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AutoGenomics, INFINITI PLUS Analyzer (Molecular, 2018)

AutoGenomics, INFINITI PLUS Analyzer (Molecular, 2018)

Automated molecular platforms, October 2018

Contact Information

Rajasri Chandra
Carlsbad, CA

Name of instrument INFINITI PLUS Analyzer
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 2011/2011/2011
Dimensions in inches (H × W × D)/Footprint in square feet/Noise generated in dB 26 × 44 × 24/7.3/—
Supplied with UPS/BTU no/—
Physical contamination control features no aspiration tubing, disposable tips
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/110 V and 220 V, 50–60 Hz
Labor and parts warranties/Advanced operator training 1 year/no
Delivery time/Delivery charges/Installer/Time to install on site 1 week/—/AGI/1–2 days
Training location/No. of techs that can receive initial training/Length of training/Retraining at company facility on and off site/1/2.5 days/yes
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 yes/20 min.
Model type of sample-handling system/Maximum sample load capacity —/48
Minimum specimen volume/Sample volume flexibility/Other sample volumes available 1 µL/no/—
Minimum dead volume/Pediatric sample volume/Primary tube sampling —/—/no
Sample tube sizes/Sample barcode reading/Autodiscrimination in 1D or 2D —/yes/—
Sample barcode languages/Sample types available in open mode
Clot detection/Open extraction platform/Sample types (open extraction) —/yes/variable, assay dependent: blood, buccal, saliva, tissue, vaginal swabs, liquid cytology media, culture, sputum, stool, more
Amplification reagents or methods supported
No. of different assays onboard at once/Programmed or calibrated at once 4/70
Tests per container set/Multiple reagent configurations supported 48/—
Reagent container placed directly on system/Onboard test auto inventory yes/yes
Determines reagent volume in container/Reagent barcode reading/Reagents barcoded yes/yes/yes
Monitors expiration date/Auto lot recognition or calibration yes/yes
Auto detection of adequate reagent or specimen/Reagents available yes/liquid
Reagent reconstitution required/Chemical contamination control no/—
Onboard test auto inventory/Capable of inventory monitoring by barcode yes/yes
System is open to homebrew/General-purpose reagents allowed no/no
Same capabilities when third-party reagent used/Lot sequestering available no/no
Closed-vial stability for amplification reagents/Extraction reagents
Storage temp. requirement for amplification reagents/Extraction reagents -20°C/—
Shipment temp. requirement for amplification reagents/Extraction reagents -20°C/—
Minimum/Maximum reagent shelf-life guarantee 12 months/24 months
Autocalibration or autocalibration alert/Multipoint calibration supported no/yes
Assay calibrations required by end user/Calibrants can be stored onboard no/no
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/no
Auto shutdown*/Instrument warm-up time/Onboard software reviews QC no/—/—
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) 5 hrs./15 min.
Uses disposable pipette tips/Maximum number of pipette tips stored yes/504
Time between start and initial result/Instrument automatic shutdown 3 hrs./no
Startup programmable/Remote system monitoring/Waste required for disposables no/no/built-in waste tray, solid state waste products
Windows technology/Mouse or touchscreen/Modular add-on capability yes/mouse/yes
Service contracts available/Mean time between failures/To repair failures annual/—/—
Turnaround time for problem solving by phone/Email/Field service 24 hrs./24 hrs./48 hrs.
No. of U.S. field reps/Service engineer on-site response time/Hours and days available —/24–48 hrs./6 am–6 pm (PDT)
Guaranteed response time/Modem servicing avail./System diagnose own malfunctions yes (within 24 hrs.)/no/yes
Order parts via modem/Onboard error codes/Maintenance training demo module no/yes/no
Average maintenance time for lab personnel/Onboard maintenance records daily: 5 min.; weekly: 10 min.; monthly: 20 min.; yearly: 45 min./no
Preventive maintenance per year for sample extraction/Amplification detection —/1
Downtime for preventive maintenance/Spare parts on site 1 day/no
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 no/yes
• Priority processing yes
• Supports accession No. redundancy/Specimen carrier and level identification
• Unique barcode per container/Multistop routing (1 tube to many workstations) yes/no
• Specimen scheduling/Routes test to workstation/Automatic reflex, repeat, dilutions yes/no/—
• Sample storage and retrieval software supports CLSI standards no
• LIS(s) interfaced live with lab automation systems/How LIS(s) interfaced with LAS yes/—
• QC results transferred automatically to LIS/Data-management capability —/yes
• 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 no/no
• Results immediately transmitted to LIS/Interface available to auto specimen-handling system yes/no
• Stores QC lot files/Worklist edit capability/Viewable PCR graphs —/yes/no
• Can print, archive, transmit data yes
Distinguishing features (supplied by company) load-and-go automation increases lab productivity by freeing up personnel; built-in replicate testing on each BioFilmChip microarray ensures assay result integrity and accuracy; broad menu of 70 assays on same instrument; easy and automated result interpretation
*for calibration and controls
Note: a dash in lieu of an answer means company did not answer question or question is not applicable
All information is supplied by the companies listed. The tabulation does not represent an endorsement by the CAP.