DST ELISA KITS Allergy and Food Intolerance Diagnostics. 600 Allergens.

 
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DST ELISA KITS Allergy and Food Intolerance Diagnostics. 600 Allergens.
DST ELISA KITS
Allergy and Food Intolerance Diagnostics.
600 Allergens.
DST ELISA KITS Allergy and Food Intolerance Diagnostics. 600 Allergens.
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 Allergy and Food Intolerance Diagnostics. 600 Allergens.
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 KITS Allergy and Food Intolerance Diagnostics. 600 Allergens.
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 Allergy and Food Intolerance Diagnostics. 600 Allergens.
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 KITS Allergy and Food Intolerance Diagnostics. 600 Allergens.
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 Allergy and Food Intolerance Diagnostics. 600 Allergens.
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
DST ELISA KITS Allergy and Food Intolerance Diagnostics. 600 Allergens.
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.
DST ELISA KITS Allergy and Food Intolerance Diagnostics. 600 Allergens.
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