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Abbott Point of Care, i-STAT 1 analyzer (Chemistry-Immunoassay POC Low Volume, 2018)

Abbott Point of Care, i-STAT 1 analyzer (Chemistry-Immunoassay POC Low Volume, 2018)

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

Contact Information

Abbott Point of Care
Laetitia Crouch
Princeton, NJ

Name of instrument i-STAT 1 analyzer
Type of instrument combination chemistry/immunoassay
Operational type/Model type —/handheld
List price/First year sold in U.S. —/2000
Targeted hospital bed size/Targeted daily test volume all/—
Company manufactures instrument yes
Other models in this family of analyzers
No. of units in clinical use in U.S./Outside U.S. (countries) ≥ 30,000/—
Dimensions (H × W × D)/Instrument footprint (square feet) 9.25 × 3 × 2.85 in./< 1 sq. ft.
Weight empty/Weight fully loaded
Tests available on analyzer in U.S. troponin I, CK-MB, lactate, BUN, creatinine, glucose, ionized calcium, sodium, potassium, chloride, hematocrit, pH, PCO2, PO2, TCO2, ACTc, ACTk, more
Tests not available in U.S. but available in other countries
Tests in development for analyzer
No. of different measured assays onboard simultaneously
No. of user-definable (open chemistry) channels
Test throughput per hour/Assay run time
No. of direct ion-selective electrode channels
Detection methods potentiometry, amperometry, conductometry
Stat time until completion/specimen throughput for:
• Ion-selective electrode 2 min./—
• Basic metabolic panel 2 min./—
• Complete metabolic panel
Typical time delay from ordering stat test until aspiration of sample none
Fully automated microplate immunoassay system
Methodologies supported
Separation methodologies
Stat time until completion of a ß-hCG test 10 min.
Typical time delay from test order to aspiration of sample none
Stat time until completion of a cTn test 10 min.
• Typical time delay from test order to aspiration of sample none
Approx. No. of tests per reagent set or pack/Reagent type —/self-contained single use
Reagents refrigerated onboard/Reagents ready to use no/yes
Reagent lot tracking/Reagent inventory
Reagent form/Reagents barcoded — (closed reagent system)/yes
Separate reagent pack for each specimen/for each test run yes/no
Walkaway capability/Walkaway duration yes/—
Design of sample handling system
Uses washable cuvettes/Uses disposable cuvettes no/no
Min.–max. sample volume that can be aspirated at one time 16 µL minimum
Min. reaction volume/Min. specimen volume/Min. dead volume
Dedicated pediatric sample cup no
Primary tube sampling/Pierces caps on primary tubes no/no
Protects against probe collision no
Detects clots/liquid level/short sample yes/no/yes
Detection for hemolysis/icterus/lipemia/clots no/—/—/yes
Dilutes patient samples onboard/Susceptibility to carryover no/—
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 (recommended avg. frequency: each test)
Typical calibration frequency for ISE/therapeutic drugs/ drugs of abuse/general chemistries/immunoassays each test/—/—/each test/each test
Automatic programmable start/Automatic programmable shutdown yes/yes
Onboard real-time QC/Onboard software capability to review QC yes/yes
Supports multiple QC lot numbers per analyte yes
Waste management manually by user
Sample barcode-reading capability/Autodiscrimination yes/yes
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 no/optional add-on
LIS or EHR systems interfaced
LIS interface provided/Bidirectional interface capability yes (additional cost)/yes (broadcast download and host query)
Modem servicing provided/Service engineer on-site response time yes/— (product replacement within 24 hrs.)
Mean time between failures — (displays error codes for troubleshooting)
Average scheduled maintenance time by lab personnel
Maintenance records kept onboard for user/vendor
Maintenance training demonstration module onboard
Training included with purchase/Avg. time for basic user training
Advanced operator training/Where advanced training is held yes/customer site
Warranty provided/Cost of annual service contract (24 h/7 d) yes/—
Distinguishing features (supplied by company) • handheld portable analyzer; unit use system can perform chemistry, blood gas, cardiac marker, and coagulation tests • CLIA-waived menu of tests, including basic metabolic panel • uses 2 drops of whole blood or plasma
Note: a dash in lieu of an answer means company did not answer question or question is not applicable
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