Orvosi diagnosztikai eszközök, labor műszerek,
reagensek beszerzése és forgalmazása

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Frank Diagnosztika Kft.
1031 Budapest, Szentendrei út 176.
+36 1 250-1813
frankdiagn@frank-diagn.hu




Új antitestek
Műszerek és eszközök
H.pylori (RM)
Gyártó: Biocare Medical
Catalog Number: API 3191 AA OAI 3191 T60
Description: 6.0 ml, prediluted 60 tests, prediluted
Dilution: Ready-to-use Ready-to-use
Diluent: N/A N/A

IVD

Intended Use:
For In Vitro Diagnostic Use
H. pylori (RM) [EP279] is a rabbit monoclonal antibody that is intended
for laboratory use in the qualitative identification of H. pylori protein by
immunohistochemistry (IHC) in formalin-fixed paraffin-embedded
(FFPE) human tissues. The clinical interpretation of any staining or its
absence should be complemented by morphological studies using
proper controls and should be evaluated within the context of the
patient’s clinical history and other diagnostic tests by a qualified
pathologist.

Summary and Explanation:
Helicobacter pylori (H. pylori) infection represents the major cause of
peptic ulcer disease and is a likely contributing factor in the
development of gastric neoplastic diseases such as gastric
adenocarcinoma and mucosa-associated lymphoid tissue (MALT)
lymphoma (1). H. pylori are spiral-curved, gram-negative bacteria.
The majority of H. pylori microorganisms reside in the unstirred layer
of the gastric mucus, but some bind to the luminal aspect of gastric
foveolar cells, and attach at or near intercellular junctions, or even
locate within cells (2-3). However, generally they do not invade the
underlying lamina propria (3). Immunohistochemical (IHC) detection of
H. pylori can specifically distinguish the microorganisms from other
types of bacterial infections. Complete staining of the H. pylori
microrganism has been shown with the rabbit monoclonal. An IHC
technique, with heat-induced-antigen retrieval for detection of H. pylori
in gastric biopsies, is highly reliable, highly sensitive, specific, and can
be used on fully automated IHC platforms.

Principle of Procedure:
Antigen detection in tissues and cells is a multi-step
immunohistochemical process. The initial step binds the primary
antibody to its specific epitope. After labeling the antigen with a
primary antibody, an enzyme labeled polymer is added to bind to the
primary antibody. The detection of the bound antibody is evidenced by
a colorimetric reaction.

Source: Rabbit monoclonal
Species Reactivity: Human; others not tested
Clone: EP279
Isotype: IgG
Total Protein Concentration: ~10 mg/ml. Call for lot specific Ig
concentration.

Epitope/Antigen: H. pylori
Cellular Localization: Spiral shaped bacterium
Positive Tissue Control: Gastric tissue infected with H. pylori

Known Applications:
Immunohistochemistry (formalin-fixed paraffin-embedded tissues)
Supplied As: Buffer with protein carrier and preservative

Storage and Stability:
Store at 2°C to 8°C. Do not use after expiration date printed on vial. If
reagents are stored under conditions other than those specified in the
package insert, they must be verified by the user.

Protocol Recommendations (manual use):
Peroxide Block:
Block for 5 minutes with Biocare's Peroxidazed 1.
Pretreatment: Perform heat retrieval using Biocare’s Borg Decloaker.
Refer to the Borg Decloaker data sheet for specific instructions.
Protein Block (Optional): Incubate for 5-10 minutes at RT with
Biocare's Background Punisher.

Primary Antibody: Incubate for 30 minutes at RT.
Probe: N/A
Polymer: Incubate for 30 minutes at RT with a secondary-conjugated
polymer.
Chromogen: Incubate for 5 minutes at RT with Biocare’s DAB – OR –
Incubate for 5-7 minutes at RT with Biocare’s Warp Red.

Counterstain:
Counterstain with hematoxylin. Rinse with deionized water. Apply
Tacha's Bluing Solution for 1 minute. Rinse with deionized water.
Protocol Recommendations (ONCORE Automated Slide

Staining System):
OAI3191 is intended for use with the ONCORE Automated Slide
Staining System. Refer to the ONCORE Automated Slide Staining
System User Manual for specific instructions on its use. Protocol
parameters in the ONCORE Automated Slide Stainer Protocol Editor

should be programmed as follows:
Protocol Name: H. pylori Rb
Protocol Template (Description): Rb HRP Template 1
Dewaxing (DS Option): DS2
Antigen Retrieval (AR Option): AR2, low pH; 101°C
Reagent Name, Time, Temp.: H. pylori Rb, 30 min., 37°C
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