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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 | |
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. |