POC not reading INRs correctly

[Freddie]

Wow, this is really odd. They used two different monitors and basically the results were the same.
The only thing I can think of is the possibility of the monitors are on 1 of 2 different settings (beside the INR setting).

On the Coaguchek XS unit you can set the monitor to read in a %Q - which the results are displayed as a Quick percentage value, or the monitor can be set to read in seconds.

FWTW I agree with you and your pharmacist for routine weekly lab draws and to revisit the POC issue again a later time.

 

[pellicle]

Hi

They were re-trained in the lab by a rep from the CoaguCheck company because the procedure had been changed. He told them the new procedure is to use the SECOND drop of blood.

interesting ... given that's not in Roch publications I wonder if the trainers actually know what they're on about?

BTW the clinic is using the CoaguCheck XS machines. She agreed with me it would be a good idea to try both ways and see if it made a difference in my out of whack readings. Answer: NOPE both drops had POC machine MUCH higher than lab draw INR of 3.0

interesting ... clearly there is something in your blood chemistry which is making either the XS read wrong or the lab read wrong or both ... I assume that the lab are testing the blood using reagents and not just another machine (I'd ask this as the lab I just went to were quite "professional and confident" until I asked if they were using reagents or a commercial machine like an i-Stat ... to which they suddenly got off their horse and said "oh, well sorry but we don't know")

. She used two machines side by side. One machine got the first drop, the other machine got the second. (Machine 1-- first drop, read 5.4, machine 2-- second drop read 5.3)

that's pretty close ... I say that speaks volumes for the quality assurance that Roche have in their product.

Recall that each XS machine needs the strips and the code chip that comes with each batch of strips. The code chip contains calibration information on the batch of strips used. The machine will not allow you to use the strips from a different coded batch.

Of course there could be some variance because two different machines were used, but results were essentially the same.

So essentially I expect that the difference is in the strips and the chip not the machines

just my thoughts

Hope all is well your end

Best Wishes

 

[newmitral]

Hello Linda,

Your problem with the POC meter readings certainly does seem puzzling. My first inclination was to blame using the second rather than the first blood drop, but now that you have eliminated that as the cause, the only other thing I can suggest is to ask if you have an unusual hematocrit level, since the meter manufacturers state that this can throw off the readings.

Is there anyone anywhere in the northern Va. area who has a CoaguSense meter they'd be willing to let me take a test on???

Although I don't have a CoaguSense meter, I do have both a CoaguChek-XS and an Inratio2 meter. I'm a bit farther from Woodbridge, since I'm in the Laurel, MD area, diametrically opposite to you on the other side of the beltway. But, if you happen to be on my side of the beltway and want to give the Inratio2 meter a try, send me a PM and you are welcome to test on that meter as well as the CoaguChek-XS to see what happens.

For my particular blood chemistry, both of these meters give pretty much the same result, and agree closely with lab INR test results (venous blood draw).

I suspect that the INRatio is an older tech machine (and I am not sure if its still using electro-mechanical).

Pellicle, the Inratio2 machine uses the time between electrical impedance inflection points as the blood and reagent mixtures interact in the test strip. I believe this is similar to the test technique employed by the CoaguChek-XS, but I haven't really examined the CoaguChek-XS methodology in enough detail to say for certain how similar they actually are.

 

[pellicle]

Pellicle, the Inratio2 machine uses the time between electrical impedance inflection points as the blood and reagent mixtures interact in the test strip. I believe this is similar to the test technique employed by the CoaguChek-XS, but I haven't really examined the CoaguChek-XS methodology in enough detail to say for certain how similar they actually are.

Ok ... good to know. As a user of Brand X I seldom do serious reading on Brand Y (cos I'm not a swinger ;-)

Thanks

 

[Protimenow]

The Anticoagulation Clinic that I go to (I've gotten them to allow me to extend visits out to every 3 or 4 months, instead of monthly) uses a Hemochron Jr. meter to test the patient's blood. The Hemochron Jr. is made by ITC, and is supposedly accurate enough for use in Operating Rooms. It does a variety of tests, using a different strip for each test. It may be possible that, if your cardiologist or the clinic is friendly with someone in the E.R., and they actually DO use the Hemochron Jr., perhaps they'll let you run a test against THEIR machine.

When I was getting some crazy high results using the InRatio and XS, I was concerned about other blood factors and had a CBC - the Hematocrit and other blood markers were okay -- the meters just, for some reason or other, just showed high INR values.

