Requirement 9.docx
DOCX document 17 KB Posted
- Attached to
- Automated Cell Counter
- Solicitation number
- 75N98026Q00775
About this file
This is a Requirements document for an automated cell counter system to support clinical research at the National Institutes of Health's Liver Diseases Branch. The system must provide image-based automated cell counting with dual-channel fluorescence and brightfield imaging capabilities to replace manual microscopy counting of white blood cells and other immune cells from patients with liver disease and research subjects. The system shall process a minimum of eight samples per slide, complete counting in under 60 seconds, capture two, four, or eight images per sample, and analyze sample volumes as small as 10 microliters. The system must support analysis of diverse cell types including mouse immune cells, bone marrow cells, human blood lymphocytes, hepatocytes, and primary cell populations while maintaining compatibility with existing laboratory workflows.
The system must feature customizable and storable experimental protocols for ongoing research, support 21 CFR Part 11 compliance through audit trails, user access controls, and electronic signature functionality, and have a compact footprint suitable for laboratory bench placement (approximately 15 inches deep by 10 inches wide). These requirements are issued by the Department of Health and Human Services National Institutes of Health Office of Logistics and Acquisition Operations under solicitation number 75N98026Q00775 as a pre-solicitation notice to identify potential vendors capable of providing this specialized laboratory equipment.
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Text version
Requirements:
The Liver Diseases Branch requires an automated cell counter to support ongoing clinical research studies involving immune cells obtained from patients with liver disease. These studies require the isolation and quantification of white blood cells for downstream research analyses.
Currently, white blood cells are counted manually using microscopy. To improve efficiency, increase counting throughput, enhance differentiation between white blood cells and red blood cells, distinguish live and dead cells, and reduce inter-operator variability, the laboratory requires an image-based automated cell counting system with dual-channel fluorescence and brightfield imaging capabilities.
The following product features and characteristics are required:
· The system shall provide compatibility with existing laboratory workflows and support the use of customizable and saved experimental protocols for ongoing research studies.
· The system shall be capable of processing a minimum of eight samples on a single slide.
· The system shall complete cell counting in less than 60 seconds and provide the ability to capture two, four, or eight images per sample.
· The system shall incorporate dual-channel fluorescence and brightfield imaging capabilities for cell counting and viability assessments.
· The system shall support analysis of a wide range of sample types, including mouse immune cells, bone marrow cells, human blood lymphocytes, hepatocytes, and other primary cell populations.
· The system shall be capable of analyzing sample volumes as small as 10 microliters.
· The system shall allow users to customize, store, and retrieve commonly used experimental settings and analysis protocols.
· The system shall be capable of supporting 21 CFR Part 11 compliance through available audit trail, user access control, and electronic signature functionality.
· The system shall have a compact footprint suitable for placement on laboratory bench space approximately 15 inches deep and 10 inches wide.
· The system shall include a minimum 12-month manufacturer's warranty.
File details come from the government source that posted it. Updated .