RPP HT9425-24-R-0005-0001 - Vendor Questions and Government Responses (10 May 2024).xlsx
XLSX spreadsheet 16 KB Posted
- Solicitation number
- HT9425-24-R-0005
- Issued by
-
Defense Health Agency
About this file
This document is a Q&A sheet for Request for Prototype Proposal (RPP) No. HT9425-24-R-0005 for "Rapid Donor Screening" (RDS) technology. The Government is seeking multiplexed assays for HIV-1/2, Hepatitis B/C, blood type and Rh factor, that use a whole blood sample and provide results in 20 minutes or less. The RDS technology must be FDA-cleared with a donor screening indication and support screening blood from donors in conflict zones. It must be rugged, lightweight, compact, and operate without cloud connectivity. The Government addresses questions about start date, advance payments, capital expenditures, and testing requirements. Respondents can propose solutions using two separate devices (immunohematology and serology) and must address both capabilities. No preference is given for collection methods or sample volumes as long as they are rapid, simple, and use less than 3mL of blood. The Government notes the RDS technology must ultimately achieve CLIA-waived status.
View the file
Other files
Show all 13
On GovTribe
Work with this file
- Download the original file
- Contacts named in this file
- Similar government files
- Ask GovTribe AI about this file
Text version
Sheet1 Request for Project Proposal (RPP) No. HT9425-24-R-0005 for “Rapid Donor Screening” for “Ultrasound Field Portable (USFP) Assessment & Development Efforts”
| Questions and Answers |
| Date Posted to SAM.gov: 10 May 2024 |
| General Questions | |||
| Offeror Question | Government Response | Government Changes (if applicable) | |
| 1 | What is the anticipated start date to be incorporated into the project plan? | The Government does not have an exact start date. However, it is anticiapted to begin prior to September 30, 2024. | |
| 2 | The current Other Transactions Guide (July 2023) anticipates “instances in which advance payments may be beneficial include reducing financing costs for large, up-front expenditures and ensuring sufficient cash flow for small companies.” Will the Government consider proposed SOW by small businesses that include advance payments to help cover initial startup costs for performance? | Yes, the Govt will consider proposed advanced payments from a small business. | |
| 3 | With regard to the Cost Sheet Template, will the Government consider requests for reimbursement of Capital expenditures for special purpose equipment required to conduct the project? If additional lab space is required by a small business to accommodate Objective 1 and the additional staff necessary to complete it, will the Government consider proposals for reimbursement of costs related to lab space expansion and related renovation? | The government will allow the purchase of equipment under ODCs. Reimbursement will be based on the percentage of usage (of the equipment) dedicated to this project. As for lab space, the government will permit leasing of additional lab space and reimburshment will be based on percentage of usage (of the lab) dedicated to this project. Offerors shall proposal all required/needed labor to complete the effort. Renovations to lab space will not be considered/reimbursed. |
| RPP Questions | ||||
| Offeror Question | Government Response | Government Changes (if applicable) | ||
| 1 | Is there any specific analyte that DoD is looking for in the scope of this development work for the HepB | |||
| tests? (Antigen test vs Antibody test) | Hepatitis B surface antigen (HBsAg) | The list of additional tasks for Objective 1 in the SOO was updated to include a Hepatitis B surface antigen test. | ||
| 2 | For the blood type test, do we need to develop a test that can focus all blood type targets that Eldon cards test | |||
| can detect, or do we have the option to develop a simpler version? | The blood typing test needs to be able to determine whether a specimen is A, B, AB or O as well as its Rh status. | |||
| 3 | For HIV-1 and 2 tests for donor screening, is the antibody test good enough to meet your target? Does the test need to differentiate HIV-1 from HIV-2 infection? | The test must identify antibodies to HIV1 and HIV2, but it does not need to differentiate them. | ||
| 4 | What is the assumed collection device/materials to interface with the screening consumable? | The government does not have an assumption or restriction on the specimen collection materials or methodologies. | ||
| 5 | What is the sample input volume into the screening device from the assumed collection device/materials? | The government does not have a requirement for the input volume necessary for the assay, however, methodologies that are rapid, simple and require the collection of less than 3 mls blood are prefered. | ||
| 6 | For HIV-1&2, Hepatitis B and C, what are the analytical and clinical LoDs assumed for each target? | Limits of detection will vary for each pathogen and test methodology, so the government is looking for a general requirement that assays achieve 99.5% sensititivity and specificity. Any specific limits of detection would be established in coordination with FDA and the submission package. | ||
| 7 | What are the 3 current tests used by the DoD for HIV-1&2, Hepatitis B and C, blood type and Rh factor? | Tests are currently being conducted with the OraQuick HCV Rapid Antibody Test, OraQuick Advance HIV 1/2 Rapid Antibody Test, Determine HBsAg 2 Hepatitis B Surface Antigen Assay, and the Eldon Card rapid blood and Rh typing test. | ||
| 8 | We've developed a device that we feel meets the ImmunoHematology-IH- needs expressed in this request for proposal. However, the serology part has not been included yet in the development of this new device. We would therefore like to know whether the two types of test (IH and serology) could be carried out on two separate devices (using the same or different technologies). If so, is it acceptable to submit a proposal that includes only the IH part? | Utilization of 2 multi-plex panels (which can use different technical methodologies) to complete all the required tests is acceptable. Proposals will need to include solutions that address the serological and immunohematology requirements. | ||
| 9 | If the proposal has to include both parts (IH and serology), will we have to include a search for potential partners to complete the IH part, or will the DoD be able to direct us towards a preferred partnership ? | The government requires proposals to address both parts (IH and serology). It is up to Offerors to determine if a potential partner (i.e. subcontractor) is required to fulfill the Government's requirements. As such, the Government cannot direct Offerors towards a preferred partnership/subcontractor. Teaming arrangements/Partnerships are allowed and are addressed in Volume II of the Request for Proposal (RPP). | ||
| 10 | What is the acceptable volume and precision for the whole blood sample? | |||
| example: pipette or Pasteur pipette from a blood tube, or even a finger prick? | The government does not have a requirement for the input volume necessary for the assay or for collection/transfer methodologies; however, methodologies that are rapid, simple and require the collection of less than 3 mls blood are prefered. | |||
| 11 | Is the use of a small, portable centrifuge (operating with a battery allowing a certain autonomy) acceptable? Note that the current device could also work by capillary. | The government does not have a restriction on what technological approaches vendors use as long as they fulfill the key performance parameters and can ultimately achieve CLIA-waived status. | ||
| 12 | Although not strictly within the context of this application, the titration test for LTOWB is mentioned. This test traditionally requires a red cell reagent (limited shelf-life) and a reagent for diluting plasma. Would these reagents be acceptable? Note our company has ongoing projects that could provide alternatives (synthetic structure on which A and B antigens are coated). | The government does not have a restriction on what technological approaches vendors use as long as they fulfill the key performance parameters and can ultimately achieve CLIA-waived status. |
File details come from the government source that posted it. Updated .