical utility that the use of AI has improved patient outcomes.

Various Diagnostic Methods for Helicobacter pylori Infection (헬리코박터 파일로리 감염의 다양한 진단법)

  • Han Jo Jeon;Hyuk Soon Choi
    • The Korean Journal of Medicine
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    • v.99 no.2
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    • pp.104-110
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    • 2024
  • Helicobacter pylori (H. pylori) is a bacterium that colonizes the human stomach, leading to various gastrointestinal diseases including gastritis, peptic ulcers, and gastric cancer. There is no gold standard test that relies entirely on one method in H. pylori diagnosis. We must be aware of the pros and cons of various testing methods to perform an appropriate test according to the situation. Accurate diagnosis and eradication therapy are essential for disease management. Diagnostic methods include invasive techniques like tissue biopsy and rapid urease test, as well as non-invasive tests such as urea breath test, serology test, and stool antigen test. Each method has its advantages and limitations, requiring careful consideration in clinical practice. Understanding these diagnostic tools is crucial for effective H. pylori management and prevention of associated complications.

PULSE OXIMETER AS A DIAGNOSTIC TEST OF PULP VITALITY (Pulse Oximeter를 이용한 치수생활력측정)

  • Koo, Bon-Kyung;Lee, Jae-Ho;Lee, Jong-Gap
    • Journal of the korean academy of Pediatric Dentistry
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    • v.27 no.1
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    • pp.103-107
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    • 2000
  • Traditionally, EPT and thermal tests were used as diagnostic methods for pulp vitality test. The thermal and electrical stimulation tests are the methods to determine the vitality of a tooth based on its neuronal response. These have certain limitations, one of them is the difficulty of approaching the correct result in case of treatment of children. The reason is management problem caused by the unpleasant stimulation. Also, the response from patients are not objective, and false positive or false negative could be happened. Recently, laser doppler flowmetry and pulse oximeter which evaluate vascular integrity are introduced in an effort of overcoming to limitation of traditional methods. The principle of pulse oximeter is to and out level of oxygen saturation by ratio of the two pulses between emitted light and detected light penetrating them to the termination of body, such as ears or fingers. From this point of view, it can be applied to a tooth to determine its vitality. The objective of this study lies mainly on varifying pulse oximeter as a method of determining tooth vitality and providing basic data of its clinical implementation. The result of the research showed that level of oxygen saturation in vital teeth was average of 96.3% and 0.0% in pulpless teeth. As a comprehensive result, pulse oximeter could be an useful diagnostic equipment in determining of tooth vitality.

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The Usefulness of Endobronchial Ultrasonogram for Peripheral Lung Lesion (폐주변부 병변의 진단시 기관지 초음파(Endobronchial Ultrasonogram)의 유용성)

  • Kim, Sung Bin;Park, Jin Hee;Kim, Ye Na;Oak, Chul Ho;Jang, Tae Won;Jung, Man Hong;Chun, Bong Kwon
    • Tuberculosis and Respiratory Diseases
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    • v.67 no.6
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    • pp.545-550
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    • 2009
  • Background: Endobronchial ultrasonogram (EBUS) has increased the diagnostic yield of a bronchoscopic biopsy of peripheral pulmonary lesions (PPL). This study evaluated the diagnostic yield of EBUS-guided transbronchial biopsy (TBB) and the visibility of EBUS PPL. Methods: Between August 2007 and November 2008, 50 patients (32 men and 18 women, median age, 61.1${\pm}$10 yrs; range, 16 to 80 yrs) whose PPL lesions could not be detected with flexible bronchoscopy were enrolled in this study. Among the 50 patients, 40 cases were malignant lesions (adenocarcinoma 25, squamous cell carcinoma 10, small cell carcinoma 5) and 10 cases were benign lesions (tuberculoma 7, fungal ball 1, other inflammation 2). Results: The mean diameter of the target lesion was 35.4${\pm}$4.3 mm. Of the 50 patients examined, the overall diagnostic yield by EBUS-TBLB was 46.0% (23/50). The visualization yield of EBUS was 66.0% (33/50). A definitive diagnosis of PPL localized by EBUS was established using EBUS-TBLB in 69.6% (23/33) of cases. The diagnostic yields from washing cytology and brushing cytology from a bronchus identified by EBUS were 27.0% and 45.4% respectively. The diagnostic yields reached 78.7% when the three tests (washing cytology, brushing cytology and EBUS-TBLB) were combined. The visualization yield of EBUS in lesions <20 mm was significantly lower than that in lesions ${\geq}$20 mm (p=0.04). The presence of a bronchus leading to a lesion (open bronchus sign) on the chest CT scan was associated with a high visualization yield on EBUS (p=0.001). There were no significant complications associated with EBUS-TBLB. Conclusion: EBUS-TBLB is a safe and effective method for diagnosing PPL. The lesion size and open bronchus signs are significant factors for predicting the visualization of EBUS.

