• Quality Improvement in Health Care
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• v.19 no.1
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• pp.64-72
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• 2013

Objective: To improve customer satisfaction through accurate information using computerized automation of the test reservation system and by performing all fasting tests on the same day with one fasting. Methods: Quality improvement activities of the test reservation system of Seoul National University Bundang Hospital improves internal and external customer satisfaction at the time of test scheduling by having the reservation system reflect test order and test time automatically and making the system to increase the same day test reservation rate. Results: Test process was smooth due to accurate test reservation and information based on test priority due to the introduction of the computerized test reservation system. Internal and external customer satisfaction improved due to the marked reduction in time required for making a reservation thanks to the improvement of work process. Conclusion: Building a computerized test reservation system was an effective measure to improve external and internal customer satisfaction.

• Journal of Korean Dental Science
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• v.15 no.2
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• pp.101-111
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• 2022

The purpose of laboratory tests in the field of oral medicine can be divided into two categories: (1) medical evaluation of patients with systemic diseases that are planning to receive dental care and (2) diagnosis of patients with certain oral diseases. First, laboratory tests are commonly used to evaluate patients with systemic diseases who need dental management. A combination of multiple tests is usually prescribed as a test panel to diagnose and assess a specific disease. Test panels closely related to oral medicine include those for rheumatoid arthritis, connective tissue disease/lupus, liver function, thyroid screening, anemia, and bleeding disorders. Second, laboratory tests are used as auxiliary diagnostic methods for certain oral diseases. They often provide crucial diagnostic information for infectious diseases caused by bacteria, fungi, and viruses that are associated with pathology in the oral and maxillofacial regions. Laboratory tests for infectious diseases are composed of growth-dependent methods, immunologic assays, and molecular biology. As the field develops, further application of laboratory tests, including synovial fluid analysis in temporomandibular joint disorders, salivary diagnostics, and hematologic biomarkers associated with temporomandibular disorders and orofacial pain conditions, is currently under scrutiny for their reliability as diagnostic tools.

• Asian Pacific Journal of Cancer Prevention
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• v.15 no.21
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• pp.9077-9083
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• 2014

Background: This study aimed to summarize the potential diagnostic value of serum DKK1 levels in cancer detection. Materials and Methods: Serum DKK1 was measured using enzyme-linked immunosorbent assay in a case-control study. Then we performed a meta-analysis and the pooled sensitivity, specificity, diagnostic odds ratio, and summary receiver operating characteristic (sROC) curves were used to evaluate the overall test performance. Results: Serum DKK1 levels were found to be significantly upregulated in gastric cancer as compared to controls. ROC curve analysis revealed an AUC of 0.636, indicating the test has the potential to diagnose cancer with poor accuracy. The summary estimates of the pooled sensitivity, specificity and diagnostic odds ratio in meta-analysis were 0.55 with a 95% confidence interval (CI) (0.53-0.57), 0.86 (95%CI, 0.84-0.88) and 12.25 (95%CI, 5.31-28.28), respectively. The area under the sROC was 0.85. Subgroup analysis revealed that the diagnostic accuracy of serum DKK1 in lung cancer (sensitivity: 0.69 with 95%CI, 0.66-0.74; specificity: 0.95 with 95%CI, 0.92-0.97; diagnostic odds ratio: 44.93 with 95%CI, 26.19-77.08) was significantly higher than for any other cancer. Conclusions: Serum DKK1 might be useful as a noninvasive method for confirmation of cancer diagnosis, particularly in the case of lung cancer.

• Asian Pacific Journal of Cancer Prevention
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• v.14 no.8
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• pp.4699-4704
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• 2013

