{ "ProductData": { "ID": "RTD001169", "ProductType": "Others", "BrandName": "Trichrome Staining Kit", "ProductNameAddition": "", "RegulatoryDisclaimer1": "For in vitro diagnostic use.", "DisclaimerGroup1": "IVD", "RegulatoryDisclaimer2": null, "DisclaimerGroup2": null, "RegulatoryDisclaimer3": null, "SampleType": [ "Formalin-Fixed Paraffin-Embedded Tissue (FFPET)" ], "LicenseDisclaimers": [ ], "RelatedLinks": "", "Clone": "", "ControlTissue": [ "Colon", "Kidney", "Liver", "Skin" ], "ISOtypes": "", "Species": [ "" ], "StainLocalization": [ "" ], "ProductNameGlobal": "Trichrome Staining Kit" }, "ProductImageDetails": { "ImagePath": "https://pim-media.roche.com/Images/Product_RTD001169_im_en.jpg", "ImageType": "Image main" }, "Product2Taxonomy": { "Product2TaxonomyReferences": [ { "StructureSystemIdentifier": "Product_Grouping", "StructureSystemName": "Product Grouping", "NodeID": "05-0025", "StructureNodeStatus": "Active", "NodeName": "Special Stains Staining Kits" }, { 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"INS_3198", "BrandName": "BenchMark Special Stains", "ProductNameAddition": "", "ReferenceType": "Instrument", "Classification": [ { "IdentifierofStructureSystem": "1", "NameofStructureSystem": "GPCH", "StructureNodeID": "7682", "StructureGroupPath": "Histology->Systems / Digital Products->Primary Staining->BenchMark Special Stains", "StructureGroupName": "BenchMark Special Stains", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "OWP_Product_Types", "NameofStructureSystem": "Product Types", "StructureNodeID": "10-000-00", "StructureGroupPath": "Analyzer Instruments and Systems", "StructureGroupName": "Analyzer Instruments and Systems", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "080", "StructureGroupPath": "BenchMark", "StructureGroupName": "BenchMark", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Lab_Type", "NameofStructureSystem": "Lab Types", "StructureNodeID": "080-00", "StructureGroupPath": "Pathology Lab", "StructureGroupName": "Pathology Lab", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "010", "StructureGroupPath": "Histopathology", "StructureGroupName": "Histopathology", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "120-00", "StructureGroupPath": "Special Stains", "StructureGroupName": "Special Stains", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Applications", "NameofStructureSystem": "Applications", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Pathogens", "NameofStructureSystem": "Pathogens", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" } ] } ] }, "ProductSpec": [ { "ProductSpecVariant": { "Chapters": [ { "Name": "Storage Conditions (Product)", "Value": "The Trichrome Staining Kit should be stored at 2-8°C.", "Language": "en", "Country": "XG", "Code": "Storage Conditions (Product)" }, { "Name": "Intended Use", "Value": "Trichrome Staining Kit is intended for laboratory use as a qualitative histologic stain to demonstrate collagen fibers, muscle and connective tissue by light microscopy in sections of formalin-fixed, paraffin-embedded (FFPE) tissue stained on a BenchMark Special Stains instrument.

This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls.

This product is intended for in vitro diagnostic (IVD) use.", "Language": "en", "Country": "XG", "Code": "Intended Use" }, { "Name": "Content", "Value": "The reagent vials are supplied in barcode labeled carriers to insert into the reagent tray of the instrument. Each kit contains sufficient reagent for 60 tests:

One 27 mL vial of Trichrome Bouin’s reagent contains approximately 24% formaldehyde, 5% acetic acid, 71% picric acid.

One 22 mL vial of Trichrome Hematoxylin A reagent contains approximately 1% hematoxylin.

One 22 mL vial of Trichrome Hematoxylin B reagent contains approximately 1.16% ferric chloride and 1% acetic acid.

One 27 mL vial of Trichrome Red reagent contains approximately 0.9% Biebrich scarlet, 0.1% acid fuchsin and 1% acetic acid.

