• Journal of Veterinary Science
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• v.25 no.2
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• pp.28.1-28.11
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• 2024

Background: Porcine circovirus type 2 (PCV2) infection is ubiquitous around the world. Diagnosis of the porcine circovirus-associated disease requires clinic-pathological elements together with the quantification of viral loads. Furthermore, given pig farms in regions lacking access to sufficient laboratory equipment, developing diagnostic devices with high accuracy, accessibility, and affordability is a necessity. Objectives: This study aims to investigate two newly developed diagnostic tools that may satisfy these criteria. Methods: We collected 250 specimens, including 170 PCV2-positive and 80 PCV2-negative samples. The standard diagnosis and cycle threshold (Ct) values were determined by quantitative polymerase chain reaction (qPCR). Then, two point-of-care (POC) diagnostic platforms, convective polymerase chain reaction (cPCR, qualitative assay: positive or negative results are shown) and EZtargex (quantitative assay: Ct values are shown), were examined and analyzed. Results: The sensitivity and specificity of cPCR were 88.23% and 100%, respectively; the sensitivity and specificity of EZtargex were 87.65% and 100%, respectively. These assays also showed excellent concordance compared with the qPCR assay (κ = 0.828 for cPCR and κ = 0.820 for EZtargex). The statistical analysis showed a great diagnostic power of the EZtargex assay to discriminate between samples with different levels of positivity. Conclusions: The two point-of-care diagnostic platforms are accurate, rapid, convenient and require little training for PCV2 diagnosis. These POC platforms can discriminate viral loads to predict the clinical status of the animals. The current study provided evidence that these diagnostics were applicable with high sensitivity and specificity in the diagnosis of PCV2 infection in the field.

• KSBB Journal
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• v.31 no.1
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• pp.46-51
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• 2016

Recently paper based diagnostic kits have drawn great interest in the point-of-care testing market (POCT). The paper based detection systems provide inexpensive, rapid and safe analyses for disease markers and/or pathogens. Vitamin C (i.e., ascorbic acid) regulates body's immune system as an antioxidant agent. Humans, however, do not have enough amounts of enzymes involved in the synthesis of vitamin C that it is required to be obtained from their diets (e.g., beverages and/or supplements). Here, we have prepared a paper based kit to detect the concentration of Vitamin C presented in commercially available beverages. The evaluation provides the fast, simple and accurate results for detecting Vitamin C in the prepared paper based kit.

• Ceramist
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• v.21 no.3
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• pp.293-301
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• 2018

Paper-based analytical devices (${\mu}PAD$) are highly advantageous for portable diagnostic systems owing to their low costs and ease of use. ${\mu}PADs$ are considered as the best candidates for realizing the World Health Organization (WHO) ASSURED criteria: affordable, sensitive, specific, user-friendly, rapid and robust, equipment-free, and deliverable to end users. However, they have several limitations such as low sensitivity and accuracy. This article reports a mini review for a micro-fluidic paper-based analytical devices (${\mu}PAD$), especially for addressing low sensitivity and accuracy issues.

• 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.

• Tuberculosis and Respiratory Diseases
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• v.84 no.3
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• pp.226-236
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• 2021

Background: Although the Quidel Sofia rapid influenza fluorescent immunoassay (FIA) is widely used to identify influenza A and B, the diagnostic accuracy of this test remains unclear. Thus, the objective of this study was to determine the diagnostic performance of this test compared to reverse transcriptase-polymerase chain reaction. Methods: A systematic literature search was performed using MEDLINE, EMBASE, and the Cochrane Central Register. Pooled sensitivity, specificity, diagnostic odds ratio (DOR), and a hierarchical summary receiver-operating characteristic curve (HSROC) of this test for identifying influenza A and B were determined using meta-analysis. A sensitivity subgroup analysis was performed to identify potential sources of heterogeneity within selected studies. Results: We identified 17 studies involving 8,334 patients. Pooled sensitivity, specificity, and DOR of the Quidel Sofia rapid influenza FIA for identifying influenza A were 0.78 (95% confidence interval [CI], 0.71-0.83), 0.99 (95% CI, 0.98-0.99), and 251.26 (95% CI, 139.39-452.89), respectively. Pooled sensitivity, specificity, and DOR of this test for identifying influenza B were 0.72 (95% CI, 0.60-0.82), 0.98 (95% CI, 0.96-0.99), and 140.20 (95% CI, 55.92-351.54), respectively. The area under the HSROC for this test for identifying influenza A was similar to that for identifying influenza B. Age was considered a probable source of heterogeneity. Conclusion: Pooled sensitivities of the Quidel Sofia rapid influenza FIA for identifying influenza A and B did not quite meet the target level (≥80%). Thus, caution is needed when interpreting data of this study due to substantial betweenstudy heterogeneity.

