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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. |
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