A DIFFERENT Meter - Coagusense

[Protimenow]

I haven't been accused of getting just one meter and sticking with it. I remain interested in one that gives results that are closest to a lab results (assuming, of course, that the lab is competent and that the blood isn't mishandled before it gets to the lab). My goal is still, eventually, to see a day when anyone who is taking an anticoagulant can get regular testing, regardless of ability to pay. From a pure public health standpoint, it's a critical issue. In my mind, if testing becomes universally affordable (and even at $5 a test, this is not the case for far too many people), there will still be too many people with negative events that are completely avoidable -- strokes and hemorrhaging being perhaps the most probable.

My personal goal is also to determine which meter (right now, just from personal experience) is the most accurate (although such a term, in relation to INR may be an impossible ideal).

In any case - recent experience shows that a) I discovered and reported a bad lot of 3-channel ProTime cuvettes to the manufacturer and - for whatevver reason - they issued a recall and replaced them with the more accurate and reliable 5-channel cuvettes. b)InRatio USUALLY (though not always) gave me values of .3-.6 above a hospital lab. c) The 5-channel ProTime cuvettes - though requiring more blood and being less easy to use than InRatio also seems to correlate better with the hospital lab than the InRatio did.

I haven't been fortunate enough to get a CoaguChek XS, so I can't personally vouch for its correlation with a lab.

--

All this being said - I've also been watching a new (?) meter that few of us seem to have heard about -- the Coag-Sense. This works a bit differently from the other meters, because there's a little wheel in the strip. When the blood mixes with the reagent in the strip, the meter starts to spin the wheel -- the clot makes the wheel stop spinning. A light shines through the wheel, when it stops, a sensor detects this, and a prothrombin time is determined. When divided by a factor that is coded into the strip, the meter provides an INR and a Prothrombin time. In theory, this sounds pretty interesting - and potentially even more accurate than other tests that don't measure the formation of physical clots in the same way.

In spite of the theoretical strength of this meter, it doesn't seem to have drawn much attention.

--

I was able to buy one today, brand new. Once I get the strips for it, I'll add it to my testing regimen. If possible, I'll get the meter and some strips before my next lab blood draw, so that I can make a comparison from day one. If not, I'll make comparisons to my InRatio, and every few weeks, between the Coag-Sense, Inratio and Protime meters.

I will report on my results.

I hope to see if the apparently low sales are more a result of inadequate marketing than they are with issues relative to the meter. (The actual testing process adds a layer of complexity to the test that doesn't exist with the InRatio or the CoaguChek XS -- although you apparently need a small drop of blood, this has to be sucked into a micropipette and deposited onto a small spot on the strip. It may not be quite as easy as just dropping a drop of blood onto an InRatio strip or touching the side of a Coaguchek XS strip).

If any of you have already had experience with the CoaguSense, I'd certainly like to read about it.

 

[pellicle]

Looking forward to your results and experiences.

 

[Protimenow]

The meter is on its way. I'm looking forward to it.

I've learned that the meter's name has been changed slightly -- now, they're calling it Coag-Sense. (I'm assuming that the 'coagu' in Coagusense sounded a bit too close to the Coagu in Coaguchek, but the name change could have been for some other reason). The company is still Coagusense -- it didn't change its name.

I'll post more once I've received the meter and had a chance to use it.

 

[Protimenow]

I just received the meter. It's somewhat larger than I was expecting -- making it potentially less portable than, say, an InRatio meter, but it is designed to sit solidly on a test surface during testing. The meter has a low serial number (less than 2000), which suggests that either this is a somewhat old meter, or that sales are less robust than they are for the big two meter manufacturers.

I'm somewhat surprised by the 2004 date on the machine when the batteries are first inserted. This suggests that the technology behind the meter may already be at least 8 years old. (This shouldn't make any difference, but I bring it up here. The Protime and Protime 3 meters were first available even earlier, and the strips for either meter work in both. The original InRatio was probably even earlier than the Coag-Sense, and Coaguchek XS isn't all that much newer, either). One nice thing about the meter and strips is that both, apparently, are Made in USA.

I'm anxious to get the strips, so I can start testing with this meter. I've put off a blood draw so that I can run a test - but I may just have to get the blood drawn, compare it to my ProTime and InRatio results, and when I get the strips, try to run a test and compare those results. (In comparison to the InRatio and the CoaguChek XS, I'm guessing that running a test may be just slightly more difficult -- you have to suck the blood drop into a mini-pipette or a transfer tube, then transfer it onto the strip. Any drops of air could mess up the test. I'm wondering if this is a problem for people who are just learning to test with the meter).

