Shinjin Medics Inc. of Goyang at MEDICA 2017 in Düsseldorf -- MEDICA Trade Fair
Manufacturers

Shinjin Medics Inc.

B301, 138, Ilsan-ro, Ilsandong-gu, 10442 Goyang
Korea, Republic

Telephone +82 31 909-8855
Fax +82 31 908-0982
diakey@diakey.com

Hall map

MEDICA 2017 hall map (Hall 3A): stand 3AD61

Fairground map

MEDICA 2017 fairground map: Hall 3A

Our range of products

Product categories

  • 01  Electromedical equipment / Medical Technology
  • 01.01  Diagnostics
  • 01.01.01  General Diagnostics

Our products

Product category: General Diagnostics

RIAKEY Anti-HAV IgG IRMA Tube

INTENDED USE
Immunoradiometric assay for qualitative determination of Hepatitis A Virus antibody (Anti-HAV IgG) in human serum or plasma

PRINCIPLE OF THE ASSAY
The RIAKEY Anti-HAV IgG IRMA is a non-competitive immunoradiometric (IRMA) method (‘‘sandwich’’). Recombinant antigen-coated polystyrene tubes serve as solid phase. The 125I tracer antibody and the coated antigen react simultaneously with the Anti-HAV IgG present in the control serum and samples. Unbounded material is removed by a washing step. The amount of bound tracer will be directly proportional to the Anti-HAV IgG concentration. The remaining radioactivity bound to the tubes is measured in a gamma scintillation counter.

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Product category: General Diagnostics

RIAKEY AFP IRMA Tube II

INTENDED USE
Immunoradiometric assay for quantitative determination of alpha-fetoprotein (AFP) in human serum or plasma

INTRODUCTION
Alpha-Fetoprotein (AFP) is a glycoprotein of about 65.000 daltons molecular weight synthesized by the parenchymal cells of the fetal liver and the yolk sac. The properties and amino acid composition are similar to those of albumin. Synthesis of AFP occurs primarily in the liver and yolk sac of the fetus. The AFP level increases progressively as pregnancy progresses and reaches a peak at about the 14th week in the fetal serum and the 30th week in the maternal serum; it then progressively decreases. Elevated serum AFP levels subsequently reappear during pregnancy and in conjunction with several malignant diseases.

CLINICAL SIGNIFICANCE
During pregnancy, AFP is synthesized mainly by fetal liver and the yolk sac and is secreted into fetal serum, where a peak (2~3 mg/mL) is reached in the 13th~14th week, thereafter gradually decreasing up to the time of birth. In the amniotic fluid, levels of AFP which finds its way there through urinary excretion of the fetus, follow the evolution of fetal serum with values about 200 times lower. AFP passes onto maternal serum mainly as a result of diffusion through the placenta. But AFP concentrations in pregnant women sera however follow a different course from that of fetal serum, being detectable to a greater extent than usual from the 10th~12th week and continuing to increase up to a maximum of 200~400ng/mL in the 30th~31th week and then falling off up to the time of delivery. If the fetus exhibits malformations of the neural tube (anencephaly, spina bifida), AFP diffusion into the amniotic fluid is found to increase, by causing a rise in maternal AFP. AFP levels in adults, normally below 15ng/mL, are found to be considerably higher in several tumoral forms (primary hematoma, testicular tumors) and non-tumoral pathologies (viral hepatitis, hepatic cirrhosis. telangiectasis, and ataxia). ** Pregnancy monitoring: For a prenatal diagnosis of anencephaly, it is advisable to test for AFP in maternal serum during the 16th~18th week; an AFP value higher than the normal limits for the period, if confirmed by a second assay, calls for a subsequent check by echography as well as AFP testing in amniotic fluid. It has to be borne in mind that other fetal pathologies, such as renal deficiencies, omphalocele, intrauterine death of the fetus or multiple pregnancies, may cause an increase in maternal AFP. During gestation, abnormally low serum AFP concentrations may indicate hydatidiform mole or Down's syndrome. ** Tumoral pathologies: Some 70~90% of patients with primary hepatoma exhibit high AFP levels, ranging up to a concentration of 1~5mg/mL. High AFP concentrations are also found in about 90% of patients suffering from germ cell testicular tumors. ** Non-tumoral pathologies: Non-tumoral hepatic affections such as viral hepatitis (acute or chronic) or cirrhosis, or even hereditary thyroxinemia, telangiectasis, ataxia and atresia of the biliary tracts, may produce an increase in serum AFP.

