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B -- Devise/Evaluate IgG Capture Enzyme Immunoassay for Use as a Measure of Proportion of Anti-C6 IgG Antibodies Present in Total IgG in Serum Samples

Notice Date
Notice Type
Combined Synopsis/Solicitation
541712 — Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
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
Solicitation Number
Point of Contact
Linda M Young, Phone: (770) 488-2655
E-Mail Address
Small Business Set-Aside
The Centers for Disease Control and Prevention requires a vendor to work on the following project: I. BACKGROUND Serology is a valuable tool for evaluating exposure of mammals to Borrelia burgdorferi, the bacteria that cause Lyme borreliosis ("Lyme disease"). One of the laboratory tests that has been approved by the U. S. Food and Drug Administration for measuring antibodies (both IgM and IgG together) to B. burgdorferi in human serum is based on a peptide antigen called "C6." This peptide reproduces the sequence of an invariable region within an immunodominant protein of B. burgdorferi called VlsE. There is published evidence that declining titers of antibodies to C6 are correlated with successful antibiotic treatment of patients with early Lyme disease. Specifically, a fourfold decrease or decrease to a negative value in anti-C6 antibody titer over a period of 6 months after treatment coincides with effective therapy in early disease. This method requires multiple assays (doubling dilutions of serum) to determine antibody titer, which is costly in time and reagents and therefore impractical for routine clinical use. A single-well test to determine the proportion of anti-C6 IgG antibodies relative to total IgG potentially could have utility in clinical practice. This contract is to develop and compare an IgG capture enzyme immunoassay with titers determined using an FDA-approved C6 commercial test kit. Most patients with early Lyme disease have excellent outcomes after standard courses of antimicrobial therapy. About 10% of patients treated for early Lyme disease have subjective, non-specific symptoms months after treatment. The preponderance of evidence indicates that persistent infection after antibiotic treatment rarely occurs. Nevertheless, a serologic test in a practical format could be an aid in the clinical evaluation of individual patients who have nonspecific symptoms after antibiotic therapy. The statutory authority permitting this procurement is 40 U.S.C. 759(g), as amended, and/or 41 U.S.C. *253-(c)(I). II. PURPOSE The purpose of this procurement is to devise and evaluate an IgG capture enzyme immunoassay that can be used as a measure of the proportion of anti-C6 IgG antibodies present in total IgG in serum samples. The evaluation should be done with samples from culture-confirmed early localized or early disseminated Lyme disease both before and 6-12 months after antimicrobial therapy. CDC may benefit from this procurement by acquiring data that may support the use of serology as a predictor of the efficacy of antibiotic therapy for B. burgdorferi infection. III. SCOPE OF WORK The vendor shall furnish all labor, materials and equipment necessary to: 1. Acquire serum samples that were obtained from patients with culture-confirmed early Lyme disease at the time of treatment and at suitable intervals thereafter (6-12 months after antibiotic therapy). The number of serum samples should be large enough to demonstrate that decline (of 4x or to zero values) in C6 antibody titers is statistically significantly associated (p<0.05) with successful clinical outcome after antimicrobial therapy using the established commercial assay. 2. Develop and evaluate an IgG capture enzyme immunoassay for measuring antibodies to C6 peptide. 3. Compare the results of the IgG capture assay with the commercial assay, using serum samples acquired as per point 1 above. 4. Provide both the protocol and the research data to CDC in electronic form. IV. TASKS TO BE PERFORMED The vendor shall perform the following tasks: 1. Task I (months 1-2): Obtain study materials (serum samples), reagents and test kits, and engage qualified personnel for performing the scope of work. Notify project officer by email. 2. Task II (months 1-6): Perform the research specified in the scope of work. 3. Task III (month 6): Write and deliver a technical report that provides in detail all protocols and results obtained under this contract. Deliver report by e-mail as a MS word document. Deliver figures by e-mail as a PowerPoint document. Other formats acceptable by mutual agreement. V. GOVERNMENT FURNISHED PROPERTY None VI. PERIOD OF PERFORMANCE The period of performance for this procurement shall be for 6 months from the date of purchase award. Anticipated date of award is September 1, 2009. VII. DELIVERABLES The vendor shall provide the following deliverables to the project officer by the date required: A. Notification by email that project personnel have been identified and engaged to perform the scope of work and that supplies have been purchased. Due within 1-2 months of purchase award date. B. A technical report containing the IgG capture assay protocol and results comparing it to titers obtained using a commercial C6 immunoassay kit. Due on or before the end of the 6th month after purchase award date. VIII. MINIMUM VENDOR QUALIFICATIONS Previous experience performing research to design and evaluate serologic assays, as evidenced by publications in the peer-reviewed scientific literature. Perference will be given to vendors with previous experience developing C6 serologic assays. Interested parties should submit separate technical capability statements and quotations to Linda M. Young at the e-mail address provided. Please make sure your technical statement does not contain financial information or it shall be redacted before technical review. Any potential offerers on the Excluded Parties List will be immediately disqualified. Your organization must be registered at www.ccr.gov in order to do business with the Federal Government. Please submit any questions to Linda M. Young as well and they will be answered and posted on this site.
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Place of Performance
Address: To be determined, to be determined, United States
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