So, this will be my first post, but I have been a lurker for over 1 year. Today is my 1 year surgery anniversary for Aortic valve to On-X.
This thread caught my eye as I have been using the Coag-Sense for almost one year to manage my INR. I did two lab draws early on and then compared to my Coag-Sense, was within .1 each time, so to save my arm, I have been doing weekly Coag-Sense checks.
I only have 1 arm for blood draws due to prior cancer treatment in 2010 - too many lymph nodes gone. My veins like to hide and roll courtesy of the Chemo I had, so I was thankful that my doctor allowed me to do home testing. I bought the machine outright and have been happy with it.
This thread though gives me pause if I am making the right decision.
The home service that was offered is very pricy, and part of the reason I bought my own meter.
Is there no one else other that protimenow using this meter?
If you read my two posts on the first page of this sequence, I have been using the Coag-Sense since approximately Sept of last year. Three years ago, I decided on a meter based on my reactions to what Pellicle and Protime had posted.
My health plan finally signed a contract to provide a meter last year. I went thru the process, they wanted me to rent one (a CoagUChek). I resisted that because they could provide me no written documentation for the contract. I got a prescription and purchased a CougSense - the new model. It took me several months to get used to it. I am a retired operations research engineer and once I was comfortable, I started systematically going thru the dosing to move me from the bottom of my "safe" range (2.0 to 4.0) to the top by 0.5 increments in my dosing. I did the increments every two weeks. I got 7 tests done. Each test was a paired Lab Test INR with a CoagSense INR. I did the CoagSense Prick within 30 minutes of the Laboratory Blood Draw. I had read studies done by Stacy A. Johnson, MD and Sara Vazquez, PharmD on the general topic of Point-of-Care or Clinical Lab INR for AntiCoagulation Monitoring. It was fairly straightforward to apply their statistical methods to compare my Health Plan's Laboratory INR testing to the CoagSense. Dr. Johnson warned me to look out for variations in the test strip and Laboratory Based Reagents and to look out that the Lab did not shift what machine they were using for the testing. After 7 paired tests the virus struck and forced me to rely on the CoagSense exclusively. However, by that time, I could predict the Health Plan INR within plus minus 0.1 to 0.2 100% of the time. This applied for the range 2.4 to 3.7. With regression analysis, one cannot make accurate predictions outside of the data range. However, by making minor adjustments to my dosage of 0.25 or 0.5, I can generally stay between 2.8 and 3.2 on my meter. I have only been out of range twice since the epidemic. Once was because of taking too much Tylenol (INR too high). The other time was because I did not warm my hand properly and got a barely adequate drop of blood (INR too low). Both times my INR came back into range after three days.
The references that I relied on for developing this approach, beyond those listed by Pellicle and Protime are:
1) Van Geest-Daalderop, J.H., Pequeriaux, N.C., & van den Besselaar, A.M. (2009). Variability of INR in patients on stable long-term treatment with phenprocoumon and acenocoumarol and implications for analytical quality requirements. Thromb Haemost 102, 588-592.
2) “Correction factor to improve agreement between point-of-care and laboratory International Normalized Ratio values”, American Journal of Health-System Pharmacy, Volume 74, Issue 1, 1 January 2017, Pages e24–
e31,
https://doi.org/10.2146/ajhp150813
3) “Comparison of two point-of-care international normalized ratio devices and laboratory method”Sara R. Vazqueza, Ryan P. Fleminga and Stacy A. Johnson, 2017 March 15 abstract available from:
Comparison of Two Point-Of-Care International Normalized Ratio Devices and Laboratory Method - PubMed
4) “Point-of-Care or Clinical Lab INR for Anticoagulation Monitoring: Which to Believe?”Stacy A. Johnson, 2017 April 01 article available from American Association for Clinical Chemistry (AAAC) Clinical Laboratory News
Page Not Found | AACC.org /point-of-care-or-clinical-lab-inr-for-anticoagulation- monitoring-which-to-believe
5) Roche Diagnostics GmbH. (2006). CoaguChek® XS Evaluation Study (internal reference). Cited at:
http://www.coaguchek.ro/content/dam/internet/
dia/coaguchek/coaguchek_ro/coaguchek_patient/pdf/CoaguChek_accuracy- precision_Bro_12pg_RO.pdf
6) “Preanalytical variability: the dark side of the moon in laboratory testing”, Lippi G, Guidi GC, Mattiuzzi C, Plebani M.. Clin Chem Lab
Med. 2006;44:358–65.http://dx.doi.org/10.1515/CCLM.2006.073. [PubMed]
Preanalytical Variability: The Dark Side of the Moon in Laboratory Testing - PubMed
7) “Preanalytical variables and off-site blood collection: influences on the results of the prothrombin time/international normalized ratio test and implications for monitoring of oral anticoagulant therapy” van Geest- Daalderop JH, Mulder AB, Boonman-de Winter LJ, et al. . Clin
Chem 2005;51:561-8. 10.1373/clinchem.2004.043174 [PubMed]
Preanalytical Variables and Off-Site Blood Collection: Influences on the Results of the Prothrombin time/international Normalized Ratio Test and Implications for Monitoring of Oral Anticoagulant Therapy - PubMed [CrossRef] [Google Scholar]
The regression equation I developed was Y=0.9646x + 0.0606. This had a Rsquare of 0.92 which is supposed to be very good. What was particularly interesting to me was that I found that the standards for Lab testing allowed a 10% drop in ink for a 6 hour lag between blood draw and test resulting. Applying this to create a "corrected" INR result had the CoagSense meter in 3 of the 7 data pairs within 0.2 of the Lab and in 4 of the 7 tests with 0.1 of the lab. My conclusion is that, for the reagents on the strips from CoagSense and the reagents used by MY health plan lab, there is no real difference.
If you plot the predicted (from the regression equation and the CoagSense) lab values versus the actual lab values. they overlap closely. Similarly, if you plot the corrected lab values with the CoagSense values, they overlap closely.
I am totally comfortable with my meter. I use a thermophore heating kit to warm my hand for 3-4 minutes prior to the blood draw.
However, you need to develop your own regression equations, you would need to find a Laboratory that consistently uses the same Laboratory machine and reagent and then run a series of tests across the low to high end of your recommended range and probably 0.5 above and below it in the generally safe range (Pellicle posted a chart that shows that 2.0 to 2.5 and 3.5 to 4 are general safe) or the very safe range 2.5 to 3.5 for my St. Jude mitral valve.
After the epidemic is over (hopefully by the mid-Fall? ) you can do your own paired testing. If you are good at tracking numbers, Microsoft Excel and Apple Numbers both give the same regression equation answers. I plotted them one time in Libre Office / Open Office and got the same answers.
I believe you are making the right decision to use the CoagSense. However, you need to prove it to yourself by running through the math.
I have the advantage that my health plan has its own laboratories and sends all INR test blood to be tested on the same machine. They let me use the same phlebotomist each time (she is very good and leaves no blood or bruises ! - ) Thus, making the paired tests, for me, is much easier then it is for some.
Walk in His Peace,
Scribe With a Stylus