Q and A Neutralization Assay A002.pdf
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- Solicitation number
- W911QY-20-S-C001-A002
About this file
This document contains a question and answer file and related federal contract opportunity solicitation for neutralization assay services. BARDA seeks technology transfer of a qualified SARS-CoV-2 neutralization assay to a new BSL3 laboratory in compliance with GCLP, along with subsequent validation of the assay and testing of up to 1,000 serum samples per week from COVID-19 vaccine clinical trials using the validated assay over a 12-month period. Offerors must submit solution briefs by July 31, 2020 to the Army Contracting Command in response to solicitation number W911QY-20-S-C001-A002. Compliance with GCLP is acceptable in lieu of GCLP for the contract base period. The government will provide an assay SOP, qualification protocol, stability testing plan for reagents, comparability and qualification reports, while offerors must propose a validation protocol and reports along with reagent stability testing.
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Question Government Response As it relates to the above subject solicitation, can the government confirm that it already has a qualified SARS-CoV-2 virus specific neutralization assay?
The laboratory work has been completed and the statistical analysis is ongoing. A qualification report is expected by 8/7/2020.
Will BARDA provide the SARS-CoV-2 assay and validation protocols or does BARDA expect the Contractor to propose an assay and validation protocols?
BARDA will provide a technology transfer protocol which will include the following: i. An assay specific Standard Operating Procedures (SOP)
ii. A qualification protocol.
iii. A plan for stability testing of reagents
iv. Comparability panel
v. A qualification report The Offeror shall provide:
i. A validation protocol that evaluates precision, dilutional linearity, LOD, LOQ, selectivity (matrix effects), and specificity as appropriate. The validation protocol should include a statistical analysis plan.
ii. A plan for stability testing of reagents
iii. A validation report
Are there a number of assays and time period? That would be helpful in providing a ROM price?
Offerors proposing less than 1000 samples per week (40 hours/week) will not be considered responsive. The proposed immunoassay capacity must be available for use in full no later than October 30, 2020. The total proposed duration of this work is 12 months from award.
Is compliance with GLP acceptable in lieu of GCLP?
Yes
For the ROM, do you have a rough sample size in mind for the LOE? Asking because the range could be vast when looking at say the current sample group of 30,000 receiving vaccine trials.
Offerors proposing less than 1000 samples per week (40 hours/week) will not be considered responsive. The proposed immunoassay capacity must be available for use in full no later than October 30, 2020. The total proposed duration of this work is 12 months from award.
File details come from the government source that posted it. Updated .