New Coag-Sense meter

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Ha, Only about a 5 hour flight away ;-). I am in Atlanta. Hope to have my INR lab work back by Friday to see how close mine is to my labs.
 
This is interesting. I don't recall lab results that were lower than my Coag-Sense or the PT2. Like Keithl, I'd be interested in what a CoaguChek XS would report, and even more interested in values from another lab. I don't recall whether you've had many results from this lab, and compared them to the PT2, or if it was just these recent labs that were lower. (I've seen cases where the reagent values used by the lab seemed just a bit off. In a few cases, the prothrombin times of the lab were identical to those with my meter - but the INRs were different because the lab's reagent values were different from the values used by the strips). If possible, I record not only the INR but, at least out of some interest in it, the prothrombin times, too. (Although the prothrombin times are worthless without a reagent value to divide the prothrombin times by, I still find it interesting. In the case of my tests with equal prothrombin times, it may have been safe to assume that the reagent values (which promote the clotting) should have also been the same)
 
Chris - this may be an exercise in futility. Two weeks ago, I compared my Coag-Sense 'Classic' and my PT2 to each other. The 'classic' gave me a 2.8, and the PT2 gave me a 3.0. This was a bit surprising, but they were well within any reasonable margin of error.

Same batch of strips, done within minutes of each other.

It might be fun to do the comparison. And it would be good to put the comparison on this or another thread.

I'm in Northridge.

I'm imagining the arrival of two people at a Jack In The Box, or a more REAL restaurant. They're both carrying boxes. They order (maybe) and take a seat at a table, sitting across from each other.

They open the boxes and take out some small devices that look like electronics. These aren't cell phones. They don't look like they play music. WHAT THE HELL ARE THEY? Then they take out these small foil envelopes, some tiny tube-like objects, and small, odd looking plastic things.

What the hell are these guys up to?

A manager walks to the table. 'Is there something I can help you with?'

One of the two says, 'no, thanks, we've got this.'

The manager repeats 'is there something I can help you with?'

The other man says, 'no, thanks, we're just testing our blood.'

The manager, confused, looks closely at the meters. They don't look likes something he's ever seen.

'Are you SURE you're okay?' the manager asks, increasingly confused.

By now, the meters are ready for a test. Both beep.

The men push the 'Test' button on this odd electronic device. They open the foil packets and remove plastic strips. They then push them into the meter. A countdown begins.

The manager may let this continue. Or, he may yell 'everybody out! It's a bomb.' Or, perhaps, police cars pull up to the door of the restaurant.

Or, perhaps, the manager says 'hey, my grandmother used to test her blood. Meters sure have improved.'

Then the men prime the incision device, pulling out a plastic piece, and squeeze below the first knuckle to get blood to pool in the fingertip. The machine beeps. The men put the plastic tube where they can easily get it, then they poke a hole in their fingertips, getting a good drop of blood. The transfer tube draws the blood into the tube, and the blood is deposited on the strip. Less than a minute later, the machine beeps.

A few minutes later, they try again. After filling the transfer tube, they TRADE TUBES. Each man is now running a test on the OTHER meter.

Finally, the food arrives.

The two men pack up their machines, strips, and incision devices. They might eat their food or drink their drinks, and talk a bit about self-testing.

And, as they walk out, the staff and managers follow them with their eyes, wondering what the hell that was all about.
 
Chris - this may be an exercise in futility. Two weeks ago, I compared my Coag-Sense 'Classic' and my PT2 to each other. The 'classic' gave me a 2.8, and the PT2 gave me a 3.0. This was a bit surprising, but they were well within any reasonable margin of error.

Same batch of strips, done within minutes of each other.

It might be fun to do the comparison. And it would be good to put the comparison on this or another thread.

I'm in Northridge.

I'm imagining the arrival of two people at a Jack In The Box, or a more REAL restaurant. They're both carrying boxes. They order (maybe) and take a seat at a table, sitting across from each other.

They open the boxes and take out some small devices that look like electronics. These aren't cell phones. They don't look like they play music. WHAT THE HELL ARE THEY? Then they take out these small foil envelopes, some tiny tube-like objects, and small, odd looking plastic things.

What the hell are these guys up to?

A manager walks to the table. 'Is there something I can help you with?'

One of the two says, 'no, thanks, we've got this.'

The manager repeats 'is there something I can help you with?'

The other man says, 'no, thanks, we're just testing our blood.'

The manager, confused, looks closely at the meters. They don't look likes something he's ever seen.

'Are you SURE you're okay?' the manager asks, increasingly confused.

By now, the meters are ready for a test. Both beep.

The men push the 'Test' button on this odd electronic device. They open the foil packets and remove plastic strips. They then push them into the meter. A countdown begins.

The manager may let this continue. Or, he may yell 'everybody out! It's a bomb.' Or, perhaps, police cars pull up to the door of the restaurant.

