36C24418Q0087-001.docx

36C244-18-Q-0087

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30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

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7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

646-18-1-080-0016

36C24418Q0087 01-05-2018 Matthew D. Parlett

610.384.7711 EXT 3233

01-17-2018

12:00 PM

36C244 Department of Veterans Affairs Network Contracting Office 4 Attn: Matthew D. Parlett (90C) 1400 Blackhorse Hill Road Coatesville PA 19320-2096

610.384.7711 EXT 3233

matthew.parlett@va.gov X

325413 1250 Employees

N/A

36C460 Department of Veterans Affairs VA Pittsburgh Healthcare System Pathology & Laboratory Medicine - Histology University Drive C Pittsburgh PA 15240 36C244 Department of Veterans Affairs Network Contracting Office 4 (See box 9)

Austin Payment Center Department of Veterans Affairs

PO Box 149971 Austin TX 78714-9971

(877) 353-9791

(512) 460-5429

See CONTINUATION Page Histology Staining Reagents.

All items quoted must be brand name or equal to the Roche catalog numbers listed in section B.3.

See page 77 and section E.1.1 for documents to submit with quote.

See CONTINUATION Page

Matthew D. Parlett Contracting Officer

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

(Continuation from Standard Form 1449, block 18A.)

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR: (FILL IN POINT OF CONTACT)

b. GOVERNMENT: Matthew D. Parlett Contracting Officer

610.384.7711 EXT 3233

matthew.parlett@va.gov Department of Veterans Affairs Network Contracting Office 4 (90C) 1400 Blackhorse Hill Road Coatesville PA 19320-2096

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

3. INVOICES: Invoices shall be submitted monthly in arrears.

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

Department of Veterans Affairs Financial Services Center PO Box 149971 Austin TX 78714-8971

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2 PRICE/COST SCHEDULE

Contract type will be Fixed Price, Indefinite Delivery, Indefinite Quantity (IDIQ) with five year ordering period. Contract type was selected as the Government cannot adequately predict the exact number of reagents that will need to be delivered in any given period of time. The quantities of reagents specified in the schedule are estimates only and are not purchased by this solicitation. Offeror may quote quantity discounts. Fill in prices below under contract line items (CLINs) 0001 through 0129; be sure to also provide a grand total.

Once a contract is awarded, unit prices will be fixed throughout the contract. Delivery orders will be issued in accordance with the terms and conditions of the contract. Delivery Orders may be issued by e-mail, facsimile, or US Mail. Minimum value of services to be ordered over the life of the contract is $10,000.00. Maximum value of items to be ordered over the life of the contract is $3,000,000.00.

All items quoted must be brand name or equal to the Roche part/catalog numbers listed below in regards to their use and salient characteristics (See section B.3).

