Home monitoring for coumadin. I have a mechanical heart valve

[Sheenas7]

Hi my name is Sheena. I would like your advise on what is the best home monitoring. I live in northern virginia and my doctor is in chevy chase Maryland. With the coronavirus I would like to have a home monitor in case I should need to home test. I am 70 years old female and my valve surgery was in Cleveland Clinic in 2001.
Thank you. Advise for ease of use, test strips, accuracy and whether medicare covers it. I have medicare and Cigna as my secondary.
Thank you
Sheena

 

[dick0236]

Hi my name is Sheena. I would like your advise on what is the best home monitoring. I live in northern virginia and my doctor is in chevy chase Maryland. With the coronavirus I would like to have a home monitor in case I should need to home test. I am 70 years old female and my valve surgery was in Cleveland Clinic in 2001.
Thank you. Advise for ease of use, test strips, accuracy and whether medicare covers it. I have medicare and Cigna as my secondary.
Thank you
Sheena

Medicare does cover home testing. I test at home weekly and my out of pocket cost is about $16/month (20% of total). The meter and supplies are provided to me at no cost. My INR servicing company is "Coaguchek Patient Services" 1-800-428-4674. They can give you all the details. I am 84(on warfarin 52 years) and have been self-testing for about 10 years with complete satisfaction and better control of my INR...........try it, you'll like it

 

[Sheenas7]

Medicare does cover home testing. I test at home weekly and my out of pocket cost is about $16/month (20% of total). The meter and supplies are provided to me at no cost. My INR servicing company is "Coaguchek Patient Services" 1-800-428-4674. They can give you all the details. I am 84(on warfarin 52 years) and have been self-testing for about 10 years with complete satisfaction and better control of my INR...........try it, you'll like it

Thank you for your information. It is very helpful.
Do you have to calibrate or clean the machine?
Are you still able to have a lab do it once in a while and be covered? I appreciate your advise

 

[Sheenas7]

Thank you for your information. It is very helpful.
Do you have to calibrate or clean the machine?
Are you still able to have a lab do it once in a while and be covered? I appreciate your advise

 

[pellicle]

Hi

**** sure knows the US situation better than me (I live in Australia or Europe, pick one based on time). However I can answer these questions:

Do you have to calibrate or clean the machine?

no, not if you have a Roche Coaguchek

Are you still able to have a lab do it once in a while and be covered?

I'm sure you Dr could request a lab best as you need / desire it.

I use a Coaguchek ... for about 8 years now

 

[Sheenas7]

Hi

**** sure knows the US situation better than me (I live in Australia or Europe, pick one based on time). However I can answer these questions:



no, not if you have a Roche Coaguchek


I'm sure you Dr could request a lab best as you need / desire it.

I use a Coaguchek ... for about 8 years now

Thank you so much. I will see how it goes. I don’t think I would be comfortable self dosing if out of range. But it may be good to have this option instead of having to drive to my doctor’s office. He uses this method. Thank you again

 

[dick0236]

Do you have to calibrate or clean the machine?
Are you still able to have a lab do it once in a while and be covered? I appreciate your advise

There is no calibration with the Coaguchek XS meter.....each set of strips comes with a "code chip" (30-second installation). No need to clean the machine. I just wipe the meter down occasionally. For the first few years I did, occasionally, check my meter against my docs (he uses the same mode). My doc gets my INR results from my servicing company and he manages my dosing......although he and I very seldom disagree with the few changes we make in dosing.

 

[pellicle]

Hi

... I don’t think I would be comfortable self dosing if out of range. But it may be good to have this option instead of having to drive to my doctor’s office. He uses this method. Thank you again

its not difficult, its pretty simple really. However like a good many here I spent more time out of range when dealing with clinics than when doing it myself. Plus I could move country (which I did, twice) and there was zero problems with "who do I see, who do I talk to" ... always just me.

 

[Protimenow]

The Coag-Sense (the earlier PT1, and the new PT2) don't require calibration. Each strip has a code that is read by the meter when the strip is inserted. The PT2 also uses a code for each batch of strips - this can be scanned in from a NFC label on the box or in the bag of strips. Alternately, the barcode can be entered into the meter.

The meter doesn't require cleaning - both the CoaguChek XS and the Coag-Sense make it difficult to get the area on the meter where the actual detection is done - dirty or bloody. These meters are made to last a long time, and to be able to run thousands of tests without issues. They don't just do self-testing - they're also used at doctor's offices, anticoagulation clinics, possibly for fast results at hospitals or in emergency rooms, and probably elsewhere. The results must be fast and accurate.

FWIW - I occasionally get a blood draw. The last few times, the lab results were higher - sometimes MUCH higher - than the meters. I trusted the meters more than the lab results - because the meter manufacturers have much more to lose if test results are wrong (potentially for thousands of tests), than a lab does.

I am still considering going to the FDA about one lab that was consistently wrong - and it's been about a month since I heard from them. It may be time to drop the hammer.

