SOURCES SOUGHT
B -- Metabolite Profiling for the Development of Diagnositc Biosensor for Malaria
- Notice Date
- 7/1/2013
- Notice Type
- Sources Sought
- NAICS
- 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
- 30341-4146
- Solicitation Number
- 2013-59437
- Archive Date
- 7/25/2013
- Point of Contact
- Tayaria L Smith, Phone: 7704882797
- E-Mail Address
-
gqq4@cdc.gov
(gqq4@cdc.gov)
- Small Business Set-Aside
- N/A
- Description
- Notice of Intent 2013-59437 The Centers of Disease Control and Prevention intends to award a sole source, firm fixed price contract, in accordance with FAR Part 13, using simplified acquisition procedures, to Emory University, Atlanta GA, 30322. Emory University will deliver the following: Performance Work Statement Metabolite Profiling for the Development of Diagnostic Biosensor for Malaria A. Background and Need The Malaria Branch at the US Centers for Disease Control and Prevention (CDC/MB) conducts surveillance, investigations, and studies of malaria to develop effective methods for the prevention, control, and elimination of disease worldwide. To that end, programs of epidemiologic and laboratory research investigating the biology, ecology, and host relationships of the malaria parasite have been established. In rural malarious areas, the currently available malaria diagnostic tools based on morphology, parasite antigen recognition, or DNA analysis of blood samples are limited to large-scale laboratories capable of expert microscopy or real-time molecular screening of asymptomatic and low density malaria. A primary aim of this collaborative project is to first determine the malaria parasite specific low-molecular-weight metabolites found in the urine and saliva of malaria infected humans. The ultimate goal is to provide proof of concept in the use of parasite-specific metabolites as biomarkers for the development of a sensitive, low-cost, simple and field-deployable urine and/or saliva diagnostic biosensor for detection of malaria infection. CDC provides substantial technical support to various malaria control programs globally and is a key partner in the President's Malaria Initiative (PMI), a vital component of the CDC priority to improve global health. Previous success in malaria controls has led to increased discussion about the medium- term feasibility of malaria elimination in selected areas, and in the long-term, malaria eradication. One of the critical elements in malaria elimination/eradication is large-scale and real-time screening of asymptomatic and low density malaria infection at the community level. Achieving prompt treatment will decrease the parasite reservoir and further reduce malaria transmission. Development of sensitive, low-cost, simple and field-deployable non-invasive diagnostic tools for malaria infection will have an enormous impact on monitoring the current PMI and future global malaria elimination programs. I. Background Current malaria diagnostic tools include: 1) parasite detection by microscopic examination of blood smears, 2) antigen-based rapid diagnostic tests (RDTs), and 3) sensitive DNA-based assays. All these diagnostic methods require blood sampling by finger-prick and their implementation has been limited by either their labor/time intensive nature and requirement of specific training (microscopic method), low sensitivity (RDTs), or high cost of sample preparation and supporting infrastructure needed (DNA-based methods). Although a few recent studies have reported a new non-invasive sampling of urine and saliva to detect malaria infection using the previously defined parasite antigens or DNA-based targets developed for existing methods, targeting such large molecules in urine and saliva has resulted in lower sensitivity compared to the same tests using blood samples. For malaria elimination efforts aiming to decrease the parasite reservoir to further transmission reduction, large-scale and real-time screening of asymptomatic, low density malaria infection using a sensitive, low-cost, simple and field-deployable non-invasive diagnostic tool at the community level (as opposed to clinical cases in hospitals) is increasingly important. This project addresses one of the monitoring and assessment challenges to successful implementation of the President's Malaria Initiative (PMI), which is one of the key components for the CDC strategic priority of improving global health. II. Project Description The targets of the non-invasive sampling are malaria parasite-specific low-molecular-weight metabolites. Based on biochemical principles, the concentration of naturally-eliminated parasite metabolic small molecule wastes (end products) should be higher in urine or in saliva than in blood, making them ideal biomarkers for non-invasive detection of malaria infection. Achieving malaria parasite detection using this low cost and portable method has several advantages including: 1) increased sensitivity, 2) non-invasive sample collection, 3) ease of use in rural settings, and 4) eliminating the need for cold-chain logistics. Based on the results from our initial in vitro parasite culture system, this study will focus on the quantitation of four malaria parasite specific metabolites in the urine and saliva collected from malaria infected humans. We will further test one of the metabolites (3-Methylindole) for proof of concept in the use of biosensor platforms for the detection of the target compound. Given the well-established metabolomics analytical technologies such as mass spectrometry (MS) and bioinformatics in metabolome and the several existing inexpensive and simple biosensor platforms that are currently used for detection of small molecules for other various applications), this proposed project will have a high likelihood for success. The study is divided into two parts with specific objectives. Part 1: The first labe will determine the concentration and stability of the above identified malaria parasite specific metabolites in urine and saliva collected from humans with and without malaria infection. The urine, saliva and blood samples collected at same time from humans will be obtained in a malaria endemic area of western Kenya. Samples from 60 individuals with malaria infection only, 60 with other infections and 60 without any infection as normal controls will be needed from the field. In addition, the samples from 30 individuals in Atlanta who have never been exposed to malaria will be collected as additional normal controls. These samples will be examined first using an MS-based top-down approach followed by bottom-up MS profiling to determine the difference in the concentration of the malaria parasite specific metabolites in urine, saliva and blood samples. The concentration of metabolites in urine and saliva will be further linked to parasitemia in blood to determine if there is a positive linear relationship between the concentration of metabolites and parasite density and most importantly the metabolite concentration that reflects 1 parasite/µl, the limit of detection (LOD) by