SOURCES SOUGHT
65 -- Biological Diagnostics Manufacturing
- Notice Date
- 3/31/2006
- Notice Type
- Sources Sought
- NAICS
- 423450
— Medical, Dental, and Hospital Equipment and Supplies Merchant Wholesalers
- Contracting Office
- Department of Health and Human Services, Center for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, GA, 30341-4146
- ZIP Code
- 30341-4146
- Solicitation Number
- 2006-Q-08478
- Response Due
- 4/21/2006
- Archive Date
- 5/6/2006
- Description
- The National Pandemic Plan of 2005 designates the Department of Health and Human Services (HHS) as the lead agency for public health and medical response for pandemic preparedness and response. Following the issuance of the HHS Pandemic Plan of 2005, the Office of Public Health Emergency Preparedness (OPHEP) was assigned the responsibility for the advanced development, establishment of surge capacity, and acquisition of medical countermeasures such as diagnostics, vaccines and antiviral drugs that may be used to diagnosis, contain, control, and mitigate the mortality and morbidity associated with influenza pandemics in the U.S. The tactical and logistical implementation of policies and decisions regarding these pandemic medical countermeasures is the responsibility of the Office of Research and Development Coordination (ORDC) in OPHEP. This is a Request for Information (RFI) only. It is not a request for proposals and does not commit the U.S. Government to issue a solicitation, make an award, or pay any costs associated with responding to this announcement. All submitted information shall remain with the U.S. Government and will not be returned. The Office of Research Development and Coordination of the Office of Public Health Emergency HHS/OPHEP/ORDC has an interest in identifying potential technologies, methods, assays and reagents that can be applied to the detection, diagnosis and monitoring of influenza virus infections and disease. The appropriate use of diagnostic assays and equipment during influenza seasonal or pandemic outbreaks may provide for more timely and accurate detection of influenza outbreaks and thus delay or contain influenza infections in local communities, may reduce the morbidity and mortality, and may mitigate the overwhelming load that will be placed on the healthcare system. Early detection of influenza by the use of appropriate tests will allow for an accurate triage of patients and the determination of the parameters of the pandemic in enough time to provide best use of disease spread countermeasures. Rapid, accurate high throughput laboratory bench systems and portable low cost point of care (POC) systems are both needed to identify the outbreak as quickly as possible and provide timely data and information for situational awareness to guide and monitor effective response measures. Responses to this RFI may address either or both of these areas of identified interest but should clearly indicate which area of need is being addressed in the response. Rapid diagnostics for influenza viruses currently lack sufficient specificity and sensitivity and timeliness of results to provide clinically relevant information. A need is present to have diagnostic platforms and assays for influenza and influenza like illnesses to provide timely diagnostic information to health care providers in the face of an emerging pandemic. Information is being sought on assays, methods and platforms that may meet near term and long-term program needs. High Through-put Bench Diagnostics tests should be: 1) Rapid: less than 4 hours from sample collection to results at point of care 2) Sensitive: the exact lower confidence bound for the 2-sided 95% CI should be greater than 95%, relative to culture at clinically significant levels of virus (10E1 to 10E6 TCID50/mL of a specified influenza A virus strain 3)Specific: better than 95% ability to differentiate the target organism in the presence of ten fold excess of near neighbors to distinguish specific strains of influenza virus 4)Cost effective: less than four dollars per organism characteristic identified, 12 dollars total per test cost (exclusive of test reader equipment cost if needed) 5)Flexible: able to be modified for newly emergent threats within weeks of their discovery 6)Cross-Reactivity: able to detect true positives and true negatives in the presence of typical commensal and pathogenic microorganisms, typically 108 TCID50 viruses, 108 bacteria or 106 yeasts per ml 7)Diagnostic would be used on currently available and widely used commercial diagnostic platforms where trained personnel are used in CLIA compliant settings. Point of Care Diagnostics tests should be: 1)Rapid: less than 30 minutes from sample collection to results at point of care 2)Sensitive: the exact lower confidence