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Fully Executed Page 1 of 4 FULLY EXECUTED - CHANGE 1 Contract Number: 4400022351 Original Contract Effective Date: 01/22/2020 Valid From: 02/01/2020 To: 01/31/2023 All using Agencies of the Commonwealth, Participating Political Subdivision, Authorities, Private Colleges and Universities Purchasing Agent Name: Danner Shawn Your SAP Vendor Number with us: 135557 Phone: 717-787-8085 Fax: Supplier Name/Address: CENTER FOR DISEASE DETECTION LLC P.O. Box 8112 BURLINGTON NC 27216-8112 US Please Deliver To: To be determined at the time of the Purchase Order unless specified below. Supplier Phone Number: 2109515189 Supplier Fax Number: 210-590-3121 Contract Name: Payment Terms STD/ HIV Laboratory Services NET 30 Solicitation No.: Issuance Date: Supplier Bid or Proposal No. (if applicable): Solicitation Submission Date: This contract is comprised of: The above referenced Solicitation, the Supplier's Bid or Proposal, and any documents attached to this Contract or incorporated by reference. Item Material/Service Qty UOM Price Per Total Desc Unit 1 HIV-1/2 Ag/Ab Immunoassay (4th 0.000 Each 6.00 1 0.00 Generatio Item Text FDA-approved antigen/antibody (Ag/Ab) immunoassay (4th generation) with an antibody immunoassay that differentiates HIV-1 antibodies from HIV-2 antibodies. -------------------------------------------------------------------------------------------------------------------------------------------------------- 2 Geenius HIV 1/2 Differentiation Assay 0.000 Each 43.00 1 0.00 Item Text FDA-approved qualitative assay for the confirmation and differentiation of individual antibodies to HIV-1 and HIV-2 in whole blood, serum, or plasma specimens. -------------------------------------------------------------------------------------------------------------------------------------------------------- 3 HIV-1 quantitative viral load 0.000 Each 100.00 1 0.00 Information: Supplier's Signature _________________________________ Title ____________________________________ Printed Name _________________________________ Date _____________________ Integrated Environment Systems Form Name: ZM_SFRM_STD_MMCOSRM_L, Version 1.0, Created on 06/27/2006, Last changed on 03/29/2005. Page 2 of 4 FULLY EXECUTED - CHANGE 1 Contract Number: 4400022351 Original Contract Effective Date: 01/22/2020 Valid From: 02/01/2020 To: 01/31/2023 Supplier Name: CENTER FOR DISEASE DETECTION LLC Item Material/Service Qty UOM Price Per Total Desc Unit Item Text FDA-approved quantitative test that measures the amount of HIV-1 in a blood sample. Results are reported as the number of copies of HIV RNA per milliliter of blood, and used to diagnose acute HIV infection, guide treatment choices, and monitor response to antiretroviral therapy (ART). -------------------------------------------------------------------------------------------------------------------------------------------------------- 4 HIV-1 qualitative Nucleic Acid Test 0.000 Each 100.00 1 0.00 Item Text FDA-approved qualitative nucleic acid testing (NAT) for HIV-1 RNA in cases where the initial immunoassay is reactive (or repeatedly reactive if recommended by manufacturer), and negative on the HIV-1/HIV/2 differentiation test. Additionally, the HIV-1 NAT must also be utilized in the event the HIV-1/HIV-2 differentiation test result is indeterminate or undifferentiated. -------------------------------------------------------------------------------------------------------------------------------------------------------- 5 CD4 Lymphocyte Subset 0.000 Each 40.00 1 0.00 Item Text FDA-approved test for the enumeration of lymphocyte subsets for classification and diagnosis of primary immunodeficiency diseases and for evaluating and monitoring AIDS patients. -------------------------------------------------------------------------------------------------------------------------------------------------------- 6 Syphilis-EIA 0.000 Each 2.25 1 0.00 Item Text FDA-approved treponemal enzyme immunoassay (EIA) with documentation, according to the manufacturer's direction, on the sensitivity and specificity of the test for Primary, Secondary, and Early Latent Syphilis. -------------------------------------------------------------------------------------------------------------------------------------------------------- 7 Syphilis-RPR/Confirm TP-PA 0.000 Each 5.00 1 0.00 Item Text Centers for Disease Control and Prevention (CDC) and FDA-approved the rapid plasma reagin (RPR) card test followed by an FDA-approved fluorescent treponemal antibody absorption (FTA-ABS) test using an indirect fluorescent antibody technique when the EIA is positive and the RPR is non-reactive. -------------------------------------------------------------------------------------------------------------------------------------------------------- 