PRINCIPLE OF THE ASSAY
The RIAKEY AFP IRMA II is an non-competitive immunoradiometric (IRMA) method (“sandwich”). The method employs two highly specific monoclonal anti-AFP antibodies which recognize two different epitopes of the molecule. One antibody is coated on solid phase (coated tube), the other, specific for the AFP and labeled with Iodine-125, is used as a tracer. Antibody-coated polystyrene tubes serve as solid phase. The tracer antibody and the coated antibody react simultaneously with the AFP antigen present in the standards, control serum and samples. Unbounded material is removed by a washing step. The amount of bound tracer will be directly proportional to the AFP antigen concentration and the remaining radioactivity bound to the tubes is measured in a gamma scintillation counter.

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Product category: General Diagnostics

DIAKEY Anti-HIV 1_2 ELISA

INTENDED USE
Enzyme-Linked Immuno Sorbent assay for qualitative detection of Anti-HIV 1/2 in human serum or plasma

INTRODUCTION
CLINICAL SIGNIFICANCE
PRINCIPLE OF THE ASSAY
The DIAKEY Anti-HIV 1/2 ELISA is an enzyme-linked immunosorbent assay of non-competitive reaction and based on the ‘sandwich’ principle. The method employs the recombinant HIV Antigen (p24, gp41, gp36). The recombinant antigen is coated on solid phase (coated plate) and labeled with HRPO, is used as a conjugate. The coated antigen and the conjugate react simultaneously with the Anti-HIV present in the controls and samples. Unbound material is removed by a washing step. The amount of bound materials will be directly proportional to the Anti-HIV concentration and the remaining materials bound to the plates are measured in a spectrophotometer at 450nm.

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Product category: General Diagnostics

DIAKEY H.Pylori IgG ELISA

INTENDED USE
Enzyme immunometric assay for quantitative determination of anti-H.Pylori IgG in human serum or plasma

INTRODUCTION
The genus Campylobacter comprises Gram negative bacteria 0.5~5um long and 0.2~0.5um in diameter. These bacteria have a typical curved, spiral single or multiple ‘’S‘’ shape. They are highly motile with a characteristic movement making them easy to identify in gresh preparations. Helicobacter Pylori (previously called Campylobacter pyloridis and successively Campylobacter pylori) was initially isolated by Warren and Marshall from biopsy samples taken from patients suffering from active chromic gastritis. Subsequently many other authors have confirmed the close association between this bacterium and gastroduodenal pathologies. In fact it is now clear that Helicobacter pylori is the principal etiologic agent in type B gastritis (chronic active antral gastritis) a pathology for which it appears to be the triggering and perhaps aggravating factor (debate continues on this point). Undoubtedly data are available which substantiate the predominant role of Helicobacter pylori in recurrent duodenal ulcer.

CLINICAL SIGNIFICANCE
Growing interest in bacteric involvement in gastric pathology has led to a remarkable step forward in studies in this field. Increasing data are being accumulated regarding the fundamental role of Helicobacter pylori in active chronic gastritis, in gastric ulcer and in duodenal ulcer and its close correlation with gastric lesions. Data have also been reported in support of a close correlation between eradication of the microorganism and complete cure of gastritis. A diagnosis of chronic active gastritis is usually based on numerous data such as: patient’s case history, radiologic and endoscopic findings and laboratory analyses. Helicobacter is isolated in culture medium and examined by microscopy after staining or is detected by urease test. Both these techniques are lengthy to implement and their sensitivity and specificity have yet to be demonstrated. The availability of enzyme immunoassay techniques(ELSIA) for the detection of antibodies specific to Helicobacter pylori has substantially resolved these problems, ensuring a serological monitoring in a very short space of time using simple, highly specific technology without recourse to invasive techniques. Various studies have been carried out on the presence of antibodies against Helicobacter pylori and associated gastric pathology. A significant correlation has been demonstrated between antibody (IgG) serum levels and histological findings, together with a marked tiein between increases in immunoglobulin titers and acute gastritis. The serum test for Helicobacter pylori can be utilized as a rapid screening process for large populations of patients and is highly indicated in the early diagnosis of Helicobacter infection as the immune response can of ten precede clinical manifestations of the disease. From a diagnostic point of view, a high serum level of specific antibodies against Helicobacter pylori must be interpreted as an indication of type B asymptomatic gastritis.