Or, perhaps, the manager says 'hey, my grandmother used to test her blood. Meters sure have improved.'

Then the men prime the incision device, pulling out a plastic piece, and squeeze below the first knuckle to get blood to pool in the fingertip. The machine beeps. The men put the plastic tube where they can easily get it, then they poke a hole in their fingertips, getting a good drop of blood. The transfer tube draws the blood into the tube, and the blood is deposited on the strip. Less than a minute later, the machine beeps.

A few minutes later, they try again. After filling the transfer tube, they TRADE TUBES. Each man is now running a test on the OTHER meter.

Finally, the food arrives.

The two men pack up their machines, strips, and incision devices. They might eat their food or drink their drinks, and talk a bit about self-testing.

And, as they walk out, the staff and managers follow them with their eyes, wondering what the hell that was all about.

That's pretty good. Are you a writer by trade?

Maybe we should start a new comparison thread.

The two comparisons I've made thus far are my only two. I just got my mechanical valve five weeks ago, so the AC therapy is new to me. I started making the comparisons as soon as I got the meter. I plan to do a comparison every time they send me for a draw. And I'll start asking them what the prothrombin times are when they call me with the INR results.
 
Yes, Chris. I AM a writer.

I've recorded all tests - self-test and lab tests - since I started self-testing. I also record where the test was done (if a lab, clinic, hospital or doctor's office), or the machine that I use for testing. I also record time and date of the test, current dose, and any comments (factors that may affect the INR, changes to diet, illnesses, changes in medications, etc.). If you aren't already recording your results for each test, I suggest that you do.

Because you're only five weeks post-op, it may be a bit of a challenge to get good control of your dosing.

Pellicle and others also track their results. I'm not sure what you mean by comparison thread.

Do you mean we occasionally swap meters and compare our results on the two (or more) meters? Do you mean posting results and comparing to labs?

It may be interesting to get together a few times and test our blood on the other's meter, but I'd be quite surprised if the results vary by .1 or .2 .

I'm willing to do this, but it may not tell us much.

It may be more interesting, if you have a doctor who uses a CoaguChek XS to do some parallel testing.

If I had some XS strips, I may do a few parallel tests on the CoaguChek XS and PT2.
 
OK lab work is back, so I used CoagSense Friday AM and was fasting for additional labs and 2 hours later had a blood draw, the meter said 2.6 and the lab work came back as 2.6, dead on. I did NOT do the CoagCheck XS that day but as listed previously it is consistently .2-.4 higher. I will do a few more meter comparisons and then another lab check in a few months, but I am sold on the accuracy of the Coagsense PT2.
 
Keithl -- it's good to hear about the comparison between results of the PT2 and the lab.

I also wouldn't be surprised by the CoaguChek XS results being slightly higher than the lab - but well within the permissible range of error.

I'm now convinced (and have written this earlier) that the meters may, perhaps, be more trustworthy than the lab results. I've encountered some very inaccurate lab results - and wrote about them in the 'You can't always trust the labs' thread.

Now, I'm looking at this logically. The meter makers have a LOT MORE TO LOSE if their results are inaccurate.

Look at Alere - they had the InRatio. I trusted mine, didn't compare to labs, and had a TIA because of my blind faith in their accuracy. The InRatio gave me a 2.6 - the hospital said 1.7. This was enough error to cause a clot to form on my valve, and travel to my brain. Similar problem reports plagued Alere, and they had to discontinue the machine. I didn't sue -- but probably should have.

I found some errors in the ProTime strips and reported it to them. I don't think these meters are being made or supplies available for this one anymore.

Roche had a recall of a few batches of CoaguChek XS strips last year. Although end users may not have been aware (unless they had a recalled lot and wound up with bad results, or their vendor told them about the recall), but I've heard that this recall has hurt their reputation, and has driven some clinics and physicians away from the XS.

Clearly, errors in INR results coming from meters can harm the reputation of these meters and, in some cases, can even cause them to be removed from the market.

Therefore, the meter makers MUST be sure that the results are accurate - that the strips will give accurate results -- and they are damned careful to make sure that this happens.

I haven't heard of any lab going out of business because it reported some bad INR results. THEY will keep going if their results are shown to be wrong. Meter makers might not, and the damage to their reputation outlasts any short-term problems at the labs.

So - the point is this: although Alere used to tell me to 'trust the labs' when the meter gave me a different value, I think we're at the point now that it's a case of 'trust the meter,' then check the labs.

This may sound a bit counter-intuitive, but I think it now makes more sense.
 