bound for the 2-sided 95% CI should be greater than 95%, relative to culture at clinically significant levels of virus (10E1 to 10E6 TCID50/mL of a specified influenza A virus strain 3)Specific: better than 95% ability to differentiate the target organism in the presence of ten fold excess of near neighbors to distinguish specific strains of influenza virus 4)Cost effective: less than four dollars per organism characteristic identified, 12 dollars total per test cost (exclusive of test reader equipment cost if needed) 5)Flexible: able to be modified for newly emergent threats within weeks of their discovery 6)Cross-Reactivity: able to detect true positives and true negatives in the presence of typical commensal and pathogenic microorganisms, typically 108 TCID50 viruses, 108 bacteria or 106 yeasts per ml. 7)Ideally testing can be done in multiple settings with minimum operator training; rapid tests should be adaptable to near patient testing (either CLIA waived or under supervision of a central laboratory Combinations of sample preparations, screening tests and confirmation tests may be able to meet such over all requirements. The initial testing capability may require assays based on currently available commercial platforms but ideal future capabilities should accommodate all the indicated desired assay and system characteristics including purchase price, per assay costs, weight, foot print, sensitivity and specificity performances. An acceptable system would be easily portable with a simple clinical sample loading design. The equipment should isolate the sample in a manner that minimizes bio-safety concerns and cross contamination concerns for subsequent or concurrent sample handling. An acceptable POC system would be capable of meeting system requirements of performance from sample collection to test result for 1 sample within 30 minutes by 1 technician. Sample types could include: Nasal and throat swabs, Nasal wash aspirates, Blood, or Urine. The instrument-based system or assay should be able to identify the 20 leading causes (bacterial, fungal and viral) of respiratory illness clinical presentation with Influenza Like Illness symptoms, and differentiate novel influenza A viruses from seasonal influenza A viruses (i.e., H1N1 and H3N2) and other respiratory pathogens. Influenza or Influenza like Pathogens should be identified with a high level of certainty, using at least two characteristics per pathogen. Methods should be able to detect and differentiate specific influenza strains. Genotypic or phenotypic characterization should include capability to discriminate phylogenetic relationships including gene swaps, or influenza serotypes. Reagents should be optimized for maximum self-life with corresponding positive and negative controls. Desired reagent shelf life should be at least 6 months at room temperature. Integrated sample prep and detection with minimal sample handling during the analysis would be optimal. Serial or batch sample analysis to maximize throughput would be ideal. If a reader or equipment is involved integrated Bi-Directional communication monitoring Software to report out results, interpolate detection metrics, interpret the presence or absence of each pathogen , report results and receiving protocol updates should be discussed. Discussion of data optimization management systems is of interest for quality management and quality control measures during the life cycle of the device including developmental, testing and field use of the equipment or assay. HHS will use information obtained by this RFI in making recommendations and decisions on the development of an appropriate procurement strategy for National Pandemic Preparedness. All information submitted to HHS will be kept confidential as allowed by relevant federal law. Please submit information in the following format: 1) Name of Submitter 2) Address of Submitter 3) Name of Device, Assay or technology 4) Technical / Method Summary 5) Device specifications 6) Performance Summary including any supportive data 7) Clinical samples tested to date 8) Viral straines tested to date 9) Points of Contact 10) Bibliography and/or References Information must be submitted by April 21, 2006. Responses should be limited to 20 pages, 12 Font, Times Roman, single space, one sided or equivalent in an electronic and hard copy formats and can be e-mailed to the attention of Jeff Miller, Contract Specialist, phone 770-488-2651, e-mail afx2@cdc.gov. Please ensure that at least one electronic and TWO (2) HARD COPIES of all responses are submitted. A form to facilitate submission can be obtained by e-mail request from Mr. Miller at the above address.
- Record
- SN01018968-W 20060402/060331211931 (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 |