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One 5 mL dispenser of CONFIRM anti-CD20 (L26) antibody contains approximately 1.5 μg of a mouse monoclonal (L26) antibody.
The antibody is diluted in Tris-HCl with carrier protein and ProClin 300, a preservative.
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Refer to the appropriate VENTANA detection kit method sheet for detailed descriptions of: Principle of the Procedure, Material and Methods, Specimen Collection and Preparation for Analysis, Quality Control Procedures, Troubleshooting, Interpretation of Results, and Limitations.",
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},
{
"Name": "Intended Use",
"Value": "CONFIRM anti-CD20 (L26) Primary Antibody is intended for laboratory use in the qualitative immunohistochemical detection of CD20 by light microscopy in sections of formalin-fixed, paraffin- embedded tissue stained on a BenchMark IHC/ISH instrument.
This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls.
This antibody is intended for in vitro diagnostic (IVD) use.",
"Language": "en",
"Country": "XG",
"Code": "Intended Use"
},
{
"Name": "Background Information",
"Value": "CONFIRM anti-CD20 (L26) Primary Antibody (CONFIRM anti-CD20 (L26) antibody) is a mouse monoclonal antibody produced against the CD20 antigen. CD20 is a 33-36 kDa non-glycosylated transmembrane protein that is expressed on B lineage cells.1,2,3,4,5,6 Expression is first noted in the pre-B cell stage and continues throughout all stages of B- cell maturation.3,4,5,6,7,8 However, this antigen is not expressed on pro-B cells or plasma cells.3,4,5,6,7,8 CD20 is the most commonly used pan B-cell marker for assessment of B- cell lineages and is expressed in almost all mature B-cell neoplasms and almost no T- cells.3,4,5,6,7,8 Of note, detection of or expression of CD20 within a tissue specimen may diminish in patients treated with anti-CD20 targeted therapies.9,10 Therefore, under these circumstances, confirmation of B-cell lineage would rely on other pan-B cell markers such as CD19, CD79a, or Pax5, the expression of which is not affected by anti-CD20 therapeutics.9,10
The detection of CD20 by immunohistochemistry (IHC) with CONFIRM anti-CD20 (L26) antibody may be used to aid in the identification of normal and neoplastic B-cells. It may be used as part of a panel of IHC studies. The staining pattern is membranous.
1. Mason DY, Comans-Bitter WM, Cordell JL, Verhoeven MA, van Dongen JJm . Antibody L26 recognizes an intracellular epitope on the B-cell-associated CD20 antigen. Am J Pathol. 1990;136(6):1215-1222.
2. Chu PG, Loera S, Huang Q, Weiss LM. Lineage determination of CD20-B-Cell neoplasms: an immunohistochemical study. Am J Clin Pathol. 2006;126(4):534-544.
3. Swerdlow S, Campo E, Harris NL, et al. Who Classification of Tumours. Lyon: IARC; 2017.
4. O'Malley DP, Fedoriw Y, Grimm KE, et al. Immunohistology of Lymph Node and Lymph Node Neoplasms, 5th Edition. In: Dabbs DJ, ed. Diagnostic Immunohistochemistry. Elsevier 2019:160-202 5. Higgins RA, Blankenship JE, Kinney MC. Application of Immunohistochemistry in the Diagnosis of Non-Hodgkin and Hodgkin Lymphoma. Arch Pathol Lab Med. 2008;132(3):441-461.
6. O'Malley DP, Auerbach A, Weiss LM. Practical Applications in Immunohistochemistry: Evaluation of Diffuse Large B-Cell Lymphoma and Related Large B-Cell Lymphomas. Arch Pathol Lab Med. 2015;139(9):1094-1107
7. Bene MC, Nebe T, Bettelheim P, et al. Immunophenotyping of Acute Leukemia and Lymphoproliferative Disorders: A Consensus Proposal of the European Leukemianet Work Package 10. Leukemia. 2011;25(4):567-574.
8. Buske C, Hutchings M, Ladetto M, et al. ESMO Consensus Conference on Malignant Lymphoma: General Perspectives and Recommendations for the Clinical Management of the Elderly Patient with Malignant Lymphoma. Ann Oncol. 2018;29(3):544-562.
9. Cragg MS, Walshe CA, Ivanov AO, et al. The Biology of CD20 and Its Potential as a Target for Mab Therapy. In: Stohl W, ed. B Cell Trophic Factors and B Cell Antagonism in Autoimmune Disease. Vol 8. Basel, Karger 2005:140-174
10. Casan JML, Wong J, Northcott MJ, et al. Anti-CD20 Monoclonal Antibodies: Reviewing a Revolution. Hum Vaccin Immunother. 2018;14(12):2820-2841.",
"Language": "en",
"Country": "XG",
"Code": "Background Information"
},
{
"Name": "Principle",
"Value": "CONFIRM anti-CD20 (L26) antibody may be used as the primary antibody for immunohistochemical staining of paraffin tissue sections. CONFIRM anti-CD20 (L26) antibody binds to CD20 protein in formalin-fixed, paraffin-embedded (FFPE) tissue sections and exhibits a membranous staining pattern. CONFIRM anti-CD20 (L26) antibody can be visualized using OptiView DAB IHC Detection Kit (Cat. No. 760-700 / 06396500001) or ultraView Universal DAB Detection Kit (Cat. No. 760-500 / 05269806001). Refer to the respective method sheet for further information.
In addition to staining with CONFIRM anti-CD20 (L26) antibody, a second slide should be stained with the appropriate negative control reagent.",
"Language": "en",
"Country": "XG",
"Code": "Principle"
},
{
"Name": "Product Purpose",
"Value": "CONFIRM anti-CD20 (L26) Primary Antibody is intended for laboratory use in the qualitative immunohistochemical detection of CD20 by light microscopy in sections of formalin-fixed, paraffin- embedded tissue stained on a BenchMark IHC/ISH instrument.
This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls.
This antibody is intended for in vitro diagnostic (IVD) use.",
"Language": "en",
"Country": "XG",
"Code": "Product Purpose"
}
]
}
}
]
}
