• Title/Summary/Keyword: antigen test kit

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Fusion Analytical Sensitivity of Rapid Influenza Antigen Limit of Detection Tests for Human Influenza virus (인플루엔자 바이러스에 대한 신속 항원 검출 검사 검출한계의 융합적 분석)

  • Song, Chang-Sub;Sung, Hyun-Ho;Kim, Jung-Hyun;Kim, Dae-Eun;Park, Chang-Eun;Yoon, Joong-Soo
    • Journal of the Korea Convergence Society
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    • v.9 no.3
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    • pp.165-171
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    • 2018
  • In this study, to analyze the detection of limit for sensitivity of the influenza rapid antigen test kit, the positive detection of limits were analyzed by serial dilution of influenza virus A and B type for five influenza rapid antigen test kits in Korea. As a result of analysis, visual measurement of type A were up to 1:8192 for the Wellsbio product and up to 1:4096 for the II product, up to 1:512 for the I and III products, and only 1:128 for the IV product, and type B were positive for up to 1:8192 for the Wellsbio product, up to 1: 4096 for the II product and up to 1:1024 for the I, III and IV products. For instrument readings with the same specimen, both A and B types were found to be positive for up to 1:8192 for the Wellsbio product, up to 1: 4096 for the II product, and up to 1:2048 for the I product. The sensitivity of the rapid antigen test for influenza differs greatly depending on the sampling area of the patient, infection period, specimen volume, etc. Therefore, it is necessary to observe exactly the collection timing and method of the specimen. And it is necessary further study to improve the sensitivity for influenza rapid antigen test.

The Comparison of Results Among Hepatitis B Test Reagents Using National Standard Substance (국가 표준물질을 이용한 B형 간염 검사 시약 간의 결과 비교)

  • Lee, Young-Ji;Sim, Seong-Jae;Back, Song-Ran;Seo, Mee-Hye;Yoo, Seon-Hee;Cho, Shee-Man
    • The Korean Journal of Nuclear Medicine Technology
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    • v.14 no.2
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    • pp.203-207
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    • 2010
  • Purpose: Hepatitis B is infection caused by Hepatitis B virus (HBV). Currently, there are several methods, Kits and equipments for conducting Hepatitis B test. Due to ununiformed methods, it would cause some differences. To manage these differences, it needs process evaluating function of test system and reagent using particular standard substance. The aim of this study is to investigate tendency of RIA method's reagent used in Asan Medical Center through comparing several other test reagents using national standard substance. Materials and Methods: The standard substance in National Institute of Food and Drug Safety Evaluation's biology medicine consists of 5 things, 4 antigens and 1 antibody. We tested reagents using A, B company's Kits according to each test method. All tests are measured repeatedly to obtain accurate results. Results: Test result of "HBs Ag Mixed titer Performance panel" is obtained match rate compared S/CO unit standard with RIA method and EIA 3 reagents, CIA 2 reagents is that company A's reagent is 94.4% (17/18), 83.3% (15/18), B is 88.9% (16/18), 77.8% (14/18). Test result of "HBs Ag Low titer Performance panel" is obtain that EIA 2 reagents is shown 7 posive results, CIA 3 reagents is 11, and RIA method's company A's reagent is 3, B is 2 of 13 in low panel. "HBV surface antigen 86.76 IU/vial" tested dilution. A is obtain positive results to 600 times(0.14 IU/mL), B is 300 times (0.29 IU/mL). Case of "HBV human immunoglobulin 95.45 IU/vial", A is shown positive result to 10,000 times (9.5 mIU/mL) and B is 4,000 times (24 mIU/mL). Test result of "HBs Ag Working Standards 0.02~11.52 IU/mL" is shown that Company A's kit concentration level was 0.38IU/mL, company B was 2.23 IU/mL and higher level of concentration was positive results. Conclusion: When comparing various test reagents and RIA method according to National Standard substances for Hepatitis B test, we recognized that there were no significant trends between reagents. For hepatitis B virus antigen-antibody titers even in parts of the test up to 600 times the antigen, antibodies to 10,000 times the maximum positive results could be obtained. Therefore, we confirmed that results from Asan Medical Center are performed smoothly by reagents and system for hepatitis B virus test.