 

[vitdoc]

Roche Coaguchek does have a calibration but it is done by Roche. Each set of strips come with a chip from the company. If you use strips from a different batch they will not work with a chip from another batch. So there is nothing the user has to do. The blood only touches the strip and does not enter the meter. So there is no need for cleaning the innards of the meter. The only connection is an electrical connection of the strip to the meter when the strip is placed in the meter. I suppose over time that connection could become an issue. I have had my meter for about six years and the connection is fine.
So these devices are well engineered , long lasting and easy to use. Far better than going to the lab.
Also better for your blood vessels.

 

[ATHENS1964]

What is this in following link is on set ?
https://www.praxisdienst.com/en/Hum...es/CoaguChek+XS+control+solution+4+vials.html

 

[LondonAndy]

What is this in following link is on set ?
https://www.praxisdienst.com/en/Hum...es/CoaguChek+XS+control+solution+4+vials.html

That's interesting. It looks a genuine product, but is not offered on the Roche (manufacturer) website as far as I can tell. Roche no longer sell the XS in Europe, having replaced it with the CoaguChek INRange device that uses the same test strips as the XS, but in the 5 years of buying from Roche I have never seen the control solution offered.

(A control solution is where a drop of a liquid would be applied to a test strip instead of blood, and the instructions would tell you to expect a certain result, eg 2.9 to 3.1, for the meter to be considered operating within design range)

 

[dick0236]

Interesting. I agree that the "control solution" product looks authentic but......I have dealt directly with a division of Roche for my in-home testing program and they have never sent me a product like this or mentioned any need for such a "control solution". Maybe this is just another "after market" product to generate additional revenue.......OK to use but not necessary.

Maybe this would be useful for a lab that does many tests per day?

 

[ATHENS1964]

and this
https://www.praxisdienst.com/en/Hum...s/CoaguChek+PT+Controls+Control+Solution.html

 

[ATHENS1964]

That's interesting. It looks a genuine product, but is not offered on the Roche (manufacturer) website as far as I can tell. Roche no longer sell the XS in Europe, having replaced it with the CoaguChek INRange device that uses the same test strips as the XS, but in the 5 years of buying from Roche I have never seen the control solution offered.

(A control solution is where a drop of a liquid would be applied to a test strip instead of blood, and the instructions would tell you to expect a certain result, eg 2.9 to 3.1, for the meter to be considered operating within design range)

Because my English does not good can you call the roche ?

 

[ATHENS1964]

here is the instructions for use
file:///Users/englezopoulosnikos/Downloads/coaguchek-xs-plus-pt-controls-package-insert1%20(1).pdf

 

[Protimenow]

The question was about calibration. As Vitdoc noted, the 'calibration' is done when the strips are manufactured. Roche adjusts the calibration factor to match the current reagent to the batch of strips (reagents aren't exact values - the code chip adjusts for the value of the reagent), enabling the meter to perform an accurate test.

Coag-Sense also does a similar 'calibration' on their strips, matching the value of the reagent used by the strip with a correction value. Both manufacturers stake their reputations on the accuracy of their strips.

Roche may provide the calibration solution - possibly for clinics that, by law, may require calibration at specific intervals. Although I know of no actual settings or changes that can be made to the meter by the labs or the consumer, it may be necessary to demonstrate that the results of tests using calibration solutions are in range.

Similarly, with each box of Coag-Sense strips, two high INR and two low INR strips are included. A liquid that comes with the strips activates the reagents in the strips. The meter will recognize the high or low INR strips, test the strips, and indicate whether the strips pass the test. Again, this may be necessary to meet certain regulations. I've tested with the high and low control strips a few times. For this self-tester, these tests didn't seem to be of much value - they always passed the control test -- again, perhaps this is a requirement in some agencies, or part of the protocol that labs perform when they get a new set of strips (or, perhaps, if they get a test result that they aren't confident of, and want to test the functioning of the meter to confirm whether the suspicious result is a meter error or actually a person whose INR result was questionable).

 

[ScribeWithALancet]

I live in Northern Virginia and have my INR checked by my HMO, a group that believes in spacing out the tests as much as possible. I purchased a Coag-Sense from Wilburn Medical
( 1 (877) 945-2876 )
https://wilburnmedicalusa.com/pt-inr-testing/
***** The current listing at the site is almost $900. ouch ! - ( ******
"COAG-SENSE PT2 PT/INR SELF-TEST SYSTEM 1 BOX PROMOTION FOR HOME USER 03P70-01-P METER BY COAGUSENSE
Coag-Sense - Includes: Meter, One box of Coag-Sense Test Strips 03P56-50 (50 Patient Test Strips), Self-Test User's Manual, Self-Test Quick Reference Guide, Auto Single Use 21G Lancets 100, AC wall adapter, 54 Sample Transfer Tubes with...
$995.00 $895.00"

