SOLE-SOURCE DETERMINATION The Purchasing Division has been requested to approve a sole source purchase for the commodity or service described below. Pursuant to West Virginia Code 5A-3-10c, the Purchasing Division is attempting to determine whether the commodity or service is a sole source procurement. If you believe your company meets the required experience and qualification criteria stated below, please e-mail the Purchasing Division Buyer at Roberta.A.Wagner@wv.gov with a copy to w.michael.sheets@wv.gov to express your interest in the project. Please forward any and all information that will support your company s compliance with required qualification and eligibility criteria along with any other pertinent information relative to this project to the Purchasing Division no later than 1:30 PM on 11/26/2012. Requisition Number: LBS13085 Department/Agency: WVDHHR, Bureau for Public Health, Office of Laboratory Services Detailed Description of Project: To provide Bio-Rad approved Hepatitis A, B, C reagent and Human Immunodeficiency Virus (HIV) assay test kits, calibrators, and related disposables that will run on an automated, selfcontained Evollis Microplate Processor or equal with an Evolis UPS already in place and currently being used by the Office of Laboratory Services. Proposed Sole Source Vendor: Bio-Rad Laboratories, Inc. 6565 185 th. Avenue, NE Redmond, WA 98052 Specific Eligibility Criteria: Tests must be Bio-Rad approved and meet the following requirements: 1. HIV Kit, Bio-Rad HIV-1/2 Plus O, Bio-Rad Product #32588 or equal a. Test must be approved by the US Food and Drug Administration (FDA) for the detection of HIV-1, HIV-1 Group O and HIV2 in human serum, plasma or cadaveric serum specimens. b. Test must use a form of Enzyme Immunoassay (EIA) 2. HIV Combo Kit, Bio-Rad HIV Combo Ag/Ab, Bio-Rad Product #26217 or equal a. Test must be FDA approved for the detection of HIV p24 antigen and antibodies to HIV-1 (groups M and O) and HIV-2 in human or plasma. b. Test must use a form of EIA. 3. Hepatitis A Immunoglobulin M (HEPA-IgM) Kit, Bio-Rad Monolisa Anti- HAV IgM, Bio-Rad Product #72495 or equal.
a. Test must be FDA approved for in vitro detection of Anti-HAV IgM in adult and pediatric patients (serum or plasma). b. Test must use a form of EIA. 4. Hepatitis B Surface Antigen (HBsAG) Kit, Bio-Rad HBsAG 3.0 EIA, Bio-Rad Product #32591 or equal. a. Test must be FDA approved for the detection of Hepatitis B Surface Antigen in human serum, plasma, and cadaveric serum specimens. b. Test must use a form of EIA. 5. Hepatitis B Surface Antigen Confirmatory Kit, Bio-Rad HBsAG 3.0 Confirmatory Assay, Bio-Rad Product #32594 or equal. a. Test must be FDA approved for testing of specimens using serum, plasma, and cadaveric serum. b. Test must use a form of EIA 6. Hepatitis B Core Antibody (Anti-HBc) Kit, Bio-Rad Monolisa Anti-HBc, Bio-Rad Product #26186 or equal. a. Test must be FDA approved for the detection of total antibodies to Hepatitis B Nucleocapsid Antigen (core) in human serum and plasma. b. Test must use a form of EIA. 7. Hepatitis B Surface Anti-body (Anti-HBs) Kit, Bio-Rad Monolisa Anti- HBs, EIA, Bio-Rad Product #25220 or equal. a. Test must be FDA approved for the qualitative and quantitative detection of Antibody to Hepatitis B Surface Antigen (anti-hbs) in human serum and Ethylenediaminetetraacetic acid (EDTA) or citrated plasma. b. Test must use a form of EIA 8. Hepatitis B Core - IGM (HepB-IgM) Kit, Bio-Rad Monolisa Anti-HBc IgM EIA, Bio-Rad Product #26174 or equal. a. Test must be FDA approved for the detection of IgM Antibody to Hepatitis B Core Antigen (anti-hbc IgM) in human serum and plasma. b. Test must use a form of EIA 9. Hepatitis C (HCV), Bio-Rad HCV EIA v3.0, Bio-Rad Product #930740 or equal. a. Test must be FDA approved for the detection of antibody to Hepatitis C Virus (Anti-HCV) in human serum or plasma. b. Test must use a form of EIA. 10. Hepatitis C (HCF) Wash Solution, Bio-Rad Ortho HCF Wash Solution, Bio-Rad Product #933730 or equal. 11. Hepatitis C (HCV) Stop Solution, Bio-Rad Ortho HCV Stop Solution, Bio-Rad Product #933040 or equal. 12. Anti-HAV IgM, Monolisa Barcode Kit, Bio-Rad Product #26190 or equal 13. Anti-HBs EIA Barcode Kit, Bio-Rad Product #25280 or equal 14. GSC HBsAG 3.0 Barcode Kit, Bio-Rad Product #25163 or equal 15. GSC HBsAG 3.0 Confirmatory Barcode Kit, Bio-Rad Product #25163 or equal. 16. Barcode Kit, HIV-1/2 PLUS-O Seq, Bio-Rad Product #25064 or equal
17. HIV Combo Ag/Ab Bv Seg Barcode Kit, Bio-Rad Product #26214A or equal. 18. Monolisa Anti-HBc Barcode Kit, Bio-Rad Product #26184 or equal 19. Monolisa Anti-HBclgM Barcode Kit, Bio-Rad Product #26185 or equal 20. Monolisa Anti-HBs Calabrator Kit, Bio-Rad Product #25219 or equal 21. ODS Ortho HVC 3.0 Barcode Kit, Bio-Rad Product #31113 or equal 22. Tips, Conductive, 1100ul, 960 per box, Bio-Rad Product #25098 or equal. 23. Tips, Conductive, 300ul, 960 per box, Bio-Rad Product #25097 or equal. 24. Performance Evaluation Kit, Evo, Bio-Rad Product #89894 or equal. Specific Qualification Criteria: Bio-Rad Laboratories owns the Evolis Microplate Processor (Catalog Number 89700DR) with an Evolis UPS (Catalog Number 4260206) and has provided it for use to the Office of Laboratory Services at no charge. The terms and conditions of the equipment require that only Bio-Rad approved reagents, calibrators, and disposables be used. Bio-Rad Laboratories is the sole-source provider of its products.