As noted elsewhere, it's sometimes almost as hard to trust some labs as it is to trust the meters. I'm sure that the reagents used in the strips are very carefully checked (against what standard?) because the meter makers conceivably have more to lose than a lab with faulty reagents). As others have noted elsewhere, the goal should be to get within your range.

I'd probably give it some time for your INR on the meters to get closer to that of the labs. (If your INR is TOO HIGH, you may wind up with other symptoms - bloody urine, excessive bruising, and other nasty things like that -- a HIGH INR can give signals saying that you should cut back right away or just be damned careful until your INR is in range).

(I have a second Coag-Sense meter that was only used once, for comparison to the one that I use for most of my testing. PM me if you're interested in it).

The 'second drop' instruction is good for me --- I use the first drop for my Coag-Sense testing, with my new lancets, I usually have enough blood (second drop) for the XS, so I won't need two incisions.

 

[Aggie85]

Newmitral, THANKS for the offer to come test on your machine!!!! I know exactly where Laurel is. I used to live in Cheverly and come up to Laurel for my glass for fusing (over on Old Baltmore Pike). Car rides are still murder on my chest, so will PM you sometime when I'm feeling better and heading up your way (my cardiologist is at Bethesda in Rockville area too.) interested to hear someone liking the INRatio as I definitely got the impression from Protimenow that the brand was not his recommendation (granted he always qualifies "for him"!)

Protimenow, also thank you for your offer, as stated before, I'm going to wait on getting any until we get better clarification on what's going on.

I will definitely check into the hematocrit level issue. I know at one point it was low but not sure if still is. I'll ask the next time I'm there and maybe have it rechecked. Thanks for the idea. It makes sense, it could affect INR machine readings.

Pellicle, I'll also ask what lab is using. I suspect some sort of machine only because on one of the vein draws the phlebotomist was having trouble filling the tube and was going to go short, but other tech said "no, the MACHINE needs a full tube of blood." They're using a pink topped tube that needs about 10cc of blood. They partially draw one tube, discard that blood and draw a second full tube of veinous blood. Not sure about how reagent or lab machines use the blood but they certainly need a lot more than the POCs use (given it's just a drop.) I wouldn't be surprised if the techs drawing the veinous blood have no idea how it's actually processed, they're just getting the samples; it's the lab techs themselves who would know the process specifics. But my pharmacists in the AC clinic would know.

Thanks for suggestions and ideas ALL. hematocrit issue sounds promising.
Linda

 

[dick0236]

..........interested to hear someone liking the INRatio as I definitely got the impression from Protimenow that the brand was not his recommendation (granted he always qualifies "for him"!)
Linda

I have used the CoaguchekXS(program thru Alere) in the past and currently use the INRatio2(purchased from Ebay) with similar acceptable results.

For the past 20 months I have tested weekly at home(INRatio2) and gone to my PCP monthly for a "finger stick" using their CoaguchekXS. On the day of my monthly CoaguchekXS test, I also test at home as a check of both machines. Seldom have they been different by more than a tenth or two. Because of the current problems with availability of the INRatio2 strips I have decided to return to an INR home testing program.....BUT NOT THRU ALERE(extremely poor service). I applied thru Rouche "CoaguChek Patient Services" (800-780-0675) in late May and received notice of insurance approval today....actually got the approval phone call while typing this post.....should have new CoaguchekXS and supplies within a week. I have a very good INRatio2 for sale....$200 if interested. My "program cost" will be less than $6/test.....about what I was paying for strips via Ebay. So far, my experience with Rouche Patient Services has been very positive.....much different from the poor service from Alere.

I strongly believe in home testing and personally believe it has allowed me to easily stay in INR range with only minor diet or infrequent warfarin adjustments.

 

[Aggie85]

Dick, thanks for offer, but not for me. First, I gotta find out if I even can do home testing. If it turns out POC won't work because of some weird blood antiphospholipid thing, home INRs won't work either. If eventually, I do start getting correct results on machines, vs vein draws, my insurance fully covers the machines and all supplies. I suspect I won't have a choice of brand, but if I can make a case for a particular one I can probably get it.