Once I get my strips, I'll start report on the actual operation and assumed accuracy of this meter.

 

[Protimenow]

I received the strips yesterday, and got a 'training' call this morning. Let me say right off that I don't work for the company, and have no financial or other relationship with them. I'm saying this because I am going to write a nice report on the meter and want to avoid any suggestion of conflict of interest.

The meter is large - designed to sit solidly on a testing surface. It's larger than my InRatio and InRatio 2, and is large like my ProTime 3. The device may take a bit of training for initial use - but the learning curve, for me, at least, was minimal.

The strip is an interesting device -- a tiny wheel is positioned near the back of the strip. After the blood is put onto the strip, the wheel starts to turn. Actual clotting time is measured, and a result is displayed on the meter. Getting a good drop of blood - without bubbles - onto the strip may be the biggest challenge. This meter came with a small pipette (a pump that is designed to 'inhale' 12 microliters). A minipipette - kind of like a tiny tube - is attached to the end of the pipette/pump. After the finger is lanced, the minipipette is positioned at the side of the finger - not touching skin - and the plunger on the pipette is pushed down. The plunger is slowly retracted, and if all goes well just slightly more than the 10 microliters that the meter needs are drawn in.

You have to rest your hand on the meter and carefully and slowly put the blood onto the blinking light. With the plunger still pressed, the pipette is removed from the strip (if the button is released before removing the strip, it may remove some of the blood, giving you a non-result).

This meter worked fine for me -- I got a result in about 30 seconds. (I've gotten used to waiting a minute or more for results from other meters).

If you look closely while it's testing, you can see a wheel turning. An optical mechanism inside the meter detects when the clot is formed and the wheel stops spinning, then the result shows up on the meter. Unlike the other meters, which use such things as a change in impedance to indicate clotting, the Coag-Sense uses a direct mechanical method to detect a clot.

The meter holds 100 test results. Strips cost about $5 or so apiece (about $4 if you get a box of 50). I was fortunate enough to get a new meter on eBay for considerably less.

Now that I have nearly 70 InRatio strips, I think that I may prefer the Coag-Sense for speed and accuracy. (This is not to say that I may not run into some issues in the future, related to air bubbles in the sample or sample size, but for now, I'm quite impressed).

The company is called Coagusense -- but they've changed the name of the meter and strips to Coag-Sense.

According to the CEO, the company is currently selling these meters into clinics, where they run a lot of tests, but I think that it can be a good home machine. I'm pretty sure that the meter can be reimbursed by some insurances (I haven't checked this) and the meter looks like a good, fast alternative to the other meters.

I'm getting a blood draw in a few hours, and will also be comparing results to my five-channel ProTime 3 and InRatio meters.

I'll report on these results later.

 

[Protimenow]

It's later in the day. I had a blood draw a few hours ago (today is Friday), and I should know the results on Monday.

My first attempt at testing with my Protime 3 and InRatio for some reason failed. I just repeated the test with the InRatio and got a 2.9. This doesn't surprise me or seem inconsistent with the 2.5 reported by the Coag-Sense. If the Coag-Sense is accurate (and I assume that it is), to have the InRatio reporting .4 high is pretty consistent with my previous experience with the InRatio usually reporting results that were higher than niormal by .3-.7 or so.

Once I get my results from the blood draw, I'll report what the lab determined.

(Prothrombin time testing and INR calculation are not exact science, so I wouldn't be surprised if none of the three completely agree.)

 

[Protimenow]

Coag-Sense update.

The result of my first test with the Coag-Sense was 2.5. For some reason, I wasn't able to immediately follow the Coag-Sense test with tests on my ProTime and InRatio 2 machines. A few hours after my Coag-Sense test, I had a blood draw at a hospital lab. The lab's result was a 2.66 - comfortably close to the Coag-Sense. I tested a bit later, using an InRatio2 and got a 2.9. (This value was not surprising -- I typically expect InRatio to report higher values than the lab, and by extension, the Coag-Sense). As long as both meters, and the lab, tell me that I am in range, I won't change anything.

I also just got control strips for the meter. I will run one high control and one low control test in the next few days.

I plan to continue to report on my experience with this interesting meter.

 

[Protimenow]

Another update.

