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Patológia » Új antitestek
Műszerek és eszközök
Galectin-3
Gyártó: Biocare Medical
Catalog Number: ACI 3174 A, B API 3174 AA
Description: 0.1, 0.5 ml, concentrated
6.0 ml prediluted
Dilution: 1:100-1:200 Ready-to-use

Intended Use:
For In Vitro Diagnostic Use Galectin-3 [GAL3-3B8] is a mouse monoclonal antibody that is intended for laboratory use in the qualitative identification of galectin-3 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.

Storage and Stability:
Store at 2ºC to 8ºC. 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. Diluted reagents should be used promptly; any remaining reagent should be stored at 2ºC to 8ºC.
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ERG + C4d
Gyártó: Biocare Medical
Catalog Number: API 3176DS AA
Description: 6.0 ml, prediluted
Dilution: Ready-to-use

Intended Use:
For In Vitro Diagnostic Use
ERG + C4d is a cocktail of mouse monoclonal and rabbit monoclonal antibodies that is intended for laboratory use in the qualitative identification of ERG and C4d proteins 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.

Storage and Stability:
Store at 2ºC to 8ºC. Do not use reagent after the expiration date printed on the vial. If reagents are stored under conditions other than those specified in the package insert, they must be verified by the user.
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HDME-1
Gyártó: Biocare Medical
Catalog Number: API 3177 AA
Description: 6.0 ml, prediluted
Dilution: Ready-to-use

Intended Use:
For In Vitro Diagnostic Use HBME-1 is a mouse monoclonal antibody that is intended for laboratory use in the qualitative identification of mesothelial cells 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.

Storage and Stability:
Store at 2ºC to 8ºC. 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.
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Mesothelin
Gyártó: Biocare Medical
Catalog Number: ACI 3175 A, B API 3175 AA
Description: 0.1, 0.5 ml, concentrated
6.0 ml prediluted
Dilution: 1:50-1:100 Ready-to-use

Intended Use:
For In Vitro Diagnostic Use Mesothelin [MSLN-15C11] is a mouse monoclonal antibody that is intended for laboratory use in the qualitative identification of mesothelin 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.

Storage and Stability:
Store at 2ºC to 8ºC. 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. Diluted reagents should be used promptly; any remaining reagent should be stored at 2ºC to 8ºC.
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Ki-67 + pHH3
Gyártó: Biocare Medical
Catalog Number: API 3198DS AA
Description: 6.0 ml, prediluted
Dilution: Ready-to-use
Diluent: N/A

IVD - CE

Intended Use:
For In Vitro Diagnostic Use
Ki-67 + pHH3 is a cocktail of mouse and rabbit monoclonal antibodies that is intended for laboratory use in the qualitative identification of Ki-67 and phosphohistone H3 (Ser10) proteins 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:
The Ki-67 nuclear antigen is associated with cell proliferation and found throughout the cell cycle; though not in G0 phase (1,2). The assessment of Ki-67 proliferation in breast cancers has shown the Ki-67 labelling index is an important predictor of survival (3).
Microscopic evaluation of mitotic figures on H&E is a routine procedure in the assessment of the tumor grades (4). However, the counting of mitosis is manual and time consuming with assorted difficulties as well as variabilities between interobserver assessments (5). Histone H3 phosphorylation at Serine10 (pHH3) is in association with mitotic chromatin condensation in late G2 and M phase of the cell cycle. pHH3 can distinguish mitosis from apoptotic nuclei (6). The immunohistochemical staining of Serine10-pHH3 has been reported to be comparable to mitotic figures in the H&E section (7-10).
Immunohistochemical studies have shown immunostaining using anti- Ki-67 and anti-pHH3 antibodies provided improved prediction of recurrence of tumors and may become effective ancillary tools in deciding on optimal therapeutic management (11). Other studies have shown Ki-67 and pHH3 can be useful in separating malignant melanoma from benign nevi (12).

Principle of Procedure:
This product is a primary antibody cocktail of mouse and rabbit antibodies, which may be used in a Multiplex IHC staining procedure to produce a two-color stain. Following application of the primary antibody cocktail to the tissue
sample, detection is performed by separate secondary antibodies specific for each species (i.e. mouse or rabbit)
of the primary antibody cocktail, which are conjugated to horseradish peroxidase (HRP) or alkaline phosphatase (AP) enzymes. Visualization is accomplished by the application of chromogenic substrates (DAB and Warp Red), which are enzymatically activated (by HRP or AP, respectively) to produce a colored reaction product at the antigen site. The specimen may be counterstained and coverslipped. Results are interpreted using a light microscope.

Reagent Provided:
Ki-67 + pHH3 is provided as a prediluted antibody cocktail of anti- Ki-67 and anti-pHH3 antibodies in buffer with carrier protein and preservative.

