SOLICITATION NOTICE
66 -- Purchase of High Performance Liquid Chromatography GeneSys Newborn Screening Analyzer
- Notice Date
- 4/12/2011
- Notice Type
- Presolicitation
- NAICS
- 325413
— In-Vitro Diagnostic Substance Manufacturing
- Contracting Office
- Department of Health and Human Services, Centers for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, Georgia, 30341-4146
- ZIP Code
- 30341-4146
- Solicitation Number
- 94994
- Archive Date
- 5/12/2011
- Point of Contact
- Vallerie M Redd, Phone: 770-488-2845
- E-Mail Address
-
gfj3@cdc.gov
(gfj3@cdc.gov)
- Small Business Set-Aside
- N/A
- Description
- The Centers for Disease Control and Prevention (CDC), National Center for Environmental Health (NCEH), Division of Laboratory Sciences, intends to award a sole source contract to Trinity Biotech USA, Inc., 2823 Girts Road, Jamestown, NY 14701 for the acquisition of a High Performance Liquid Chromatography GeneSYS Newborn Screening Analyzer. The statutory authority for this sole source acquisition is 10 U.S.C 2304(c)(1) in accordance with FAR Part 6.302-1- only one responsible source and no other supplies or services will satisfy the agency requirement. The NAICS code for this procurement is 325412, Pharmaceutical Preparation Manufacturing. The period of performance for this procurement is 5 months. The Trinity Biotech High Performance Liquid Chromatography GeneSys Newborn Screening Analyzer can provide both a screening run and a confirmatory run as well as identify thalassemisa in addition to hemoglobin variants. This instrument will also allow CDC continuity of the current methods run in our laboratory and it will fulfill all of our requirements by performing all of the following functions. • The hemoglobin fractionation system employs the principles of ion-exchange chromatography and high performance liquid chromatography. • The system utilizes a Windows XP TM based program especially designed for hemoglobin variant analysis of neonatal samples. • The software is able to be changed/customized at any time to accommodate laboratory needs. • The system incorporates a 2 minute Quick Scan program and an 8 minute High Resolution program with the ability to automatically reflex from Quick Scan program to High Resolution program for unattended screening and confirmation of hemoglobin variants in neonatal and adult (samples not considered neonatal) samples. • System is able to perform screening-2minute and confirmation-8 minute testing utilizing the same reagents and columns. • Reagents and columns are not lot dependant. User will be able to use any combination of lot reagents with any lot columns. • The system uses a FASC reference material • The system uses a relative retention time approach in the presumptive identification of variant hemoglobin. • The system offers automated hemolysate preparation for dried blood spots in a microtiter plate and direct sampling of microtiter plates. The automated sample preparation is an integrated step in the sampling program selected by user. • The system produces reports with the sample identification information, date and time, followed by the chromatogram with retention times indicated at the apex of each peak. A peak summary report can be printed after the chromatogram with the retention time, relative retention time, % area, phenotype and comments for each peak in the chromatogram. A batch summary report can be generated at the end of every run. • System is able to label Hbs; A, S, C, D, E, O and Bart's with presumptive IDs in the High Resolution mode. The phenotype for each sample is labeled based on the highest to lowest concentration of Hb. • Reports and results are able to be printed to a pdf file on the system or printed on 8" x 11" paper. This instrument is essential to the laboratory work of the Newborn Screening Molecular Biology Branch. As such, it is in continuous use and must be maintained appropriately to ensure accuracy and quality results. This is also the only vendor that can run both a 2 mintue Quick Scan program and an 8 minute High Resolution program using the same reagents and consumables. Furthermore, this is the only instrument that can automatically reflex from the Quick Scan to the High Resolution program for unattended screening and confirmation of hemoglobin variants. This is also the only instrument that is capable of identifying the of hemoglobinopathies A, S, C, D, E, O and Bart's with presumptive IDs in the High Resolution mode. The phenotype for each sample shall be labeled based on the highest to lowest concentration of Hb. This is also the only instrument that will allow our laboratory the flexibility to change and customize the software to accommodate other laboratory needs without purchasing a new instrument. Only Trinity Biotech and Bio-Rad Clinical Diagnostics have HPLC instruments and software specific for newborn screening specimens in the dried-blood spot matrix. We currently have a Bio-Rad instrument but it is less flexible, cannot confirm hemoglobin variants in a longer sampling time, and cannot identify thalassemia automatically. Other kits and columns would be required and it would be inefficient to switch between methods with one instrument. As a result of this synopsis, no competitive solicitation will be posted on FedBizOpps. We will issue only one solicitation to Trinity Biotech. However, all responsible sources that believe they can meet these requirements may submit their capabilities/qualifications statement to provide the services to Vallerie Redd via email ONLY at gfj3@cdc.gov with the solicitation number 94994 referenced in the subject line NO LATER THAN April 27, 2011. A determination by the Government not to compete this proposed action will be based on responses to this notice and are solely within the discretion of the Contracting Officer. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/CDCP/PGOA/94994/listing.html)
- Place of Performance
- Address: CDC Facility, United States
- Record
- SN02422434-W 20110414/110412234253-10ec4db133418f43bb05e11c1c6131d5 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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