The Coag-sense seems to have an interesting learning curve. One of the issues with the device is that the drop of blood must first be removed from the finger, then transferred onto the strip. I've wasted a few strips trying to get the procedure down correctly. I'm not sure why I wasn't able to get an adequate drop for sucking into the pipette or transfer tube -- it could have been inadequate prep of my finger, or perhaps could have been related to my lancing device not going deep enough to make a good cut. (My last try, on my pinky, was made with a Unistik 2 Extra on my pinky, and I had no trouble getting the blood into the minipipette, or transferring onto the meter).

One thing that users of this meter should be aware of is that it can give erroneous results if you do something really wrong. For example, I did a test last week, making a second incision on a finger that had already not provided enough blood -- the two samples were apparently mixed in the minipipette when I put the blood onto a strip, and I got a value that was too low. (I don't know if the other meters would have responded in a similar way). I also was able to get an inadequate (too small) drop of blood onto the strip -- it spun for almost the maximum amount of time and gave me a 6.7 -- an error that I suspect anyone could detect - and that was a result of inadequate blood being applied.

I still like the meter. I'll probably verify 'iffy' results with my ProTime or InRatio 2 (which brings up the point -- if you still have the other meters as backup, why do you need the Coag-Sense?) The answer is a) when the Coag-Sense gets a properly prepared drop of blood, it is probably more accurate than the other meters and b)it's always good to have a backup (if you can afford it) to help validate any questionable results. c) verifying at home beats a trip to the doctor or the lab).

I'll report after my next test whether or not I still had problems getting that 10 microliter drop; and if I have any other problems with transferring it onto the strip.

Although the meter is FDA approved, it hasn't been gaining much momentum. I wonder if it's the somewhat trickier sampling methods (and going against Roche and Alere) that are holding back more widespread adoption.

 

[pellicle]

Although the meter is FDA approved, it hasn't been gaining much momentum. I wonder if it's the somewhat trickier sampling methods (and going against Roche and Alere) that are holding back more widespread adoption.

Could be, though I suspect most don't know of the issues you mention, so are not taking it into their selection choice.

Your work is valuable. Thank you

 

[Protimenow]

I doubt that few people have even HEARD of this meter. There's a definite name challenge - some versions are called Coagusense (a name that I'm sure Roche isn't very fond of). The company is called Coagusense. But now the meter and supplies are called 'Coag-Sense.' Plus, there's the David vs. Goliath (X2) thing, and possibly a rejection by early adopters because of some sampling issues like the one I described.

I'll repeat testing on Friday (I upped my dose last friday from 7.5 to 8 mg/day, because I was at the low end of my range, and I'm testing to see where this minor increase brings me). I'll see if the practice that I've gotten - and the new lancing device, if necessary, will smooth out the process..

(Oddly enough, I probably didn't get enough blood for my InRatio meter, either, so the issues may be less significant than I make them out to be)

 

[Protimenow]

I've received my box of Unistik 3 lancing devices. I've been oddly eager to test again. My test on March 15 went smoothly - the meter told me that my INR was 2.5. I was unable to get a good test with the InRatio - not sure why, but may not have gotten a good drop on the strip.

It's now March 22, and I'm testing again. The meter is larger than the InRatio - and this may make it less portable, if this is an issue for people who travel and want to test their INRs.

I'm now using the micropipette that comes with the Coag-Sense meter. It's a small pipette device -- press the plunger, and it releases enough air so that the pipette attachment that you slide onto the micropipette will draw in the right amount of blood for testing. I'm using the Unistik 3 lancing devices.

This time, the test went very smoothly. The lancing device hardly felt like it lanced my finger - but it did, and I was able to get enough blood to fill the pipette. Transferring the blood onto the strip was also easy. In 34 seconds I had my result. Fast, little waiting and, I think, probably superior accuracy when compared to other meters. (I'll know more next week when I get a blood draw).

I transferred (still within fifteen seconds) some blood from the first incision onto the InRatio strip -- but missed the little light. I was tempted to use the micropipette - but it doesn't take as much blood as the InRatio needed. The blood went everywhere BUT the little dot on the strip. I made another incision, and was able to get the blood onto the dot.

Results:
Coag-Sense - 2.7
InRatio 2 - 3.6

Realizing that the InRatio is often higher than a lab result, I'm comfortable in believing that my INR is at least 2.7 -- meaning that I am in range.

There are things that I'm beginning to like about the Coag-Sense:

You don't have to use a code chip, or confirm the code on the strip when you insert it into the machine.
A digital countdown tells you how long you have to wait while it's heating the strip
You quickly get a result
You get to see a clot in the little wheel on the strip (that may get boring after a while)
The use of a small drop collection and transfer device actually makes it easier to get the blood onto the strip than with the InRatio; and compared to the ProTime, you don't have the hassle of wiping away the first drop then trying to squeeze what seems like a pint of blood into the small collection cup.

