DST ELISA KITS Allergy and Food Intolerance Diagnostics. 600 Allergens.
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DST The DST ELISA KITS are used for in vitro diagnostics of allergen-specific IgE and IgG4 antibodies in serum or plasma. DST develops, manufactures and markets in vitro diag- nostics for laboratory use – a variety of microtitreplate- based detection systems: ELISA (enzyme-linked immu- nosorbent assay) kits for diagnostics of specific IgE and for diagnostics of specific IgG4.* Intended Use The DST ELISA KITS are intended to use for the quantitative allergy (immediate type) in patients with symptoms of determination of specific IgE and IgG4 antibodies against a suspected allergic cause. selection of over 600 allergens for the serological diagnosis of type I allergy and food interolerance. ELISA KIT sIgG4 is an enzyme immunoassay for quantita- tive determination of antigen-specific IgG4 antibodies ELISA KIT sIgE is an enzyme immunoassay for the in human serum or plasma for laboratory use.* This test is quantitative determination of allergen-specific IgE in an aid in the screening and diagnosis of food intolerance. human serum or plasma for laboratory use. This test is an aid in the screening and diagnosis of sensitization of type I 2 * This test should only be performed by medical personnel who have been trained in the use of in vitro diagnostics products.
DST | ELISA KITS DST ELISA KITS. EASE OF uSE, LESS TIME InvESTED. DST arrays core allergens according to different influencing fast and clear diagnostic results. These allergens are factors, e.g. according to region, season and food culture. used in our ELISA KITS and ensure an excellent diagnostic Through our own research and laboratory developments, quality. our allergens possess excellent reactivities in a combina- tion of quality, purity, precision and validity. This ensures ELISA KIT sIgE – in cases of suspected allergy. ELISA KIT sIgG4 – in cases of Allergens are available precoated on microtitre suspected food intolerance. plates or can be coated rapidly for use by the customer‘s laboratory. Individual composition of the panels with a choice of over 600 available allergens. Pre-designed panels with selected symptom-specific or regional allergen combinations Very small sample volumes required for special lgG4 determination. PrE- Or FrESHLY COATED – IT‘ S YOur CHOICE. 3
DST ELISA FOr THE DETECTIOn OF SPECIFIC IgE AnD IgG4. ELISA KITS sIgE determine the intensity of specific IgE- ELISA KITS sIgG4 determine the intensity of the specific mediated sensitization (atopy) to a selection of over IgG4-mediated sensitization to a selection of over 300 food 600 allergen extracts or mixtures in about two hours. It is extracts or mixtures in about two hours. It is for patients particularly suitable for patients who can not get who are not suitable for time-consuming provocation and a skin test. elimination diets. 600 allergens Incubation time 120 min DST ELISA KITS Diagnostics at a drop. Fast, valid, precise. • Pre-designed panels with selected • sIgE is determined from 10 µl of • Controls included, calibrators symptom-specific or regional allergen serum or plasma per allergen in optional. combinations (based on recommen- less then 2.5 hours. Fully quanti- • Standard microtitreplate readers dations of experts). tative results can be read out with compatible, readout at 450 nm. • Individual composition of the panels a standard microtitreplate reader • Quantification using a 6-point stan- with a choice of over 600 available starting as low as 0.35 ku/L. dard curve. allergens. • sIgG4 is determined from either • sIgE: The identified units/ml can • Ease of use, direct and easy to 10 or less than 1 µl of serum or be assigned to CAP-classes and read results. plasma per antigen in less than represent the level of specific • We offer allergen extracts of 2.5h/4h. sIgG4 levels are given as IgE sensitization. highest excellence. fully quantitative results and re- • sIgG4: The identified units/ml of presented in 6 classes of reaction sIgG4 represent the level of food severity. sensitization. 4
DST | ELISA KITS Expertise and professionAL Solutions. With every drop you get a valid result from DST. For your Three diagnostic possibilities and still more reasons to requirements and inquiries we offer a comprehensive and work together with us: our own laboratory, DST ELISA KITS, supportive expert service in the background. FastCheckPOC® and cerascreen®. DST LAB Professional Accurate diagnosis. Every contact to DST helps you. • We offer you an all-round service. • We advise and provide answers to your questions. • With the use of the DST ELISA KITS, • We offer validation of your results upon request. allergies that are increasing among • We provide you with individual allergen compositions. the population can be recognised • Other tests of DST (e.g. FastCheckPOC®) give you the highest and treated flexibly and cost-effec- possible flexibility and quality in diagnostics. tively at an early stage. • Physicians, non-medical practitio- ners and pharmacies offer you not only first-class results, but also the same service. 5
