• Title/Summary/Keyword: 신속진단키트

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How accurate are rapid diagnostic tests for covid-19? (코로나19 신속진단검사는 얼마나 정확한가?)

  • Yeo, In-Kwon
    • The Korean Journal of Applied Statistics
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    • v.35 no.3
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    • pp.435-443
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    • 2022
  • In this paper, using Covid-19 diagnostic data provided by the Korea Disease Control and Prevention Agency (KDCA), we examine the probability of confirmed cases and the probability of actually being confirmed when the rapid test is negative according to the sensitivity and specificity of the rapid diagnostic kit. When we know the conditional probability of confirmation given a positive test, we induce the relationship between sensitivity and specificity, and compute the actual sensitivity of the rapid diagnosis kit based on the data of KDCA.

Development of COVID-19 Neutralizing Antibody (NAb) Detection Kits Using the S1 RBD Protein of SARS-CoV-2 (코로나 바이러스 감염증-19의 재조합 S1 RBD 단백질을 이용한 COVID-19 바이러스의 중화항체 검사 키트의 개발)

  • Choi, Dong Ok;Lee, Kang Moon
    • Korean Journal of Clinical Laboratory Science
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    • v.53 no.3
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    • pp.257-265
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    • 2021
  • The COVID-19 virus is a β-genus virus that causes infection by mediating the angiotensin convertible enzyme 2 (ACE2) receptor, which is distributed in large numbers in the human respiratory tract. The disease requires effective post-management of antibody production by complete healers and vaccinators because there is no perfect remedy for the virus infection. This study aimed to develop recombinant proteins specifically responsive to neutralizing antibodies in clinical specimens and use them to develop a rapid diagnostic kit to diagnose neutralizing antibodies quickly and conveniently against the COVID-19 virus and confirm the possibility of commercialization through a performance evaluation. Rapid diagnostic kits using COVID-19 S1 RBD recombinant proteins can be applied to rapid diagnostic kits, with positive percentage agreement (PPA) and negative percentage agreement (NPA) of 100% and 98.3%, respectively, compared to the U.S. FDA-approved ELISA kits. If the performance of the rapid diagnostic kit is improved and neutralizing antibodies can be analyzed quantitatively using quantitative analysis equipment, it can be used as important data to predict immunity to the COVID-19 virus and determine additional vaccinations.

Improvement of the detection limit of rapid detection kit for Salmonella Typhimurium using image analysis system (이미지 분석을 이용한 살모넬라 신속 진단키트의 측정감도 향상)

  • Lee, Sangdae;Kim, Giyoung;Park, Saet-Byeol;Moon, Ji-Hea
    • Korean Journal of Agricultural Science
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    • v.39 no.3
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    • pp.421-425
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    • 2012
  • The objective of this study was to improve the detection limit of rapid detection kit for Salmonella Typhimurium by image analysis system. The rapid detection kit was comprised of four elements: sample pad, conjugate pad, nitrocellulose pad and absorbent pad. Gold nanoparticle and Salmonella antibody were used as a tag and a receptor. Salmonella antibody and goat rabbit IgG antibody were used as test and control lines on nitrocellulose membrane. The color intensity of test line began to increase from $10^5CFU/mL$ of Salmonella sample. A multiple linear regression analysis was employed to explain the relationship between predicted and measured number of Salmonella cells. The developed model could successfully predict the cell number of Salmonella with validation against extra-experimental result.