because my HMO wanted me to go thru a Medical Service that charges a monthly fee to Kaiser for me to use a CoagUChek (probably due to Medicare rules). When I looked into it, it looked like fraud because the fee they were charging Kaiser would let me buy a Coag-Sense in about 3 months. I ended up paying about $800 for a package with the meter and a years worth of test strips, lancets and transfer tubes. This way, I can call my Anti-Coagulation clinic with intermediete results if they look funny and otherwise just go in every 4 to 6 weeks just to verify that the machine is still working right. It took me almost 5 months to convince them that the meter is accurate (I sent them a new spreadsheet with correlation and regression numbers and charts every time I got a lab test and a duplicate meter test)
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Others have purchased Coag-Sense and CoagUChek meters off of eBay. I personally do not like eBay but they have had good experience and good prices. They just have a bunch of alerts they use to warn to them off of bad sellers. You can search these on the site.
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I created a spreadsheet to record my readings. I also have a spreadsheet to compare the readings on days when I get my laboratory readings to the lab readings. I get an estimated lab reading from a Apple Numbers Spreadsheet and it is within +- 0.1 unit of INR from the Lab reading. (The actual readings are with -0.2 in the middle of the range and within -4 at the high and low ends of the range) The correlation is at 90+%. According to a doctor that I talked with at an University Anti-Coagulation Lab, that is about the best you can do. He said that he got well corrected values from both the Coag-Sense and the CoagUChek meter. He did extended testing on both to make sure the regression worked. It is a very simple Y=mX+B equation where Y is the predicted Lab Value, m is the slope, X is the meter reading and B is the intercept correction. He tells his patients to get a lab test when the predicted reading is above 5 and otherwise just to call the lab if it is out of range.

Buying your own meter so that you have control over your testing between lab visits. It can prevent a lot of phone discussions. I sometimes test several times in a week when things do not feel right. I have also tested extra times (to see what is going on) when I goof and miss a dose of Warfarin or of vitamin K.

I take vitamin K1 and vitamin K2 supplements but built into them gradually with the aid of a Coumadin Lab Pharmacist. The vitamins seem to minimize the variation in my INR but at the cost of having a higher level of Coumadin/Warfarin dosage. Being able to self test also lets you notice when you are drifting higher or lower and make smaller mid course corrections.

Walk in His Peace,
Scribe With a Lancet

I second Protime's and the others comments in this thread.

 

[Protimenow]

Hey, Scribe - my first question is 'how long does the clinic spread tests out?'' If they stretch them more than a week -maybe two weeks, they're putting their patients at risk. I had a clinic that, once they were certain that my INR was stable (because I self-test, and self-manage) wanted to switch my testing to once a month and, perhaps, to once every two months. This was, and is, unacceptable.

I'm glad to see that you've upgraded to the new Coag-Sense model (I know that you had the original model). The results of the two are almost identical, if not actually the same. (They couldn't get FDA approval if the new meter's results didn't match those of the original). They may not offer it now, but some distributors gave you the meter if you bought three? boxes of test strips. These would expire before you could use them up - but, conceivably, you could also sell them and reduce the cost of the meter.

I've seen the original model for sale, new, for around $100. I've seen a liquidator selling strips (often strips, transfer tubes, and a case for less than $3 a strip. I've checked with Coagusense (manufacturer of the Coag-Sense meter) and they told me that the batches were accurate - they couldn't explain the price. But the strips are good.

Doctors seem to believe that they know better how to manage anticoagulation (most don't). My last PCP was uncomfortable prescibing warfarin, and wanted me to go an anticoagulation clinic. I switched doctors. I don't know if my new PCP is as narrow minded as my previous physician.

With the exception of my new Coag-Sense meter,, and a replacement of a defective Hemosense meter, I've bought all my meters on eBay (Protime Classic, Protime 3, Coaguchek S, Coaguchek XS, Coaguchek XS Pro, Hemochron, Coag-Sense) and haven't had issues with any of hem (aside from the inaccuracy of the Hemosense, which was not the seller's fault. The reason for all the meters was my search for one that I trust with my life. I had a TIA because of inaccurate results, and I tested meters against each other, and against blood draws.

The CoaguChek XS and Coag-Sense meters both, mostly, work right. The CoaguChek XS does less well than the Coag-Sense at INRs above 3 - but for most of us whose INR is in range, this shouldn't be an issue. I validated my meter results with hospital lab (or their finger stick using a Hemochron - used in operating rooms to get results of blood tests) and both meters correlated well. In fact, in many cases, the blood draw results were almost an average of the results of the two meters.

Recently, I've encountered a lab that gave multiple errors - as high as 5.1 when my meter showed 2.9. The lab got it wrong multiple times.

I'd rather trust my meter than trust some labs.

 

[Sheenas7]

Medicare does cover home testing. I test at home weekly and my out of pocket cost is about $16/month (20% of total). The meter and supplies are provided to me at no cost. My INR servicing company is "Coaguchek Patient Services" 1-800-428-4674. They can give you all the details. I am 84(on warfarin 52 years) and have been self-testing for about 10 years with complete satisfaction and better control of my INR...........try it, you'll like it

Hi. I called the service Advanced Cardio Services. They told me they would send me the monitor and all the supplies and then I would do weekly testing. They recommended the Coagsene PT2. They said it is as accurate as a lab draw. They said that they also could give me a CoaguCheck XS if I preferred.
Any recommendations here on which I should have? Thank you