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Gold Standard Diagnostics, Bolt (Chemistry-Immunoassay POC Low Volume, 2018)

Gold Standard Diagnostics, Bolt (Chemistry-Immunoassay POC Low Volume, 2018)

Chemistry and immunoassay analyzers for point-of-care and low-volume laboratories, June 2018

Contact Information

Gold Standard Diagnostics
Christina Brusca
cbrusca@gsdx.us
Davis, CA
530-759-8000


Name of instrument Bolt
Type of instrument immunoassay
Operational type/Model type batch/benchtop
List price/First year sold in U.S. —/2017
Targeted hospital bed size/Targeted daily test volume 50–500/1–300
Company manufactures instrument yes
Other models in this family of analyzers
No. of units in clinical use in U.S./Outside U.S. (countries) 20/40
Dimensions (H × W × D)/Instrument footprint (square feet) 19 × 21 × 22 in./3.5 sq. ft.
Weight empty/Weight fully loaded 59.5 lbs./60 lbs.
Tests available on analyzer in U.S.
Tests not available in U.S. but available in other countries
Tests in development for analyzer
No. of different measured assays onboard simultaneously > 8 (> 8 can be run and calibrated at one time)
No. of user-definable (open chemistry) channels
Test throughput per hour/Assay run time —/avg. 90 min.
Chemistry:
No. of direct ion-selective electrode channels
Detection methods
Stat time until completion/specimen throughput for:
• Ion-selective electrode
• Basic metabolic panel
• Complete metabolic panel
Typical time delay from ordering stat test until aspiration of sample
Immunoassay:
Fully automated microplate immunoassay system yes (96 tests per unit; 96 wells per microplate)
Methodologies supported chemiluminescence, EIA
Separation methodologies coated microwell
Stat time until completion of a ß-hCG test
Typical time delay from test order to aspiration of sample
Stat time until completion of a cTn test
• Typical time delay from test order to aspiration of sample
Approx. No. of tests per reagent set or pack/Reagent type —/open reagent system
Reagents refrigerated onboard/Reagents ready to use no/yes
Reagent lot tracking/Reagent inventory no/no
Reagent form/Reagents barcoded liquid chemistry (open reagent system)/no
Separate reagent pack for each specimen/for each test run no/yes
Walkaway capability/Walkaway duration yes/—
Design of sample handling system rack
Uses washable cuvettes/Uses disposable cuvettes no/no
Min.–max. sample volume that can be aspirated at one time 1–400 µL
Min. reaction volume/Min. specimen volume/Min. dead volume 300 µL/1 µL/200 µL
Dedicated pediatric sample cup no
Primary tube sampling/Pierces caps on primary tubes yes (tubes [in mm]: 12 × 75, 13 × 75, 16 × 75, 12 × 100, 13 × 100, 16 × 100)/no
Protects against probe collision yes
Detects clots/liquid level/short sample yes/yes/yes
Detection for hemolysis/icterus/lipemia/clots no/no/no/no
Dilutes patient samples onboard/Susceptibility to carryover yes (can be programmed to perform dilutions prior to analysis)/—
Automatic rerun capability no
Sample volume can be diluted to rerun out-of-linear-range high results/concentrated to rerun out-of-linear-range low results no/no
Analyzer requires dedicated water supply no
Autocalibration/Multipoint calibration supported yes (calibrants are not stored onboard)/yes
Typical calibration frequency for ISE/therapeutic drugs/ drugs of abuse/general chemistries/immunoassays
Automatic programmable start/Automatic programmable shutdown no/yes
Onboard real-time QC/Onboard software capability to review QC yes/yes
Supports multiple QC lot numbers per analyte no
Waste management manually by user
Sample barcode-reading capability/Autodiscrimination yes (Interleaved 2 of 5, UPC, Codabar, Code 39, Code 128)/no
Lab can control analyzer from remote computer yes
Instrument can diagnose its own malfunctions yes (operator intervention required to order parts)
System malfunctions can be diagnosed via remote monitoring yes
UPS backup power supply/Data-management capability —/onboard
LIS or EHR systems interfaced Sunquest, Orchard Harvest, CGM LabDaq, Meditech 5.65
LIS interface provided/Bidirectional interface capability no/yes (host query)
Modem servicing provided/Service engineer on-site response time no/48 hrs.
Mean time between failures 420 days (displays error codes for troubleshooting)
Average scheduled maintenance time by lab personnel daily: 5 min.; weekly: 30 min.
Maintenance records kept onboard for user/vendor some records/no
Maintenance training demonstration module onboard yes
Training included with purchase/Avg. time for basic user training yes/2–3 hrs. (at customer or vendor site)
Advanced operator training/Where advanced training is held yes (extra charge)/customer or vendor site
Warranty provided/Cost of annual service contract (24 h/7 d) yes (1 year)/—
Distinguishing features (supplied by company) • small footprint for small laboratory spaces • no consumable tips and bottles; greatly reduced consumable use for lowering laboratory expenses • simple 1-plate affordable design
Note: a dash in lieu of an answer means company did not answer question or question is not applicable
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