Antibody anti-Ki-67 anti-pHH3
Clone MIB-1 BC37
Source Mouse monoclonal Rabbit monoclonal
Isotype IgG/kappa IgG
Epitope/ Antigen 1002 bp Ki-67 cDNA
fragment PhosphoSer10 of Histone H3
Cellular Localization Nuclear Nuclear (mitotic figure)
Staining Red Black (Deep Space)
(Warp Red)
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. Diluted reagents should be used promptly; any remaining reagent should be stored at 2°C to 8°C.

Known Applications:
Immunohistochemistry (formalin-fixed paraffin-embedded tissues)
Species Reactivity: Human; others not tested
Positive Tissue Control: Melanoma or colon cancer

Protocol Recommendations:
Peroxide Block:
Block for 5 minutes with Biocare's Peroxidazed 1.

Pretreatment: Perform heat retrieval using Biocare’s Diva Decloaker. Refer to the Diva Decloaker data sheet for specific instructions.

Protein Block: Incubate for 10 minutes at RT with Biocare's Background Punisher.

Primary Antibody: Incubate for 30 minutes at RT.

Double Stain Detection: Incubate for 30 minutes at RT using Biocare's MACH 2 Double Stain 1.

Chromogen (1): Incubate for 5 minutes at RT with Biocare's Deep Space Black.

Chromogen (2): Incubate for 5-7 minutes at RT with Biocare's Warp Red. Rinse in deionized water.

Counterstain:
Counterstain with hematoxylin. Rinse with deionized water. Apply Tacha's Bluing Solution for 1 minute. Rinse with deionized water.

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CDX2 [BC39]
Gyártó: Biocare Medical
Catalog Number: ACI 3184 A, C API3184 AA
Description: 0.1, 1.0 ml, 6.0 ml, prediluted
concentrated
Dilution: 1:100 Ready-to-use
Diluent: Van Gogh Yellow N/A

IVD - CE

Intended Use:
For In Vitro Diagnostic Use
CDX2 [BC39] is a mouse monoclonal antibody that is intended for laboratory use in the qualitative identification of CDX2 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:
CDX2 is a homeobox gene that encodes an intestine-specific transcription factor and is expressed in the nuclei of epithelial cells of the intestine, from duodenum to rectum. The CDX2 protein is expressed in primary and metastatic colorectal carcinomas (1,2). It has also been identified in primary ovarian mucinous tumors and metastatic mucinous carcinomas involving the ovary (3). Studies have shown that the CDX2 marker is a more specific and sensitive marker when compared to CK20 (4). According to in-house studies, CDX2 [BC39] showed equal or superior sensitivity to clone CDX2-88, with virtually identical specificity.

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, a secondary antibody is added to bind to the primary antibody. An enzyme label is then added to bind to the secondary antibody; this detection of the bound antibody is evidenced by a colorimetric reaction.

Source: Mouse monoclonal
Species Reactivity: Human; others not tested
Clone: BC39
Isotype: IgG1/kappa

Total Protein Concentration: ~10 mg/ml. Call for lot specific Ig concentration.
Epitope/Antigen: CDX2
Immunogen: Human CDX2 recombinant protein (aa106-305)
Cellular Localization: Nuclear
Positive Tissue Control: Colon cancer

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

Storage and Stability:
Store at 2ºC to 8ºC. 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. Diluted reagents should be used promptly; any remaining reagent should be stored at 2ºC to 8ºC.

Protocol Recommendations:
Peroxide Block: Block for 5 minutes with Biocare's Peroxidazed 1.
Pretreatment: Perform heat retrieval using Biocare’s Diva Decloaker. Refer to the Diva 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: Incubate for 10 minutes at RT with a secondary probe.
Polymer: Incubate for 10-20 minutes at RT with a tertiary 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.

Technical Note:
This antibody has been standardized with Biocare's MACH 4 detection system. Use TBS buffer for washing steps.

Performance Characteristics:
Sensitivity and specificity on diseased and normal tissues are summarized in Tables 1 and 2, respectively.

Limitations:
The optimum antibody dilution and protocols for a specific application can vary. These include, but are not limited to fixation, heat-retrieval method, incubation times, tissue section thickness and detection kit used. Due to the superior sensitivity of these unique reagents, the recommended incubation times and titers listed are not applicable to other detection systems, as results may vary. The data sheet recommendations and protocols are based on exclusive use of Biocare products. Ultimately, it is the responsibility of the investigator to determine optimal conditions. The clinical interpretation of any positive or negative staining should be evaluated within the context of clinical presentation, morphology and other histopathological criteria by a qualified pathologist. The clinical interpretation of any positive or negative staining should be complemented by morphological studies using proper positive and negative internal and external controls as well as other diagnostic tests.