Background: MicroRNAs have been demonstrated to play important roles in the development and progression of colorectal cancer. Several studies utilizing microRNAs as diagnostic biomarkers for colorectal cancer (CRC) have been reported. The aim of this meta-analysis was to comprehensively and quantitatively summarize the diagnostic value of microRNAs for detecting colorectal cancer. Methods: We searched PubMed, Embase and Cochrane Library for published studies that used microRNAs as biomarkers for the diagnosis of colorectal cancer. Summary estimates for sensitivity, specificity and other measures of accuracy of microRNAs in the diagnosis of colorectal cancer were calculated using the bivariate random effects model. A summary receiver operating characteristic (SROC) curve was also generated to summarize the overall effectiveness of the test. Result: Thirteen studies from twelve published articles met the inclusion criteria and were included. The overall sensitivity, specificity, positive likelihood ratio, negative likelihood ratio and diagnostic odd ratio of microRNAs for the diagnosis of colorectal cancer were 0.81 (95%CI: 0.79-0.84), 0.78 (95%CI: 0.75-0.82), 4.14 (95%CI: 2.90-5.92), 0.24 (95%CI: 0.19-0.30), and 19.2 (95%CI: 11.7-31.5), respectively. The area under the SROC curve was 0.89. Conclusions: The current evidence suggests that the microRNAs test might not be used alone as a screening tool for CRC. Combining microRNAs testing with other conventional tests such as FOBT may improve the diagnostic accuracy for detecting CRC.

• Journal of Genetic Medicine
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• v.8 no.1
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• pp.28-34
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• 2011

Most clinicians understand clinical trials as the evaluation process for new medicine before their use. However, clinical trials can also be applied to laboratory diagnostic tests (LDTs) to verify diagnostic accuracy and efficacy before their clinical laboratory implementation for patients. The clinical trial of LDT has two distinctive characteristics that are different from the case of pharmaceuticals and thus worth special consideration. One of them is the level of evidence. The well-designed randomized controlled trials (RCTs) are known to provide the best evidence to prove the clinical efficacy of any pharmaceutical products. However, RCTs lose practicality when applied to LDTs due to various issues including ethical complications. For this reason, comparative study format is considered more feasible approach for LDTs. In addition pharmaceuticals and LDTs are different in that the user's intervention is not required for the former but critical to the latter. Moreover, in the case of pharmaceuticals, end-products are produced by manufacturers before being used by clinicians. However, in LDTs, once reagents and instruments are provided by manufacturers, they are first utilized by clinical laboratories to produce test results in order for clinicians to use them later. In other words, when it comes to LDTs, clinical laboratories play the role of manufacturers, providing reliable test results with improved quality assurance. Considering the distinctive characteristics of LDTs, we would like to offer detailed suggestions to successfully perform clinical trials in LDTs, which include analytical performance measures, clinical test performance measures, diagnostic test accuracy measures, clinical effectiveness measures, and post-implementation surveillance.

• Korean Journal of Clinical Laboratory Science
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• v.52 no.3
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• pp.271-277
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• 2020

"Health examinations" means medical examinations conducted by health examination institutions, including a physical examination, consultation, physical measurement, diagnostic laboratory test (also known as clinical laboratory test, clinical pathology test), pathology test, and Imaging test for checking the health condition and the prevention and early detection of diseases. The types of health examinations include general health examinations, comprehensive health examinations, special health examinations, and other health examinations. The proportion of the general health examination work of medical technologists working at health examination centers has been estimated to comprise more than 50% of the total work. The cost aspect of suspicious diseases can be estimated to be more than 25%. The cost of diagnostic laboratory test has been estimated to be approximately 5%, and the proportion of medical diagnosis use is 70%. The results show that it is time to revisit whether medical technologists are receiving appropriate social, economic, and reasonable policy treatment in health examination work. The future of medical technologists will further expand their professionalism in diagnostic laboratory test and quality control in precision medicine and telemedicine in the future. Therefore, medical technologists will need to participate proactively in government policy decisions related to national health examinations and make efforts to improve treatment.

• Parasites, Hosts and Diseases
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• v.60 no.3
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• pp.173-179
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• 2022

Malaria remains a global health threat. Approximately 97% of the population is at risk in sub-Saharan countries, particularly Nigeria. This study compared the performance of 2 diagnostic methods in assessing malaria endemicity in the rural communities of Ebonyi State, Nigeria. A total of 1,140 study participants were screened for malaria parasite using Rapid Diagnostic Test kits (RDT) in the field, while thick and thin films for microscopy were examined in the laboratory. Our result showed that malaria prevalence was 56.8 by RDT and 38.6% by microscopic test. Age group under 10 years had the highest prevalence of 28.9% (RDT) and 23.6% (microscopy), respectively. The highest prevalence of 19.5% by RDT was recorded in Onicha Local Government Area, while the highest prevalence of 13.4% with microscopy was recorded in Ezza North Local Government Area. The sensitivity and specificity of microscopic examination were both 100%, while those of RDT were 95.5% and 75.9%, respectively.