• Parasites, Hosts and Diseases
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• v.60 no.4
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• pp.281-288
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• 2022

Malaria continues to be one of the most crucial infectious burdens in endemic areas worldwide, as well as for travelers visiting malaria transmission regions. It has been reported that 8-aminoquinolines are effective against the Plasmodium species, particularly primaquine, for anti-hypnozoite therapy in P. vivax malaria. However, primaquine causes acute hemolytic anemia in individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency. Therefore, G6PD deficiency testing should precede hypnozoite elimination with 8-aminoquinoline. Several point-of-care devices have been developed to detect G6PD deficiency. The aim of the present study was to evaluate the performance of a novel, quantitative G6PD diagnostics based on a metagenomic blue fluorescent protein (mBFP). We comparatively evaluated the sensitivity and specificity of the G6PD diagnostic modality with standard methods using 120 human whole blood samples. The G6PD deficiency was spectrophotometrically confirmed. The performance of the G6PD quantitative test kit was compared with that of a licensed control medical device, the G6PD strip. The G6PD quantitative test kit had a sensitivity of 95% (95% confidence interval (CI): 89.3-100%) and a specificity of 100% (95% CI: 94.3-100%). This study shows that the novel diagnostic G6PD quantitative test kit could be a cost-effective and time-efficient, and universally mandated screening tool for G6PD deficiency.

• 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.

• 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.

• Health Policy and Management
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• v.33 no.2
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• pp.173-184
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• 2023

Background: The coronavirus disease 2019 pandemic has been challenging the healthcare service, i.e., the vitalization of the point of care accompanying self-testing in vitro diagnostic medical devices (IVDs). This study aims to suggest priority criteria to classify self-testing IVDs using the analytic hierarchy process technique. Methods: Two dimensions of the characteristics embedded in the IVDs and the diseases to be diagnosed with self-testing IVDs were parallelly considered and independently investigated. In addition, three expert panels consisting of laboratory medical doctors (n=11), clinicians (n=10), and citizens (n=11) who have an interest in the selection of self-testing IVDs were asked to answer to questionnaires. Priorities were derived and compared among each expert panel. Results: First of all, ease of specimen collection (0.241), urgency of the situation (0.224), and simplicity of device operation (0.214) were found to be the most important criteria in light of the functional characteristics of self-testing IVDs. Medical doctors valued the ease of specimen collection, but the citizen's panel valued self-management of the disease more. Second, considering the characteristics of the diseases, the priority criteria were shown in the order of prevalence of diseases (0.421), fatality of disease (0.378), and disease with stigma (0.201). Third, medical doctors responded that self-testing IVDs were more than twice as suitable for non-communicable diseases as compared to communicable diseases (0.688 vs. 0.312), but the citizen's group responded that self-testing IVDs were slightly more suitable for infectious diseases (0.511 vs. 0.489). Conclusion: Our findings suggested that self-testing IVDs could be primarily classified as the items for diagnosis of non-communicable diseases for the purpose of self-management with easy specimen collection and simple operation of devices, taking into account the urgency of the situation as well as prevalence and fatality of the disease.

• Parasites, Hosts and Diseases
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• v.52 no.5
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• pp.501-505
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• 2014

In recent years, rapid diagnostic tests (RDTs) have been widely used for malaria detection, primarily because of their simple operation, fast results, and straightforward interpretation. The Asan $EasyTest^{TM}$ Malaria Pf/Pan Ag is one of the most commonly used malaria RDTs in several countries, including Korea and India. In this study, we tested the diagnostic performance of this RDT in Uganda to evaluate its usefulness for field diagnosis of malaria in this country. Microscopic and PCR analyses, and the Asan $EasyTest^{TM}$ Malaria Pf/Pan Ag rapid diagnostic test, were performed on blood samples from 185 individuals with suspected malaria in several villages in Uganda. Compared to the microscopic analysis, the sensitivity of the RDT to detect malaria infection was 95.8% and 83.3% for Plasmodium falciparum and non-P. falciparum, respectively. Although the diagnostic sensitivity of the RDT decreased when parasitemia was ${\leq}500\;parasites/{\mu}l$, it showed 96.8% sensitivity (98.4% for P. falciparum and 93.8% for non-P. falciparum) in blood samples with parasitemia ${\geq}100\;parasites/{\mu}l$. The specificity of the RDT was 97.3% for P. falciparum and 97.3% for non-P. falciparum. These results collectively suggest that the accuracy of the Asan $EasyTest^{TM}$ Malaria Pf/Pan Ag makes it an effective point-of-care diagnostic tool for malaria in Uganda.