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Optimized Expression, Purification, and Rapid Detection of Recombinant Influenza Nucleoproteins Expressed in Sf9 Insect Cells

  • Yoon, Sung-Jin;Park, Young-Jun;Kim, Hyun Ju;Jang, Jinwoo;Lee, Sang Jun;Koo, Sunwoo;Lee, Moo-Seung
    • Journal of Microbiology and Biotechnology
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    • v.28 no.10
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    • pp.1683-1690
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    • 2018
  • Accurate and rapid diagnosis of influenza infection is essential to enable early antiviral treatment and reduce the mortality associated with seasonal and epidemic infections. Immunochromatography is one of the most common methods used for the diagnosis of seasonal human influenza; however, it is less effective in diagnosing pandemic influenza virus. Currently, rapid diagnostic kits for pandemic influenza virus rely on the detection of nucleoprotein (NP) or hemagglutinin (HA). NP detection shows higher specificity and is more sensitive than HA detection. In this study, we time-dependently screened expression conditions, and herein report optimal conditions for the expression of recombinant nucleoprotein (rNP), which was 48 h after infection. In addition, we report the use of the expressed rNP in a rapid influenza diagnostic test (SGT i-flex Influenza A&B Test). We constructed expression vectors that synthesized rNP (antigen) of influenza A and B in insect cells (Sf9 cells), employed the purified rNP to the immunoassay test kit, and clearly distinguished NPs of influenza A and influenza B using this rapid influenza diagnostic kit. This approach may improve the development of rapid test kits for influenza using NP.

Evaluation of an ELISA kit for the Serodiagnosis of Pulmonary Tuberculosis by Using Mixed Antigens of Mycobacterium Tuberculosis (폐결핵진단에서 결핵균 혼합항원을 이용한 혈청학적 검사의 유용성에 관한연구)

  • Park, Seung-Kyu;Kim, Phil-Ho;Kim, Seung-Chul;Choi, In-Hwan;Cho, Sang-Nae;Song, Sun-Dae
    • Tuberculosis and Respiratory Diseases
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    • v.49 no.5
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    • pp.558-567
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    • 2000
  • Background : Recently, serologic techniques for tuberculosis have been developed and some of them, which are focusing on detection of serum antibodies mainly directed against specific 38-kDa Mycobacterium tuberculosis, have already been introduced into the markel. In this study, diagnostic significance of a new serologic test(ELISA kit) for pulmonary tuberculosis was evaluated. Method : Serologic test with newly developed ELISA kit was performed upon 474 individuals, who include 333 active pulmonary tuberculosis patients, 80 healthy cases, and 61 tuberculosis contact cases. This serologic test was based on the ELISA technique and designed to detect antibodies to mixed complex antigens including 38-kDa, which were developed by Erume Biotech Co., Seoul. Active pulmonary tuberculosis was diagnosed by sputum AFB smear and culture methods. Results : The seropositivities using this ELISA kit were 82.1% and 73.6% in smear-positive and negative groups among active pulmonary tuberculosis, respectively. And, it also showed that seronegativities were 97.5% and 85.2% in healthy and contact groups, respectively. As a whole, the results of our study using the ELISA kit as a diagnostic method for pulmonary tuberculosis showed 80.0% sensitivity for active pulmonary tuberculosis, 97.5% specificity, 96.1% positive predictive value, and 65.0% negative predictive value when the prevalence of tuberuclosis in the samples was 60.1%. Conclusion : Our results reveal that the detection of antibody its reaction with 38-kDa antigen of M. tuberculosis is not sufficient to be accepted as single diagnostic method for pulmonary tuberculosis. However, they suggest that ELISA kit may be considered as an adjunctive test to standard diagnostic techniques of pulmonary tuberculosis.

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Survey on the Distrributions of Swine Toxoplasma Antibodies by Latex Agglutination Test in Gyeongnam Central Area (경남 중부지역에서의 Latex응집반응을 이용한 돼지 톡스플라즈마병 항체분포 조사)

