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BD Diagnostic Systems, BD Viper LT (Molecular, 2018)

BD Diagnostic Systems, BD Viper LT (Molecular, 2018)

Automated molecular platforms, October 2018

Contact Information

BD Diagnostic Systems
Chris Busa
Sparks, MD

Name of instrument BD Viper LT
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 2014/2014/2014
Dimensions in inches (H × W × D)/Footprint in square feet/Noise generated in dB 46 × 51 × 36/12.75/65
Supplied with UPS/BTU yes/up to 3,000 (1,000 when idle)
Physical contamination control features closed system
List price/Price for sample extraction and amplification detection modules
Purchase options/Minimum test volume requirements straight purchase, reagent rental, lease/—
Co. performs installation, operation, and performance qualifications/Electrical requirements yes/100V–240 V, 50–60 Hz
Labor and parts warranties/Advanced operator training 1 year/yes
Delivery time/Delivery charges/Installer/Time to install on site 2–3 weeks/origin/BD service engineer/<2 days
Training location/No. of techs that can receive initial training/Length of training/Retraining at company facility off site/2–4/2 days/no
Test menu Chlamydia trachomatis, Neisseria gonorrhoeae, human papillomavirus
No. of tests for which analyzer has FDA-cleared applications/CE mark 3/3
Tests available on instrument in U.S./Outside U.S. Chlamydia trachomatis, Neisseria gonorrhoeae, human papillomavirus/ Chlamydia trachomatis, Neisseria gonorrhoeae, human papillomavirus
Tests not available in U.S. but submitted to FDA/Available in other countries only 0/0
Research-use-only assays/Tests in development 0/0
Open-channel capabilities/Start-up and preparation time no/<10 min.
Model type of sample-handling system/Maximum sample load capacity Hamilton pipettor/120
Minimum specimen volume/Sample volume flexibility/Other sample volumes available 500 µL/no/swabs: 2 mL; urine: 2–3 mL; liquid-based cytology: 2.2 mL
Minimum dead volume/Pediatric sample volume/Primary tube sampling <400 µL/—/yes
Sample tube sizes/Sample barcode reading/Autodiscrimination in 1D or 2D 4 mL tubes/—/—
Sample barcode languages/Sample types available in open mode
Clot detection/Open extraction platform/Sample types (open extraction) no/no/none
Amplification reagents or methods supported SDA, PCR
No. of different assays onboard at once/Programmed or calibrated at once 3/2
Tests per container set/Multiple reagent configurations supported 2/no
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/no
Auto detection of adequate reagent or specimen/Reagents available yes/liquid and dry
Reagent reconstitution required/Chemical contamination control no/no
Onboard test auto inventory/Capable of inventory monitoring by barcode no/no
System is open to homebrew/General-purpose reagents allowed no/yes
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 room temperature/room temperature
Shipment temp. requirement for amplification reagents/Extraction reagents room temperature/room temperature
Minimum/Maximum reagent shelf-life guarantee 8 months/18 months
Autocalibration or autocalibration alert/Multipoint calibration supported yes/yes
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 no/yes
Auto shutdown*/Instrument warm-up time/Onboard software reviews QC yes/—/—
Total number of controls per batch for 24 tests/48 tests/72 tests/96 tests 1/2/3/4
Walkaway capacity/Tech hands-on time (both for batch of 96 samples) 30 samples/<5 min.
Uses disposable pipette tips/Maximum number of pipette tips stored yes/480
Time between start and initial result/Instrument automatic shutdown ~3 hrs./—
Startup programmable/Remote system monitoring/Waste required for disposables —/yes/—
Windows technology/Mouse or touchscreen/Modular add-on capability yes/touchscreen/no
Service contracts available/Mean time between failures/To repair failures multiyear/—/—
Turnaround time for problem solving by phone/Email/Field service <1 day/<2 days/variable
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 —/yes/no
Order parts via modem/Onboard error codes/Maintenance training demo module no/yes/no
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 —/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/no
• Priority processing no
• Supports accession No. redundancy/Specimen carrier and level identification yes/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 yes
• LIS(s) interfaced live with lab automation systems/How LIS(s) interfaced with LAS
• QC results transferred automatically to LIS/Data-management capability
• Interfaces operational in active user sites
• Rules-based control subsystem/Process control via control subsystem
• LIS operates simultaneously with assays running
• Uses LOINC to transmit orders and results/Unidirectional interface capability
• Results immediately transmitted to LIS/Interface available to auto specimen-handling system
• Stores QC lot files/Worklist edit capability/Viewable PCR graphs —/—/no
• Can print, archive, transmit data yes
Distinguishing features (supplied by company) benchtop, integrated molecular platform for HPV and CT/GC in a compact package; offers standardized, ready-to-use reagents, LIS connectivity with automated result reporting, and remote connectivity for faster serviceability; BD Onclarity Assay provides genotyping results for HPV 16, 18, and 45 and is FDA approved for ASCUS reflex testing, cotesting, and primary screening
*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.