Quidel-Ortho Vitros 3600
Waiver type - Procurement: Nonavailability
Agency: CENTERS FOR DISEASE CONTROL AND PREVENTION (7523) • Product Service Code (PSC) : 6640 | Last Modified: 08/28/2024
Procurement Summary
Buy out purchase of a Ortho Clinical Diagnostics VITROS® 3600 Immunodiagnostic System. Chemistry, Immunoassay, and Integrated systems reduce potential for error and the need for repeat testing to increase first pass yield, decrease costs, and improve turnaround time. Comprehensive testing menu including SARS-CoV-2 IgG and Total antibody, HIV combo, B·R·A·H·M·S Procalcitonin, Immunosuppressive drugs, and Drugs of abuse. This instrument is an instrument already in the DVH laboratory under a reagent rental contract. The company is providing a buyout price for a capital purchase so that we may purchase a separate service agreement for the instrument. No other companies can provide a buyout quote for an instrument already placed in the laboratory. DVH is required to continue using this instrument for testing of National Health and Nutrition Examination Survey (NHANES) specimens until a cross over study is completed and approved by NHANES. Other immunoanalyzers have not been approved under CLIA and NHANES does not permit changing equipment or manufacturer’s in the middle of a cycle without a cross over study being conducted The NHANES examines a nationally representative sample of about 5,000 persons each year. Findings from this survey will be used to determine the prevalence of major diseases and risk factors for diseases. The use of this instrument is imperative to maintain consistent data results that are comparable to current and previous data using the same system.
Waiver Rationale Summary
This is a buy out purchase of an Ortho Clinical Diagnostics VITROS® 3600 Immunodiagnostic System that is currently being used in the lab for several years under a reagent rental contract. The buyout cost is $20,000 with the current rental reagent agreement of $90,000 per year, which provides a cost savings. The CDC Division of Viral Hepatitis is required to continue using this instrument for testing of National Health and Nutrition Examination Survey (NHANES) specimens until a cross over study is completed and approved by NHANES. Other immunoanalyzers have not been approved under CLIA and NHANES does not permit changing equipment or manufacturer’s in the middle of a cycle without a cross over study being conducted The NHANES examines a nationally representative sample of about 5,000 persons each year. Findings from this survey will be used to determine the prevalence of major diseases and risk factors for diseases. The use of this instrument is imperative to maintain consistent data results that are comparable to current and previous data using the same system. Therefore, no other immunoanalyzer can meet the government's needs.
No
Yes
Consistent with Policy
LABORATORY EQUIPMENT AND SUPPLIES
334515 - Instrument Manufacturing for Measuring and Testing Electricity and Electrical Signals
08/05/2024
75D30124P19215
000HCKED-2024-87063
Post-solicitation
0 - 6 months
Individual Waiver
CENTERS FOR DISEASE CONTROL AND PREVENTION