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Natural Killer (NK) Cell Assay Tests for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)


Maryland, United States
Government : Federal
RFP
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This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice.

This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only.


BACKGROUND
Following the direction of Dr. Francis Collins, NINDS has initiated an effort to study Post-Infectious Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (PI-ME/CFS). This disorder refers to chronic and disabling fatigue, inability to recover after exercise, and physical and emotional discomfort occuring after a person has an infection.


Natural Killer (NK) cells are a type of cytotoxic lymphocyte critical to the innate immune system. They respond quickly to virally-infected cells and to tumor formation. The relationship between viral infection and ME/CFS has created considerable interest in NK cell function in ME/CFS.
Prior studies have documents alterations in NK cell function in subsets of ME/CFS patients. Successful phenotyping of our study participants will require measurements of NK cell function.


NK cell function is tested on live cells collected from a blood draw. Samples must be measured within 24 hours of collection. The ‘gold standard' test is the chromium release assay. Target cells are labeled with 51Cr. The NK cells of interest are then exposed to the labeled target cells for 4 hours. The NK cells will lyze a percentage of the labeled cells, releasing 51Cr. The sample is then centrifuged and the radiation of the supernatant is measured. This percentage of released 51Cr is an estimate of the lytic ability of the NK cells.


PURPOSE AND OBJECTIVES
The ME/CFS at NIH protocol (16-N-0058) requires Natural Killer (NK) cell function to be measured. The contractor shall provide testing of NK cell function and provide a report of the results.


PROJECT REQUIREMENTS
Blood samples from 21 study participants have already been collected, sent, and analyzed by Cincinnati Children's Hospital Diagnostic Immunology Laboratory. This represents half of the healthy volunteers and a quarter of the ME/CFS participants that will be enrolled in the protocol. It is therefore essential to continue to use Cincinnati Children's Hospital for all future NK cell functional tests. Using more than one NK cell function testing vendor will allow technical variation between laboratories to confound the study results. To switch vendors at this point in the study would make the interpretation of all of the past measurements and future measurements unreliable, invalidating the purpose of measuring NK cell function in the first place.


The contractor will receive individual blood samples shipped from NIH. The contractor will perform NK cell function analysis on the samples within a 24 hour time window required for proper testing. The contractor will provide results by fax within 7 business days.


Specific Requirements:
1.    Using chromium release methodology, natural Killer cells (NK cells), obtained from peripheral blood mononuclear cells, are assayed for the ability to lyse target cells at four different effectors: target (E: T) ratios. Lytic units are a calculated measure based on the cytotoxicity results. CD16/56 (NK Cell) percentage of the mononuclear cell preparation is measured and reported to confirm the presence of NK Cells in the plated sample.


2.    The laboratory shall be regulated under CLIA as qualified to perform high-complexity clinical laboratory testing. This test is used for clinical purposes. It should not be regarded as investigational or for research.


3.    The contractor will receive individual blood samples shipped from NIH. The contractor shall perform NK cell function analysis on the samples within a 24 hour time window required for proper testing.


4.    The contractor will provide results by fax within 7 business days.


5.     The contractor shall receive a minimum of 15 blood samples for testing annually. The Government has the option to increase this quantity in increments of 5 samples (3 options to add 5 samples) within each year of the contract.


6.    All final reports will be reviewed by a medical doctor for accuracy before delivery to the Government.


ANTICIPATED PERIOD OF PERFORMANCE
One year with four option years estimated to begin on or about:
Base Year:        6/1/2018-5/31/2019
Option Year 1:        6/1/2019-5/31/2020
Option Year 2:     6/1/2020-5/31/2021
Option Year 3:        6/1/2021-5/31/2022
Option Year 4:        6/1/2022-5/31/2023


DELIVERABLES


Base Year: 15 blood samples with three optional quantities of five blood samples each.


Option Year 1: 15 blood samples with three optional quantities of five blood samples each. 


Option Year 2: 15 blood samples with three optional quantities of five blood samples each.


Option Year 3: 15 blood samples with three optional quantities of five blood samples each.


Option Year 4: 15 blood samples with three optional quantities of five blood samples each.


The lab sends us a fax of the results within a week. There is no confidential information being shared or faxed.


OTHER IMPORTANT CONSIDERATIONS
The NIH protocol team will send by FedEx a 10mL whole blood sample collected in a heparizied tube and maintained at room temperature. The samples will be sent with a deidentified patient code specific to Protocol 16-N-0058.


CAPABILITY STATEMENT/INFORMATION SOUGHT
Please provide a capability statement, this includes:
•    Provide evidence the respondent has performed services.
•    Provide evidence of similar previous contracts of research of the same magnitude.
•    Information regarding (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed project of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information.


Please provide your DUNS number, organization name, address point of contact, and size and type of business (e.g., 8(a), HubZone, etc.,) pursuant to the applicable NAICS code and any other information that may be helpful.


Respondents should provide responses accordingly: (1) submit information electronically by email. No mail, telephone or facsimile responses will be accepted; (2) format capability statements using Microsoft Word or Adobe PDF including attachments, resumes, charts, etc. Use single space, 12 font minimum and 8.5 x 11 size paper; (3) organize material in such a manner that clearly identifies and addresses capability requirements and provide an executive summary; (4) capability statement should not exceed two pages not including the cover page, executive summary, or references; (5) RESPONSES SHOULD BE RECEIVED NO LATER THAN 4:00 PM EASTERN TIME ON May 22, 2018; (6) include respondents' technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and email addresses; and (7) send responses to this notice via email to danny.cohn@nih.gov.


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 presolicitation synopsis and solicitation may be published in Federal Business Opportunities. 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 nonproprietary technical information in any resultant solicitation(s).


Danny Cohn, Phone 3014027111, Email danny.cohn@nih.gov

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