{ "ProductData": { "ID": "RTD000925", "ProductType": "Others", "BrandName": "Giemsa 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": [ "Bone Marrow", "Lymph Node", "Spleen" ], "ISOtypes": "", "Species": [ "" ], "StainLocalization": [ "" ], "ProductNameGlobal": "Giemsa Staining Kit" }, "ProductImageDetails": { "ImagePath": "https://pim-media.roche.com/Images/Product_RTD000925_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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"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 Giemsa Staining Kit should be stored at 15-30°C.", "Language": "en", "Country": "XG", "Code": "Storage Conditions (Product)" }, { "Name": "Content", "Value": "The reagent vial is supplied in a barcode labeled carrier to insert into the reagent tray of the instrument. Each kit contains sufficient reagent for 75 tests:

One 22 mL vial of Giemsa stain contains approximately 0.4% modified Giemsa stain in 70% methanol.

One vial insert with sipping straw.", "Language": "en", "Country": "XG", "Code": "Content" }, { "Name": "Background Information", "Value": "The Giemsa Staining Kit utilizes a Giemsa stain that belongs to a group of neutral stains known as Romanowsky stains.^1,2 Giemsa is a versatile polychromatic stain which can be used in hematopoietic tissues to assess bone marrow/tissue cellularity and cellular differentials due to the differential binding of the dyes to the different cellular components.³ In addition, the properties of the stain also enable the visualization of microorganisms, including Helicobacter pylori.⁴ H. pylori are curved, highly motile, gram-negative bacteria, which generally colonize the stomach within the mucus layer overlying the epithelium.⁵

The Giemsa Staining Kit is used to aid the pathologist in the diagnosis of infection by H. pylori in the stomach.

1. Bezrukov AV. Romanowsky Staining, the Romanowsky Effect and Thoughts on the Question of Scientific Priority. Biotech Histochem. 2017;92(1):29-35.
2. Woronzoff-Dashkoff KK. The Wright-Giemsa Stain. Secrets Revealed. Clin Lab Med. 2002;22(1):15-23.
3. Stefanovic D, Stefanovic M, Nikin Z. Romanowsky-Giemsa as a Counterstain for Immunohistochemistry: Optimizing a Traditional Reagent. Biotech Histochem. 2013;88(6):329-335.
4. Rotimi O, Cairns A, Gray S, et al. Histological Identification of Helicobacter Pylori: Comparison of Staining Methods. J Clin Pathol. 2000;53(10):756-759.
5. Cover TL BM. Helicobacter Pylori and Other Gastric Helicobacter Species. In: Mandell, Douglas, and Bennett's Principles and Practice of Infectious Diseases. Elsevier; 2020.", "Language": "en", "Country": "XG", "Code": "Background Information" }, { "Name": "Intended Use", "Value": "The Giemsa Staining Kit is intended for laboratory use as a qualitative histologic stain to demonstrate Helicobacter pylori in the stomach and differentiate hematopoietic cells by light microscopy in sections of formalin-fixed, paraffinembedded (FFPE) tissue stained on 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": "Principle", "Value": "The staining reaction is based on the differential affinity of cell types and organisms for the dyes in the stain. Because of the high degree of dissociation, active molecules (eosin and thiazine dyes) are absorbed by cellular structures very quickly.

This kit is optimized for use on the BenchMark Special Stains instrument. 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": "The Giemsa Staining Kit is intended for laboratory use as a qualitative histologic stain to demonstrate Helicobacter pylori in the stomach and differentiate hematopoietic cells by light microscopy in sections of formalin-fixed, paraffinembedded (FFPE) tissue stained on 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" } ] } } ] }