Alere INRatio®2 PT/INR Monitoring - Clinical Performance
Proven Performance You Can Depend On
Since the precision of PT/INR results can influence therapy decisions and patient outcomes, clinicians should select an INR monitoring device that provides precise results.
For the last five years, the Alere INRatio®2 PT/INR Monitoring System has been the preferred choice by physicians in PT/INR testing at the point-of-care.1 Why? Because of its outstanding performance, 2-level on-board quality control system, 1-drop sample size, and the protective individual foil-wrapped test strips preferred by cardiologists.2
Data You Can Believe
No two methodologies will produce identical results. In fact, no single technology will provide the same result each time.
The difference plot shown below compares the Alere INRatio®2 PT/INR System capillary results to Sysmex CA-560/Dade Innovin® results. This figure shows that 97% of the results in the therapeutic interval of 2.0 to 4.5 are within the ±30% interval compared to 90% requirement per ISO guideline.The expectation is that the differences will not be clinically significant.
Each lab may claim to be correct. If the results fit the clinical assessment and the patient uses the same lab every time; then they can be properly managed regardless of method.
The key is that you monitor patients using a single technology over time, rather than multiple technologies per patient.
These charts show the results of a three-way correlation study conducted at a customer site. Both the Alere INRatio®2 INR results and the other point-of-care (POC) method INR results compare well with the lab method. However, comparing the two POC methods, there are greater differences.
Thick solid line is the linear regression best fit; think solid lines indicate ISO 17593:2007 POC INR 90% acceptance limts;4 dotted line is the line of identity (y = x).
Consider the data
All INR meters are designed to monitor patients over time, so there is other data to consider. If a patient has been trending on the edge of therapeutic for months and now with a different meter reads slightly higher, or lower, what is the clinical difference? Moving forward, a new result should continue to show the same trend, but at the newly established level.
- GHX HPIS Data 2005-2009.
- Test Strip Packaging Survey of Cardiologists, November 2008 American Heart Association Annual Meeting; data on file at Alere. Blinded study sponsored by Alere.
- American Proficiency Institute 2011 Chemistry/Immunology/Immunohem 3rd Event, specimen COA-11, www.api-pt.com ; 1853 labs total, all methods with peer groups of ≥20 labs shown: Method 1, 921 labs; Method 2, 265 labs; Method 3, 206; Method 4, 102 labs; all other methods, fewer than 100 labs.
- ISO 17593: 2007, Clinical laboratory testing and in vitro medical devices - Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy.
Alere™ Home Monitoring Service Program
Alere has developed an industry leading program to help healthcare professionals provide the highest quality anticoagulation management.
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