Questions from Industry - 28 Aug 2023.pdf

Questions from Industry 12805B23Q0874 As of 28 Aug 2023

WHNRC Points:

• WHNRC conducts more than 15,000 tests per year on our current clinical chemistry analyzer for various biomarkers. Seven Research Scientists and their staff, including the Bioanalytical Support Laboratory staff, use the analyzer and therefore, workflow and time efficiency is of utmost importance.

• WHNRC is following a USDA, ARS Environmental Management System policy that requires us to reduce our environmental footprint, prevent pollution, and continually improve operations. If reagents have a long shelf-life, that means less shipping and packaging of reagents, and especially reduced plastic waste and water use. In addition, use of reagents that do not need refrigeration/freezing equate to less reliance on refrigerator/freezer space and therefore, less electricity usage and cost savings.

1. Can the requirement for Auto calibrations of reagents be made preferred not required? Our methodology has 6 months on chemistry stability on calibrations or lot change. Calibrations are included as part of our assay offering and do not affect cost.

Govt Response: Required. The Auto Calibrations are required for efficient use of the instrument and our scientist's time. When performing studies, it is important that our staff have the ability to run many samples without having to be concerned about stopping midpoint for long calibrations. While a 6 month calibration stability is helpful, it is likely that we will run into situations where we will transition from one lot of reagent to a new lot in the middle of a study. Having to stop to take the time to calibrate would not be optimal, if it can be avoided.

2. Can the requirement for >100 days stability of reagents be made preferred not required? Our methodology doesn’t require large amounts of assays stay aboard an instrument. This language is restrictive and is not indicative of cost.

Govt Response: Required as a cost and time savings. The benefit to USDA from having a large number of tests per kit, or tests on board that remain stable at room temperature for a long period of time, is that our scientists will spend less time loading and unloading reagents. In addition, we run a large number of samples at one time. If tests/reagents are refrigerated, then scientists will continually need to take reagents out of the freezer or refrigerator and allow them to warm up 30 – 45 minutes prior to loading them onto the instrument. This would be very inefficient for workflow. Cost is also a factor, but the workflow efficiency of not having to interrupt testing to load more reagents and/or unload used reagent packs or consumable items is just as important.

3. Can the requirement that Reagents should be all liquid and ready to use, be removed? Our methodology uses dry chemistry and is ready to use.

Govt Response: We can remove the requirement that the reagents be liquid; however, we would like to maintain the requirement that all reagents be ready to load on the analyzer without any manual off-line preparation or requirement to wait to allow them to be ready to load on the instrument. This instrument is used by 8 research groups and turnaround time must be kept to a minimum. Thus, we want to minimize the steps required for scientists to complete the testing, and reagent preparation of any kind that will make our workflow less efficient.

4. Can the requirement for Ultrasonic mixing be changed to state it is for wet chemistry only? Ultrasonic mixing is not required in our methodology.

Govt Response: Yes, we can change the requirement to, "In order to reduce the possibility of carry-over between tests, the system does not require a sample-reagent mixer that is reused between multiple samples."

5. Are the product dimensions inclusive of water filter? Our offering is slightly larger but doesn’t require water filtration devices.

Govt Response: No. The dimensions are a requirement. We have very limited space.