ITEM INFORMATION

LOCAL STOCK NUMBER: 760-2601

LOCAL STOCK NUMBER: 760-4605

LOCAL STOCK NUMBER: 760-027

LOCAL STOCK NUMBER: 760-2603

LOCAL STOCK NUMBER: 790-2918

LOCAL STOCK NUMBER: 760-080

LOCAL STOCK NUMBER: 790-4464

LOCAL STOCK NUMBER: 760-4241

LOCAL STOCK NUMBER: 760-2037

LOCAL STOCK NUMBER: 760-2609

LOCAL STOCK NUMBER: 790-4467

LOCAL STOCK NUMBER: 950-124

LOCAL STOCK NUMBER: 950-123

LOCAL STOCK NUMBER: 790-4341

LOCAL STOCK NUMBER: 790-4423

LOCAL STOCK NUMBER: 790-4451

LOCAL STOCK NUMBER: 860-005

LOCAL STOCK NUMBER: 790-4460

LOCAL STOCK NUMBER: 760-2504

LOCAL STOCK NUMBER: 760-2531

LOCAL STOCK NUMBER: 760-4245

LOCAL STOCK NUMBER: 790-4408

LOCAL STOCK NUMBER: 790-2926

LOCAL STOCK NUMBER: 760-4378

LOCAL STOCK NUMBER: 790-2927

LOCAL STOCK NUMBER: 760-2505

LOCAL STOCK NUMBER: 790-4465

LOCAL STOCK NUMBER: 790-2931

LOCAL STOCK NUMBER: 790-4452

LOCAL STOCK NUMBER: 760-2507

LOCAL STOCK NUMBER: 760-2519

LOCAL STOCK NUMBER: 790-4554

LOCAL STOCK NUMBER: 790-4462

LOCAL STOCK NUMBER: 790-4431

LOCAL STOCK NUMBER: 860-026

LOCAL STOCK NUMBER: 790-4508

LOCAL STOCK NUMBER: 760-4395

LOCAL STOCK NUMBER: 760-2513

LOCAL STOCK NUMBER: 860-004

LOCAL STOCK NUMBER: 790-4463

LOCAL STOCK NUMBER: 760-4383

LOCAL STOCK NUMBER: 750-102

LOCAL STOCK NUMBER: 760-2642

LOCAL STOCK NUMBER: 760-4384

LOCAL STOCK NUMBER: 760-2699

LOCAL STOCK NUMBER: 760-2688

LOCAL STOCK NUMBER: 760-2686

LOCAL STOCK NUMBER: 760-2687

LOCAL STOCK NUMBER: 760-2685

LOCAL STOCK NUMBER: 760-2681

LOCAL STOCK NUMBER: 760-2680

LOCAL STOCK NUMBER: 760-2682

LOCAL STOCK NUMBER: 760-4345

LOCAL STOCK NUMBER: 790-4564

LOCAL STOCK NUMBER: 860-028

LOCAL STOCK NUMBER: 790-1014

LOCAL STOCK NUMBER: 760-2021

LOCAL STOCK NUMBER: 790-4366

LOCAL STOCK NUMBER: 760-4260

LOCAL STOCK NUMBER: 760-4350

LOCAL STOCK NUMBER: 790-4373

LOCAL STOCK NUMBER: 760-1209

LOCAL STOCK NUMBER: 760-1201

LOCAL STOCK NUMBER: 760-1202

LOCAL STOCK NUMBER: 760-1203

LOCAL STOCK NUMBER: 760-1204

LOCAL STOCK NUMBER: 790-4286

LOCAL STOCK NUMBER: 760-1205

LOCAL STOCK NUMBER: 760-1206

LOCAL STOCK NUMBER: 760-1207

LOCAL STOCK NUMBER: 760-1208

LOCAL STOCK NUMBER: 243-4369

LOCAL STOCK NUMBER: 243-4370

LOCAL STOCK NUMBER: 243-4399

LOCAL STOCK NUMBER: 243-4400

LOCAL STOCK NUMBER: 860-009

LOCAL STOCK NUMBER: 760-097

LOCAL STOCK NUMBER: 780-4148

LOCAL STOCK NUMBER: 860-019

LOCAL STOCK NUMBER: 790-2990

LOCAL STOCK NUMBER: 650-010

LOCAL STOCK NUMBER: 790-4535

LOCAL STOCK NUMBER: 760-4265

LOCAL STOCK NUMBER: 860-011

LOCAL STOCK NUMBER: 790-4561

LOCAL STOCK NUMBER: 760-4529

LOCAL STOCK NUMBER: 760-2659

LOCAL STOCK NUMBER: 760-4446

LOCAL STOCK NUMBER: 760-4392

LOCAL STOCK NUMBER: 790-2912

LOCAL STOCK NUMBER: 790-4509

LOCAL STOCK NUMBER: 760-2595

LOCAL STOCK NUMBER: 790-4420

LOCAL STOCK NUMBER: 860-014

LOCAL STOCK NUMBER: 760-2506

LOCAL STOCK NUMBER: 760-4273

LOCAL STOCK NUMBER: 950-300

LOCAL STOCK NUMBER: 780-2218

LOCAL STOCK NUMBER: 860-024

LOCAL STOCK NUMBER: 860-015

LOCAL STOCK NUMBER: 950-110

LOCAL STOCK NUMBER: 860-025

LOCAL STOCK NUMBER: 860-018

LOCAL STOCK NUMBER: 790-4407

LOCAL STOCK NUMBER: 760-2671

LOCAL STOCK NUMBER: 1632900

LOCAL STOCK NUMBER: 860-023

LOCAL STOCK NUMBER: 790-4398

LOCAL STOCK NUMBER: 790-4365

LOCAL STOCK NUMBER: 650-210

LOCAL STOCK NUMBER: 950-224

LOCAL STOCK NUMBER: 950-223

LOCAL STOCK NUMBER: 760-500

LOCAL STOCK NUMBER: 760-501

LOCAL STOCK NUMBER: 790-2917

LOCAL STOCK NUMBER: 790-4558

LOCAL STOCK NUMBER: 760-4397

LOCAL STOCK NUMBER: 860-035

LOCAL STOCK NUMBER: 860-036

LOCAL STOCK NUMBER: 860-016

LOCAL STOCK NUMBER: 860-037

LOCAL STOCK NUMBER: 860-030

LOCAL STOCK NUMBER: 860-023

LOCAL STOCK NUMBER: 860-031

LOCAL STOCK NUMBER: 1418702

LOCAL STOCK NUMBER: 860-034

LOCAL STOCK NUMBER: 760-2523

LOCAL STOCK NUMBER: 790-4576

LOCAL STOCK NUMBER: 790-4367

B.3 STATEMENT OF NEED & SALIENT CHRACTERISTICS SPECIFICATION

Statement of Need

The VAPHS Pathology & Laboratory Medicine Service at University Drive has a need to develop a contract for the expeditious ordering of antibodies, special stains, cell conditioners and other reagents for the Roche Diagnostic IHC/IHS staining platforms currently in use in the department. These platforms provide top quality immunohistochemistry, in situ hybridization and special stains used in the specific diagnosis of both common and rare tumors encountered in human tissues. This allows for more efficient workflow management. Equipment/platforms currently in use are as follows:

· Benchmark LT, Serial# 610312

· Benchmark XT, Serial# 712703

· Nexes Special Stains, Serial # 511421

· Benchmark Ultra, Serial # 310367

· Benchmark Special Stainer, Serial # 5110199 In order to maintain a high level of consistency, the following salient characteristics must be met.

