Loren Data's SAM Daily™

FBO DAILY ISSUE OF JULY 19, 2012 FBO #3890
SOURCES SOUGHT

B -- Assay Validation for Virus Isolation and RNA isolation assays and Specific Antibody Testing

Notice Date

7/17/2012
 

Notice Type

Sources Sought
 

NAICS

541380 — Testing Laboratories
 

Contracting Office

Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, Bldg 50 Room 422, Jefferson, Arkansas, 72079, United States
 

ZIP Code

72079
 

Solicitation Number

FDA-1107122
 

Archive Date

8/3/2012
 

Point of Contact

Nicholas E Sartain, Phone: 870-543-7370
 

E-Mail Address

nick.sartain@fda.hhs.gov
(nick.sartain@fda.hhs.gov)
 

Small Business Set-Aside

N/A
 

Description

MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The U.S. Food and Drug Administration (FDA), is conducting market research to support the Center for Biologics Evaluation and Research (CBER) requirement for assay validation and optimization and H5N1 antibody response evaluation. The FDA is seeking business sources, including total small businesses, service-disabled veteran-owned small businesses, HUBZone small businesses, 8(a) certified companies and other than small businesses. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort. The government is seeking capability statements from businesses capable of meeting the performance requirements. The U.S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) requires assay validation and optimization and H5N1 specific antibody response evaluation: Draft performance work statement Part I: General Information A. Introduction 1. Preparation of a sample panel and performance of assay validation studies for the virus isolation and RNA isolation assays used in a previous study 2. Performing antibody testing in the plasma and nasal wash samples of 9 naïve ferrets. B. Background The original project proposal included that the laboratory work (of isolating the H5N1 virus and the nucleic acid isolation experiments) would be performed at the BSL3 facility at FDA / CBER. This part of the project could not be completed due to the FDA BSL3 facility not being available for use. The project was realigned and the virus isolation, including RNA isolation assays, was performed at Bioqual. The first task on the original project was the validation and optimization of the virus isolation, RNA isolation and Taqman assays. This included the different sample storage conditions as needed for the study design using a sample set generated by Bioqual (the original vendor). This study was never completed due to the unavailability of the FDA-BSL3 lab. Additionally, since the virus isolation and RNA isolation assays used in the study are now the Bioqual assays, it is required that this study gets repeated with the testing being performed at Bioqual in order to maintain the established standard. As part of the original study design antibody testing was to be performed at CBER on both the plasma and nasal wash samples. Since the BSL3 lab is not available and the samples are infected with H5N1, a BSL3 laboratory capable of performing the required serological tests on the samples stored at Bioqual is required. The laboratory must demonstrate expertise in performing these assays on the required sample types and they should have well validated assays and all of the required facility certifications. The following is a summary of the original study: 1. Challenge of Ferrets with H5N1 Virus and Sample Collection at Bioqual Inc. - Receipt of Animals and Acclimation. - A total of 9 mature male (age 20-24 weeks), canine distemper vaccinated ferrets will be purchased. The ferrets will be purchased from a commercial vendor that guaranties delivery of flu-free animals. - During the 2-week acclimation period at BIOQUAL, a serum sample will be obtained from each ferret and screened for exposure to recently circulating influenza A virus strains (pandemic H1N1, H3N2), B virus, and for cross-reactivity against the H5N1 challenge strain. For this purpose, a standard (HAI) assay will be performed to determine the serum antibody titers. - Challenge with H5N1 virus A/VN/1203/04 (H5N1) stock. - Post-Challenge Monitoring. Body weight and temperature of the ferrets will be recorded pre-challenge and daily post challenge until the day-30 blood collection. - Collection of Nasal Washes and Bleeds. 