Selection of next-generation antigen protein for diagnosis of pfhrp2/pfhrp3 gene deleted plasmodium falciparum based on bioinformatics (pfhrp2/pfhrp3 유전자 결여 열대열 말라리아 특이 진단을 위한 생물정보학 기반 차세대 항원 단백질 선정)

  • Seo, Seung Hwan;Lee, Jihoo;Choi, Jae-Won;Kim, Hak Yong
    • Proceedings of the Korea Contents Association Conference
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    • 2016.05a
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    • pp.187-188
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    • 2016
  • 열대열 말라리아(Plasmodium falciparum, P. falciparum, P. f) 신속진단키트의 경우, P. falciparum에 특이적인 단백질로써 Histidine Rich Protein 2 (PfHRP2)가 사용되고 있다. 그러나 최근 연구에서 남아메리카와 중앙아메리카를 중심으로 pfhrp2/pfhrp3 유전자가 결여된 P. falciparum 열원충이 나타나는 것으로 보고된 바 있다. 본 연구에서는 생물정보학을 기반으로 PfHRP2 항원 단백질을 대체할 수 있는 새로운 P. falciparum 특이 항원 단백질을 선정하고자, PlasmoDB에서 5,777개의 P. falciparum 관련 단백질 리스트를 얻었다. 이후 NCBI BLAST를 통해 단백질 아미노산 서열을 분석하고 정상인에게 존재하지 않으며, 동시에 다른 말라리아 열원충(P. vivax, P. ovale, P. malariae, P. knowlesi)에도 존재하지 않는 P. falciparum 특이 아미노산 서열을 가진 단백질 15개를 추출하였다. IEDB analysis를 이용하여 에피토프, 수용성, 베타-턴, 접근성, 유연성, 면역원성을 분석하여 높은 평균값을 갖는 상위 3개 단백질을 선별하였다. KEGG pathway와 EMBL-EBI를 통해 선별된 3개 단백질의 혈액내 검출 가능성 및 아미노산 서열의 보존성을 분석하여 최종적으로 Glutamate-Rich Protein (GLURP)을 선정하였다. AIDA를 통해 단백질 아미노산 서열을 이용한 3차 구조 예측으로 GLURP의 구조 및 항체와의 결합을 도식화하였다. 최종적으로 선정한 GLURP는 pfhrp2/pfhrp3 유전자 결여 P. falciparum까지 특이적으로 진단이 가능하여 차세대 P. falciparum 특이 신속진단키트 개발에 도움이 될 수 있을 것으로 기대한다.

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Prevalence-based Interpretation of Predictive Values of Diagnostic Tests: An Example for Detection of Canine Heartworm Infection (진단키트 검사결과에 대한 유병율 위주 해석: 개 심장사상충의 예)

  • Park, Choi-Kyu;Pak, Son-Il
    • Journal of Veterinary Clinics
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    • v.26 no.2
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    • pp.130-133
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    • 2009
  • The use of screening tests as part of a diagnostic work-up is common in domestic canine practice, but understanding of the diagnostic test characteristics and factors affecting diagnostic accuracy is not clear among clinicians. This article was aimed to provide clinicians with a better understanding on the selection of test kits and with a proper interpretation of test results using an example from heartworm(Dirofilaria immitis) studies. From the literatures, diagnostic accuracy varied depending on the kits: percent average sensitivity and specificity of ELISA antigen-detecting kits were DiroChek(Synbiotics, USA) 78.1 and 95.2, SNAP(IDEXX, USA) 66.3 and 98.1, and Solo Step(Heska, Switzerland) 69.5 and 97.5, respectively, while the values for three hematological methods(Modified Knott's, direct smear and capillary tube) ranged from 38.4 to 81.8% and from 96.9 to 100%, respectively. Furthermore, it was also reported that the prevalence of heartworm disease in domestic dog populations varied depending on the regions studied: 2.5-22.8% for microfilarial test and 2.2-66.3% by ELISA. The values of predictive values for positive(PPV) and negative(NPV) provide useful information to clinicians on the probability of heartworm infection, but the PPV and NPV are greatly dependent on the heartworm prevalence. This suggests that PPV or NPV values of a test should be interpreted carefully in different clinical settings. Practical methods on the interpretation taking into account heartworm prevalence were discussed.