8 GC/Chlamydia - Nucleic Acid Amplificatio 0.000 Each 12.50 1 0.00 Item Text FDA-approved nucleic acid amplification test with documentation, according to the manufacturer's direction, on the sensitivity and specificity of the test for the following specimens: Vaginal, Cervical, Urine, Rectal, and Oropharyngeal. -------------------------------------------------------------------------------------------------------------------------------------------------------- 9 Hepatitis B Surface Antigen 0.000 Each 8.50 1 0.00 Item Text FDA-approved Hepatitis B surface antigen test that detects the actual presence of the hepatitis B surface antigen in the specimen. -------------------------------------------------------------------------------------------------------------------------------------------------------- Information: Integrated Environment Systems Form Name: ZM_SFRM_STD_MMCOSRM_L, Version 1.0, Created on 06/27/2006, Last changed on 03/29/2005. Page 3 of 4 FULLY EXECUTED - CHANGE 1 Contract Number: 4400022351 Original Contract Effective Date: 01/22/2020 Valid From: 02/01/2020 To: 01/31/2023 Supplier Name: CENTER FOR DISEASE DETECTION LLC Item Material/Service Qty UOM Price Per Total Desc Unit 10 Hepatitis B Surface Antibody 0.000 Each 8.50 1 0.00 Item Text An FDA-approved test that detects antibodies to Hepatitis B Surface Antigen on serum or plasma specimens. -------------------------------------------------------------------------------------------------------------------------------------------------------- 11 Hepatitis C Antibody 0.000 Each 8.50 1 0.00 Item Text An FDA-approved test that detects Hepatitis C Antibody used to detect, diagnose, and monitor the treatment of a hepatitis C viral infection. -------------------------------------------------------------------------------------------------------------------------------------------------------- 12 Reflex to RNA PCR for Positive HCV Ab 0.000 Each 65.00 1 0.00 Sc Item Text An FDA-approved HCV RNA test used to confirm active infection in patients with a positive HCV Ab result; and to establish the baseline HCV viral load in the blood specimen. -------------------------------------------------------------------------------------------------------------------------------------------------------- 13 PrEP-Basic Metabolic Panel 0.000 Each 4.50 1 0.00 Item Text An FDA-approved Basic Metabolic Panel provides important information about the status of a person's kidneys, electrolyte and acid/base balance, and blood glucose and calcium levels. -------------------------------------------------------------------------------------------------------------------------------------------------------- 14 PrEP-Comprehensive Basic Metabolic 0.000 Each 5.00 1 0.00 Panel Item Text An FDA-approved comprehensive metabolic panel is a blood test that measures a patient's sugar (glucose) level, electrolyte and fluid balance, kidney function, and liver function. -------------------------------------------------------------------------------------------------------------------------------------------------------- 15 PrEP-Renal Function Panel 0.000 Each 4.75 1 0.00 Item Text An FDA-approved Renal Function Panel used to evaluate kidney function in patients. The renal function panel includes albumin, calcium, carbon dioxide, creatinine, chloride, glucose, phosphorous, potassium, sodium, and BUN and a calculated anion gap value. -------------------------------------------------------------------------------------------------------------------------------------------------------- 16 PrEP-Hepatic Function Panel 0.000 Each 4.40 1 0.00 Item Text An FDA-approved liver function panel to evaluate liver function in patients. Includes information about the levels of: Albumin and total protein, liver enzymes: Alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST). -------------------------------------------------------------------------------------------------------------------------------------------------------- 17 Viral Load-HIV-1 RNA 0.000 Each 100.00 1 0.00 Information: Integrated Environment Systems Form Name: ZM_SFRM_STD_MMCOSRM_L, Version 1.0, Created on 06/27/2006, Last changed on 03/29/2005. Page 4 of 4 FULLY EXECUTED - CHANGE 1 Contract Number: 4400022351 Original Contract Effective Date: 01/22/2020 Valid From: 02/01/2020 To: 01/31/2023 Supplier Name: CENTER FOR DISEASE DETECTION LLC Item Material/Service Qty UOM Price Per Total Desc Unit Item Text An FDA-approved Human Immunodeficiency Virus RNA, Quantitative test used to measures the amount (viral load) of HIV genetic material (RNA) in the blood. -------------------------------------------------------------------------------------------------------------------------------------------------------- 18 Hepatitis
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