Description
The Department of Veterans Affairs is seeking a compact, automated bench-top molecular diagnostic platform designed for low- to mid-volume laboratories, primarily utilized for HPV testing and STI screening. The system must offer fully automated molecular testing, integrating sample extraction, real-time PCR amplification, and detection in a single system. Key features include the automation of sample preparation, DNA extraction, amplification, detection, and result interpretation. The system must be capable of qualitative detection of specific high-risk HPV genotypes and must follow ASCP management pathway guidelines. The contractor must provide reagent kits, consumables, and patient collection materials and supplies. The system must be FDA cleared for both ThinPrep and SurePath Liquid Based Cytology.
Some key features of the system include:
• Main power switch
• Door
• Specimen rack
• Extraction rack
• BD Pre-warm Heater
• Lighted Login Station
• Monitor / Touchscreen
• USB Ports
• Thermal tool
• Onscreen keyboard
• Audible tones and alarms
• Uninterruptible power supply
• Capable of running patient-collected specimens
• Specimen collection kit that is easy to use and stable at room temperature
• Waste system that is capable of neutralizing and disinfecting biohazardous material before disposal
The contractor must provide all hardware and software, including upgrades and updates, and must provide a cross-reference to clearly show that the item(s) quoted meet or exceed all stated salient characteristics.