Attachment 0002_Salient Characteristics IHC.pdf
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- Attached to
- Immunohistochemistry (IHC) Slide Staining Platforms, Antibody Stains, Reagents, and Supplies
- Solicitation number
- W81K0225QA054
- Issued by
-
Department of the Army Medical Command
About this file
This document is a Salient Characteristics specification for an Immunohistochemistry (IHC) Automated Slide Stainer Instrument for the Madigan Army Medical Center Department of Pathology. The specification outlines detailed technical requirements for a laboratory instrument, including the ability to process at least 80 slides per eight-hour shift, simultaneously run multiple testing protocols, perform various staining techniques (IHC, ISH, SISH, immunofluorescence), and handle both paraffin and non-paraffin embedded slides. Key requirements include a fully automated system with a self-contained waste system, flash memory technology for reagent tracking, and the capability to interface with the Anatomic Pathology Laboratory Information System.
The instrument must meet specific technical specifications such as voltage requirements (~100-230V), versatility in module configuration, and an open platform for third-party antibody stains. The vendor must provide an instrument that covers up to 90% of Madigan's antibody staining menu, with FDA-cleared capabilities for specific tests like Kappa/Lambda Dual ISH, PD-L1, Cintec (P16), BRAF, and HER2. The total automation system, consisting of two floor models, must fit within a specified area of 108 in x 48 in x 72 in, and provide technicians the ability to initiate a staining run and walk away until completion.
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Text version
MADIGAN ARMY MEDICAL CENTER
DEPARTMENT OF PATHOLOGY
TACOMA, WA 98431-1100
Salient Characteristics Immunohistochemistry (IHC) Automated Slide Stainer Instrument
1. Instrument must be able to add individual samples/slides continually throughout operation eliminating the requirement to batch samples based on specific antibody stains. Slides, reagents, and self-contained waste system can be simultaneously accessed as the system is processing samples.
2. Instrument shall process at least 80 slides per eight-hour shift.
3. At a minimum, instrument shall be able to stain/process an array of antibodies listed in the
SOW.
4. Stained slides may remain on the instrument upon completion and do not require immediate removal or restricted run hours based on availability of personnel.
5. Instrument shall be able to simultaneously run testing protocols involving companion diagnostics and ISH.
6. Instrument shall be a fully automated system capable of performing baking, deparaffinization, cell conditioning, and staining based on the label that is created and affixed to the slide.
7. Instrument shall be able to perform IHC, ISH, SISH, immunofluorescence, multiparameter IHC staining (dual, triple), counter stain and titration.
8. Instrument shall be able to run paraffin embedded slides and non-paraffin embedded slides, using different types of antigen retrieval and enzyme treatment, to adjust and optimize protocol as needed.
10. System shall have a self-contained waste system, separating hazardous from non-hazardous.
11. System shall utilize flash memory technology and barcodes on dispensers or other similar system to track reagents and for quality control and quality assurance.
12. System shall be versatile with the ability to reconfigure modules and scalable to allow for volume increase in throughput.
13. Minimal instrument electrical requirements include: Voltage ~100-230 V; Continuous Amperage 4-6 Amps; Frequency 50/60 Hz.
14. Vendor shall have up to 90% of Madigan’s antibody staining menu; must be at least FDA-cleared, including but not limited to the following: Kappa/Lambda Dual ISH, PD-L1, Cintec
(P16), BRAF.
15. HER2 by Immunohistochemistry (IHC) shall be FDA-approved
16. Total automation system (two instruments – floor models) shall fit along one wall in an area of 108 in x 48 in x 72 in (Size = W x D x H).
17. Instrument shall provide the ability for technicians to walk away with no additional steps once the staining run is started until complete.
18. Instrument shall be an open platform and capable of using third party antibody stains or laboratory developed tests.
19. System shall not require remote diagnostics for troubleshooting or required software updates.
20. Instrument shall have the capability to establish bidirectional interface with the Anatomic Pathology Laboratory Information System (APLIS).
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