One 27 mL vial of Trichrome Mordant reagent contains approximately 0.25% phosphotungstic acid, 1.0% phosphomolybdic acid.

One 27 mL vial of Trichrome Blue reagent contains approximately 0.3% aniline blue and 1% acetic acid.

One 15 mL vial of Trichrome Clarifier reagent contains approximately 1% acetic acid. Seven vial inserts with sipping straws.", "Language": "en", "Country": "XG", "Code": "Content" }, { "Name": "Background Information", "Value": "Trichrome Staining Kit is a modification of Masson’s Trichrome Stain.

Fibrosis occurs when normal tissue architecture and function are compromised due to the presence of excess extracellular matrix components.¹ Fibrosis can occur in several tissues/organs and can lead to permanent scarring and organ malfunction.² The primary marker of fibrosis is overgrowth and/or scarring which is associated with collagen volume.³ The trichrome staining method employs three dyes that distinctly color smooth muscle, collagen, and connective tissues.⁴ This staining allows for a more accurate assessment of collagen in a tissue specimen by enhancing contrast of these tissue components.

The Trichrome Staining Kit is used to aid the pathologist in the assessment of fibrosis.⁵

References

1. Lupher ML, Gallatin WM. Regulation of Fibrosis by the Immune System. In:2006:245-288.
2. Kuter DJ, Bain B, Mufti G, et al. Bone Marrow Fibrosis: Pathophysiology and Clinical Significance of Increased Bone Marrow Stromal Fibres. Br J Haematol. 2007;139(3):351-362.
3. Wynn TA. Cellular and Molecular Mechanisms of Fibrosis. J Pathol. 2008;214(2):199-210.
4. Bancroft JD, Layton C. Connective and Other Mesenchymal Tissues with Their Stains. In: Bancroft's Theory and Practice of Histological Techniques.2019:153-175.
5. Tretheway D, Jain A, LaPoint R, et al. Should Trichrome Stain Be Used on All Post-Liver Transplant Biopsies with Hepatitis C Virus Infection to Estimate the Fibrosis Score? Liver Transpl. 2008;14(5):695-700.
6. Carson FL, Cappellano C. HIstotechnology; A Self-Instructional Text, 5th edition.  American Society for Clinical Pathology Press; 2020, 2022.
7. Occupational Safety and Health Standards: Occupational exposure to hazardous chemicals in laboratories. (29 CFR Part 1910.1450). Fed. Register.
8. Directive 2000/54/EC of the European Parliament and Council of 24 June 2020 on the protection of workers from risks related to exposure to biological agents at work.

", "Language": "en", "Country": "XG", "Code": "Background Information" }, { "Name": "Principle", "Value": "Trichrome Bouin’s is applied which acts as a mordant to allow penetration of subsequent dyes. Nuclei are stained with Trichrome Hematoxylin A and Trichrome Hematoxylin B (forms a complex of iron hematoxylin). Cytoplasm and muscle is stained with Trichrome Red, containing Biebrich scarlet and acid fuchsin. Trichrome Mordant removes the excess red from the collagen which is stained with Trichrome Blue, which contains aniline blue. Trichrome Clarifier is an acetic acid rinse used to remove excess blue.

This kit is optimized for use on BenchMark Special Stains instruments. The reagents are applied to tissue on microscope slides and mixed over the entire specimen.", "Language": "en", "Country": "XG", "Code": "Principle" }, { "Name": "Product Purpose", "Value": "Trichrome Staining Kit is intended for laboratory use as a qualitative histologic stain to demonstrate collagen fibers, muscle and connective tissue by light microscopy in sections of formalin-fixed, paraffin-embedded (FFPE) tissue stained on a BenchMark Special Stains instrument.

This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls.

This product is intended for in vitro diagnostic (IVD) use.", "Language": "en", "Country": "XG", "Code": "Product Purpose" } ] } } ] }