I'm just sorry that the meter hasn't really caught on -- it seems to work well (once the learning curve is breached) -- and, according to some research provided by the manufacturer, very accurate, correlating to the 'Tilt Tube' method of INR testing.

 

[Bina]

It's no wonder that this meter hasn't "caught on" and probably never will. It is a dud..... Sounds like a huge pain in the butt.
Going to stick with my tried and true, very accurate, made in Germany, Coaguchek XS

 

[Protimenow]

No, I don't think it's a dud -- it's larger than the CoaguChek XS (I assume, not having seen one close up) and the InRatio meters. It may take a bit of learning to use. It's not promoted by a Roche or Alere marketing machine. However, it gives you a result more quickly than the InRato 2 (and probably the CoaguChek XS), and it's supposed to be more accurate because it actually measures PHYSICAL clotting, rather than some secondary process used by the other meters.

It may be better suited for use in clinical settings than as a home unit, but once I figured out that my lancing device wasn't making a big enough incision, and got the hang of using the micropipette, it's both fast and easy. I'll be going to a lab tomorrow or Thursday for a blood draw, and I'll be able to compare readings.

As I said in an earlier post, I'll probably put the 48 InRatio strips that I bought a month or so ago back on EBay, because I will probably be using the Coag-Sense for my blood testing.

(If anyone wants to read a little more about the meter, the company has a website with limited information - www.coagusense.com)

 

[Rain]

Protimenow... I am really interested to know if you are still happy with your coagusense machine. And if you were to throw them all out and replace with a single machine, which would you buy?

I've had a protime machine for nearly thirteen years, but it's 'given up the ghost' on me. So I find myself searching out reviews of what's currently on the market.

Thanks!
Rain

 

[Protimenow]

Rain:

If you are still married to the Protime, I have an extra Protime3 and Protime meter, if you're interested. If you are interested - and perhaps have a supply of strips that you still want to use, PM me and we can discuss it.

Yes, I'm still happy with the Coag-Sense meter. I will be having a blood draw - probably tomorrow - and the result will help to confirm HOW pleased I am with this meter. The InRatio is smaller and takes a bit less attention to use (trying to get the drop of blood on a tiny dot), but the Coag-Sense is also pretty easy, once you get the hang of it.

As a user of the Protime meter, you're used to a deep puncture and squeezing the blood into a small cup on the Tenderlette, so the blood collection process for teh Coag-Sense won't seem all that strange. The Coag-Sense takes a smaller drop, and collecting it with a micropipette or transfer tube is fairly simple. For now, after confirming that the Coag-Sense value is closer to the lab than the InRatio, I'd probably stick with the Coag-Sense over the InRatio and InRatio2.

This may still change, in my case. After I had a stroke, I determined not to let my INR get too far out of range and wanted to get the most accurate meter available. I bought a used Hemochron - the kind used at hospitals and in operating rooms. This one requires quality control testing every 8 hours of use. I will have these QC devices in the next week or so, and if the unit passes the QC tests, I'll get cartridges for it. If not, I'll probably stick with the Coag-Sense (assuming that its reported values are close to the lab results). The Hemochron is usually not available to non-medical people so it's not much of an option for most of us - and if it doesn't pass Quality Control testing, I'll probably toss it.

One other thing -- with a ProTime meter (and I have a few extras) and the five channel strips, I was told that the results are very near lab accuracy. I don't know if the results are more accurate than the CoaguChek XS or the Coag-Sense, but I'll compare these five channel strips on my ProTime 3, and the Coag-Sense to my upcoming blood draw results.

For me accuracy trumps convenience -- I do NOT want another stroke.

I'm sorry about giving such a long answer. I'll know within a week which meter will be my absolute, final choice, and I'll update this thread at that time. (Again - if you want to stick with ProTime, PM me, I may be able to do something pretty amazing for you)

 

[Rain]

Ha ha… I have certainly felt like I was married to that rotten machine at times, but ya know there are always newer, younger, more accurate models to be had…. :smile2:
I too am concerned with accuracy. I only have three cuvettes on hand, but I'm in money saving mode right now as well, my now junior in college just called and said she needs $3,000.00 for summer tuition and an apartment, because she wants to take a couple summer classes to keep her on track to graduate in four years. Soooo... I’m all for an amazing deal, if you are comfortable with the accuracy of the machine.

Thanks for posting all the info about the machines and comparisons. I and many others appreciate it.