DST ELISA kit sIgE – for individual allergen coating. We offer our customers allergens with the highest reactivity advantage for our customers in terms of profitability and diag- and diversity in safe and flexible diagnostic carriers. Our diag- nostic competence. nostic concepts enjoy the greatest confidence among experts. Unique products and support services secure a competitive Test principle. The ELISA KIT sIgE is an enzyme immunoassay for is formed and the respective intensity correlates with the in vitro detection of allergen-specific IgE in serum or proportional amount of locally-bound antibody. The dye plasma. On the surface of each well of a microtitre plate formed is quantified photometrically by measuring the ex- allergens are bound. For testing, a diluted sample (serum tinction. The quantification of the tests is carried out using or plasma) is added to the wells. Specific IgE antibodies a point-to-point regression of a 6-point standard curve . of the sample bind to the antigens in the wells during in- Standards are calibrated according to the WHO reference cubation. Non-bound components of serum or plasma are serum 75/5021. washed away after incubation of the sample. Subsequent- The identified units/mL can be assigned to the respective ly, digoxigenin-labeled anti-human IgE antibodies CAP-classes and provide the level of specific IgE sensitiza- and horseradish peroxidase-coupled anti-digoxigenin anti- tion (Table 1). bodies (conjugate) are added. Customized regional pre-coated panels available. The digoxigenin-labeled anti-human IgE antibodies bind Individual coating of single allergens within to IgE antibodies of the sample, standards and controls. 30 minutes possible. The conjugate binds to the digoxigenin-labeled anti-hu- Wide range of allergens. man IgE antibodies. Subsequently, unbound detection Intra-assay precision/Inter-assay precision: mean antibodies are washed away. A color substrate TMB (3,3‘, coefficient of variation 4.47 %/4.61 %. 5,5‘-tetramethylbenzidine) is added, which is converted by Sensitivity/Specificity: 82.6 %/87.8 % (as the horseradish peroxidase conjugate bound enzyme. The compared with ThermoFisher ImmunoCAP reaction is stopped by adding a stop solution. A yellow dye system) (n = 440). Table 1: Correlation between U/ml of allergen-specific IgE, the CAP-class and the level of IgE-mediated sensitization allergen-specific IgE CAP-class U/mL Sensitization 0 0,00 – 0,34 none 1 0,35 – 0,69 very low 2 0,70 – 3,49 low – moderate 3 3,50 – 17,49 moderate 4 17,50 – 49,99 high 5 50,00 – 99,99 very high 6 ≥ 100 extremly high (Reference: package leaflet) 6 For more information, please see package leaflet.
DST | ELISA KITS ELISA KIT – FOr THE DETECTIOn OF SPECIFIC IgG4. The DST ELISA KITS are used for in vitro diagnostics of al- microtitreplate-based detection systems – ELISA KITS for lergen-specific IgE and IgG4 antibodies in serum or plasma. diagnostics of specific IgE and for diagnostics of specifc DST develops, manufactures and markets in vitro IgG4. diagnostics for laboratory use. More precisely: a variety of Test principle. The ELISA KIT sIgG4 is an enzyme immunoassay for The reaction is stopped by adding a stop solution. in vitro detection of allergen-specific IgG4 in serum or A yellow dye is formed and the respective intensity correla- plasma. On the surface of each well of the microtitre plate tes with the proportional amount of locally-bound antibody. antigens are bound. For testing, a diluted sample (serum The dye formed is quantified photometrically by measuring or plasma) is added to the wells. Specific IgG4 antibodies the extinction. of the sample bind to the antigens in the wells during The evaluation of the tests is carried out with help of a incubation. point-to-point regression from the measured absorbances of the standard series. non-bound components of serum or plasma are washed The identified units/mL can be assigned to the away after incubation of the sample. Horseradish peroxi- respective intensity and provide the level of specific IgG4 dase-coupled anti-IgG4 antibodies (conjugate) are added sensitization (Table 1). and bind to the IgG4 antibodies of the sample, the stan- dards or controls. Subsequently, unbound detection anti- bodies are washed away. The color substrate TMB (3,3‘, 5,5‘-tetramethylbenzidine) is added, which is converted by the horseradish peroxidase conjugate. Table 2: The identified units/ml of IgG4 represent the level of food sensitization sIgG4-Class (Range) sIgG4-Unit [Unit/m] 1 0,35 – 0,70 2 0,70 – 3,50 3 3,50 – 17,50 Customized regional pre-coated panels available. 4 17,50 – 50,00 Sample volume of less than 1 µl per allergen 5 50,00 – 100,00 needed. 6 > 100,00 Wide range of allergens. Reference: package leaflet Intra-assay precision: mean coefficient of variation 5.37%. No cross reactions with other immunglobulins. For more information, please see package leaflet. 7
ID: MK158 _002 DST Diagnostische Systeme & Technologien GmbH Gueterbahnhofstrasse 16 19059 Schwerin T +49 385 30348-0 F +49 385 30348-499 E info@dst-diagnostic.com W dst-diagnostic.com DST specialises in diagnostic solutions for allergies, food intolerances and professional diet optimisation. We stand for concentrated compe- tence and experience under one roof: science, r&D, consultation, support, allergen production. Our allergen extract production has one of the largest offers in the market: 600 allergens with valid results – fast and reliable. DST is certified by TÜv rheinland according to ISO 9001 and EN ISO 13485.
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