• KSBB Journal
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• v.28 no.4
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• pp.254-259
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• 2013

Herein we present a diagnostic paper chip that can quantitatively detect albumin without external electronic reader and dispensing apparatus. We fabricated a diagnostic paper chip device by printing wax barrier on the paper and wicking it with citrate buffer and tetrabromophenol blue to detect albumin in sample solution. The paper chip is so simple that we dropped a sample solution at sample pad and measure the ratio of two travel distances of the sample solvent and albumin under the name of retention factor. Our result confirmed that the retention factor was constant in the samples with same concentration of albumin and useful determinant for the measurement of albumin concentration. The paper chip is affordable and equipment-free, and close to ideal point-of-care test in accordance with the assured criteria, outlined by the World Health Organization. We assume that this diagnostic paper chip will expand the concept of colorimetric determination and provide a inexpensive diagnostic method to aging society and developing country.

• Journal of Appropriate Technology
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• v.6 no.1
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• pp.45-50
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• 2020

We developed the world's first wireless ultrasound diagnostic device. For the smooth delivery of pregnant women, the WHO requires four prior examinations, and the use of ultrasound diagnostic devices is essential for this purpose. However, income levels and medical facilities in developing countries are falling short. We conducted KOICA's CTS program in Vietnam using a self-developed radio ultrasound diagnostic device. We supplied Sonon300C, a portable wireless ultrasound diagnostic device, to health centers and hospitals in Huong-Hoa district, Vietnam, and conducted an outreach program in an effort to further enhance business performance. As a result, the rate of ultrasound diagnostics in the region reached 100% and the percentage of trained graduates increased to 59%.

• 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.

• Journal of Microbiology and Biotechnology
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• v.33 no.8
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• pp.1091-1100
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• 2023

Human papillomavirus (HPV) types 16 and 18 are the major causes of cervical lesions and are associated with 71% of cervical cancer cases globally. However, public health infrastructures to support cervical cancer screening may be unavailable to women in low-resource areas. Therefore, sensitive, convenient, and cost-efficient diagnostic methods are required for the detection of HPV16/18. Here, we designed two novel methods, real-time ERA and ERA-LFD, based on enzymatic recombinase amplification (ERA) for quick point-of-care identification of the HPV E6/E7 genes. The entire detection process could be completed within 25 min at a constant low temperature (35-43℃), and the results of the combined methods could be present as the amplification curves or the bands presented on dipsticks and directly interpreted with the naked eye. The ERA assays evaluated using standard plasmids carrying the E6/E7 genes and clinical samples exhibited excellent specificity, as no cross-reaction with other common HPV types was observed. The detection limits of our ERA assays were 10⁰ and 10¹ copies/µl for HPV16 and 18 respectively, which were comparable to those of the real-time PCR assay. Assessment of the clinical performance of the ERA assays using 114 cervical tissue samples demonstrated that they are highly consistent with real-time PCR, the gold standard for HPV detection. This study demonstrated that ERA-based assays possess excellent sensitivity, specificity, and repeatability for HPV16 and HPV18 detection with great potential to become robust diagnostic tools in local hospitals and field studies.

• International Journal of Oral Biology
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• v.48 no.2
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• pp.9-18
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• 2023