Quality Control:
Refer to CLSI Quality Standards for Design and Implementation of Immunohistochemistry Assays; Approved Guideline-Second edition (I/LA28-A2) CLSI Wayne, PA USA (www.clsi.org). 2011

Precautions:
1. This antibody contains less than 0.1% sodium azide. Concentrations less than 0.1% are not reportable hazardous materials according to U.S. 29 CFR 1910.1200, OSHA Hazard communication and EC Directive 91/155/EC. Sodium azide (NaN3) used as a preservative is toxic if ingested. Sodium azide may react with lead and copper plumbing to form highly explosive metal azides. Upon disposal, flush with large volumes of water to prevent azide build-up in plumbing. (Center for Disease Control, 1976, National Institute of Occupational Safety and Health, 1976) (5)
2. Specimens, before and after fixation, and all materials exposed to them should be handled as if capable of transmitting infection and disposed of with proper precautions. Never pipette reagents by mouth and avoid contacting the skin and mucous membranes with reagents and specimens. If reagents or specimens come into

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IMP3 (RM)
Gyártó: Biocare Medical
Catalog Number: ACI 3180 A, B API 3180 AA
Description: 0.1, 0.5 ml, 6.0 ml, prediluted
concentrated
Dilution: 1:100 Ready-to-use
Diluent: Renoir Red N/A

IVD - CE

Intended Use:
For In Vitro Diagnostic Use
IMP3 (RM) [EP286] is a rabbit monoclonal antibody that is intended for laboratory use in the qualitative identification of IMP3 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:
IMP3 (insulin-like growth factor II mRNA-binding protein 3) is a 580 amino acid oncofetal RNA binding protein containing four K homology domains which is encoded by a 4350 bp mRNA transcript produced by the IGF2BP3 gene on chromosome 7p11.5 (1,2). Its relevance as a novel biomarker in many kinds of cancer has been recently published and data also suggest that IMP3 may play an important role in malignant transformation (3). Cytoplasmic expression of IMP3 has been associated with a more aggressive phenotype in many cancers including triple negative (basal-like) breast cancers, colon cancers, lung cancer and prostate cancer (4-7). IMP3 has also been used in discriminating between benign vs malignant cancers and IMP3 has been shown to be a marker of high-grade dysplasia in esophageal adenocarcinoma (3, 8-10).

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: EP286
Isotype: IgG


Total Protein Concentration: ~10 mg/ml. Call for lot specific Ig concentration.

Epitope/Antigen: A synthetic peptide corresponding to the human IMP3 protein

Cellular Localization: Cytoplasmic/nuclear
Positive Tissue Control: Lung squamous carcinoma and normal pancreas

Known Applications:
Immunohistochemistry (formalin-fixed paraffin-embedded tissues)

Supplied As: Buffer with protein carrier and preservative

Storage and Stability:
Store at 2ºC to 8ºC. 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. Diluted reagents should be used promptly; any remaining reagent should be stored at 2ºC to 8ºC.

Protocol Recommendations:

Peroxide Block:
Block for 5 minutes with Biocare's Peroxidazed 1.

Pretreatment: Perform heat retrieval using Biocare’s Diva Decloaker. Refer to the Diva 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 60 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.

bővebben »

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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Ki-67 + CK7/8/18
Gyártó: Biocare Medical
The Ki-67 nuclear antigen is associated with cell proliferation and found throughout the cell cycle; though not in G0 phase.1,2 The assessment of Ki-67 proliferation in breast cancers has shown the Ki-67 labelling index is an important predictor of survival.3 Cytokeratin (CK) 7 is expressed in epithelial cells of the ovary, lung and breast. Rabbit monoclonal CK7 (Clone BC1) is often used in conjunction with CK20 and CDX-2 in distinguishing pulmonary, ovarian and breast carcinomas (CK7+) from most colon carcinomas (CK7-).4 Clones EP17 and EP30 recognize CK8 and CK18, both of which recognize low molecular weight intermediate filament proteins. In normal tissues, CK8/18 recognizes all simple and glandular epithelium.5 In neoplastic tissues, CK8/18 may prove useful for the identification of most adenocarcinomas and some squamous cell carcinomas. CK8/18 expression patterns may also aid in the classification of tumors of unknown origin and poorly differentiated carcinomas.5-7 CK8/18 rabbit monoclonal may be useful as a staining mask in a multiplex stain with mouse monoclonal antibody Ki-67.

Antibody Information
Tumor Type
Breast Cancer, Pulmonary, Ovarian
Regulatory Classification
IVD
Formats: Predilute
Clone(s: See Below
Catalog Number(s: API 3192 DS
Volume(s: 6.0 ml
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