Salient Characteristics:

The antibodies and reagents must be bioengineered specifically to conform to optimal incubation times and temperatures within the platforms. They must be delivered from bar-coded dispensers recognized by the platforms onto tissue slides with similar bar-coding. The antibodies, conditioners and other reagents must have attached information buttons that allow the platforms to keep track of product lot numbers, quantity and outdates on a test by test basis. Any possible product problem or defect can be monitored by the contractor and relayed to the pathology and laboratory medicine service. The tracking information is stored and retrieved with the platform’s software package where printouts can be ordered and filed. All items must be brand name or equal to the Roche part/catalog numbers listed below in regards to their use and specific salient characteristics.

Delivery

All reagents will be delivered to the shipping and receiving dock area of:

VA Pittsburgh Healthcare System University Drive C Pittsburgh, PA 15240

Deliveries should be marked for: “Pathology & Laboratory Medicine Service – Histology”

Product Descriptions

CLIN 0001 Actin, Muscle Specific Roche Catalog Number: 760-2601 Unit Conversion: 50 tests Controls: Skeletal Muscle Isotypes: IgG1/K Clone Name: HHF35 Species: Mouse Localization: Cytoplasmic Regulatory Status: IVD

Actin is a major component of the cytoskeleton. This antibody recognizes actin of skeletal, cardiac, and smooth muscle cells. It is not reactive with other mesenchymal cells except for Myoepithelium. Actin can be resolved on the basis of its isoelectric points into three distinctive components: alpha, beta, and gamma in order of increasing isoelectric point. Muscle Specific Actin recognizes alpha and gamma isotypes of all muscle groups. Non-muscle cells such as vascular endothelial cells and connective tissues are nonreactive. Also neoplastic cells of non-muscle-derived tissue such as carcinomas, melanomas and lymphomas are negative. This antibody is useful in the identification of rhabdoid cellular elements.

CLIN 0002 Androgen Receptor Roche Catalog Number: 760-4605 Unit Conversion: 50 tests Controls: Prostate Isotypes: IgG Clone Name: SP107 Species: Rabbit Localization: Nuclear Regulatory Status: IDV

Androgen Receptor (SP107) antibody is intended for qualified laboratories to qualitatively identify by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffin-embedded tissue sections using IHC test methods. This antibody is used as an aid in the identification of Androgen Receptor positivity in human tissues within the context of an antibody panel, the patient’s clinical history, and other diagnostic tests evaluated by a qualified pathologist. This antibody is intended for in vitro diagnostic (IVD) use.

CLIN 0003 AFB III Staining Kit Roche Catalog Number: 860-027 Unit Conversion: 75 tests Controls: Tissue Positive for Acid-Fast Bacteria

AFB III Staining Kit is used to selectively demonstrate Mycobacterium and other acid fast organisms and components in tissue. AFB III Staining Kit is a modification of the Ziehl-Neelsen stain. A carbol fuchsin solution is used to stain acid fast organisms and components red. Aniline blue counterstain is applied to provide contrasting blue background.

CLIN 0004 Alpha-1-Fetoprotein (AFP) Roche Catalog Number: 760-2603 Unit Conversion: 50 tests Controls: Fetal Liver Clone Name: Polyclonal Species: Rabbit Localization: Cytoplasmic Regulatory Status: IVD.

Positive staining with anti-AFP antibody is seen in hepatocytes of fetal liver and hepatoma. Since only the traces of AFP are found in adult serum, elevated levels suggest either a benign or malignant lesion of the liver, a yolk sac carcinoma or one of a few other tumors. In conjunction with elevated serum levels, AFP has been immunehistochemically demonstrated in yolk sac carcinomas of gonadal and extragonadal sites, in hepatic malignancies, and a few other neoplasms. The antigen is not denatured by most fixatives.

CLIN 0005 CONFIRM ALK1

Roche Catalog Number: 790-2918 Unit Conversion: 50 tests Controls: Anaplastic Large Cell Lymphoma Isotypes: IgG3/K Clone Name: ALK01 Species: Mouse Localization: Nuclear, Cytoplasmic Regulatory Status: IVD CONFIRM anti-ALK1 (ALK01) recognizes a formalin resistant epitope in both the p80 protein, identified as a hybrid of the anaplastic lymphoma kinase (ALK) protein and the nucleophosmin (NPM) protein and the 200 kD normal ALK proteins. CONFIRM anti-ALK1(ALK01) may also recognize any ALK protein chimeric produced as a result of variant translocations involving the ALK gene on chromosome 2. CONFIRM anti-ALK1 (ALK01) recognizes varying degrees of ALK expression in both the cytoplasm and nucleus of anaplastic lymphoma cells. ALK protein expression is substantially specific for anaplastic lymphomas, except for weak expression in some normal cells in the central nervous system including neurons, glial cells, and endothelial cells. ALK expression may also be seen in inflammatory myofibroblastic tumors and rare rhabdomyosarcomas.

CLIN 0006 Amplification Kit Roche Catalog Number: 760-080 Unit Conversion: 100 tests May be used in conjunction with Ventana IHC detection kits to increase the signal intensity of weak staining mouse and rabbit primary antibodies. Reagents are provided pre-diluted and ready-to-use for convenient operation on NexES IHC and BenchMark Series automated slide stainers. Components: Amplifier A, Amplifier B CLIN 0007 CONFIRM bcl-2 Roche Catalog Number: 790-4464 Unit Conversion: 50 tests Controls: Interfollicular T Cells in Tonsil, B Cells of the Mantle Zone Isotypes: IgG1 Clone Name: 124 Species: Mouse Localization: Cytoplasmic Regulatory Status: IVD CONFIRM anti-bcl-2 (124) Mouse Monoclonal Primary Antibody is directed against human bcl-2 expressed by B cells of the mantle zone and interfollicular T cells. This antibody exhibits a cytoplasmic staining pattern and may be used to aid in the identification of follicular lymphomas and diffuse large cell lymphomas, and to differentiate follicular lymphomas from reactive lymph nodes.

