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| Name of instrument | GeneXpert Infinity-48, Infinity-48s, Infinity-80 |
| Country where designed/Manufactured/Reagents manufactured | U.S./U.S./U.S. |
| Instrument FDA cleared or approved/Platform | yes/preanalytical and analytical |
| First year sold in U.S./Sold internationally/Installed | 2009/2009/2009 |
| Dimensions in inches (H × W × D)/Footprint in sq. ft./Noise generated in dB | 79.1 × 105.2 × 34.6 (48); 78.5 × 85 × 34.6 (48S); 78.5 × 108 × 35 (80)/25.25/— |
| Supplied with UPS/BTU | yes/— |
| Physical contamination control features | closed-cartridge technology |
| List price/Price for sample extraction and amplification detection modules | $199,000–$530,000/— |
| Purchase options/Minimum test volume requirements | straight purchase, reagent rental, lease/— |
| Co. performs installation, operation, and performance qualifications/Electrical req. | yes/100–120 VAC, 50–60 Hz (48); 200–240 VAC, 50–60 Hz (48S, 80) |
| Labor and parts warranties/Advanced operator training | 1 year/yes |
| Delivery time/Delivery charges/Installer/Time to install on site | 2–4 weeks/FOB origin/company/<1 day |
| Training location/No. of techs that can receive initial training/Length of training/Retraining at company facility | on site/1 or more/1–3 days/yes |
| Test menu | Xpert SA nasal complete, Xpert vanA, Xpert C. difficile, Xpert MRSA/SA SSTI, Xpert MRSA/SA BC, Xpert MRSA, Xpert GBS, Xpert EV, Xpert FII & FV, Xpert Flu, Xpert C. difficile-Epi |
| No. of tests for which analyzer has FDA-cleared applications/CE-mark | 11/13 |
| Tests available on instrument in U.S./Outside U.S. | —/Xpert MTB/RIF, Xpert CT/NG |
| Tests not available in U.S. but submitted to FDA/Available in other countries only | — |
| Research-use-only assays/Tests in development | — |
| Open-channel capabilities/Start-up and preparation time | yes/<1 minute |
| Model type of sample-handling system/Maximum sample load capacity | cartridge-based/1,300 in 24 hours |
| Min. specimen volume/Sample volume flexibility/Other sample volumes avail. | —/yes (sample-type dependent: whole blood, swab, sputum fluids, others)/— |
| Min. dead volume/Pediatric sample volume/Primary tube sampling | —/—/no |
| Sample tube sizes/Sample bar-code reading/Autodiscrimination in 1D or 2D | —/yes/yes |
| Sample bar-code languages/Sample types available in open mode | all common/no restrictions |
| Clot detection/Open extraction platform/Sample types (open extraction) | no/no/no restrictions |
| Amplification reagents or methods supported | — |
| Extraction methods supported for: RNA extract./DNA extract./total nucleic acid | yes/yes/yes |
| No. of different assays onboard at once/Programmed or calibrated at once | full menu/full menu |
| Tests per container set/Multiple reagent configurations supported | single-use cartridges/reagents contained in cartridge |
| Reagent container placed directly on system/Onboard test auto inventory | yes/yes |
| Determines reagent volume in container | yes |
| Reagent bar-code reading/Reagents bar coded | yes/yes |
| Monitors expiration date/Auto lot recognition or calibration | yes/yes |
| Auto detection of adequate reagent or specimen/Reagents available | yes/liquid and dry |
| Reagent reconstitution required/Chemical contamination control | no/closed-cartridge technology |
| Onboard test auto inventory/Capable of inventory monitoring by bar code | 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 | up to 2 years/up to 2 years |
| Storage temp. requirement for amplification reagents/Extraction reagents | amplification and extraction: room temperature (2°–8°C depending on test) |
| Shipment temp. requirement for amplification reagents/Extraction reagents | room temperature/room temperature |
| Minimum/maximum reagent shelf-life guarantee | 3 months/— |
| Autocalibration or autocalibration alert/Multipoint calibration supported | yes/yes |
| Assay calibrations required by end-user/Calibrants can be stored onboard | no/— |
| Multiple calibrant lots stored for same assay/Required calibration frequency | —/2,000 tests or 1 year per module |
| Length of assay calibration/Typical calibration frequency | 2,000 tests or 1 year per module/1 year |
| Onboard real-time QC/Supports multiple QC lot numbers per assay | yes/— |
| Auto shutdown*/Instrument warm-up time/Onboard software reviews QC | no/none/yes |
| Total number of controls per batch for 24 tests/42 tests/72 tests/96 tests | 0/0/0/0 |
| Walkaway capacity/Tech hands-on time (both for batch of 96 samples) | ~130 (48); ~115 (48S); ~175 (80): random access (not batch)/<2 minutes per sample: random access |
| Uses disposable pipette tips/Maximum number of pipette tips stored | no/— |
| Time between start and initial result/Instrument automatic shutdown | 35 minutes to 2 hours, depending on test/no |
| Startup programmable/Remote system monitoring/Waste req. for disposables | yes/no/disposable cartridges |
| Windows technology/Mouse or touchscreen/Modular add-on capability | yes/mouse and touchscreen/yes |
| Service contracts available/Mean time between failures/To repair failures | full service, labor and parts/—/24–48 hours |
| Turnaround time for problem solving by phone/e-mail/field service | M-F, 5 am–5 pm: 5 minutes–2 hours; limited on weekend/same as phone/— |
| No. of U.S. field reps/Service engineer on-site response time/Hours & days avail. | 10/within 24 hours/24-7 or M-F, 5 am–5 pm |
| Guaranteed response time/Modem servicing available | yes (M-F, 5 am–5 pm)/yes |
| System can diagnose own malfunctions | no |
| Order parts via modem/Onboard error codes/Maintenance training demo module | no/yes/yes |
| Average maintenance time for lab personnel/Onboard maintenance records | daily: <1 minute; weekly: <5 minutes; monthly: <30 minutes/no |
| Preventive maintenance per year for sample extraction/amplification detection | — |
| Downtime for preventive maintenance/Spare parts on site | 1–2 hours/no |
| Software and LIS interface: | |
| • Patient demographics and insurance data available via rules-based architecture | yes |
| • Data retrieval or Internet connectivity | yes |
| • Online real-time help, QC, stats and management reports/Evaluates results validity | yes/yes |
| • Priority processing | yes |
| • Supports accession No. redundancy/Specimen carrier and level identification | yes/yes |
| • Unique bar code per container/Multistop routing (1 tube to many workstations) | yes/yes |
| • Specimen scheduling/Routes test to workstation/Auto. reflex, repeat, dilutions | yes/yes/— |
| • Sample storage and retrieval software supports CLSI standards | yes |
| • LIS(s) interfaced live with lab automation systems/How LIS(s) interfaced with LAS | yes/TCP-IP |
| • QC results transferred automatically to LIS/Data management capability | yes/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 | yes/yes |
| Results immed. transmitted to LIS/Interface avail. to auto specimen-handling system | yes/yes |
| Stores QC lot files/Worklist edit capability/Viewable PCR graphs | yes/yes/yes |
| Can print, archive, transmit data | yes |
| Distinguishing features (provided by company) | fully automated, robotic, real-time PCR system integrates all steps required for PCR-based DNA testing: sample preparation, DNA amplification and detection; cartridge handling; fully integrated; built-in smart technology: fluid master scheduler prioritizes test runs; reduces hands-on labor |
| *for calibration and controls | |
| Note: a dash in lieu of an answer means company did not answer question or question is not applicable | |
| Tabulation does not represent an endorsement by the College of American Pathologists. |
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