The rapid detection of bacteria in the oral cavity, its species identification, and bacterial count determination are important to diagnose oral diseases caused by pathogenic bacteria. The existing clinical microbial diagnosis methods are time-consuming as they involve observing patients' samples under a microscope or culturing and confirming bacteria using polymerase chain reaction (PCR) kits, making the process complex. Therefore, it is required to analyze the development status of substances and systems that can rapidly detect and analyze pathogenic microorganisms in the oral cavity. With research advancements, a close relationship between oral and systemic diseases has been identified, making it crucial to identify the changes in the oral cavity bacterial composition. Additionally, an early and accurate diagnosis is essential for better prognosis in periodontal disease. However, most periodontal disease-causing pathogens are anaerobic bacteria, which are difficult to identify using conventional bacterial culture methods. Further, the existing PCR method takes a long time to detect and involves complicated stages. Therefore, to address these challenges, the concept of point-of-care (PoC) has emerged, leading to the study and implementation of various chair-side test methods. This study aims to investigate the different PoC diagnostic methods introduced thus far for identifying pathogenic microorganisms in the oral cavity. These are classified into three categories: 1) microbiological tests, 2) microchemical tests, and 3) genetic tests. The microbiological tests are used to determine the presence or absence of representative causative bacteria of periodontal diseases, such as A. actinomycetemcomitans, P. gingivalis, P. intermedia, and T. denticola. However, the quantitative analysis remains impossible, and detecting pathogens other than the specific ones is challenging. The microchemical tests determine the activity of inflammation or disease by measuring the levels of biomarkers present in the oral cavity. Although this diagnostic method is based on increase in the specific biomarkers proportional to inflammation or disease progression in the oral cavity, its commercialization is limited due to low sensitivity and specificity. The genetic tests are based on the concept that differences in disease vulnerability and treatment response are caused by the patient's DNA predisposition. Specifically, the IL-1 gene is used in such tests. PoC diagnostic methods developed to date serve as supplementary diagnostic methods and tools for patient education, in addition to existing diagnostic methods, although they have limitations in diagnosing oral diseases alone. Research on various PoC test methods that can analyze and manage the oral cavity bacterial composition is expected to become more active, aligning with the shift from treatment-oriented to prevention-oriented approaches in healthcare.

• Neonatal Medicine
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• v.18 no.2
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• pp.301-309
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• 2011

Purpose: Point-of-care tests (POCTs) have the potential to significantly influence management of neonates. The aim of this study was to assess the clinical usefulness of the POCT chemistry analyzer in a neonatal intensive care unit (NICU). Methods: Blood samples of neonates admitted to the NICU were tested using a POCT chemistry analyzer (Piccolo Xpress Chemistry Analyzer, Abaxis, Union City, CA, USA) and a central laboratory chemical analyzer (Chemistry analyzer 7600-110, Hitachi Ltd., Tokyo, Japan) from March to September, 2010. Correlation of 15 analytes between the POCT and the central laboratory machine was evaluated. For consistency of the POCT, three consecutive samplings were performed. Differences among the three tests were recorded. The causes of performance errors were checked through log files. Results: One hundred of 112 pairs of tests for accuracy performed in 54 neonates showed a high correlation between the two machines. Twelve performance errors occurred during the 112 tests. The most common error was insufficient sample error. Eighteen triplet tests performed in 18 patients for consistency revealed a difference range of 3-10%, which was considered to be acceptable. No error occurred during the 54 tests. Conclusion: The POCT is capable of analyzing multiple analytes with a minimal amount of whole blood in a short time. The few performance errors noted presently are likely preventable. This POCT is concluded to be suitable for use as a simple and rapid diagnostic method in the NICU with a minimal amount of blood collected in a less invasive manner.

• Proceedings of the KSME Conference
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• 2007.05b
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• pp.2781-2784
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• 2007

Early detection of a disease is important to tackle treatment issues in a better manner. Several diagnostic techniques are in use, these days; for such purpose and tremendous research is going on to develop newer and newer methods. However, more work is required to be done to develop cheap and reliable early detection techniques. Micro-fluidic chips are also playing key role to deliver new devices for better health care. The present study focuses on a review of recent developments in the interrogation of different techniques and present state-of-the-art of microfluidic sensor for better, quick, easy, rapid, early, inexpensive and portable POCT (Point of Care testing device) device for a particular study, in this case, bone disease called osteoporosis. Some simulations of the microchip are also made to enable feasibility of the development of a blood-chip-based system. The proposed device will assist in early detection of diseases in an effective and successful manner.