CLIN 0008 bcl-6 Roche Catalog Number: 760-4241 Unit Conversion: 50 tests Controls: Lymph Node, Tonsil Isotypes: IgG1 Clone Name: GI191E/A8 Species: Mouse Localization: Nuclear Regulatory Status: IVD Anti-bcl-6 is a transcriptional regulator gene which codes for a 706-amino acid nuclear zinc finger protein. Antibodies to this protein stain the germinal center cells in lymphoid follicles, the follicular and interfollicular cells in follicular lymphoma, diffuse large B-cell lymphomas and Burkitt's lymphoma, and the majority of the Reed-Sternberg cells in nodular lymphocyte predominant Hodgkin's Disease. In contrast, anti-bcl-6 rarely stains mantle cell lymphoma and MALT lymphoma. bcl-6 expression is seen in approximately 45% of CD30+ anaplastic large cell lymphomas but is consistently absent in other peripheral T-cell lymphomas.

CLIN 0009 Bluing Reagent Roche Catalog Number: 760-2037 Unit Conversion: 250 tests

Ready-to-use solution that can be applied after hematoxylin to change the hue of hematoxylin to a blue color. For use on NexES IHC and BenchMark Series automated slide stainers. Single, ready-to-use dispenser.

CLIN 0010 CA 19-9

Roche Catalog Number: 760-2609 Unit Conversion: 50 tests Controls: Colon, Salivary Gland Isotypes: IgM Clone Name: 121SLE Species: Mouse Localization: Cytoplasmic Regulatory Status: IVD

CA 19-9 antigen is highly expressed in gastrointestinal (gastric, pancreatic, and colonic) adenocarcinomas and salivary gland mucoepidermoid carcinomas. Anti-CA 19-9 antibody is usually not reactive with breast, kidney, and prostate carcinomas.

CLIN 0011 CONFIRM Calretinin Roche Catalog Number: 790-4467 Unit Conversion: 50 tests Controls: Mesothelioma, Normal Appendix Clone Name: SP65 Species: Rabbit Localization: Cytoplasmic, Nuclear Regulatory Status: IVD

CONFIRM anti-Calretinin (SP65) Rabbit Monoclonal Primary Antibody is directed against the calcium binding protein, calretinin, expressed by normal and reactive mesothelium, eccrine glands of skin, Sertoli cells of the testis, ovarian stromal cells and adrenal cortical cells. This antibody exhibits a nuclear and cytoplasmic staining pattern and may be used to aid in the identification of mesothelioma, and in distinguishing mesothelioma from adenocarcinoma.

CLIN 0012 Cell Conditioning 1 (CC1) Roche Catalog Number: 950-124 Unit Conversion: 2 L bottle Format: Ready to Use

Solution used as a pretreatment step in the processing of tissue samples for immunohistochemistry reactions carried out on BenchMark Series automated slide stainers. CC1 is a tris-based buffer with a slightly basic pH, which, at elevated temperatures is capable of disrupting the covalent bonds formed by formalin in tissue. Removing these bonds allows renaturation of protein molecules and increases antibody accessibility. Often these changes result in significant gains in antibody binding and improved signal to noise ratios.

CLIN 0013 Cell Conditioning 2 (CC2) Roche Catalog Number: 950-123 Unit Conversion: 1 L bottle Format: Ready to Use

Solution used as a pretreatment step in the processing of tissue samples for all immunohistochemistry reactions carried out on BenchMark Series automated slide stainers. CC2 is a citrate buffer at a slightly acidic pH, which, at elevated temperatures, is capable of disrupting the covalent bonds formed by formalin in tissue. Removing these bonds allows renaturation of protein molecules and increases antibody accessibility. Often these changes result in significant gains in antibody binding and improved signal to noise ratios.

CLIN 0014 CONFIRM CD3

Roche Catalog Number: 790-4341 Unit Conversion: 50 tests Controls: Spleen,Tonsil Clone Name: 2GV6 Species: Rabbit Localization: Cytoplasmic, Membranous Regulatory Status: IVD

CONFIRM anti-CD3 (2GV6) Primary Antibody is a rabbit monoclonal antibody (IgG) directed against the nonglycosylated epsilon chain of the human CD3 molecule. CD3 is expressed in the membrane and cytoplasm of normal and neoplastic T cells. The CD3 antigen is first detectable in early thymocytes and its appearance probably represents one of the earliest signs of commitment to the T cell lineage. This antibody detects both normal and neoplastic T cells.

CLIN 0015 CONFIRM CD4

Roche Catalog Number: 790-4423 Unit Conversion: 50 tests Controls: Liver, Tonsil Clone Name: SP35 Species: Rabbit Localization: Membranous Regulatory Status: IVD

CONFIRM anti CD4 (SP35) Rabbit Monoclonal Primary Antibody is intended for the qualitative detection of CD4 in sections of formalin-fixed, paraffin-embedded normal and neoplastic human tissues. CD4 is present on helper-inducer T lymphocytes that recognize antigen in the context of MHC class 2 molecules. CD4 positive staining results may aid in identifying T-cell lymphomas and in identifying the T helper-inducer cell subset of T-lymphocytes in normal tissues.