Ok I have got to put my oar in over Coaguchek XS. Back in 06 I purchased the INRatio 1 which was developed by I believe HemoSense. I used it for seven years with no problems and occasionally checked it against my doctors INRatio 1 and it was dead on plus or minus .1. Then we changed insurance to Medicare Advantage and my new medical signed us up with Alere and low and behold they started manufacturing defective test strips and convinced the FDA that the INRation was defective. So they sent me a Coagucheck XS that was giving me readings of 5.0-6.0, which caused me to make a 70 mile round trip to the lab to fine out I was in my target range of 2-3. I called Roch who then sent me a new Coagucheck which did the same thing bad readings. Finally my medical wised up from so many members complaining that they dumped Alere and we now go into the lab once a month or in my case since I am right on they now have extended me out too 1 1/2 months. I have alot more things I could say about Alere but it would get me barred from this site.
 
When I was using the InRatio (yes, it was originally Hemosense), I didn't go to the lab to compare values -- I trusted it, and couldn't afford the blood draws out of pocket. I was satisfied with the 2.6 that my meter was giving me UNTIL I HAD A TIA. The hospital lab showed that my INR was 1.7. I don't know how long it was that low, but I blame it on the InRatio.

My experience with the CoaguChek XS was that, in my post-TIA testing, it (and the InRatio) would sometimes give crazy high readings if my INR actually got close to 3.0. I'd see values as high as 4 or 5 - but the InRatio was usually higher than the CoaguChek XS. I haven't used my XS in quite a while - so I don't know if they've made changes to their strips.

The XS and the InRatio use an electronic method of testing INR. There are certain blood factors that can result in an incorrect INR reported by these meters. (If I recall correctly, a high hematocrit value can result in an erroneous value). Perhaps this is the reason your XS returned high values.

The CoaguSense that I've used (I used the 'classic' until I got their new meter in March) actually times physical clotting time. It's insensitive to issues that may cause the XS to give an abnormally high value (and, again, I haven't tested new strips, so perhaps Roche has done something about this).

A few things I should mention -- testing Monthly or (god help me) every 1 1/2 months is gross negligence. If your INR is low, you can develop a clot and stroke in as little as a week. INR isn't a stable value - it can change from week to week - or even after a few days.

Years ago, I went for years with a consistent dose, and NO TESTING. I was stupid and ignorant and awfully f'ing lucky that I didn't have any negative consequences during that period.

You shouldn't have to do the 70 mile round trip just to get your blood tested. Get a meter (my personal preference is the Coag-Sense) or continue using your XS. If the lab wants to see you every month, or every two months, or, hell, every four or five months, so be it -- as long as you test using your meter weekly.

Do you want to bet your life on a doctor or clinic that doesn't care enough to keep up with current protocols? I sure wouldn't.
 
Wanted to add to my comparison list

6/19 CS 2.8 vs XS 3.1
6/22 CS 2.9 vs. XS 3.1
6/30 CS 3.0 vs. XS 3.3
7/5 CS 2.6 vs. blood test 2.6
7/7 CS 3.1 vs. XS 3.5
7/17 CS 2.3 vs. XS 2.3

So I believe someone pointed this out that the higher the reading the more off the XS gets. Seems like under 2.5 they get close, I suspect that if I recall the FDA accuracy is tighter for <2.0 so it would make sense they would be closer on the low end.

I will be honest, I was intimidated by the CoagSense PT2 before I got it, but I love that meter compared to the CoagCheck XS.
 
Hey, Keithl - I tested both meters, and compared them to occasional lab tests, and the CoaguChek XS was always higher. For a while, using just one lab, it seemed like the lab results were the average of the two meters.

Personally, I prefer one that reports a bit lower than the labs -- this way, if I get a 2.0 on the Coag-Sense, I can be comfortable that my INR is AT LEAST 2.0 (and maybe higher). I wouldn't be as comfortable with a result of 2.0 on a CoaguChek XS.

You say that you were intimidated by the Coag-Sense. Was this because you had to use a transfer tube to move the drop from the fingertip to the strip? Once you've done it a few times (as you have), it's really no big deal (as you noted).
 
Hey, Keithl - I tested both meters, and compared them to occasional lab tests, and the CoaguChek XS was always higher. For a while, using just one lab, it seemed like the lab results were the average of the two meters.

Personally, I prefer one that reports a bit lower than the labs -- this way, if I get a 2.0 on the Coag-Sense, I can be comfortable that my INR is AT LEAST 2.0 (and maybe higher). I wouldn't be as comfortable with a result of 2.0 on a CoaguChek XS.

You say that you were intimidated by the Coag-Sense. Was this because you had to use a transfer tube to move the drop from the fingertip to the strip? Once you've done it a few times (as you have), it's really no big deal (as you noted).

Initially the transfer tube was a turn off, but once I got the meter and did some tests I find it far easier than the XS. The XS is actually more intimidating since you age to rush to get the strip out of the tube, then you get 180 seconds, all these rush items. The CoagSense is a more laid back approach, I can take. Unlike getting set up and taking the sample. Every strip is individually wrapped, and they are not fragile like the XS strips.

