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Alere, INRatio/INRatio2 PT INR Monitoring System (POC coagulation analyzers, May 2013)

Alere, INRatio/INRatio2 PT INR Monitoring System (POC coagulation analyzers, May 2013)

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Contact Information


Alere

Deborah Blundell
9975 Summers Ridge Road
San Diego, CA 92121
877-441-7440


Instrument name INRatio/INRatio2 PT INR Monitoring System
First year sold 2003 (INRatio)/2008 (INRatio2)
No. of units sold in U.S./Outside U.S.
No. of units sold in 2012
• units sold to:
Country where analyzer designed/Manufactured U.S./U.S.
Is instrument POC or self-monitoring analyzer? POC and self-monitoring analyzer
Specimen type fingerstick
Model type handheld/portable
Dimensions in inches (H × W × D)/Weight 5.9 × 2.9 × 1.8/9.3 oz with batteries
Specimen volume needs accurate volume not necessary (drop) ~15 µL
Clotting-based tests for which device has FDA-cleared applications PT (reportable range: low 7 seconds, high 75 seconds; INR: low 0.7, high 7.5)
Tests using other methodologies for which device has FDA-cleared applications
FDA-cleared tests but not yet clinically released
Tests submitted for 510(k) clearance
Tests in development but not yet submitted for clearance
Method of endpoint detection electrochemical detection, change in impedance as sample clots
Quality control methods
• Electronic no (not required, built-in two-level QC on each strip)
• Liquid no (not required, built-in two-level QC on each strip)
• Lyophilized no
• Integrated QC with each analysis yes
• Automatic lockout for QC failure yes
• Other
Time (in minutes) to perform control plus specimen test
• PT: 1
• PT and PTT:
• ACT:
Data-management capability yes
Includes QC yes
System can automatically transfer data to information system
• Patient data yes
• QC data yes
Interface supplied by instrument vendor yes
LOINC codes transmitted with results
How labs get LOINC codes for reagent kit
Commercially available systems for which interfaces are up and running in active user sites Alere CoagClinic and PC Connect
Lab can control analyzer remotely no
Real-time wireless linkage to LIS or HIS no
Positive identification system (e.g. bar code) for:
• Patient specimen no
• Reagent no
Onboard system for automatic error detection yes, for sample (volume), reagent stability
Training provided with instrument purchase yes (on site)
Approximate number of training hours needed for:
• Medical staff 1
• Patient 1
Patient self-testing program is available yes
Instrument list price $1,595 professional; $1,995 self-test
Reagent rental or lease only no
Cost per sample for:
• PT: Cost per sample for reagent rental volume-dependent
Cost per sample if device purchased
• PTT: Cost per sample for reagent rental
Cost per sample if device purchased
• ACT: Cost per sample for reagent rental
Cost per sample if device purchased
CLIA ’88 complexity rating CLIA waived
Distinguishing features (supplied by company) onboard QC—two levels of quantitative controls with reportable results; individually wrapped, nonrefrigerated test strips; one-drop fingerstick sample; 12-month dating on test strips; 120-test memory, including QC values; simple three-step test process; human recombinant thromboplastin (ISI 1.0)
Note: a dash in lieu of an answer means company did not answer question or question is not applicable
Tabulation does not represent an endorsement by the College of American Pathologists.