CLIN 0016 CONFIRM CD5

Roche Catalog Number: 790-4451 Unit Conversion: 50 tests Controls: Tonsil, Lymphoma Clone Name: SP19 Species: Rabbit Localization: Cell Membrane, Cytoplasmic Regulatory Status: IVD

CONFIRM anti-CD5 (SP19) Rabbit Monoclonal Primary Antibody is directed against human CD5 expressed on the plasma membrane of virtually all human T cells and the B1a subset of human B cells found in the follicular mantle zones, bone marrow and peripheral blood. Staining CD5 is commonly used as part of several IHC panels to determine T cell and B cell sub-classifications. CD5 may be used to aid in the identification of T cell lymphomas, and certain B cell lymphomas, including mantle cell lymphoma.

CLIN 0017 CD7

Roche Catalog Number: 790-4558 Unit Conversion: 50 tests Controls: Thymus, Tonsil Isotypes: Rabbit Ig Clone Name: SP94 Species: Rabbit Localization: Membranous Regulatory Status: IVD

Anti-CD7 (SP94) Rabbit Monoclonal Primary Antibody is directed against the 40kD transmembrane glycoprotein, CD7 which is present in thymocytes and mature T cells. Anti-CD7 (SP94) may be used to aid in the identification of T cell lymphomas.

CLIN 0018 CONFIRM CD8

Roche Catalog Number: 790-4460 Unit Conversion: 50 tests Controls: Tonsil, T Cell Lymphoma Clone Name: SP57 Species: Rabbit Localization: Cell Membrane Regulatory Status: IVD

CONFIRM anti-CD8 (SP57) Rabbit Monoclonal Primary Antibody is intended for the qualitative detection of CD8 in sections of normal and neoplastic human tissues. The CD8 glycoprotein is present on cytotoxic/suppressor T lymphocytes that recognize antigen in the context of MHC class 1 molecules. CD8 positive staining results may aid in identifying T cell lymphomas and in identifying the T cytotoxic/suppressor cell subset of T lymphocytes in normal tissues.

CLIN 0019 CONFIRM CD15

Roche Catalog Number: 760-2504 Unit Conversion: 50 tests Controls: Hodgkins Lymphoma Isotypes: IgM Clone Name: MMA Species: Mouse Localization: Cytoplasmic, Membranous Regulatory Status: IVD

Antibodies against CD15 normally react in a strong cell surface membrane staining pattern with granulocytes and granulocyte precursors, monocytes, a subset of tissue macrophages, and activated T lymphocytes. CONFIRM anti-CD15 (MMA) also reacts against the Reed-Sternberg cells of Hodgkin's disease and, because it recognizes a carbohydrate antigen, is also expressed by a variety of carcinoma types but is negative in malignant mesotheliomas. Antibodies against CD15 are used diagnostically to (1) support a diagnosis of acute myeloid leukemia, (2) help support a diagnosis of Hodgkin'sdisease, and (3) help separate poorly differentiated adenocarcinomas from malignant mesothelioma.

CLIN 0020 CONFIRM CD20

Roche Catalog Number: 760-2531 Unit Conversion: 50 tests Controls: Lymph Node, Tonsil Isotypes: IgG2a/K Clone Name: L26 Species: Mouse Localization: Membranous Regulatory Status: IVD

CONFIRM anti-CD20 (L26) specifically binds to antigens located in the plasma membrane and cytoplasmic regions of normal B lymphocytes and may also be expressed in Reed-Sternberg cells. This phosphoprotein is found on the surface of normal and malignant B cells and is thought to act as a receptor during B cell activation and differentiation. Plasma cells are negative for CD20. CONFIRM anti-CD20 (L26) can be used to detect B cells from peripheral blood, lymph node, spleen, tonsil and bone marrow. It is also used in the classification of a majority of B cell malignancies, including many acute leukemias and chronic lymphocytic leukemias.

CLIN 0021 CD21

Roche Catalog Number: 760-4245 Unit Conversion: 50 tests Controls: Lymph Node, Tonsil Isotypes: IgG2a Clone Name: 2G9 Species: Mouse Localization: Membranous Regulatory Status: IVD

CD21 antigen is an integral membrane glycoprotein of molecular weight 145 kD. Anti-CD21 is useful in the identification of follicular dendriditic cell matrix found in normally lymph nodes and tonsillar tissue. This antibody also labels follicular dendritic cell tumor/sarcomas. The antigen is absent on T lymphocytes, monocytes, and granulocytes.

Quantity: 2 box

CLIN 0022 CONFIRM CD23

Roche Catalog Number: 790-4408 Unit Conversion: 50 tests Controls: Tonsil Clone Name: SP23 Species: Rabbit Localization: Cytoplasmic Regulatory Status: IVD

Expression of CD23 has been detected in neoplastic cells from cases of B-cell chronic lymphocytic leukemias and B-cell small lymphocytic lymphomas. Some hairy cell leukemias and diffuse large B-cell lymphomas are likewise positive. CD23 is generally absent on mantle cell lymphomas. Accordingly, CD23 staining may be used in the classification of small lymphocytic lymphomas (usually positive) and mantle cell lymphomas (usually negative).