I wish CoagSense could dent this market. Even if I decide to stay with a service for the next year (as I maxed out my insurance so it is free) I had talked to a service early on that can use th a CoagSense and May switch to them to do some CoagSense to CoagSense comparisons.
 
...I have alot more things I could say about Alere but it would get me barred from this site.

You are not the only dissatisfied Allere customer. I had problems with them and customer service was so bad, and I continued on up the chain of incompetence until I got to the VP of regulatory affairs.
 
Keithl - I also wish that Coag-Sense would make a big dent in the market. It's not good for the consumer if a product that they want (or need) has no competitors. To their credit, Roche has developed other meters that use the same (I think) strips as the XS, but these aren't for the U.S. market.

Last year, when Roche had the strips recalled, Coagusense (the company) was getting more attention than before the recalls.

Their new meter, which, judging from its features, should be a great device for clinics or offices that deal with many patients (wi-fi, NFC (to scan in a new box of strips), an optional bar code reader (for reading patient information), an Ethernet port, the ability to enter a code for the person administering the test, storage for 2000 tests, an internal LiIon battery, and other features shoudl be attractive to professional users), and ease of use for self-testers make it attractive to professional users and self-testers. Plus, it uses a mechanical method that detects the actual clot. I hope that this will help to inject strong competition into the market.

I wasn't intimidated by the transfer tube because, in the past, my first meter had an even more difficult way of getting a blood sample into the strip. The Protime meters required a special combination lancing device and blood collector. You have to lance your finger, then put the drop into the other end of the collector, then - once blood is in the well - you had to connect it to the strip (Protime called it a Cuvette) and press a button on the meter. The meter then drew the blood into the strip and ran the test. It was much clunkier than the method used by other meters.

Coag-Sense ran through a few different transfer devices - a mini-pipette that drew blood in, and required that you push a plunger to deposit blood into the well on the strip, a few different 'transfer tubes' that were, essentially, capillary tubes that drew the blood in, with a hole at the top that you covered with your finger to transfer the blood into the well. This was easy, and worked well.

The new transfer tubes make it even easier. (I had to re-read the instructions to get the hang of it, but have had no failed test once I got the hang of using the transfer tube).

Plus, as you mentioned, each strip is wrapped in foil. Plus, unless you get blood or other liquid into the well on the tube, you can leave it out for quite a while, if necessary, before depositing the blood into the well.

I hope that you can switch services to one that uses Coag-Sense (having a service that uses Coag-Sense instead of CoaguChek XS is probably a good indication that some services are aware of this meter) will make it interesting to compare results from two meters from the same manufacturer. I've only made a few meter-to-meter comparisons. (Once I got the PT2, I saw little need to use the 'classic) and results were within .2 of each other. I may do more comparisons at another time.

If you DO get another meter, I'd be interesting in seeing the results of your comparisons.
 
Hi



I would agree and think this is a very sound assessment. An important part of understanding INR is that its meaningless to consider differences of less than (say) 0.2 because 1) there just isn't sufficient accuracy in the system anywhere 2) it makes essentially no difference to you in outcomes of any kind.

Once you consider how the number is produced you need to delve into a world of reagents and chemistry and physical movement cessation determining that shows that this is no "Vernier Caliper" for measuring the thickness of steel here. Consider this document:
21878002284_075c4a55ce_b.jpg


which makes it clear that depending on reagent used there will be quite some variation in readings.

...

Pellicle,
Thank you for the useful information. Do you have a link to the report that you took the table from? I am trying to compose a letter to my insurance company to ask them to let me know what reagent they use in their lab. The table is just the justification that I need to know the reagent so that I can calibrate my instrument to their lab. Dr. Stacy Johnson, a professor at the Univ. of Utah, has produced several papers showing that using simple regression statistics it is possible to correlate inr values between a Coag-Sense, a CoaguChek and a lab within 0.1 for low inr values and still very closely for values between 3 and 5. However, the catch is that the reagents must not change on either the Lab test equipment or on your INR home test instrument or you must recalibrate. Your table shows proof that this of why this is the case. Right now, the company purchases the reagents independently of the lab and does not inform either the lab or the anti-coagulation pharmacists of changes in advance. Knowing how bureaucracies work, I doubt that this was a thought out policy but rather was a minimum work approach. The purchasing agents probably have no idea that it might be hazardous for the patients or handicap the doctors and pharmacists and simply do not know enough to ask. The pharmacists and doctors probably do not know who to ask to change the policy. That is just how big bureaucracies work.
If you still have the reference citation to the paper with the table, would you please post it. Google and Duck Duck Go just result in way too many studies to find it - I looked at the first couple pages of studies by Roche and could not find it.
Walk in His Peace,
ScribeWithALance
 
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