blood PCR test. In addition, the same set of samples will be stored under different conditions for different time periods and will be further examined by MS for testing stability of the metabolites. Part 2: A second laboratory will generate the receptors against one of the metabolites, 3-Methylindole, for proof of concept in the use of an inexpensive and simple biosensor platform for detection of the target compound. The identification of novel compounds will require the concomitant generation of reagents specific for the assay of these compounds. There are two major classes of biopolymer receptors that have high affinity and specificity for small organic ligands, antibodies and aptamers. As 3-Methylindole, a mosquito attractant, seems highly relevant to malaria, we will first generate antibodies and aptamers against this compound for proof of concept in the current proposed study. It is highly likely based on what is known of extant antibodies and aptamers that it should be possible to raise high affinity (nanomolar and below) reagents against 3-Methylindole. Antibodies will be generated via a phage-display selection protocol, while DNA aptamers will be generated by iterative affinity purification from a random sequence library. The affinities and specificities (relative to other indole derivatives) will be characterized. Once the aptamers and antibodies against 3-Methylindole are ready, the receptors will be respectively applied to the second generation of Origami Paper Analytical Device (oPAD2) for detection of 3-Methylindole. The oPAD2 relies on competition assays that displace aptamer-glucose oxidase conjugates or antibody-glucose oxidase from immobilized analytes, leading to the production of an electrochemical signal that is readily read using a device as simple as a voltmeter or iPhone. The oPAD is easily stored and simple for field health care worker use, and can be disposed of via incineration after use. It is a "plug-and-play" diagnostic tool in that only the right type of aptamer or antibody is required to configure it for different applications, such as the malaria metabolite described here. The sensitivity and LOD for 3-Methylindole using oPAD2 sensor will be determined. III. Performance Work Statement This contract seeks to support CDC/MB studies by performing high-resolution metabolomics analysis of urine and saliva samples from non-infected and malaria-infected individuals that have been provided to the laboratory in a de-identified, blinded and randomized manner by CDC Malaria Branch labs. The Laboratory, will perform high-resolution metabolomics analysis of 210 urine and saliva samples from non-infected and malarial-infected individuals that have been provided to the laboratory in a de-identified, blinded and randomized manner Tables of relevant m/z features, along with information on retention time and ion dissociation patters (MS/MS) of authentic standards, to be provided where available. IV. Period of Performance The period of performance shall be 10 months from the date of award. V. Deliverable By the end of the study, the Laboratory will provide: information on the concentration and stability of the four metabolites detected by MS in urine and saliva in humans infected with malaria. VI. Minimum Vendor Qualifications Qualifications of research team: Research team should have extensive biomedical research experience in the field of metabolomics and in the development of the high-resolution mass spectrometry methods. Specific experience in laboratory and non-human primate models for malaria and also other human research projects is necessary. Research team should be supported by analytic chemists with experience in high-resolution mass spectrometry and metabolomics analyses. An experienced bioinformatician is required for data extraction, biostatistical and bioinformatics analyses to support this project. Performance Matrix: Metabolite Profiling Performance Requirement Summaries In general, the deliverables completed by the Contractor will be evaluated in terms of how well the requirements of the contract are satisfied. The COR or COTR will inspect 100% of deliverables to ensure there is a match between actual and expected performance. The Contracting Officer will be kept abreast of the Inspection findings and means to resolve identified performance concerns. Note: Periodic performance feedback given to the Contractor by the COR or COTR conducting inspection may be of great benefit to the Contractor by providing timely and insightful feedback about any "mid-course corrections" the Contractor may need to make to achieve the contract requirements. Task/Deliverable Performance Standard/ Indicator Acceptable Quality Level(s) Surveillance Method Incentives Arrange ‘kick-off" teleconference upon award of contract Timeliness Within fourteen (14) business days of the issuance of the contract Email from the vendor detailing decisions taken and project plan of action. Positive report regarding performance timeliness and completion of task. Quality Perform high-resolution metabolomics analysis of 210 urine and saliva samples from non-infected and malarial-infected individuals that have been provided to the laboratory in a de-identified, blinded and randomized manner by CDC. Timeliness No later than December 2013. Emailed report from the vendor detailing information on the concentration and stability of the four metabolites detected by MS in urine and saliva in humans infected with malaria. Positive report regarding performance timeliness and completion of task. Quality Generate tables of relevant m/z features, along with information on retention time and ion dissociation patters (MS/MS of authentic standards Submit draft publication. Timeliness 10 months after funding award Acceptance Positive report regarding performance timeliness and completion of task. Quality Report determined to be of acceptable quality to enter CDC clearance process. Emory University appears to be the only organization that can provide this service. Their research team has extensive biomedical research experience in the field of metabolomics and in the development of the high- resolution mass spectrometry methods. They have specific experience in laboratory and non-human primate models for malaria and also other human research projects. There are supported by analytic chemists with experience in high-resolution mass and metabolomics analyses, as well as a bioinformatician for data extraction, bio statistical and bioinformatics analyses. The organization has the experience and technical expertise to collect and bacteriologically test scabies specimens from populations. This advertisement ends in 3 days accordance with FAR 5.203 (A) (1). No Request for Quotes (RFQ) will be issued based upon this Notice of Intent. Any interested companies are welcome to submit their credentials and ability to provide the services, via e-mail, gqq4@cdc.gov. Include reference number (2013-59437). Send responses by Wednesday July 3, 2013.
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