SOLICITATION NOTICE
Q -- DNA Extraction from 1ml buffy coats
- Notice Date
- 8/2/2010
- Notice Type
- Presolicitation
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- NHLBI-PB-(HG)-2010-267-DLM
- Archive Date
- 8/21/2010
- Point of Contact
- Dorothy Maxwell, Phone: 301-435-0352
- E-Mail Address
-
maxwelld@mail.nih.gov
(maxwelld@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR A PROPOSAL. A SOLICITATION DOCUMENT WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The National Heart, Lung, and Blood Institute (NHLBI) Office of Acquisition (OA) intends to negotiate and award a purchase order on a noncompetitive sole source basis to Bioserve Biotechnologies, 9000 Virginia Manor Road, Suite 207, Beltsville, Maryland 20705-4214 to procure DNA extraction from 1ml buffy coats. The sole source determination is based on the fact that National Institute of Health (NIH) is the nation’s medical research agency and the primary Federal agency conducting and supporting making medical discoveries that improve people’s health and save lives. The Center for Research on Genomics and Global Health (CRGGH) of the National Human Genome Research Institute (NHGRI) mission is to advance research into the role of culture, lifestyle, genetics and genomics in disease etiology, differential susceptibility to disease and variable drug response at the individual and population levels. As part of this mission, the center has been collecting and analyzing samples from different parts of the world such as Africa, China and the United States to study the genetics of complex and common diseases in different populations. Recently, the CRGGH has been approved by the Center of Inherited Diseases Research (CIDR) to carry out the first genome-wide association study (GWAS) of type 2 diabetes in populations of African descent. BioServe is a small business with more than 20 years experience in laboratory protocols to ensure high quality results with timely turnaround time. BioServe is a local biotechnology company and a pioneer in accelerating breakthroughs in genetics, drug discovery, biomarkers research and molecular diagnostics; in addition to their biorepository and research tools development activities, BioServe has a preclinical molecular services department that has two decade of expertise in nucleic acids (DNA and RNA) extraction, genotyping and sequencing. BioServe has extensive skills in managing mid to large-scale projects in fairly short time. BioServe has the ability to extract DNA from a variety of sample types including buffy coats, whole blood, saliva, serum and more with precision using different type of reagents based on the type of biomaterials. The most common reagent used for DNA extraction is DNAQuik™ developed by BioServe scientists. These reagents are nonorganic and yield high quality genomic DNA, which is required for successful downstream genetic studies. BioServe also has in place all the equipment and manpower to provide other indispensable services related to nucleic acids such as quantification, normalization and aliquoting of the extracted DNA samples. Only one responsible source and no other supplies or services will satisfy agency requirements. The delivery point is the National Institutes of Health (NIH), National Human Genome Research Institute, NHGRI), Center for Research on Genomics and Global Health, Building 12A, Room 4047, 12 South Drive, Bethesda, Maryland 20892-5635. Statement of Work Background A large-scale genetic epidemiology studies has been conducted in the laboratory in West Africa, China and the United States. As part of these studies, the Center for Research on Genomics and Global Health—CRGGH has received thousands of blood samples for large-scale genomic projects on the genetics of common complex diseases including obesity, hypertension and diabetes. The present project hinges on the extraction, quantification, normalization and aliquoting of DNA from 2,000 samples (West Africans). This is a critical and compulsory step of the first genome-wide association study (GWAS) of type 2 diabetes (T2D) in West African populations. Due to the nature of this landmark study and the significance of a GWAS of T2D in West Africans to the genomics community, the Center of Inherited Diseases Research (CIDR) has approved the CRGGH application for this GWAS. As a result, timeliness of providing CIDR the DNA samples prepared per their specifications is paramount in order for the initiation and ultimate completion of the study. Conducting a GWAS of T2D in populations of African ancestry will not only help better understand this disease across populations but also will help in reducing the disparity gap globally. Purpose and Objectives • Extract DNA from 2,000 blood samples (Buffy coat) using SOPs developed by the contractor (BioServe); • Quantify all extracted DNA samples by fluorescence method (Picogreen); • Normalization of DNA concentrations; and • Aliquot the extracted DNA samples into “daughter” plates. Contractor Requirements • The desired results, functions, or end items required to accomplish those results. • Technical specifications and applicable standards or