Evaluation of the Reproducibility of Radiation Output from Diagnostic X-ray Equipment(Standards Based on IEC 60601-2-54) (진단용 X선 장치에서 방사선출력의 재현성 평가(IEC 60601-2-54 표준규격을 기반으로))

  • Han, Beom-Hee;Jung, Hong-Ryang;Lim, Cheong-Hwan;Kim, Chong-Yeal;Lee, Sang-Ho;Han, Sang-Hyun;Hong, Dong-Hee;Kim, Chang-Gyu;You, In-Gyu;Mo, Eun-Hee
    • Journal of Digital Convergence
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    • v.12 no.2
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    • pp.555-561
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    • 2014
  • For five diagnostic X-ray generators (DR), four units turned out to be appropriate in tests on the reproducibility of radiation output suggested in the IEC 60601-2-54 standard, but in one unit of the X-ray equipment, an item measured in a combination of 50% of the highest tube voltage of the diagnostic X-ray equipment, the test setting of Group C with authorized output doses between $1{\mu}Gy$ and $5{\mu}Gy$ of mAs turned out to be inappropriate. As a result, the radiation dose to the IEC 60601-2-54 standard for quantification standards proposed by the radiation output from diagnostic X-ray imaging device reproducibility of performance management should be aware that an important evaluation factor.

A Study on the Development and Validation of the Information Literacy Test by Guilford's Structure of Intellect Model (길포드의 지능구조모형에 의한 정보활용능력 검사도구 개발 및 타당성 연구)

  • Lee, Byeong-Ki
    • Journal of the Korean Society for Library and Information Science
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    • v.47 no.2
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    • pp.181-200
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    • 2013
  • The test instrument utilized to diagnose and evaluate a trainee's ability are necessary for an effective information literacy education. Nevertheless, there is a lack of a standardized test instrument to comprehensively measure students' information literacy. The purpose of this study is to develop a standardized test instrument to evaluate the information literacy of middle school students, and to verify the reliability and validity of the test instrument. For this purpose, this study selected factors that can show the information literacy and developed an information literacy test framework that was designed based on Guilford's SOI model and Meeker's SOI-LA test. The test instrument that was developed through this study is a 30-item Web-based multiple-choice test. This study administrated tests in middle school students (794 students joined), and analyzed difficulty, reliability, discrimination index, validity of tests, and reviewed tests items to qualify the standardized test. The cutoff score was also decided when using these tests as a diagnostic information literacy assessment.

Evaluation of Sample Testing Scheme for Designated Aquatic Animals (수산동물 지정검역물에 대한 표본검사 계획 검토)

  • Pak, Son-Il
    • Journal of Veterinary Clinics
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    • v.29 no.1
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    • pp.58-62
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    • 2012
  • To protect aquatic animal health of importing countries from the potential risks associated with exotic diseases introduced through international trade of live aquatic animals, inspection of designated commodities at ports of entry is a critical component of the safeguarding system. The only way to be 100% confident that no fishes in a shipment are infected with a specific agent is to test every fish in the commodity imported with a perfect diagnostic test. For the majority of cases, this is unrealistic since the group of interest may very large particularly for aquatic animals, or imperfect tests are often available. It is, therefore, more common to test a fixed proportion of a group by preplanned sampling schemes. However, decision making based on results of testing the sample can provide quite a chance that infected groups may be misclassified as uninfected, depending on sampling strategy employed. The objective of this study was to determine the possibility that one or more fishes in the group imported being infected but tests negative after inspecting samples. This question is critical to government authorities to examine whether sampling plan is sufficient to achieve the purpose intended for. At fixed population size, the maximum number of infected fishes when all tests negative was decreased as the sampling fraction increased. The probability of including at least one undetected but infected fish in a group for negative tests increased with the number of fish tested or true prevalence. The risk was much lesser where high sensitivity test was assumed; when increasing test sensitivity from 0.9 to 0.99, this risk was dramatically reduced to about a tenth or a fourth for prevalence ranges from 2 to 10%, given sample size ranges from 10 to 200. Based on the preliminary analysis, the author concluded that current sampling plan testing 4-8% of the import proposal for human consumption still can yield high false negative results. Therefore, from the quarantine inspection point of view, an enforced commodity-specific sampling design that accounts for the cost of testing with an imperfect test at the specified design prevalence is urgent.