CLIN 0023 CONFIRM CD30

Roche Catalog Number: 790-4858 Unit Conversion: 50 tests Controls: Hodgkins Lymphoma Isotypes: IgG1/K Clone Name: Ber-H2 Species: Mouse Localization: Membranous Regulatory Status: IVD

CD30 antigen is expressed in mononuclear Hodgkin's cells and multinucleated Reed Sternberg cells of Hodgkin's lymphoma as well as on anaplastic large cell lymphomas. This antibody variably produces membranous, cytoplasmic and Golgi staining of both lymphoma cells and of scattered large activated B and T cells in lymph nodes, spleen, tonsil, and thymus. This antibody may also stain a small proportion of plasma cells.

CLIN 0024 CD31

Roche Catalog Number: 760-4378 Unit Conversion: 50 tests Controls: Appendix, Placenta, Tonsil Isotypes: IgG1/K Clone Name: JC70 Species: Mouse Localization: Cytoplasmic, Membranous Regulatory Status: IVD

CD31 is expressed by stem cells of the hematopoietic system and is primarily used to identify and concentrate these cells for experimental studies as well as for bone marrow transplantation. Endothelial cells also express this marker, therefore, antibodies to CD31 have been used as a tool to identify the vascular origin of neoplasms. CD31 has shown to be highly specific and sensitive for vascular endothelial cells. Staining of nonvascular tumors (excluding hematopoietic neoplasms) has not been observed.

CLIN 0025 CONFIRM CD34

Roche Catalog Number: 790-2927 Unit Conversion: 50 tests Controls: Appendix, Placenta, Tonsil Isotypes: IgG1 Clone Name: QBEnd/10 Species: Mouse Localization: Membranous Regulatory Status: IVD

CD34 is selectively expressed on human lymphoid and myeloid hematopoietic progenitor cells. The antigen is also expressed on vascular endothelium. CD34 antibody is of value for the identification of vascular tumors and for the characterization of leukemias.

CLIN 0026 CONFIRM CD45 (LCA)

Roche Catalog Number: 760-2505 Unit Conversion: 50 tests Controls: Tonsil Isotypes: IgG1/K Clone Name: RP2/18 Species: Mouse Localization: Membranous Regulatory Status: IVD

CD45, LCA is expressed on the cytoplasmic membrane of T and B lymphocytes, monocytes, macrophages, mast cells, and weakly on granulocytes. CONFIRM anti-CD45, LCA (RP2/18) is directed against the CD45RB epitope found on the membrane of leukocytic cells. CONFIRM anti-CD45, LCA (RP2/18) has been shown to react with the 220-, 205-, and 190 kD isoforms of CD45.

CLIN 0027 CONFIRM CD56

Roche Catalog Number: 790-4465 Unit Conversion: 50 tests Controls: Brain, Normal Pancreas Isotypes: IgG1 Clone Name: 123C3 Species: Mouse Localization: Membrane, Cytoplasmic Regulatory Status: IVD

CONFIRM anti-CD56 (123C3) Mouse Monoclonal Primary Antibody is directed against the CD56 molecule or neural cell adhesion molecule expressed by most neuroectodermally derived cell lines, tissues and neoplasms. It is also expressed on some mesodermally derived tumors, on natural killer cells, and NK cell lymphomas. This antibody exhibits a membrane/cytoplasmic staining pattern and may be used to aid in the identification of small cell carcinomas, neuroblastoma, and rhabdomyosarcoma.

CLIN 0028 CONFIRM CD68

Roche Catalog Number: 790-2931 Unit Conversion: 50 tests Controls: Lymph Node, Tonsil Isotypes: IgG1/K Clone Name: KP-1 Species: Mouse Localization: Cytoplasmic, Membranous Regulatory Status: IVD

CONFIRM anti-CD68 reacts with a 110 kD intracellular glycoprotein associated with the cell membrane of macrophages and some myeloid elements.

CLIN 0029 CONFIRM CD99

Roche Catalog Number: 790-4452 Unit Conversion: 50 tests Controls: Pancreatic Islet Cells, Sertoli Cells of the Testis Isotypes: IgG1 Clone Name: O13 Species: Mouse Localization: Membranous Regulatory Status: IVD

CONFIRM anti-CD99 (O13) Mouse Monoclonal Primary Antibody is directed against human CD99 expressed on T lymphocytes, cortical thymocytes, granulosa cells of the ovary, pancreatic islet cells, CNS ependymal cells and Sertoli's cells. CD99 shows a plasma membrane location. This antibody may be used as part of a panel to aid in the identification of Ewing's sarcoma and related peripheral neuroectodermal tumors.

CLIN 0030 Carcinoembryonic Antigen (CEA) Roche Catalog Number: 760-2507 Unit Conversion: 50 tests Controls: Colon Isotypes: IgG1 Clone Name: TF3H8-1 Species: Mouse Localization: Cytoplasmic Regulatory Status: IVD

CEA (TF 3H8-1) Primary Antibody may be used to aid in the identification of cells of normal and abnormal epithelial lineage as an aid in diagnosis of anaplastic tumors. CEA is a highly glycosylated protein with a molecular weight of approximately 180 kD, and has the cluster designation CD66e. Positive staining carcinomas have been reported in colon, pancreas, lung and breast.