Onto new lessons...
Tried calling CoaguCheck today. WEIRD. The guy would barely give me the time of day and kept insisting I give him the lab's phone number so he could talk to them about my issue. I told him I was on my cell calling him and the lab's number was also on my cell. He couldn't seem to understand I had to get off phone and call him back with the number. Finally got that concept through and hung up. I decided to wait till tomorrow because I wanted to let the lab know first before giving out their number and to give them permission to talk to the company about me. Five min. later the CoagC tech CALLED ME to ask for the number and seemed very concerned that I get answers. I told him my plan for talking to clinic first and he agreed that was a good idea. Maybe between the company and clinic they can figure it out. He was quite puzzled that I would have the problem when I'm not a immuno compromised patient (such as having Lupus).

Also found out antibody issue is specifically called Anti-phospholipid Antibody Syndrome. It is a separate issue often found in Lupus patients but people can also be carriers of the Antibody and not have clinical signs of the syndrome. There is a blood test that can be done to see if this is the case. I'm gonna ask about that at next visit. This antibody can effect capillary blood clotting and that's what interferes with POC INRs but not with Veinous draws.

Hematocrit levels can be a factor in testing but has a pretty wide range of what will test accurately. I could see mine being out soon postop but my last set were fine and yet still having the false high POC INRs so suspect it's not a hematocrit issue.

Onward and back to the phlebotomist Vampires tomorrow.
Linda

 

[Aggie85]

Well spoke with pharmacist about antibody screening lab work. Can't do it while on Warfarin! :frown2: So we'll just be guessing that's the issue. Hematocrit, RBC, and Hemeglobin were all slightly low on last CBC but well within what Coaguacheck says is ok range. Also chided tech about milking finger and made sure she didn't this time. Same result, POC INR read of 5.6. Still waiting on lab draw INR result but sure it's not anywhere near that.

Two more sticks today for lab attempt and this was with one of favorite techs. :frown2: first time he didn't get it on first try. Also bruised the heck out my hand as vein blew while he was doing collection. Had to wait around to make sure draw was ok and not affected by difficult collection. He recognized the bruise from TWO WEEKS ago when he last Drew blood on me. Once a week vein draws is going to sure have me looking black and blue. Sigh...

Ok, enough pity pouting.... Sorry, just had to vent.

Forgot to mention calling Roche to pharmacist, but will when she calls me tomorrow with lab INR result. Maybe between the clinic and company, they can figure out something. At least ruling out issues each week if not getting any helpful or new results.

Linda

 

[Aggie85]

Pharmacist never called me with INR reading, so 1. Have no idea what it is but assume within target and 2. Didn't get to talk to her about giving Roche her direct line number. I called clinic to ask since hadn't heard, they took my info down, but no one called. Will call them Monday morning, again. This is the first they've neglected calling me with results and instructions. SURE WISH I COULD use POC and HOME TEST! Then not have to rely on someone calling me.

Linda

 

[Aggie85]

Update on this issue.
Pellicle, you said you had other questions regarding this, what were they?

For now we've quit checking with the POCs. Gonna wait a few months and try again.

Pellicle suggested on another of my threads that my taking Tramadol (a pain killer) my be affecting how the machine is reading my INR. We'll have to wait to see if stopping that drug makes a difference.

I'm slowly starting to feel more healed but still having lots of pain just under the incision. Feels like muscular and connective tissue type pain. I suspect immune system is getting closer to normal so that may help issue as well.

Just to revamp here....
The problem I'm having is NOT that my INRs are unstable. They have been fairly stable (disregarding one unaccounted for spike I just had this week, discussed on new thread). The issue is that POC machines keep reading INR way above what the vein lab draws read. For example POC reads 5.7 while Vein draw 15min later reads 3.5. POCs have been consistently high and Vein draws have been consistently in range in the 3.0s.

Linda

 

[Aggie85]

I reread my own thread here, since it's been a while. I had forgotten to post another tidbit about all this.
I finally got a rep at CoaguCheck to talk to me and give the time of day. Unfortunately no answers forthcoming. He agreed all had been done (except for blood drop issue, more on that below) correctly and all factors eliminated (Lupus, auto-immune issues, poor technique, problems with machines...). He was as stumped as pharmacist and I am.

He was very interested in issue about lab techs suddenly being told to use second drop instead of first. Apparently Roche has NOT changed that policy. So somewhere communication has gotten crossed at FtB hospital. I talked to pharmacist about milking issue (one tech IS milking fingers) and the second drop issue. She confirmed lab had retrained all techs to use second drop and was going to look into it. Of course, in my own trial, it didn't make a difference. Both drops on both machines gave a false high reading. They were close to each other, but no where near the vein blood level. She's also going to retrain the tech who is milking fingers. She was not happy to hear about that because apparently, she'd already talked to this girl about not milking fingers. When the tech did it to me, I made her start over on a new finger and no milking. No difference in result, but at least I knew wrong reading wasn't from milking.

