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BD Diagnostic Systems, BD Affirm VPIII Microprocessor (Molecular, 2018)

BD Diagnostic Systems, BD Affirm VPIII Microprocessor (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 Affirm VPIII Microprocessor
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 1996/1996/1996
Dimensions in inches (H × W × D)/Footprint in square feet/Noise generated in dB 6 × 10 × 9/0.63/quiet
Supplied with UPS/BTU no/—
Physical contamination control features
List price/Price for sample extraction and amplification detection modules
Purchase options/Minimum test volume requirements straight purchase, reagent rental, lease/72 tests per month
Co. performs installation, operation, and performance qualifications/Electrical requirements no/120 V
Labor and parts warranties/Advanced operator training 1 year/no
Delivery time/Delivery charges/Installer/Time to install on site 2 weeks/none for instrumentation/BD field applications/4 hrs.
Training location/No. of techs that can receive initial training/Length of training/Retraining at company facility on site/6/4 hrs./no
Test menu Candida species (six different), Gardnerella vaginalis, Trichomonas vaginalis
No. of tests for which analyzer has FDA-cleared applications/CE mark 3/3
Tests available on instrument in U.S./Outside U.S. 3/3
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/immediate
Model type of sample-handling system/Maximum sample load capacity swab, tube, and cap/6
Minimum specimen volume/Sample volume flexibility/Other sample volumes available —/no/—
Minimum dead volume/Pediatric sample volume/Primary tube sampling —/—/yes
Sample tube sizes/Sample barcode reading/Autodiscrimination in 1D or 2D 5 mL/no/no
Sample barcode languages/Sample types available in open mode
Clot detection/Open extraction platform/Sample types (open extraction) no/no/—
Amplification reagents or methods supported
No. of different assays onboard at once/Programmed or calibrated at once 3/3
Tests per container set/Multiple reagent configurations supported 24 or 120/—
Reagent container placed directly on system/Onboard test auto inventory yes/no
Determines reagent volume in container/Reagent barcode reading/Reagents barcoded no/no/no
Monitors expiration date/Auto lot recognition or calibration no/no
Auto detection of adequate reagent or specimen/Reagents available no/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/no
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 6 months/14 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/factory calibrated only
Length of assay calibration/Typical calibration frequency
Onboard real-time QC/Supports multiple QC lot numbers per assay no/no
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
Walkaway capacity/Tech hands-on time (both for batch of 96 samples) 30 min./3 min.
Uses disposable pipette tips/Maximum number of pipette tips stored no/—
Time between start and initial result/Instrument automatic shutdown 45 min./no
Startup programmable/Remote system monitoring/Waste required for disposables no/no/biohazardous waste
Windows technology/Mouse or touchscreen/Modular add-on capability no/—/no
Service contracts available/Mean time between failures/To repair failures repair by replacement (normally ships same day of call to tech service)/—/single swap option within 24 hrs.
Turnaround time for problem solving by phone/Email/Field service immediate during business hours; 1 hr. nonbusiness/immediately/as needed
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 no/no/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: <5 min./no
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 no
• 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 no/no
• 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/no
• QC results transferred automatically to LIS/Data-management capability no/no
• Interfaces operational in active user sites no
• 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/no
• Results immediately transmitted to LIS/Interface available to auto specimen-handling system no/no
• Stores QC lot files/Worklist edit capability/Viewable PCR graphs no/no/no
• Can print, archive, transmit data no
Distinguishing features (supplied by company) simultaneous detection/differentiation of the 3 organisms that cause up to 90 percent of vaginal infections in 1 swab; quick turnaround time (45 min. for 6 samples or 18 results); simultaneously detects mixed infections caused by 3 organisms; objective, visual results
*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.