  • 이병훈;황보훈;변유성;이순선;김차용;서명득
    • Korean Journal of Veterinary Service
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    • v.15 no.2
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    • pp.174-183
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    • 1992
  • This study was conducted to determine the serum antibodies against toxoplasma in swine from breeding-pig farm, pig farm and abattoir by latex agglutination(LA) test. LA test was carried out with commercial Toxo-MT kit (Eiken chemical co.). The results obtained were summerized as follows : 1. The cut-off titer of positive and negative reactions by Toxo-MT antigen used in this experiment was determined as the serum dilution of 1 ; 32. 2. positive rates of toxoplasma antibodies in 823 swine sera were 17.0%(140 cases) by LA test. 3. The toxoplasma antibody detection rates against 194 swine sera in breeding-pig farm, 273 swine sera in pig farm and 356 swine in abattoir were 46.9%(91 cases), 8.4%(23 cases) and 7.3% (26 cases) , respectively. 4. In LA test serum antibody titers in 823 test sera were shown as 51 cases (36.4%) in 1 : 32, 40(28.6%) in 1;64, 17(12.1%) in 1:128, 14(10.0%) in 1:256, 10(7.1%) in 1:512, 5(3.6%) in 1:1,024, and 3(2.1%) in 1 : 2,048. 5. Positive rates of toxoplasma antibodies in swine sera from each breeding-pig farm were 20.0∼61.9%.

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Prevalence of toxoplasma antibody in swine by microplate latex agglutination test in Kyeongnam district (Latex 응집반응에 의한 경남중부지역 돼지의 톡소플라즈마병 항체조사)

  • Lee, Byung-hoon;Kim, Cha-yong;Suh, Myung-deuk
    • Korean Journal of Veterinary Research
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    • v.33 no.2
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    • pp.263-268
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    • 1993
  • This study was conducted to detect the serum antibody of toxoplasma in swine from breeding-pig, rearing-pig farm and slaughtered pig in abattior by latex agglutination(LA) test. The perfomance of LA test was carried out with commercial Toxo-MT kit(Eiken Chemical Co.)by Tsubota and Ozawa's method. The cut-off titer of positive and negative reactions by Toxo-MT antigen used in this experiment was determined as the serum titer of 1 : 32. Positive rate of toxoplasma antibody from the total of 823 serum samples by LA test was 17.0%(140 cases). And positive rates of toxoplasma antibody against serum samples of 194 from breeding-pig farm, 273 from rearing-pig farm and 356 from abattior were 91 cases(46. 9%), 23 cases(8.4%) and 26 cases(7.3%), respectively. The distributions of serum antibody titers in 823 test sera by LA test were shown 51 cases(36.3%) in 1:32, 40(28.6%) in 1:64, 17(12.1%) in 1:128, 14(10.0%) in 1:256, 3(2.1%) in 1:512, 5(3.6%) in 1:1024 and 3(2.1%) in 1:2048. The ranges of positive rate from the sera in each group of breeding-pig farms were 20~61.9%.

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Comparison between indirect immunofluorescent antibody (IFA) test and enzyme-linked immunosorbent assay (ELISA) for the detection of antibody to porcine reproductive and respiratory syndrome virus(PRRSV) (돼지 생식기호흡기증후군 바이러스항체 검색에 있어 간접형광항체법(IFA) 과 효소면역법(ELISA)의 진단효율 비교)

  • Park, Choi-kyu;Lyoo, Young-soo;Lee, Chang-hee;Jung, Jong-wook
    • Korean Journal of Veterinary Research
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    • v.38 no.2
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    • pp.314-318
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    • 1998
  • An establishment of effective control measures to PRRSV infection in swine industry depends on a sensitive and specific diagnosis to detect either viral antigen and/or antibodies to PRRSV. Several diagnostic methods are available to detect antibodies against PRRSV, including IPMA, IFA and ELISA tests have been successfully developed. Sensitivity of the indirect immunofluorescent assay in MA-104 cells using Korean field isolate PL96-1 was superior to that of VR-2332 and field isolate PL96-2. Sensitivity and specificity of the IFA test with PL96-1 were comparable to those of commercial ELISA test kit but ELISA test was more sensitive for the detection of declining antibodies to PRRSV in finishing pigs. In this study we concluded that IFA and ELISA test could be utilized to detect antibodies to PRRSV and the results generated from these two tests were comparable and there were no significant difference between these two tests.

