Minimum Essential Characteristics.pdf
PDF 121 KB Posted
- Solicitation number
- HT9426-26-RFI-5892
- Issued by
-
Defense Health Agency
About this file
This document is a Minimum Essential Characteristics (MEC) specification for a sequencing system and supplies procurement.
The vendor must provide a complete Vela Diagnostics sequencing system including the Sentosa SQ301 automated next-generation sequencing (NGS) instrument (FDA-approved for HIV-1 genotype assays), Sentosa SX101 automated pipetting system for nucleic acid extraction and PCR setup, server hardware and software, and all required sub-system components. The vendor must provide preventative and emergency maintenance to maintain College of American Pathology (CAP) standards, respond to equipment failures within 48-72 hours, and ensure staff possess Real ID credentials for access to military installations. Annual requirements include 13 units each of HIV Genotyping Reagents v2.0 and Virus Testing Solutions; 8 units of HIV Positive Control; 13 units each of Virus TNA Plus Kit, IA Reactions Kit; 7 units each of IA Reagents Kit, IA Solution Kit, and multiple sequencing supplies and reagents; consumables including filter tips (31 units of 50μL and 21 units of 1000μL), PCR plates (3 units), reservoirs, and biohazard bags; capital instruments including 2 Sentosa SX101 Basic Sets, 2 Sentosa SX NGS Starter Kits, and 2 Sentosa SQ301 Sequencers; servers and software including T430 and T440 servers and Reporter v2.3; labware including magnetic plates and metal chip racks; and non-Vela items including Bio-Rad plate sealer and vacuum/pressure pump. Reagents must be delivered with minimum one-year shelf life (four months for positive controls) and within 60-90 days of request.
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Text version
CUI//PROCURE
Minimum Essential Characteristics (MEC) Sequencing System and Supplies
1. Vendor shall provide Vela Diagnostics sequencing system to include all required sub-system components, maintenance and repair, and operational supplies and consumable products. The sequencing system shall support the following specifications:
• Automated next-generation sequencing (NGS) instrument (Sentosa SQ301) for the targeted sequencing of human and viral DNA that is FDA approved vendor for HIV-1 genotype assay
• Instrument supports NGS assays and customer-developed assays.
• Server: a hardware and software system that controls the instrument and collects sequencing data.
• Automated pipetting system (Sentosa SX101) for nucleic acid extraction and polymerase chain reaction (PCR) set-up.
• Preventative and emergency maintenance shall be performed to ensure the provided instruments meet and maintain College of American Pathology (CAP) standards for clinical testing operations. The vendor shall respond to equipment failures within 48-72 hours. Vendor staff shall have real ID to ensure access to military installations to perform maintenance.
2. Listed below are the specified annual requirements.
Product Name (KITS) Item Number Quantity Sentosa SQ HIV Genotyping Reagents v2.0 (4x24) (IVD)
300731 13
Sentosa SQ Virus Testing Solutions (4x24)
(IVD)
300732 13
Sentosa SQ HIV Positive Control (8) (IVD) 300800 8 Sentosa SX Virus TNA Plus Kit (4x24)
(IVD)
300395 13
Sentosa SX IA Reactions Kit (4) (IVD) 300733 13 Sentosa SX IA Reagents Kit (8) (IVD) 300734 7 Sentosa SX IA Solution Kit (8) (IVD) 300735 7 Sentosa SQ Sequencing Supplies (IVD) 300306 7 Sentosa SQ Sequencing Reagents (IVD) 300313 7 Sentosa SQ Sequencing Solutions IVD 300316 7 Sentosa SQ 318 Chip Kit (IVD) 300300 7
Product Name (Consumables)
Sentosa SX Barcoded PCR Plate 96 (50) 400100 3 Sentosa SX Non-Partition 50μL Filter Tips (960)
400224 31
Sentosa SX Non-Partition 1000μL Filter Tips (960)
400223 21
Sentosa SX Deepwell Plate 96/2000uL (20) 400068 3 Sentosa SX 100ml Reservoir (50) 400027 2 Sentosa SX 30 ml Reservoir (50) 400028 8 Sentosa SX Biohazard bag (100) 400033 2 Sentosa SX Safe-Lock Tubes(1000) 400031 2
Product Name (Instruments) Sentosa SX101 Basic Set 400089 2 Sentosa SX NGS Starter Kit 400105 2 Sentosa SQ301 Sequencer 400103 2 Sentosa SQ301 Minicentrifuge 120V 400122 1
Product Name (Servers & Software) Sentosa SQ301 Server T430 400225 1 Sentosa SQ Reporter Server T440 400133 1 Sentosa SQ Reporter v2.3 480187 1 Sentosa SX Software 460018 2
Product Name (Labware) Sentosa SX Magnetic Plate 400090 2 Sentosa SX 318 Metal Chip Rack 400251 2
Product Name (Non-Vela Items) Bio-Rad PX1 PCR Plate Sealer 1814000 1 Bio-Rad Pierceable Foil Heat Seal (100) 400257 1 Vacuum/Pressure Pump 15.5LPM 1
• Reagents shall be delivered with at least a one-year shelf life and any positive controls shall have a four-month or longer shelf life.
• Reagents shall be delivered within 60-90 days of requesting.
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