2. Blood Transfusion of naive ferrets at Bioqual 2. Laboratory tests - Taqman test will be performed at CBER as described by Wang et. al. (1) - Antibody tests will be performed at CBER following published methods and commercial tests as applicable. C. Scope 1. Preparation of a sample panel and performance of assay validation studies for the virus isolation and RNA isolation assays used in the previous study 2. Performing antibody testing in the plasma and nasal wash samples. Part II: Technical Requirements Task1: Assay validation and optimization (9 mature, naïve ferrets are required for sampling) - Blood and Nasal aspirate samples will be collected from naive ferrets - The samples will be spiked with a serial dilution of the challenge virus. - The samples will be aliquoted (one aliquot for fresh testing and one for frozen) and stored or tested as per the study plan - The samples will be utilized to perform Virus isolation and RNA isolation - the Limit of detection (LoD) of the virus isolation method will be confirmed by Bioqual - The RNA samples will be sent to CBER to confirm the LoD for the Taqman method. - Aliquots of the samples will be frozen at -70C (CBER) to evaluate the stability of the RNA upon freezing and confirm the analytical sensitivity of the detection methods using frozen samples. This phase is expected to take 30 days for completion. Task 2: H5N1 specific antibody response evaluation - Blood and Nasal aspirate samples which are collected from the longitudinal challenge study (n=58) will be tested by Hemagglutination Inhibition (HI) and antibody class specific ELISA - The assay and study design should be finalized and agreed upon with FDA - Validation studies for the antibody tests using control material should be performed prior to the initiation of the assay and results discussed with FDA Place of Performance: All work is to be performed at Contractor's facility. The Contractor must have a BSL3 lab and Prior documented experience in H5N1 Influenza research in ferrets. The antibody assays that will be used should be agreed upon with FDA prior to the initiation of the testing, face to face meetings and teleconferences maybe scheduled to facilitate these discussions to finalize the assays that will be used, their validation information and the study design The antibody testing could be performed at any facility that has a BSL3 facility and documented expertise in performing antibody testing for H5N1 and for performing ferret studies. However, the sample panel that needs to be tested is available at Bioqual from the original study. The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offeror is capable of providing the required products identified above. Firms believing they can meet the requirements to the above specifications are encouraged to respond electronically with no less than the following information: • Business name, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address; • Sufficient descriptive literature that unequivocally demonstrates that offered products meet the specifications. • At a minimum provide the following: All descriptive material necessary for the government to determine whether the product offered meets the technical requirements including: technical specifications, descriptive material, literature, brochures and other information, which demonstrates the capabilities of the contractor to meet the requirement. Indicate whether the organization is the manufacturer of the items or authorized reseller. If reseller, include the manufacturer's name, address and DUNS number. Provide estimated time to complete the task after award. • If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement are also requested. • Provide comments on draft performance requirements if any of these specifications are too restrictive or vague. No response will be considered that the listed specifications are adequate in a competitive acquisition. • If a large business, provide if subcontracting opportunities exist for small business concerns. • Suggestions on applicable NAICS code for this requirement. • Though this is not a request for quote, informational pricing must be submitted. The government is not responsible for locating or securing any information, not identified in the response. The associated North American Industry Classification System (NAICS) Code is- 541380- Testing Laboratories; Small Business Size Standard is $14.0 million. Interested Contractors must respond with capability statements which are due in person, by postal mail or email to the point of contact listed below on or before July 19, 2012 by 13:00 hours (Central Time in Jefferson, Arkansas) at the Food and Drug Administration, OC/OA/OAGS, Attn: Nick Sartain, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502 or email nick.sartain@fda.hhs.gov. Reference FDA1107122. Notice of Intent Responses to this sources sought announcement will assist the Government in determining whether or not any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures. Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in FedBizOpps. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/FDA-1107122/listing.html)
 

Place of Performance

Address: 29 Lincoln Dr, Bethesda, Maryland, 20892, United States

Zip Code: 20892
 

Record

SN02805478-W 20120719/120717235748-69287eb0992bff1bc91fc1103f7e6e81 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

---

| FSG Index  |  This Issue's Index  |  Today's FBO Daily Index Page |