methodologies to be used. • Period of performance. • The extraction, quantification and aliquoting to be performed within 45 days of receipt of samples. • Special handling or packaging requirements. • Samples to be received by BioServe in IATA650 compliant shipping materials. The extracted DNA samples to be shipped to CRGGH by BioServe. Upon receipt, samples are inspected and logged in against the customer provided file. Discrepancies, if any, are rectified and a project specific database is established. For sample tracking, labels are printed with the customer provided sample ID as well as a Bioserve assigned simple sequential processing ID. Labels are attached to all processing tubes. Buffy coats are processed utilizing BioServe’s DNA Quik extraction kit, which is a gentle salting procedure. DNAQuik extraction process has been used at BioServe for many years and for the extraction of DNA from hundreds of thousands of samples of all types. From a sample collected and stored properly, good quality high molecular weight genomic DNA (gDNA) will be obtained. Quantitation of resulting DNA is performed using picogreen, TaqMan quantitation or OD260/280. Quantitation data is imported into the database, which is used to calculate the amount of sterile water or TE required to dilute all DNAs to a predetermined normalized concentration. DNAs are then aliquoted based on the predetermined aliquoting plan into barcode labeled tubes and/or plates and either stored or shipped back to the customer. A final report accompanies the samples, which includes all relevant extraction data. Government Responsibilities • The government is responsible of retrieving and shipping the samples to BioServe. • The government will also provide the contractor with the samples’ manifest as an electronic file (i.e., Microsoft Excel worksheets). • List of Government-furnished data, property, or facilities to be provided to the vendor. • The Government is responsible for reviewing and approving reports and similar matters generated. No government furnished equipment is required to perform the study. Samples and associate sample documentation (sample ID numbers, descriptions) is provided to BioServe. Government authorized personnel will be required to review the label information prior to finalization. Reporting Requirements and Deliverables • Itemize all progress, management, financial and fiscal or other reporting requirements and the frequency of their generation, or specific dates when due. The deliverable from BioServe is to provide DNA extracted from frozen buffy coat samples using its SOPs. BioServe can provide the following reports, upon request or using a predetermined scheduled from the client: • Sample inventory reports; • Shipping reports; • Receiving reports; • DNA extraction reports linking to parent tube; and • Invoices. Program Management and Control Requirements • Any internal management and control systems either specified by the Government or to be developed by the vendor/contractor. BioServe has in place SOPs, worksheets, and batch records to record the manipulations outlined in its procedure. In addition, BioServe keeps molecular biologist training records. Inspection and Acceptance Requirements • Identify where inspection and acceptance will be performed. • Provide the terms or criteria for acceptance of deliverables and describe how acceptance or rejection of deliverables will be conveyed to the contractor. • Identify what is to be inspected and accepted. • Identify who will inspect and accept. Industry Classification (NAICS) Code is 541711, Research and Development in Biotechnology, with size standard of 500 employees. This is a total small business set-aside. The acquisition is being conducted under FAR Part 13, simplified acquisition procedures, therefore the requirements of FAR Part 6 B Competitive Requirements are not applicable (FAR Part 6.001) and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-43 (July 23, 2010). This notice of intent is not a request for competitive proposals. Interested parties may identify their interest and capabilities in response to this synopsis, by August 6, 2010, 7:30 a.m. Eastern Standard Time. The determination by the Government not to compete the proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct future competitive procurement. Inquires to this announcement, referencing synopsis number NHLBI-PB-(HG)-2010-267-DLM, may be submitted to the National Heart, Lung and Blood Institute, Office of Acquisition, Procurement Branch, 6701 Rockledge Drive, Suite 6149, Bethesda, Maryland 20892-7902, Attention: Dorothy Maxwell. Response may be submitted electronically to maxwelld@mail.nih.gov. Faxes will not be accepted. Responses will only be accepted if dated and signed by an authorized company representative.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-PB-(HG)-2010-267-DLM/listing.html)
- Place of Performance
- Address: NIH, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN02225527-W 20100804/100802235058-011b4b7d46b90df615527ec078f98106 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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