• Title/Summary/Keyword: 신속진단키트

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Rapid Determining for Subtypes and Pandemic Type of Swine Influenza Virus by Diagnostic One-step RT-PCR (진단용 one-step RT-PCR을 통한 돼지 인플루엔자 바이러스의 아형 및 pandemic 유형에 대 한 신속한 결정)

  • Kim, Gwang Il;Kim, Jee In;Kwon, Jin-Hyeap;Min, Yoo Hong;Kang, Joo Il;Lee, Chang-Ho;Kim, Sung-Hee;Lim, Jae-Hwan
    • Journal of Life Science
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    • v.28 no.5
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    • pp.555-562
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    • 2018
  • Swine influenza virus (SIV) causes one of the most common diseases of the pig population, and its subtypes are determined by hemagglutinin (HA) and neuraminidase (NA). Recently, the SIV subtype diagnosis has been developed. The method using antigen-antibody reaction rather than PCR was mainly used because of the large change in the ribonucleotide sequences of SIV. Here, we have developed 10 diagnostic primer sets through multi-nucleotide sequences alignment of spreaded SIV since 2008 in Korea and then optimized the reaction of the one-step RT-PCR for rapid determination of SIV subtype. In addition, specific primers were designed to early determine the pandemic SIV by detecting unique M sequences proven in highly infectious and virulent subtypes of the influenza H1N1 (pH1N1). Here, some of the SIVs spread in Korea from 2008 to 2014 have been tested to determine the subtypes and pandemic potential of SIV. All diagnostic primer sets were found to be able to accurately determine the SIV subtype and to detect the pandemic SIV. In conclusion, it was confirmed that the optimized one-step RT-PCR analysis using these primer sets is useful for rapid diagnosis of SIV subtypes. These results can be used for development of SIV subtype diagnostic kit to early detect before virulent SIV spreads do.

An Alternative Method for a Rapid Urease Test Using Back-table Gastric Mucosal Biopsies from Gastrectomy Specimen for Making the Diagnosis of Helicobacter pylori Infection in Patients with Gastric Cancer (위암 환자의 헬리코박터 파이로리 감염 진단에 있어서 위절제술 직후 생검된 위점막 조직을 이용한 신속 요소 분해 효소 검사법 도입의 의의)

  • Kim, Sin-Ill;Jin, Sung-Ho;Lee, Jae-Hwan;Min, Jae-Seok;Bang, Ho-Yoon;Lee, Jong-Inn
    • Journal of Gastric Cancer
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    • v.9 no.4
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    • pp.172-176
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    • 2009
  • Purpose: The rapid urease test is a rapid and reliable method for diagnosing Helicobacter pylori infection. However it requires gastric mucosal biopsies during endoscopy, and the test is not covered by national health insurance for patients with gastric cancer. So, we introduced an alternative method for a rapid urease test using back-table gastric mucosal biopsies from gastrectomy specimen. Materials and Methods: Ninety gastric cancer patients underwent an anti H. pylori IgG ELISA test and gastrectomy. Just after gastrectomy, two gastric mucosal biopsies from the prepyloric antrum and lower body of the gastrectomy specimen were taken from the back table in the operative room, and these were fixed immediately with the rapid urease test kit, and the color change was monitored for up to 24 hours. In this study, H. pylori infection was defined as positive when the serology or rapid urease test showed positive results. Results: The positive rate of the rapid urease test and serology was 91.1% and 77.8%, respectively. The sensitivity, specificity, positive predictive value and negative predictive value of the rapid urease test and serology were 94.3 and 80.5%, 100 and 100%, 100 and 100%, and 37.5 and 15%, respectively. The accuracy of the rapid urease test was higher than that of serology (94.4 vs. 81.1%, respectively). The rapid urease test showed a higher rate of detecting H. pylori infection than that of serology (McNemar's test, P=0.019). Conclusion: The result of the rapid urease test using back-table gastric mucosal biopsies from a gastrectomy specimen is comparable to the reference data of the conventional rapid urease test using gastric mucosal endoscopic biopsies. Therefore, it can be an alternative diagnostic method for H. pylori infection.

