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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
christopher.busa@bd.com
Sparks, MD
410-316-3860


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
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