CLIN 0031 Chromogranin A Roche Catalog Number: 760-2519 Unit Conversion: 50 tests Controls: Pancreas Isotypes: IgG1/K Clone Name: LK2H10 Species: Mouse Localization: Cytoplasmic Regulatory Status: IVD

Anti-Chromogranin A (LK2H10) specifically binds to the chromogranin A protein located in the secretory granules of normal and neoplastic neuroendocrine cells. Chromogranin A is also expressed by adrenal (medulla), parathyroid, anterior pituitary cells, islet cells of the pancreas, gastrointestinal cells, bronchial endocrine cells, and thyroid C cells. Chromogranin A is expressed in tumors of neuroendocrine origin, including pheochromocytomas, pituitary adenomas, islet cell tumors, medullary thyroid carcinomas, carcinoids and Merkel cell tumors. This reagent may be used to aid in the identification of cells of normal or neoplastic neuroendocrine lineage.

CLIN 0032 Anti-Cytokeratin 5/6 Roche Catalog Number: 790-4554 Unit Conversion: 50 tests Controls: Normal Prostate and Tonsil Clone Name: D5/16B4 Species: Mouse Localization: Cytoplasmic Regulatory Status: IVD

Anti- Cytokeratin 5/6 (D5/16B4) ia a mouse monoclonal antibody produced in response to immunizing human cytokeratin 5 protein. Cytokeratin 5 is expressed in various epithelia and mesothelial cells while cytokeratin 6 is expressed by proliferating squamous epithelium. Cytokeratin 5/6 is useful in the determination of breast and prostate malignancies.

CLIN 0033 CONFIRM Cytokeratin 7 Roche Catalog Number: 790-4462 Unit Conversion: 50 tests Controls: Breast, Salivary Gland, Glandular and Ductal Epithelium of Lung Clone Name: SP52 Species: Rabbit Localization: Cytoplasmic Regulatory Status: IVD

CONFIRM anti-Cytokeratin 7 (SP52) Rabbit Monoclonal Primary Antibody is directed against a type II cytokeratin protein expressed by most ductal, glandular and transition alepithelia. Cytokeratin 7 exhibits a cytoplasmic localization. This antibody may be used to aid in the identification of normal and neoplastic cells of ovary, lung and breast epithelial origin which express Cytokeratin 7, and those of colonic and prostate epithelial lineage which lack Cytokeratin 7 production.

CLIN 0034 CONFIRM Cytokeratin 20 Roche Catalog Number: 790-4431 Unit Conversion: 50 tests Controls: Colon Adenocarcinoma Clone Name: SP33 Species: Rabbit Localization: Cytoplasmic

CONFIRM anti-Cytokeratin 20 (SP33) Rabbit Monoclonal Primary Antibody is directed against a type I cytokeratin protein of mature enterocytes and goblet cells of the gastric and intestinal mucosa. This antibody produces a cytoplasmic staining pattern, and may be used to aid in the identification of normal cytokeratin 20 expressing cells and neoplastic cells of colonic epithelial lineage.

CLIN 0035 Congo Red Staining Kit Roche Catalog Number: 860-026 05279429001 Unit Conversion: 40 tests Controls: Tissue Positive for Amyloid

Congo Red Staining Kit is used to selectively demonstrate Amyloid in tissue sections. The staining reaction is based on the application of congo red which stains the patterns of atypical proteins (amyloid). The b-pleated sheets of amyloid are suitable in size and shape to accommodate the congo red molecules, which are held in the lattice work of the b-pleated sheets. Birefringence is an intrinsic property of the amyloid fibril congo red complex. Congo red may also stain unexpected structures such as: keratin, elastic and dense collagen fibers. Without both the red staining of congo red and the apple green birefrengence under polarization a definite identification cannot be made. The hematoxylin is applied as a contrasting blue nuclear stain. The Congo Red Staining Kit stains amyloid a bright pink to red and nuclei blue. Amyloid may appear as circular or ribbon-like pink staining deposits throughout the tissue. It has a particular predilection for deposition in blood vessel walls and basement membranes. Nuclear staining may vary from light to dark blue depending on the tissue section and thickness (6-10 microns).

CLIN 0036 ANTI- CYCLIN D1

Roche Catalog Number: 790-4508 Quantity: 50 Tests Controls: Normal Tonsil Isotypes: IgG Clone Name: SP4-R Species: Rabbit Localization: Lymphocytic

Anti-Cyclin D1 is an established oncogene, important in the development of many cancers, exhibits a nuclear staining pattern and is used to identify mantle cell lymphoma from small lymphocytic lymphoma.

Anti-Cyclin D1 also plays a significant role in detection of breast carcinoma.

CLIN 0037 Podoplanin Roche Catalog Number: 760-4395 Unit Conversion: 50 tests Controls: Lymph Node, Lymphangioma Isotypes: IgG1 Clone Name: D2-40 Species: Mouse Localization: Cytoplasmic Regulatory Status: IVD

Podoplanin is a transmembrane mucoprotein (38 kd) recognized by the D2-40 monoclonal antibody. Podoplanin is selectively expressed in lymphatic endothelium as well as lymphangiomas, Kaposi sarcomas and in a subset of angiosarcomas with probable lymphatic differentiation. Podoplanin has also been shown to be expressed in epithelioid mesotheliomas hemangioblastomas and seminomas.