You can email me at [email protected]

Thanks!
Rain

 

[Protimenow]

A bit of a follow-up. Last Thursday, I tested with Coag-Sense, InRatio, and ProTime meters - before I went to a hospital lab for a blood draw.

Although I've called three times, the lab apparently decided that, because I'm in range (I assume), there's no need to bother calling me back to tell me what my INR is.

I'm beginning to appreciate my Coag-Sense meter even more than before. Today I laid out the few things that I need to run a test -- the meter, a strip, a minipipette and disposable tip, and a Unistik 3 lancing device. I set the stuff up, washed my hand in warm water, turned the meter on and inserted the strip, removed the end of the Unistik 3 (to enable it), and squeezed my fingertip, just below the knuckle. I watched the meter count down while it warmed the strip. Once the countdown was over, I lanced my finger and got a nice drop of blood. I pressed the plunger on the miniiipette, touched the tip of the pipette to the drop of blood, and slowly drew the blood into the tube. I then placed the end of the tube over the spot on the strip, pressed the pipette to transfer the blood, and drew the pipette away from the strip.

In about 40 seconds, I had my result.

It was easy. It was fast. I didn't even mind what some may refer to as a 'rigamarole' involved in getting that drop off my fingertip and onto the strip.

The method strikes me as potentially the most accurate available. (And I'm trying to be impartial here -- but a test that actually takes the blood and watches for it to clot seems like a good way to measure actual clotting).

I hope that the Anticoagulation clinic will eventually call me - and that the lab results are very close to the Coag-Sense numbers.

I'm beginning to really like this meter.

 

[Protimenow]

I am pretty sure that I'm the only person on this forum (or perhaps ANYWHERE) who has all four approved meters -- CoaguChek XS, InRatio 2 (I also have an InRatio 'classic', Coag-Sense and Protime 3 (and ProTime Classic). I don't always test with more than one (or two) - but today, I did. I was expecting to check with Coag-Sense and CoaguChek XS -- and to see similar results.
The test method of the Coag-Sense is very similar to the one used in labs - it actually detects a physical clot. The CoaguChek XS has a reputation for accuracy. I expected both to be almost the same.

Using two fingers, and testing within a minute or two of the other, I got very different results: the Coag-Sense gave me a reading of 2.7. The CoaguChek XS was a 3.6. Both results showed me that I was in range (barely so), but the .9 difference between the two was troublesome. I tested with the InRatio 2, using the other side of a finger (that actually closed up quite quickly, BTW), and also got a 3.6. In the past, my InRatio often seemed to report higher than labs--but the Coag-Sense is supposed to be similar to the lab technique - and THIS MUCH HIGHER was unexpected.

I don't want to test with ProTime and the 5-channel cuvette. Although I have enough strips, I prefer not to use what some call the 'icepick' to incise my finger, or to have to milk my finger to get enough blood.

I guess the point here is that we probably can't fully trust our meters - ANY of them. We also can't always trust the labs. At this point, I am not sure with testing method is most accurate -- but they all seem to put me in range, and above the dreaded 1s.

I'll test again in a week (if I'm still around), using the CoaguChek XS and the Coag-Sense. I'll see if the results converge a little better.

 

[pellicle]

Hi

...I got very different results:
the Coag-Sense gave me a reading of 2.7.
The CoaguChek XS was a 3.6.
...the InRatio 2...and also got a 3.
...

I guess the point here is that we probably can't fully trust our meters - ANY of them. We also can't always trust the labs.

without a baseline to measure against you really know nothing. If I had to guess then I'd say that I'd go with the reading of the XS as being closest to your actual and that then means that the coagusence is in agreement with it and that "supports" it.

without a baseline you are attempting to see which watch is showing the right time by seeing who else has a watch that shows the time.

You have said in the past that the other meters have given variance of > 0.6 (not the XS) and so I just wouldn't trust this at all.

Science has evolved methods for things for a reason

 

[Protimenow]

Right. I have nothing to really compare any of this to. I just got the XS, and I ASSUME that ALL XS meters are accurate -- but this one may not be. I may wind up repeating tests - and possibly testing with the ProTime (which is supposedly very accurate) - just to compare to the other meters.

What I believe I can safely assume is that all the meters tell me that my INR is above 2.0 -- which puts me out of danger. If, as the InRatio and Coaguchek XS tell me, my INR is REALLY (about) 3.6, I'm not going worry about it.

It would just be good to be able to get to a lab to see what their tests tell.

For now, though, being IN RANGE will have to be enough for me.