• Genomics & Informatics
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• v.19 no.3
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• pp.34.1-34.6
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• 2021

Digital PCR (dPCR) is the third-generation PCR that enables real-time absolute quantification without reference materials. Recently, global diagnosis companies have developed new dPCR equipment. In line with the development, the Lab On An Array (LOAA) dPCR analyzer (Optolane) was launched last year. The LOAA dPCR is a semiconductor chip-based separation PCR type equipment. The LOAA dPCR includes Micro Electro Mechanical System that can be injected by partitioning the target gene into 56 to 20,000 wells. The amount of target gene per wells is digitized to 0 or 1 as the number of well gradually increases to 20,000 wells because its principle follows Poisson distribution, which allows the LOAA dPCR to perform precise absolute quantification. LOAA determined region of interest first prior to dPCR operation. To exclude invalid wells for the quantification, the LOAA dPCR has applied various filtering methods using brightness, slope, baseline, and noise filters. As the coronavirus disease 2019 has now spread around the world, needs for diagnostic equipment of point of care testing (POCT) are increasing. The LOAA dPCR is expected to be suitable for POCT diagnosis due to its compact size and high accuracy. Here, we describe the quantitative principle of the LOAA dPCR and suggest that it can be applied to various fields.

• Journal of Biomedical Engineering Research
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• v.42 no.3
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• pp.125-142
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• 2021

The POCT (point-of-care test) sensing that has been a fast-developing field is expected to be a next generation technology in health care. The POCT sensors for the detection of proteins, small molecules and especially nucleic acids have lately attracted considerable attention. According to the World Health Organization (WHO), the POCT methods are required to follow the ASSURED guidelines (Affordable, Sensitive, Specific, User- friendly, Robust and rapid, Equipment-free, Deliverable to all people who need the test). Recently, several CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) based diagnostic techniques using the sensitive gene recognition function of CRISPR have been reported. CRISPR/Cas (Cas, CRISPR associated protein) systems based detection technology is the most innovative gene analysis technology that is following the ASSURED guidelines. It is being re-emerged as a powerful diagnostic tool that can detect nucleic acids due to its characteristics that enable rapid, sensitive and specific analyses of nucleic acid. The first CRISPR-based diagnosis begins with the discovery of the additional function of Cas13a. The enzymatic cleavage occurs when the conjugate of Cas protein and CRISPR RNA (crRNA) detect a specific complementary sequence of the target sequence. Enzymatic cleavage occurs on not only the target sequence, but also all surrounding non-target single-stranded RNAs. This discovery was immediately utilized as a biosensor, and numerous sensor studies using CRISPR have been reported since then. In this review, the concept of CRISPR, the characteristics of the Cas protein required for CRISPR diagnosis, the current research trends of CRISPR diagnostic technology, and some aspects to be improved in the future are covered.

• Journal of Microbiology and Biotechnology
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• v.31 no.9
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• pp.1323-1329
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• 2021

Micro-scale magnetic beads are widely used for isolation of proteins, DNA, and cells, leading to the development of in vitro diagnostics. Efficient isolation of target biomolecules is one of the keys to developing a simple and rapid point-of-care diagnostic. A zinc finger protein (ZFP) is a double-stranded (ds) DNA-binding domain, providing a useful scaffold for direct reading of the sequence information. Here, we utilized two engineered ZFPs (Stx2-268 and SEB-435) to detect the Shiga toxin (stx2) gene and the staphylococcal enterotoxin B (seb) gene present in foodborne pathogens, Escherichia coli O157 and Staphylococcus aureus, respectively. Engineered ZFPs are immobilized on a paramagnetic bead as a detection platform to efficiently isolate the target dsDNA-ZFP bound complex. The small paramagnetic beads provide a high surface area to volume ratio, allowing more ZFPs to be immobilized on the beads, which leads to increased target DNA detection. The fluorescence signal was measured upon ZFP binding to fluorophore-labeled target dsDNA. In this study, our system provided a detection limit of ≤ 60 fmol and demonstrated high specificity with multiplexing capability, suggesting a potential for development into a simple and reliable diagnostic for detecting multiple pathogens without target amplification.