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The Assessment of Ultrasensitive HBsAg kit's Sensitivity level and Performance in Detection of Mutant Forms (Ultra-sensitive HBsAg IRMA 키트의 민감도 및 변이형 검출능 평가)

  • Ha, Dong-Hyuk;Min, Kyung-Sun;Noh, Gyeong-Woon;Kim, Hyun-Ju
    • The Korean Journal of Nuclear Medicine Technology
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    • v.15 no.1
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    • pp.121-125
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    • 2011
  • Purpose: The DNA-type virus HBV, discovered by D. Dane and others in 1976, is approximately 42nm big and known as the main cause of liver-related diseases around the world. HBsAg has 4 kinds of subtypes including adw, adr, ayw and ayr and besides common antigen factor a, there are d, y, r, w. From the methods of serologically testing HBV, IRMA, EIA and CLIa were developed for testing HBsAg and are being used in examining the surface antigen of HBV. In this study, among the methods for testing HBV, the recently developed RIAKEY Ultrasensitive HBsAg IRMA kit's sensitivity level and performance in detection of mutant forms were measured and compared with CLIA. Materials and methods: Two certified reference materials, which are WHO 1st International Standard 1985(80/549) and WHO 2nd International Standard 2003(00/588. subtype adw2, genotypeA), were used in the examination and the sensitivity level was measured by diluting these materials from 0.08 IU/ml to 0.005 IU/ml. The materials for examining the detection of mutant forms included 9 kinds of subtype 'ad' and one kind of subtype 'ay' purchased from DSI company. Also, with the use of positive and negative samples, they was compared with CLIA. Result: Ultrasensitive HBsAg kit based on IRMA method showed the detection of up to 0.01 IU/ml not only for WHO 1st International Standard 1985(80/549) but also for WHO 2nd International Standard 2003(00/588. subtype adw2, genotypeA) and the sensitivity level was measured as 0.01 IU/ml by WHO standard. In testing the performance for detection of mutant forms, the 9 kinds of subtype 'ad' and one kind of subtype 'ay' mutant materials were detected, demonstrating the capacity of detecting various types of mutant forms. Conclusions: With the clinical importance of sensitivity level and performance in detection of mutant forms increasing in the field of HBsAg diagnosis, the examination of IRMA's effectiveness using RIA method in the aspects of the sensitivity level and performance in detection of mutant forms was carried out and its result is as follows. The sensitivity level was measured as 0.01 IU/ml by WHO standard and it was possible to measure various types of mutant forms with high sensitivity. Thus it is suggested that more speedy and accurate reports could be produced from a nuclear medicine laboratory for clinical practitioners requiring results of various situations.

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Clinical assessment of periodontitis in dogs using the MiriChekTM Oral Bacter test kit: An in vivo study (MiriChekTM Oral Bacter test kit를 활용한 개 치주염의 임상적 평가)

  • Choi, Hyuck;Roh, Jae-Hee;Kim, Yun-Jeong;Hwang, In-Soo;Park, Woo-Dae;Kim, Min-Seok;Jeong, Young-Eui
    • Journal of Korean society of Dental Hygiene
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    • v.21 no.4
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    • pp.337-348
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    • 2021
  • Objectives: To determine the usefulness of MiriChekTM Oral Bacter as compared to traditional clinical methods in the periodontal assessment of dogs with and without periodontitis. Methods: In this study, 61 dogs were clinically examined using the MiriChekTM Oral Bacter test kit, and information regarding breed, age (months), sex, weight, presence of disease, and periodontitis stage was recorded. The test used a sample of supragingival plaque from the upper left premolar of the dogs. Results: This study included 30 and 31 dogs with and without periodontitis, respectively. Periodontitis was more common in older dogs than in younger dogs. The average positive and negative sensitivity rates of the MiriChekTM Oral Bacter test kit were 73.3% and 80.7%, respectively, and were both strongly correlated with the severity of periodontitis. Conclusions: The findings of this study encourage the use of new diagnostic assist test kits, such as MiriChekTM Oral Bacter, for appropriately detecting and diagnosing periodontal disease in dogs.