EFFICIENCY OF SERUM TUMOR MARKERS ORAL SQUAMOUS CELL CARCINOMA PATIENTS (구강 편평세포암종 환자의 혈청 종양표지자의 유용성)

  • Bhang, Dae-Yeon;Kim, Chul-Hwan
    • Maxillofacial Plastic and Reconstructive Surgery
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    • v.31 no.1
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    • pp.18-26
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    • 2009
  • Purpose: Recently, the role of serum tumor marker has been studied for an important issue on diagnosing and treating tumors in the head and neck region because tests using tumor markers need relatively simple procedures and are acceptable to patients, compared with other test methods. Tumor marker tests were performed on patients with squamous cell carcinoma, which were known to have the highest prevalence among tumors in the head and neck region. Association between each tumor marker, and diagnosis and prognosis of tumors was assessed. Materials and methods: Tumor marker tests were carried out on 31 patients who visited Oral and Maxillofacial Surgery Department in Dankook University Dental Hospital between January 2003 and August 2008 and who were diagnosed as primary oral squamous cell carcinoma through out histopathologic diagnosis. Blood sample from these patients was performed to measure tumor markers using nuclear medicine diagnostic equipment. Measured entries were as follows: PSA(prostate-specific antibody), SCCAg( Squamous Cell Carcinoma Related Antigen), CA 19-9(Cancer Antigen 19-9), Ferritin, $\alpha$- FP(Alpha-Fetoprotein), Cyfra 21-1, CA125 (Cancer Antigen 125) and p53. Results: Analyses on each tumor marker indicated that squamous cell carcinoma in the head and neck region had statistically significant correlation with p53, SCC-Ag(TA-4), Cyfra 21-1 and Ferritin. p53 demonstrated the highest sensitivity. Especially, 4 cases among 18 cases which Ferritin was measured exhibited metastasis. In all those 4 cases, Ferritin values were higher than the standards (15 - 332ng/ml). Therefore, Ferritin is considered to have a close relation with metastasis of squamous cell carcinoma. Conclusion: This study shows that tumor marker tests are more useful in evaluating progression and prognosis of tumors rather than in diagnosing them. Particularly, serum Ferritin is considered to be beneficial in assessing metastasis of squamous cell carcinoma in the head and neck region and in developing treatment plans based on the assessment.

Genetic counseling in Korean health care system (유전상담의 제도적인 고찰)

  • Kim, Hyon-J.
    • Journal of Genetic Medicine
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    • v.4 no.1
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    • pp.1-5
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    • 2007
  • Unprecedented amount of genetic information being generated from the result of Human Genome Project (HGP) and advances in genetic research is already forcing changes in the paradigm of health and disease. The ultimate goal of genetic medicine is to use genetic information and technology to develop new ways of treatment or even prevention of the disease on an individual level for 'personalized medicine'. Genetics is play ing an increasingly important role in the diagnosis, monitoring and management of common multifactorial diseases in addition to rare single-gene disorders. While wide range of genetic testing have provided benefits to patients and family, uncertainties surrounding test interpretation, the current lack of available medical options for the diseases, and risks for discrimination and social stigmatization may remain to be resolved. However an increasing number of genetic tests are becoming commercially available, including direct to consumer genetic testing, yet public is often unaw are of their clinical and social implications. The personal nature of information generated by a genetic test, its power to affect major life decisions and family members, and its potential misuse raise important ethical considerations. Therefore appropriate genetic counseling is needed for patient to be informed with the benefits, limitations and risks of genetic tests, prior to informed consent for the tests. Physician also should be familiar with the legal and ethical issues involved in genetic testing to tell patients how w ell a particular genetic risk factor relates with likelihood of disease, and be able to provide appropriate genetic counseling. Genetic counseling become a mandatory requirement as global standard for many genetic testing such as prenatal diagnosis, presymtomatic DNA diagnostic tests and cancer susceptibility gene test for familial cancer syndrome. In oder to meet the challenge of genetic medicine of 21 century in korean health care system, professional education program and certification board for medical genetics specialist including non-MD genetic counselors should be addressed by medical society and regulatory policy of national health insurance reimbursement for genetic counseling to be in place to promote the implementation of clinical genetic service including genetic counseling for proper genetic testing.

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