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AutoGenomics, INFINITI High Throughput System (Molecular, 2018)

AutoGenomics, INFINITI High Throughput System (Molecular, 2018)

Automated molecular platforms, October 2018

Contact Information

Rajasri Chandra
Carlsbad, CA

Name of instrument INFINITI High Throughput System
Country where designed/Manufactured/Reagents manufactured U.S./U.S./U.S.
Instrument FDA cleared or approved/Platform yes/analytical
First year sold in U.S./Sold internationally/Installed 2014/—/2014
Dimensions in inches (H × W × D)/Footprint in square feet/Noise generated in dB
Supplied with UPS/BTU no/—
Physical contamination control features discrete units
List price/Price for sample extraction and amplification detection modules
Purchase options/Minimum test volume requirements straight purchase, reagent rental, lease/1 µL
Co. performs installation, operation, and performance qualifications/Electrical requirements yes/—
Labor and parts warranties/Advanced operator training 1 year/yes
Delivery time/Delivery charges/Installer/Time to install on site
Training location/No. of techs that can receive initial training/Length of training/Retraining at company facility on site/—/—/—
Test menu >70 tests on women’s health, infectious diseases, pharmacogenomics, oncology, and genetic disorders
No. of tests for which analyzer has FDA-cleared applications/CE mark 5/29
Tests available on instrument in U.S./Outside U.S. IVD assays: CYP2C19, warfarin assay, factor II, factor V, factor II–V Leiden panel/MDR-TB, ApoE, CFTR-31, FMF panel, 5-FU, UGT1A1/HPV genotyping, STD6, bacterial vaginosis, candida vaginitis, H. pylori, HCV genotyping, respiratory viral panel, respiratory bacterial panel, GBS, genital ulcer disease, NTM, CYP450-2C9-VKORC1, 2D6, 2B6, 1A2, 3A4-3A5, neurotransmitter panel, neural response panel, age-related macular degeneration, KRAS-BRAF, EGFR, NRAS, Ashkenazi Jewish panel, more
Tests not available in U.S. but submitted to FDA/Available in other countries only
Research-use-only assays/Tests in development 65/5
Open-channel capabilities/Start-up and preparation time —/<1 hr. for 96 tests
Model type of sample-handling system/Maximum sample load capacity —/96 each plate (up to 8 plates)
Minimum specimen volume/Sample volume flexibility/Other sample volumes available 2 µL/yes/can be adjusted by user as needed
Minimum dead volume/Pediatric sample volume/Primary tube sampling —/—/no
Sample tube sizes/Sample barcode reading/Autodiscrimination in 1D or 2D —/—/no
Sample barcode languages/Sample types available in open mode
Clot detection/Open extraction platform/Sample types (open extraction) no/yes/variable, assay dependent: blood, buccal, saliva, tissue, liquid cytology media, culture, vaginal swabs, sputum, stool, more
Amplification reagents or methods supported
No. of different assays onboard at once/Programmed or calibrated at once all 70 assay types/50+
Tests per container set/Multiple reagent configurations supported
Reagent container placed directly on system/Onboard test auto inventory
Determines reagent volume in container/Reagent barcode reading/Reagents barcoded
Monitors expiration date/Auto lot recognition or calibration
Auto detection of adequate reagent or specimen/Reagents available —/liquid
Reagent reconstitution required/Chemical contamination control no/—
Onboard test auto inventory/Capable of inventory monitoring by barcode —/yes
System is open to homebrew/General-purpose reagents allowed no/no
Same capabilities when third-party reagent used/Lot sequestering available no/yes
Closed-vial stability for amplification reagents/Extraction reagents
Storage temp. requirement for amplification reagents/Extraction reagents
Shipment temp. requirement for amplification reagents/Extraction reagents
Minimum/Maximum reagent shelf-life guarantee 3 months/18 months
Autocalibration or autocalibration alert/Multipoint calibration supported
Assay calibrations required by end user/Calibrants can be stored onboard
Multiple calibrant lots stored for same assay/Required calibration frequency
Length of assay calibration/Typical calibration frequency
Onboard real-time QC/Supports multiple QC lot numbers per assay yes/—
Auto shutdown*/Instrument warm-up time/Onboard software reviews QC no/—/yes
Total number of controls per batch for 24 tests/48 tests/72 tests/96 tests
Walkaway capacity/Tech hands-on time (both for batch of 96 samples) —/1 hr.
Uses disposable pipette tips/Maximum number of pipette tips stored no/—
Time between start and initial result/Instrument automatic shutdown —/no
Startup programmable/Remote system monitoring/Waste required for disposables no/yes/—
Windows technology/Mouse or touchscreen/Modular add-on capability no/mouse/no
Service contracts available/Mean time between failures/To repair failures standard/—/—
Turnaround time for problem solving by phone/Email/Field service
No. of U.S. field reps/Service engineer on-site response time/Hours and days available
Guaranteed response time/Modem servicing avail./System diagnose own malfunctions
Order parts via modem/Onboard error codes/Maintenance training demo module
Average maintenance time for lab personnel/Onboard maintenance records
Preventive maintenance per year for sample extraction/Amplification detection
Downtime for preventive maintenance/Spare parts on site
Software and LIS interface:
• Patient demographics and insurance data available via rules-based architecture no
• Data retrieval or Internet connectivity yes
• Online real-time help, QC, stats, and management reports/Evaluates results validity yes/yes
• Priority processing no
• Supports accession No. redundancy/Specimen carrier and level identification yes/no
• Unique barcode per container/Multistop routing (1 tube to many workstations) no/—
• Specimen scheduling/Routes test to workstation/Automatic reflex, repeat, dilutions yes/yes/—
• Sample storage and retrieval software supports CLSI standards
• LIS(s) interfaced live with lab automation systems/How LIS(s) interfaced with LAS yes/wireless or Ethernet
• QC results transferred automatically to LIS/Data-management capability yes/no
• Interfaces operational in active user sites yes
• Rules-based control subsystem/Process control via control subsystem yes/yes
• LIS operates simultaneously with assays running yes
• Uses LOINC to transmit orders and results/Unidirectional interface capability
• Results immediately transmitted to LIS/Interface available to auto specimen-handling system yes/—
• Stores QC lot files/Worklist edit capability/Viewable PCR graphs yes/yes/no
• Can print, archive, transmit data yes
Distinguishing features (supplied by company) scalable high-throughput molecular testing from 1 to 864 multiplexed microarrays tested in 8 hrs.; broad spectrum of 70 assays; built-in replicate testing on each BioFilmChip microarray ensures assay result integrity and accuracy; easy and automated result interpretation
*for calibration and controls
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