Clinical Availability of Rapid Strep Test in Children with Group A Streptococcal Pharyngotonsilitis (A군 연쇄구균 상기도 감염에 있어 신속검사의 유용성)

  • Kim, Yeon Ho;Bae, Young Min;Cha, Sung Ho;Ma, Sang Hyuk
    • Pediatric Infection and Vaccine
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    • v.8 no.1
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    • pp.90-93
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    • 2001
  • Purpose : The accurate diagnosis and proper treatment of group A streptococal infection should be emphasized concerning about possible development of late sequelae, such as acute rheumatic fever and acute glomerulonephritis. Inadequate & improperance of antobiotics have resulted in increased number of antibiotic-resistant bacteria. We would like to know the clinical usefulness of rapid strep test compared with conventional throat culture in out-patients with acute pharyngotonsilitis. Methods : From Sep. 2000. to Jan. 2001, rapid strep test(LINK 2 Strep A, USA) & throat culture were taken from 87 patients with clinically suspect pharyngotonsilitis from Masan Fatima hospital & kyunghee university hospital. Results : Of 87 cases with pharyngitis, 39 cases proved to have group A streptococci by throat culture. The positive predictive value of rapid test was 92.3%(36 of 39 cases) and sensitivity test was 81.8%(36 of 44 cases). The specificity of rapid test was 93.0%(40 of 43 cases) and negative predictive value was 83.3%(40 of 48 cases). Conclusion : The positive predictive value & specificity of rapid strep test is high. And so, this test will give the pediatricians practical guidance of antibiotic use in patients with pharyngitis. But more efforts should be made to prevent antibiotics abuse and correct diagnosis of pharyngitis.

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Development of Monoclonal Antibodies Specific to Galectin of Pine Wood Nematode, Bursaphelenchus xylophilus (Steiner and Buhrer) Nickle and Their Utilization for Detection of Pine Wood Nematodes (소나무재선충[Bursaphelenchus xylophilus (Steiner and Buhrer) Nickle]의 GaLectin에 대한 특이적인 단클론 항체 제작과 진단에의 활용)

  • Kim, A-Young;Kim, Young Ha;Choi, Bo-Hye;Nguyen, Trang;Yoon, Kyungjae Andrew;Lee, Si Hyeock;Han, Hye-Rim;Koh, Young Ho
    • Korean journal of applied entomology
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    • v.57 no.1
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    • pp.7-13
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    • 2018
  • Currently, there is no available tool that rapidly diagnoses pine wood nematode (PWN)-infected pine trees in the field. In this study, we synthesized and purified PWN Galectin, which might be an antigen specific to PWN, using the Baculovirus expression system. We used PWN Galectin as an antigen for generating 1,464 fusion hybridoma cell lines secreting monoclonal antibodies (Mabs). Among them, we selected 62 fusion hybridoma cell lines showing high reactivity to PWN Galectin. We further selected 12 fusion hybridoma cell lines showing high reactivity to the standard PWN-infected pine tree phosphate buffered saline (PBS) extract. Additionally, two fusion hybridoma cell lines showing no or extremely low reactivity were used as controls. The selected fusion hybridoma cell lines were subjected to limiting dilutions for selecting and establishing Mab-secreting cell lines showing higher reactivity to the standard PWN-infected pine tree extract than to the standard normal pine tree PBS extract. Moreover, the selected fusion hybridoma cell lines were further selected based on their higher reactivity to PWN protein extracts than to three non-pathogenic nematode protein extracts. The Mab-secreting cell lines established in this study could be used to develop rapid diagnostic tools that can be used in the field or in laboratories for detecting PWN-infected pine trees or PWN.

Rapid Detection Kit for Salmonella typhimurium (살모넬라 식중독균 신속 검출용 간이 진단키트)

  • Kim, Gi-Young;Yang, Gil-Mo;Park, Saet-Byeol;Kim, Yung-Hwun;Lee, Kang-Jin;Son, Jae-Yong;Kim, Hyuck-Joo;Lee, Sae-Rom
    • Journal of Biosystems Engineering
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    • v.36 no.2
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    • pp.140-146
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    • 2011
  • This study was performed to develop a rapid test kit for pathogenic Salmonella in various samples. The rapid detection kit has been fabricated based on nitrocellulose lateral-flow strip. Colloidal gold and biotin conjugated Salmonella antibodies were used as a tag and a receptor, respectively. Manually spotted Salmonella antibody and Neutravidin on nitrocellulose membrane were used as test and control lines, respectively. Feasibility of the rapid kit to detect Salmonella typhimurium in samples were evaluated. The intensity of the color of the test line started to increase with the samples in which higher concentration of the cells were contained. The sensitivity of the sensor was $10^6$ cfu/mL Salmonella spiked in PBS. Also, the rapid test kit could detect $10^6$ cfu/mL of Salmonella in chicken meat extract.