Clinical Evaluation of a Rapid Diagnostic Test Kit for Canine Parvovirus and Coronavirus (개 파보바이러스와 코로나바이러스 진단을 위한 신속진단키트의 임상적 유용성)

  • Chaeyeong MIN;Won-Shik KIM;Chom-Kyu CHONG;Yong LIM
    • Korean Journal of Clinical Laboratory Science
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    • v.55 no.1
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    • pp.45-51
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    • 2023
  • Canine parvovirus type 2 (CPV-2) and canine coronavirus (CCoV) are major pathogens that can induce gastroenteritis in dogs. They are highly contagious and have a high morbidity rate. There are no specific treatments available for them to date. Therefore, rapid and accurate diagnosis becomes essential. The rapid diagnostic test (RDT) for animals can be used widely in the field because it is fast and easy to use for diagnosis. Thus, this study aimed to clinically evaluate and confirm the clinical utility of CPV-2/CCoV RDT. The parameters evaluated included the limit of detection (LoD), cross-reactivity, interference, sensitivity, specificity, negative likelihood ratio (NLR), and kappa value. The results revealed that the LoD values for CPV-2 and CCoV were 9.7×10 50% tissue culture infectious dose (TCID50)/mL and 2.5×102 TCID50/mL, respectively. There was no cross-reactivity with nine pathogens or interference by interfering materials. The RDT showed a sensitivity of 90.0%, a specificity of 100.0%, NLR of 0.1, and a kappa value of 0.90 for diagnosing both viruses. In conclusion, CPV-2/CCoV RDT is useful as a screening test because of its high sensitivity, specificity, kappa value, and low NLR.

Evaluation of Avian Influenza and Newcastle Disease Virus Detection Kit using Field Samples from Domestic and Semi-domestic Birds (닭과 야생사육조류로부터 야외샘플을 사용한 조류인플루엔자와 뉴캣슬병 바이러스 검출 키트의 평가)

  • Rahman, Md. Siddiqur;Malek, Md. Abdul;Islam, Md. Alimul;Uddin, Muhamad Jasim;Ahasan, Md. Shamim;Chakrabartty, Amitavo;Sakib, Md. N.;Chae, Joon-Seok
    • Journal of Veterinary Clinics
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    • v.29 no.4
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    • pp.309-314
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    • 2012
  • The study was undertaken to evaluate sensitivity and specificity of rapid Avian Influenza (AI) and Newcastle Disease virus (NDV) combo antigen kits from field samples of domestic (broiler and layer chicken, native chicken) and semi-domestic (duck, goose, pigeon and quail) birds of Bangladesh. Samples were collected from naturally infected AI suspected domestic and semi-domestic birds of five different outbreak areas in Bangladesh. From each area two birds were selected for sampling, and from each bird three types of samples (tracheal, cloacal and oro-nasal swabs) were collected. A total of 210 field samples from a total of 70 birds were collected and tested using AI and NDV combo antigen rapid diagnostic kits in the study. All three different samples from a bird showed similar pattern of reaction. Out of 210 samples, 15 samples (5 birds), 63 samples (21 birds) and 27 samples (9 birds) were positive for AIV, NDV and both for AIV and NDV, respectively; whereas the remaining birds were negative for either AIV or NDV in this screening test. Among the five AIV positive, a layer chicken from wet market in Mymensingh, Netrokona, Gibandha and Kurigram and a native chicken from wet market in Kurigram area was positive to AIV. The semi-domestic birds are either positive to NDV or free from both AIV and NDV. This study revealed that the AIV and NDV rapid diagnostic kits could be effectively use to diagnose the respective virus in trachea, oro-nasal and cloacal samples simultaneously. AIV-NDV combo Ag test result clearly indicates that the test kit designed for AIV and NDV could diagnose the disease rapidly with less effort and higher scientific know how which could be used for the detection of AIV and NDV using field samples in large scale.

