B.08 Questions and Answers.docx
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- Attached to
- Immunohistochemistry Stainer and Supplies
- Solicitation number
- W91YTZ21Q0015
- Issued by
-
Department of the Army Medical Command
About this file
This document contains questions and answers related to federal contract solicitation number W91YTZ21Q0015 for immunohistochemistry stainers and supplies. The solicitation requires the contractor to provide two instruments for immunohistochemistry staining due to the agency's sporadic and unpredictable workload. Total cost per test must be included and should cover all reagents, ancillaries, antibodies, detection, and other expenses. The agency needs the flexibility to use third party detection systems for some antibodies in the event pathologist opinions find the standard detection results subpar.
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| B.08 Questions and Answers- Part 2.docx | DOCX document | |
| W91YTZ21Q0015.pdf |
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SUBJECT: Questions and Answers for W91YTZ21Q0015
Question # 1: Can we quote 1 instrument? At the current volume, we believe we can process the workflow on one instrument. Do you want to see the cost analysis for one instrument?
Answer: No. The reason we need two instruments is because our workload is sporadic and unpredictable. We’ve had companies in the past quote us for only one instrument and we’ve experienced longer turn-around times due to extended wait times to load additional slides for staining. Also, when the instrument experiences mechanical or software issues, we will have an additional instrument to use reducing or eliminating any longer turn-around times.
Question # 2: CPK or CPT? In order to quantify spend for the total volume (12,000 slides), we use a cost per test (CPT). We will pass along the total CPT (detection, bulk reagents and service). Also of note, a primary antibody is used on each slide. We will pass along that cost per test as well…just know that the lab won’t use a Leica antibody 100% of the time. This would be true of any vendor. Generally speaking, labs will use our antibodies the vast majority of the time but also use antibodies from other vendors.
Answer: CPT (cost per test/slide) is definitely what we want. Please include total cost per test/slide (any reagent, ancillaries, antibodies, detection, etc). In the past, we have had certain companies provide a CPT/Cost Per Slide and leave out the ancillary cost and some of the more expensive antibody(s) cost(s) associated with each slide.
Question # 3: Third party detection? Using third party detection doesn’t invalidate FDA approval for the instrument for routine (IVD) IHC Antibodies, which comprise approximately 95% of the antibodies we use. However, using third party detection would invalidate FDA approval for the instrument using Class I and Class II Antibodies. It’s imperative that we have the option to use a third party detection system(s) for our IVD Antibodies in the event that certain IVD antibody(s) staining results are sub-par based on the opinions of our pathologists. We have experienced this in the past with certain IVD Antibodies.
Answer: Using third party detection doesn’t invalidate FDA approval for the instrument for routine Class I (IVD) IHC Antibodies, which comprise approximately 95% of the antibodies we use. However, using third party detection would invalidate FDA approval for the instrument using only certain specific Class I Antibodies and all Class II Antibodies. It’s imperative that we have the option to use a third party detection system(s) for our IVD Antibodies in the event that certain IVD antibody(s) staining results are sub-par based on the opinions of our pathologists. We have experienced this in the past with certain IVD Antibodies.
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