Rapid Detection Kit for Staphylococcus aureus (황색포도상구균 신속 검출용 간이 진단키트)

  • Kim, Gi-Young;Park, Saet-Byeol;Moon, Ji-Hea;Lee, Sang-Dae;Lee, Sea-Rom;Jang, Youn-Jung
    • Korean Journal of Agricultural Science
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    • v.40 no.2
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    • pp.139-146
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    • 2013
  • This study was performed to develop a rapid test kit for pathogenic Staphylococcus in various samples. The rapid detection kit has been fabricated based on nitrocellulose lateral-flow strip. Colloidal gold and Staphylococcus antibodies were used as a tag and a receptor, respectively. Manually spotted Staphylococcus antibody and anti-mouse antibody on the surface of nitrocellulose membrane were used as test and control lines, respectively. Feasibility of the rapid kit to detect Staphylococcus aureus in samples were evaluated. The intensity of the color of the test line started to increase with the samples in which higher concentration of the cells were contained. The sensitivity of the sensor was $10^6$ cfu/mL Staphylococcus spiked in PBS. Also, the rapid test kit could detect $10^5$ cfu/mL of Staphylococcus in chicken meat extract.

Diagnostic Techniques for SARS-CoV-2 Detection (SARS-CoV-2의 진단기술)

  • Kim, Jong-Sik;Kang, Na-Kyung;Park, Seon-Mi;Lee, Eun-Joo;Chung, Kyung Tae
    • Journal of Life Science
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    • v.30 no.8
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    • pp.731-741
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    • 2020
  • Coronavirus disease 19 (COVID-19) is caused by SARS-CoV-2 (Severe Acute Respiratory SyndromeCoronavirus 2). To date, seven coronaviruses that can infect humans were reported. Among them, infections with four coronavirus strains (HCoV-229E, HCoV-OC43, HCoV-NL63, and HCoV-HKU1) resulted in mild symptoms such as common cold, whereas SARS-CoV and MERS-CoV caused severe symptoms and epidemics in 2002 and 2012, respectively. In the most recent, SARS-CoV-2 was first reported in Wuhan, China in December 2019 and became a notorious cause of the ongoing global pandemics. To diagnose, treat, and prevent COVID-19, the development of rapid and accurate diagnostic tools, specific therapeutic drugs, and safe vaccines essentially are required. In order to develop these powerful tools, it is prerequisite to understand a phenotype, a genotype, and life cycle of SARS-CoV-2. Diagnostic techniques have been developing rapidly around world and many countries take the fast track system to accelerate approval. Approved diagnostic devices are rapidly growing facing to urgent demand to identify carriers. Currently developed commercial diagnostic devices are divided into mainly two categories: molecular assay and serological & immunological assay. Molecular assays begins the reverse transcription step following polymerase chain reaction or isothermal amplification. Immunological assay targets SARS-CoV-2 antigen or anti-SARS-CoV-2 antibody of samples. In this review, we summarize the phenotype, genome structure and gene expression of SARS-CoV-2 and provide the knowledge on various diagnostic techniques for SARS-CoV-2.

Comparison of Laboratory Tests Applied for Diagnosing the SARS-CoV-2 Infection (SARS-CoV-2 감염의 진단에 이용되는 검사실 테스트의 비교)

  • Lee, Chang-Gun;Lee, Dongsup
    • Korean Journal of Clinical Laboratory Science
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    • v.54 no.2
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    • pp.79-94
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    • 2022
  • Due to the highly contagious nature and severity of the respiratory diseases caused by COVID-19, economical and accurate tests are required to better monitor and prevent the spread of this contagion. As the structural and molecular properties of SARS-CoV-2 were being revealed during the early stage of the COVID-19 pandemic, many manufacturers of COVID-19 diagnostic kits actively invested in the design, development, validation, verification, and implementation of diagnostic tests. Currently, diagnostic tests for SARS-CoV-2 are the most widely used and validated techniques for rapid antigen, and immuno-serological assays for specific IgG and IgM antibody tests and molecular diagnostic tests. Molecular diagnostic assays are the gold standard for direct detection of viral RNA in individuals suspected to be infected with SARS-CoV-2. Antibody-based serological tests are indirect tests applied to determine COVID-19 prevalence in the community and identify individuals who have obtained immunity. In the future, it is necessary to explore technical problems encountered in the early stages of global or regional outbreaks of pandemics and provide future directions for better diagnostic tests. This article evaluates the commercially available and FDA-approved molecular and immunological diagnostic assays and analyzes their performance characteristics.