HPV Analyzer and Reagents

The Joint Base Lewis-McChord Health Contracting Branch is issuing this sources sought notice as a means of conducting market research to identify parties having an interest in and the resources to support the requirement for Molecular Diagnostics analyzers and reagents testing for qualitative detection and genotyping of the DNA of Human Papilloma Virus (HPV). The intention is to procure these items on a competitive basis. PLEASE read the salient characteristics below. The intention is for the vendor to supply an analyzer and required reagents and controls for a one year base period and up to two 12-month options. Estimated start date is 1OCT2022.Based on the responses received to this notice, this requirement may be set-aside for small businesses, sole sourced, or Full and Open competition, and multiple awards MAY be made. All Small Business Set-Aside categories will be considered.Telephone inquiries will not be accepted or acknowledged, and no feedback or evaluations will be provided

to companies regarding their submissions.DISCLAIMER“THIS SOURCES SOUGHT IS FOR INFORMATIONAL PURPOSES ONLY. THIS IS NOT A “REQUEST FOR PROPOSAL (RFP)” TO BE SUBMITTED. IT DOES NOT CONSTITUTE A SOLICITATION AND SHALL NOT BE CONSTRUED AS A COMMITMENT BY THE GOVERNMENT. RESPONSES IN ANY FORM ARE NOT OFFERS AND THE GOVERNMENT IS UNDER NO OBLIGATION TO AWARD A CONTRACT AS A RESULT OF THIS ANNOUNCEMENT. NO FUNDS ARE AVAILABLE TO PAY FOR PREPARATION OF RESPONSES TO THIS ANNOUNCEMENT. ANY INFORMATION SUBMITTED BY RESPONDENTS TO THIS TECHNICAL DESCRIPTION IS STRICTLY VOLUNTARY. RESPPONSES WILL NOT BE RETURNED TO THE RESPONDER. NOT RESPONDING TO THIS NOTICE DOES NOT PRECLUDE PARTICIPATION IN ANY FUTURE REQUEST FOR QUOTE (RFQ) OR INVITATION FOR BID (IFB) OR RFP, IF ANY ISSUED. IF A SOLICITATION IS RELEASED, IT WILL BE SYNOPSIZED ON SAM.GOV.  IT IS THE RESPONSIBILITY OF POTENTIAL OFFERORS TO MONITOR THE SITE FOR ADDITIONAL INFORMMATION PERTAINING TO THIS REQUIREMENTGeneral instrument characteristics include being able to run HPV, MRSA/SA, HSV 1/2, Cdiff, CT/NG, BRAF, KRAS, Factor II/V, EGFR v2 based assays on one RT-PCR technology based platform in batch sizes up to 96.Characteristics:Automated sample ID scanning.Bar-coded data entry capabilities.Bi-directional interface for host connection to connect to LIS.Test-specific reagents.Ready-to-use reagents, bar-coded cassettes.All in one bench top instrument.120 Voltage.Must be able to provide system installation and set-up.Computer system (CPU, Monitor, Keyboard, Printer,), UPS for all instruments for the life of the instruments.Must be able to provide complete system validation (or assist facility with validation, as needed).Must be able to provide training for staff how to use and troubleshoot the system.Operate within the existing environmental conditions of 15-35 °C and 15-75% relative humidity.Accepts multiple primary and secondary vial formats.Able to identify both low and high risk HPV at the same time.Must be approved by the FDA for ASC-US triage, co-testing and first-line primary screening.HPV testing with internal cellularity controls ensuring no false negatives if used as a primary screening method.Utilizing integrated HPV16/18 genotyping and 12 other high risk HPV genotypes.The HPV test must use amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of 14 high-risk (HR) HPV types in a single analysis.The test specifically identifies (types) HPV 16 and HPV 18 while concurrently detecting the rest of the high-risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68) at clinically relevant infection levels.Highly efficient signal excitation and data capture to reduce signal artifacts and ensure data integrity.Pipette tip locking and monitoring technology, including CO-RE, TADM and anti-droplet control (ADC) for reliable sample transfer.General instrument characteristics should include being able to run HPV DNA based assays on a RT-PCR technology based platform in flexible batch sizes of 24 or 96 for efficient reagent usage.A proprietary Kinetic Algorithm ensures results are positive, negative, or invalid and growth curve analysis is unnecessary.Capable of multiplexing up to 6 detections per amplified sample.An Internal Control/Quantitation Standard (IC/QS) incorporated into each individual sample and is carried through the sample preparation.Collaborating controls should be included as part testing from the same manufacturer.The systems must improve overall productivity in the Molecular Diagnostics Lab, reducing the need for repeat testing thus reducing reagent waste.The system should be able to accept the primary specimen container.The system should not require monitoring/user intervention during an extraction run and should be 100% “walk-away” system.Overnight operation capabilities.One test in one run, from one patient sample (1mL) eliminates the need for reflex testing and reduces the risk of insufficient quantity.Able to destroy previously generated PCR amplification to help significantly reduce the risk of false positive results. Eliminate the use of bleach solutions to prevent cross-contamination issues.Approved ATO to operate on the DHA network and is bi-directionally interfaced with the LIS.