PRINCIPLE OF THE ASSAY
The DIAKEY Helicobacter Pylori IgG ELISA is enzyme immunoassay method (ELISA), where horseradish peroxidase is used as enzyme conjugate. During the first incubation, the sample anti-H.Pylori IgG antibodies binding with antigen, if any, are bound to the streptavidin coated wells. A wash cycle eliminates all unbound material, in the incubation that follows, a second antibody (anti-human IgG conjugated with horseradish peroxidase) will bind to the H.Pylori-antigen-antibody complex. After a further wash cycle a colorless Chromogen solution (Tetramethyl-benzidine, TMB) is added to the wells, where it yields a colored compound, by reacting with the peroxidase enzyme, Color development will be stopped by adding H2SO4. The color intensity, measured in a spectrophotometer at 450 and at 620nm, will thus be directly proportional to the anti-H.Pylori IgG antibody concentration in calibrators and samples.

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Product category: General Diagnostics

RIAKEY Ferrtin IRMA Tube

INTENDED USE
Immunoradiometric Assay for quantitative determination of FERRITIN in human serum or plasma

CLINICAL SIGNIFICANCE
One of the most prevalent disorders of man is the dietary deficiency of iron and the resulting anemia. Therefore, the assays of iron, total iron binding capacity and other assessments of iron compounds in the body are clinically significant. Iron-storage compounds in the body include hemoglobin, hemosiderin, myoglobulin and the cytochromes. In most tissues, ferritin is a major iron-storage protein. Human ferritin has a molecular weight of approximately 450,000 daltons, and consists of a protein shell around an iron core; each molecule of ferritin may contain as many as 4,000 iron atoms. Under normal conditions, this may represent 25% of the total iron found in the body. In addition, ferritin can be found in several isomers. High concentrations of ferritin are found in the cytoplasm of the reticuloendothelial system, the liver, spleen and bone marrow. Methods previously used to measure iron in such tissues are invasive, cause patient trauma and lack adequate sensitivity. The measurement of ferritin in serum is useful in determining changes in body iron storage, and is non-invasive with relatively little patient discomfort. Serum ferritin levels can be measured routinely and are particularly useful in the early detection of iron deficiency anemia in apparently healthy people. Serum ferritin measurements are also clinically significant in the monitoring of the iron status of pregnant women, blood donors, and renal dialysis patients. High ferritin levels may indicate iron overload without apparent liver damage, as may be noted in the early stages of idiopathic hemochromatosis. Ferritin levels in serum have also been used to evaluate clinical conditions not related to iron storage, including inflammation, chronic liver disease, and malignancy.

PRINCIPLE OF THE ASSAY
The RIAKEY FERRITIN IRMA is an one step non-competitive immunoradiometric (IRMA) method (“sandwich”). The method employs two highly specific monoclonal anti-FERRITIN antibodies which recognize two different epitopes of the molecule. One antibody is coated on solid phase (coated tube), the other, specific for the FERRITIN and labelled with Iodine-125, is used as a tracer. Antibody-coated polystyrene tubes serve as solid phase. The tracer antibody and the coated antibody react simultaneously with the FERRITIN antigen present in the standards, control serum and samples. Unbounded material is removed by a washing step. The amount of bound tracer will be directly proportional to the FERRITIN antigen concentration and the remaining radioactivity bound to the tubes is measured in a gamma scintillation counter.

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About us

Company details

Welcome To Shinjin Medics Inc.
Shin Jin Medics Inc. researches, develops, manufactures, and supplies immunodiagnostic products.

Since 1992, Shin Jin Medics Inc. has been dedicated to everlasting R&D through diagnostic business that today accumulates our own know-how and span advanced technology.

As staple products of Shin Jin Medics Inc. a wide range of diagnostic kits and the instruments such as Gamma counter, Automatic Tube Washer and Incubator are used domestic market as well as world-wide.

We, Shin Jin Medics Inc., will make all possible to become the highest quality diagnostic reagent and instrument manufacturer in Korea, based on the guaranteed quality and technical achievements, and take the lead in global market so that it makes a significant contribution to development of immunodiagnostic and life science technology.

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