Attachment 002 - Matrix.pdf
PDF 522 KB Posted
- Solicitation number
- 123A9424Q0003
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This document contains evaluation criteria for screening technologies to detect Shiga Toxin-Producing Escherichia coli (STEC). The screening technologies will be evaluated based on their ability to detect seven STEC serogroups from enriched samples using criteria such as limits of detection, accuracy, predictive values, and inclusivity/exclusivity panels. The technologies must be capable of analyzing at least 96 tests per run, create exportable result files, and meet size, power, and IT requirements for use in three Food Safety and Inspection Service laboratories. Vendors will be evaluated on additional performance criteria according to an unspecified appendix. Relatedly, the Department of Agriculture Food Safety and Inspection Service is soliciting proposals for a new STEC screening technology to meet the described evaluation criteria.
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Other files
| File | Type | Posted |
|---|---|---|
| 24Q0003 Revised.pdf | ||
| Attachment 003.pdf | ||
| 24Q0003.pdf | ||
| Attachment 001 - PWS.pdf |
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A B C D E Technical Criteria
Uses an enriched sample and isolated colony, as prescribed in current MLG 5C Pass/fail
Provide detection of Shiga Toxin-Producing Escherichia coli (STEC) O157, O26, O45, O103, O111, O121 and O145 Pass/fail Preference given to genes/virulence that cause human illness
Provide detection of eae and stx 1/2 (results reported separately) Pass/fail
Achieve 90% accuracy of detection of target organisms Pass/fail Achieve 90% accuracy of detection of non-target organisms Pass/fail
Accuracy, compared to cultural method (90% or higher) Pass/fail Positive predictive value (90% or higher) Pass/fail Negative predictive value (90% or higher) Pass/fail Accurate results for a complete panel of strains for Inclusivity and Exclusivity Pass/fail Minimum limit of detection of at least 10^4 colonies Pass/fail Method is to have a published validation by an internationally recognized, third-party standards organization Pass/fail Capable of creating csv files for importing and exporting templates and data Pass/fail
Provides a run report with positive and negative results Pass/fail Preference given to pdf versions of results produced from instrument without analyst manipulation
Analyze at least 96 tests per instrument run (minimum) Pass/fail Information Technology components will meet current Government requirements and be compatible with Windows 10 Pass/fail Require a laboratory benchtop footprint of less than 10 linear square feet for instrument, hardware, PC and additional components
Instrumentation is to include all mandatory components from initial screen of enriched sample up to final confirmation on the MALDI.
Optional components should be identified and use will be at the discretion of the government Pass/fail Operate within manufacturer’s operational specifications within the existing environments of the three FSIS laboratories, including maximum power requirements of 120 Volts, 10 Amps AC Pass/fail
Appendix - Criteria for Vendor Performance Criteria
Vendor Measure Legend
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