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BD Diagnostic Systems, BD Viper System with XTR Technology (Molecular, 2018)

BD Diagnostic Systems, BD Viper System with XTR Technology (Molecular, 2018)

Automated molecular platforms, October 2018

Contact Information

BD Diagnostic Systems
Chris Busa
Sparks, MD

Name of instrument BD Viper System with XTR Technology
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 2009/2008/2009
Dimensions in inches (H × W × D)/Footprint in square feet/Noise generated in dB 83 × 75 × 42/262/<65
Supplied with UPS/BTU yes/2,048 per hr.
Physical contamination control features closed solid barrier amplification
List price/Price for sample extraction and amplification detection modules
Purchase options/Minimum test volume requirements straight purchase, reagent rental, lease/12,000 specimens per year
Co. performs installation, operation, and performance qualifications/Electrical requirements yes/208–240 VAC
Labor and parts warranties/Advanced operator training 1 year/yes
Delivery time/Delivery charges/Installer/Time to install on site 30 days/FOB (origin)/field service engineer/3 days
Training location/No. of techs that can receive initial training/Length of training/Retraining at company facility on and off site/1/3 days/yes
Test menu chlamydia, gonorrhea, HSV-1, HSV-2, trichomonas
No. of tests for which analyzer has FDA-cleared applications/CE mark
Tests available on instrument in U.S./Outside U.S. 5/5
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 no/10 min.
Model type of sample-handling system/Maximum sample load capacity sample rack/96
Minimum specimen volume/Sample volume flexibility/Other sample volumes available 2.5 mL/no/—
Minimum dead volume/Pediatric sample volume/Primary tube sampling 800 µL/—/yes
Sample tube sizes/Sample barcode reading/Autodiscrimination in 1D or 2D 2.5 mL/yes/no
Sample barcode languages/Sample types available in open mode Interleaved 2 of 5, Codabar codes 39 and 128/vaginal and endocervical swabs, urethral swabs, urine, liquid-base cytology (SurePath, ThinPrep)
Clot detection/Open extraction platform/Sample types (open extraction) yes/no/vaginal and endocervical swabs, urethral swabs, urine, more
Amplification reagents or methods supported strand displacement amplification
No. of different assays onboard at once/Programmed or calibrated at once 5/5
Tests per container set/Multiple reagent configurations supported CT: 1,152; GC: 1,152; HSV-1 and HSV-2: 96/no
Reagent container placed directly on system/Onboard test auto inventory yes/no
Determines reagent volume in container/Reagent barcode reading/Reagents barcoded no/yes/yes
Monitors expiration date/Auto lot recognition or calibration yes/no
Auto detection of adequate reagent or specimen/Reagents available yes/liquid and dry
Reagent reconstitution required/Chemical contamination control no/—
Onboard test auto inventory/Capable of inventory monitoring by barcode no/no
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 18 months/18 months
Storage temp. requirement for amplification reagents/Extraction reagents room temperature/room temperature
Shipment temp. requirement for amplification reagents/Extraction reagents room temperature/room temperature
Minimum/Maximum reagent shelf-life guarantee 3 months/24 months
Autocalibration or autocalibration alert/Multipoint calibration supported no/no
Assay calibrations required by end user/Calibrants can be stored onboard no/no
Multiple calibrant lots stored for same assay/Required calibration frequency no/—
Length of assay calibration/Typical calibration frequency
Onboard real-time QC/Supports multiple QC lot numbers per assay no/yes
Auto shutdown*/Instrument warm-up time/Onboard software reviews QC no/—/no
Total number of controls per batch for 24 tests/48 tests/72 tests/96 tests 2/2/4/4
Walkaway capacity/Tech hands-on time (both for batch of 96 samples) 3 hrs., 5 min./10 min.
Uses disposable pipette tips/Maximum number of pipette tips stored yes/768
Time between start and initial result/Instrument automatic shutdown 3 hrs., 15 min./no
Startup programmable/Remote system monitoring/Waste required for disposables yes/yes/solid (disposable tips) and neutralized liquid waste
Windows technology/Mouse or touchscreen/Modular add-on capability yes/touchscreen/no
Service contracts available/Mean time between failures/To repair failures 5 days, 8 am–5 pm, and 7 days, 24 hrs./280 days/24 hrs.
Turnaround time for problem solving by phone/Email/Field service real time/—/24 hrs
No. of U.S. field reps/Service engineer on-site response time/Hours and days available >30/24 hrs./24–7
Guaranteed response time/Modem servicing avail./System diagnose own malfunctions —/yes/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, weekly, and monthly: 15 min./no
Preventive maintenance per year for sample extraction/Amplification detection 1/1
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 yes/yes
• Priority processing no
• Supports accession No. redundancy/Specimen carrier and level identification no/yes
• Unique barcode per container/Multistop routing (1 tube to many workstations) no/no
• Specimen scheduling/Routes test to workstation/Automatic reflex, repeat, dilutions no/no/no
• Sample storage and retrieval software supports CLSI standards no
• LIS(s) interfaced live with lab automation systems/How LIS(s) interfaced with LAS no/LIS-RS-232 serial ASTM 1381-1394
• 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 no/no
• LIS operates simultaneously with assays running no
• Uses LOINC to transmit orders and results/Unidirectional interface capability no/yes
• Results immediately transmitted to LIS/Interface available to auto specimen-handling system yes/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) reduced hands-on time for setup and maintenance; fully automated specimen processing with high walkaway time; FDA cleared for 2 common liquid-base cytology specimens for CT-GC and fully automated for FDA-cleared HSV-1 and HSV-2 assays
*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.