• Korean Journal of Clinical Laboratory Science
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• v.50 no.1
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• pp.20-28
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• 2018

Tuberculosis (TB) is a bacterial infection disease caused by members of the species Mycobacterium tuberculosis (MTB) complex. Approximately one third of the world's population is infected with TB. In Korea, approximately 40,000 new patients are identified each year. Moreover, infections from non-tuberculous mycobacteria (NTM) have also increased. In the diagnosis of TB and NTM, traditional bacterial cultures are required for 3 to 4 weeks. Therefore, rapid and accurate diagnostic tests for TB and NTM are needed. To distinguish between TB and NTM, a range of diagnostic methods have been developed worldwide. In vitro diagnostic assays are constantly being developed to meet the increasing need for the rapid and accurate identification for TB and NTM. On the other hand, the performance evaluations of in vitro diagnostic reagents for TB and NTM are lacking. Recently, the Korea Food and Drug Administration (KFDA) issued a guideline for in vitro diagnostic reagents for MTB and NTM. Here, this study analyzed the performance of currently developed in vitro diagnostic reagents for TB and NTM in the US FDA. This analysis of US FDA approved molecular assays could serve as a useful reference for an evaluation of the reagent performance of TB and NTM.

• Korean Journal of Clinical Laboratory Science
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• v.42 no.1
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• pp.38-45
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• 2010

The aim of this study was to assess the Clinical Usefulness of Helicobacter pylori Stool Antigen (HpSA) immunochromatographic assay for the diagnosis of H. pylori infection. In this study, we had compared HpSA-immunochromatographic assay with CLO test and UBT test. From a total of 140 patients (M:F=88:52) with upper endoscopy, biopsy specimens were obtained for CLO test. Stool specimens was collected from all patients and tested using a HpSA-immunochromatic assay. H. pylori infection status was defined as infected if the results of both CLO test and UBT test were positive. CLO test and UBT test findings showed that 92 patients were H. pylori positive and 48 patients were H. pylori negative. According to this definition, the sensitivity, specificity, and positive or negative predictive value (PPV, NPV) of HpSA-immunochromatographic assay were 97.8%, 100%, 100%, and 96%, respectively. Cross reactivity test of HpSA-immunochromatographic assay were performed with 10 enteric bacteria strains in fecal habitat, and there were no false positive reaction. We evaluated the usefulness of HpSA assay for eradication therapy with 10 of 92 H. pylori positive patients, positive results of them at pre-eradication therapy were converted to negative at post-eradication. The HpSA-immunochromatographic assay is a highly sensitive and specific non-invasive diagnostic method for detection of H. pylori infection, a useful diagnostic method for H. pylori in post eradication stage.

• Clinical and Experimental Pediatrics
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• v.49 no.11
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• pp.1140-1151
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• 2006

Inherited metabolic disorders are individually rare but as a whole, they are nor rare. Since Archibald Garrod introduced a concept of "inborn error of metabolism" or "chemical individuality", more than 500 diseases are currently known, affecting approximately one in 500 newborns cumulatively. They frequently manifest with acute, life-threatening crisis that require immediate specific intervention or they present with insidious diverse symptoms and signs involving multiple visceral organs or tissues as well as central nervous system, hampering a correct diagnosis. In addition, many pediatricians are not familiar with all diagnostic and therapeutic strategies for diverse inherited metabolic disorders. However, the prognosis of affected children are heavily dependent on rapid and effective treatment. In this lecture, practical guidelines for the specific diagnosis based on diverse clinical features of inherited metabolic disorders will be described. Many sophisticated laboratory tests are available for confirmatory diagnosis of each disease, which challenge to general pediatricians with respect to knowledge about biochemical metabolite assay test, enzymatic test and DNA diagnostic tests. Sample collections, indications, methods and interpretation of results in varying laboratory tests will be listed as well.