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A Rapid Diagnostic Test for Toxoplasmosis using Recombinant Antigenic N-terminal Half of SAG1 Linked with Intrinsically Unstructured Domain of GRA2 Protein

  • Song, Kyoung Ju;Yang, Zhaoshou;Chong, Chom-Kyu;Kim, Jin-Soo;Lee, Kyung Chan;Kim, Tong-Soo;Nam, Ho-Woo
    • Parasites, Hosts and Diseases
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    • v.51 no.5
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    • pp.503-510
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    • 2013
  • Toxoplasma gondii is an apicomplexan parasite with a broad host range of most warm-blooded mammals including humans, of which one-thirds of the human population has been infected worldwide which can cause congenital defects, abortion, and neonatal complications. Here, we developed a rapid diagnostic test (RDT) for T. gondii infection. Antigenic N-terminal half of the major surface antigen (SAG1) was linked with intrinsically unstructured domain (IUD) of dense granule protein 2 (GRA2). The recombinant GST-GRA2-SAG1A protein was successfully expressed and purified as 51 kDa of molecular weight. Furthermore, antigenicity and solubility of the rGST-GRA2-SAG1A protein were significantly increased. The overall specificity and sensitivity of GST-GRA2-SAG1A loaded RDT (TgRDT) were estimated as 100% and 97.1% by comparing with ELISA result which uses T. gondii whole cell lysates as the antigen. The TgRDT tested with Uganda people sera for field trial and showed 31.9% of seroprevalence against T. gondii antibody. The TgRDT is proved to be a kit for rapid and easy to use with high accuracy, which would be a suitable serodiagnostic tool for toxoplasmosis.

Quantitative Method of Rapid Immunochromatographic Assay Kit for HBsAg-screening using Computer Image Analysis (컴퓨터 상 분석을 이용한 HBsAg-screening용 Rapid Immunochromatographic Assay Kit의 정량적 측정법)

  • 신형순;허태련
    • KSBB Journal
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    • v.15 no.3
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    • pp.243-246
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    • 2000
  • One of recent topics in the case of hepatits B virus(HVB) is the value of hepatitis B surface antigen(HBsAg) concentration as a prognostic maker. We developed uantitative method of rapid immunochromatographic assay(ICA) kit for HBsAg using computer image analysis (CIA) for the purpose of home diagnosis. uantitative ICA using CIA demonstrated integrated optical density(IOD) values proportional to log of reference HBsAg concentrations in the range of 2-200 ng/mL and enzyme-linked immunosorbent assay(ELISA) demonstrated the same in the range of 0.1-100 ng/mL however the test results with sample sear showed the same concentration on both kits. Furthermore repeated tests with the same samples revealed that this quantitative ICA using CIA would be reproducible and coefficient of variation(CV) of the results was 1.38~6.30%.

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Heat-Shock Protein 70 as a Tumor Antigen for in vitro Dendritic Cell Pulsing in Renal Cell Carcinoma Cases

  • Meng, Fan-Dong;Sui, Cheng-Guang;Tian, Xin;Li, Yan;Yang, Chun-Ming;Ma, Ping;Liu, Yun-Peng;Jiang, You-Hong
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.20
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    • pp.8947-8950
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    • 2014
  • Immunological functions of heat shock proteins (HSPs) have long been recognized. In this study we aimed to efficiently purify HSP70 from renal cell carcinoma and test it as a tumor antigen for pulsing dendritic cells in vitro. HSP70 was purified from renal cell carcinoma specimens by serial column chromatography on Con A-sepharose, PD-10, ADP-agarose and DEAE-cellulose, and finally subjected to fast protein liquid chromatography (FPLC). Dendritic cells derived from the adherent fraction of peripheral blood mononuclear cells were cultured in the presence of IL-4 and GM-CSF and exposed to tumor HSP70. After 24 hours, dendritic cells were phenotypically characterized by flow cytometry. T cells obtained from the non-adherent fraction of peripheral blood mononuclear cells were then co-cultured with HSP70-pulsed dendritic cells and after 3 days T cell cytotoxicity towards primary cultured renal cell carcinoma cells was examined by Cell Counting Kit-8 assay. Dendritic cells pulsed in vitro with tumor-derived HSP70 expressed higher levels of CD83, CD80, CD86 and HLA-DR maturation markers than those pulsed with tumor cell lysate and comparable to that of dendritic cells pulsed with tumor cell lysate plus TNF-${\alpha}$. Concomitantly, cytotoxic T-lymphocytes induced by HSP70-pulsed dendritic cells presented the highest cytotoxic activity. There were no significant differences when using homologous or autologous HSP70 as the tumor antigen. HSP70 can be efficiently purified by chromatography and induces in vitro dendritic cell maturation in the absence of TNF-${\alpha}$. Conspecific HSP70 may effectively be used as a tumor antigen to pulse dendritic cells in vitro.