CLIN 0038 CONFIRM Desmin Roche Catalog Number: 760-2513 Unit Conversion: 50 tests Controls: Intestine Isotypes: IgG1/K Clone Name: DE-R-11 Species: Mouse Localization: Cytoplasmic Regulatory Status: IVD

CONFIRM anti-Desmin (DE-R-11) identifies normal muscle cells and myogenic neoplasms bearing the desmin antigen. The most obvious application of anti-desmin antibodies is in the characterization of myogenic neoplasms or in the recognition of myogenic cell lines in mixed sarcomas. Among neoplasms, carcinomas do not react with anti-desmin antibodies, leiomyosarcomas, and rhabdomyosarcomas are positive, and other sarcomas (with some exceptions) are negative. Myogenic sarcomas can be classified as such, due to their positive staining with antibodies to muscle (specific) actin and desmin. Because of the different sensitivities and specificities of these antibodies, they are best used in combination.

CLIN 0040 Diastase Kit Roche Catalog Number: 860-004 05279208001 Unit Conversion: 75 tests Controls: Liver Diastase is an enzyme which selectively digests (breaks down) glycogen. It is used to remove glycogen from tissue. This produces "negative PAS" staining of the glycogen. Any remaining PAS staining after diastase digestion must be due to non-glycogen protein-bound neutral polysaccharides, such as mucin or fungus. Diastase for PAS is an accessory reagent that is used with the PAS Staining Kit to a) identify glycogen with certainty, by its removal and/or b) eliminate it from the tissue section when it is interfering with the identification of other PAS-positive tissue structures. Because the glycogen is removed, the magenta staining is absent, but the nuclei still stain light purple with the Hematoxylin Counterstain. Note: This is not a stand-alone reagent; it must be used in conjunction with PAS Staining Kit.

CLIN 0041 EMA (Epithelial Membrane Antigen) Roche Catalog Number: 790-4463 Unit Conversion: 50 tests Controls: Normal Pancreas Isotypes: IgG2a Clone Name: E29 Species: Mouse Localization: Cytoplasmic, Membranous Regulatory Status: IVD

CONFIRM anti-EMA (E29) Mouse Monoclonal Primary Antibody is directed against epithelial membrane antigen expressed on the apical surface of glandular epithelia. This glycoprotein is primarily membrane localized on normal and tumor tissue, although it may exhibit a cytoplasmic localization in less differentiated carcinomas. This antibody may be used to aid in the identification of epithelial membrane antigen in adenocarcinomas derived from secretory epithelia, malignant mesothelioma, renal cell carcinomas and meningiomas.

CLIN 0042 Ep-CAM (Epithelial Specific Antigen) Roche Catalog Number: 760-4383 Unit Conversion: 50 tests Controls: Adenocarcinoma, Columnar Epithelium Isotypes: IgG1/K Clone Name: Ber-EP4 Species: Mouse Localization: Cytoplasmic Regulatory Status: IVD

Ep-CAM consists of two glycoproteins, 34 and 39 kDa, sometimes designated epithelial antigen, epithelial specific antigen, and epithelial glycoprotein. The glycoproteins are located on the cell membrane surface and in the cytoplasm of virtually all epithelial cells with the exception of most squamous epithelia, hepatocytes, renal proximal tubular cells, gastric parietal cells and myoepithelial cells. However, focal positivity may be seen in the basal layer of squamous cell epithelium of endoderm (e.g., palatine tonsils) and mesoderm (e.g., uterine cervix). In liver lesions like hepatitis and cirrhosis, the hepatocytes frequently become Ep-CAM positive. Normal mesothelial cells are Ep-CAM negative, but may express focal reaction when undergoing reactive changes. Mesenchymal cells and cells from the neural crest are negative, with the exception of olfactory neurons.

Ep-CAM is found in the large majority of adenocarcinomas of most sites (50-100% invarious studies); as well as neuroendocrine tumours, including small cell carcinoma. Renal cell carcinoma and hepatocellular carcinoma stain in about 30% of the cases. Squamous cell carcinoma of endoderm and mesoderm is usually Ber-EP4 positive, while that of ectoderm is negative. Basal cell and basosquamous carcinoma are Ber-EP4 positive in almost all cases. Choroid plexus papilloma and carcinoma are usually negative. Malignant mesothelioma (epithelioid and biphasic) is Ep-CAM positive in 4-26% of the cases. The staining is usually focal, but may occasionally be widespread. Synovial sarcoma (epitheloid and biphasic) and desmoplastic small round cell tumour stain for Ep-CAM in most cases.

Seminoma, embryonal carcinoma, yolk sac tumor and choriocarcinoma reveal Ber-EP4 positivity in a minor proportion of cases. Among neural tumours, Ep-CAM positivity is seen only in olfactory neuroblastoma. Ep-CAM can be of great help in the differential diagnosis of malignant involvement in the peritoneal and pleural cavities. The lack of reactivity in the majority of malignant mesothelioma can in an appropriate panel be utilized in the discrimination between this tumour and adenocarcinoma.

CLIN 0043 EZ Prep (10x) Roche Catalog Number: 950-102 Unit Conversion :2 L bottle Format: Concentrate

Solution that, when diluted ten-fold, is used for paraffin removal from tissue samples during immunohistochemistry reactions carried out on…