Ebola Hemorrhagic Fever Outbreaks: Diagnosis for Effective Epidemic Disease Management and Control (에볼라 출혈열 발병 : 효과적인 전염병 관리 및 통제를 위한 진단)

  • Kang, Boram;Kim, Hyojin;Macoy, Donah Mary;Kim, Min Gab
    • Microbiology and Biotechnology Letters
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    • v.45 no.2
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    • pp.87-92
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    • 2017
  • The first Ebola hemorrhagic fever outbreak occurred in the Democratic Republic of Congo and Sudan in 1976 and then emerged in West Africa in 2014 with a total of 27,741 cases and 11,284 deaths. The fever is caused by the Ebola virus, which belongs to the Filoviridae family and contains a ssRNA genome. The known subtypes of the virus are Bundibugyo ebolavirus, Reston ebolavirus, Sudan ebolavirus, $Ta\ddot{i}$ Forest ebolavirus, and Zaire ebolavirus. The Ebola outbreak was historically originated majorly from the East and Central African tropical belt. The current outbreaks in West Africa caused numerous deaths and spread fear in global society. In the absence of effective treatment strategies and any vaccine, accurate diagnosis is the most important contributing factor in the management and control of the epidemic disease. WHO (World Health Organization) has announced emergency guidance for the selection and use of Ebola in in vitro diagnostic assays. Numerous companies and research institutions have studied the various diagnosis methods and identified four WHO procurement approved as diagnosis kits: RealStar Ebolavirus Screen RT-PCR kit 1.0 (Altona), Liferiver-Ebola Virus (EBOV) Real time RT-PCR kit, Xpert Ebola Assay, and ReEBOV Antigen Rapid Test Kit. The efficiency of novel diagnostic kits such as Rapid Diagnosis Test (RDT) is currently being evaluated.

Robust Influenza Analysis Algorithm Based on Image Processing under Varying Radiometric Conditions (광원 환경에 강인한 영상 기반 인플루엔자 판독 기법)

  • Lee, Ji Eun
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.20 no.7
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    • pp.127-132
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    • 2019
  • Influenza is an infectious disease caused by an influenza virus with symptoms of high fever and headache. Since influenza especially mutates into multiple subtypes in the carrier's body, it is a serious threat for mankind such as Spanish influenza. The treatment of influenza infection mandates the use of antiviral drugs through rapid diagnostic test. Generally, immunochromatography-based rapid influenza diagnostic tests are used for rapid diagnosis in an emergency. In this paper, we propose an influenza analysis algorithm based on image processing to examine a large number of patients suspected of being infected with influenza. Also, we propose a robust influenza analysis algorithm based on the joint cumulative mass function under varying radiometric conditions such as illuminant and exposure differences. Simulation results show that the proposed algorithm significantly reduces the error of influenza diagnosis under different radiometric conditions.

Analysis of prevalence and risk factors of diarrhea in dairy calf using a rapid diagnostic kit in Gyeonggi province (신속진단키트를 활용한 경기지역 젖소 송아지 설사병 유병률과 위험요인 분석)

  • Taemook Park;Gil Jae Cho;Young Jin Yang;Il-Sun Ryu
    • Korean Journal of Veterinary Service
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    • v.46 no.2
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    • pp.147-156
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    • 2023
  • Between February 2020 and September 2021, a total of 452 dairy calves with diarrhea were investigated across 17 dairy farms in Gyeonggi province, Korea, using a rapid diagnostic kit. The study aimed to examine the infection rates of major pathogens causing diarrhea in dairy calves, categorizing them by season, age, and birth month. Additionally, logistic regression analysis was conducted to investigate the factors affecting the infection rate. The infection rates of the major pathogens causing infectious diarrhea in dairy calves, including bovine rotavirus, bovine coronavirus, Cryptosporidium, and E. coli, are influenced by season, age, and birth month. Bovine coronavirus and Cryptosporidium showed variations in infection rates according to season, age, and birth month, while bovine coronavirus was influenced by age and birth month, and E. coli showed variations in infection rates based on age. Furthermore, in the analysis of risk factors influencing the infection rates of these pathogens, age and birth month were identified as risk factors for bovine rotavirus, bovine coronavirus, and Cryptosporidium.