Linda

 

[pellicle]

Hi

I finally got a rep at CoaguCheck to talk to me and give the time of day. ...

all very interesting. Why not see if the Roche rep (who probably does patient training too) will meet you and demo the system and also read your INR for you? They may be forthcoming on that.

wouldn't hurt (well a small prick on the finger ;-) and may be informative

 

[Aggie85]

Hmmm... My understanding is that they won't unless you have script for home monitoring. But I never tired that route, I could try. All they could say is no, you need a script. I was calling the tech support for professional labs and not home monitoring. As I explained to them, I'd called that department because it was machines being used in a professional AC clinic that was reading my INRs wrong, not a home unit malfunctioning. The first two people would barely give me the time of day and said they would only talk to my AC clinic rep. When I checked back with them after she had tried to call them and got no answer, they gave me a song and dance about my clinic person never calling them back (she said they'd never called her when I gave them her number. BTW she has a direct line and ALWAYS answers when I call it; she'd also been expecting their call). It wasn't until I pointed out that they were being incredibly rude for no reason, that I'd been a cardiac nurse myself and knew what I was talking about, that they finally agreed to even listen to my information. After listening to all I had (specific correlated POC and lab results, description of testing methods and what I'd done to have techs verify procedures, what I'd done to rule out variables or possible issues, etc....) they finally said it was puzzling and also had no answers. The tech said he'd talk to his superiors and took down my contact info. I've not heard back from them, but frankly, even with the supposed cooperation, I'd be surprised if he really did follow up or called me back with any news.

I'm going to try again finding someone in Virginia area with a CoagSense machine and see if their method makes any difference.

Linda

 

[Protimenow]

I'm in California, so I can't help with a CoagSense.

You might try contacting the manufacturer/distributor -- perhaps they can help you find someone in your area who has one. (They were originally called CoaguSense, but now call it Coag-Sense. Using one spelling or the other should get you to their website -- and from there, you should be able to find an Info link and a phone number.)

 

[Aggie85]

Well, stopped Tramadol over the weekend. Did INR with both POC and Vein draw. Same stupid POC problem. POC read 6.1 and Vein draw read 3.8 .

Got a reply from CoaguSense which wasn't very helpful. Their rep. suggested I have my clinic do a correlation study between the POC machine and the lab. Problem is, I don't think that would make any difference. These whacky INR levels have come up on three different machines and NO ONE else using the clinic has had this problem. If there was a correlation problem going on, it would show up in other patients as well, not just me. Also, very unlikely that three machines would be that out of whack for three months now and not be showing bad results on other patients.

Anyway, we'll keep trying again every few months and I'm still going to pursue CoaguSense option. His email said he'd tried to call me and he left me a number. So, I'll try calling him and see if he has another ideas.

Linda

 

[Aggie85]

Reading one of the other threads made me think of something to bring up here. It may not be clear in my postings, and according to Protimenow's reply in the other thread about the accurate of INRatio machines, could be construed as a factor inmy situation. He was talking about proper handling of the lab samples depending on where the lab who draws the blood and where the testing facility are. To be clear in my case; AC clinic AND the blood draw lab who processes the veinous sample are both in the same hospital. They test independently but are in the same facility and correlate the lab's testing and the clinic's POC machines so that results are consistent with each other. Normally that is with the other patients, my results being the exception. One other factor, the lab keeps walking my sample directly down to the testing room to make sure the sample is good before I leave the hospital. One time I had to make an hour drive each way to go back and have the lab draw done over again, because the sample wasn't acceptable, now they make sure it's ok before I leave. I'm VERY confident in how both the clinic and the lab are performing their jobs. Just wish the POCs would work. :confused2:

Linda

 

[Protimenow]

Linda:

Remind me (I'm too lazy to check the original posts): which POC is giving these inconsistent results?

You might also try a ProTime meter (you can probably get one fairly reasonably -- and I have two that I no longer use). These, from what I recall, measure actual clotting time. They may overcome some of the issues that other POC machines have run into.

 

[Aggie85]

Hi Protimenow.
It's the CoaguCheck XS machines. 4 different ones in the same AC clinic. They've had the strips checked, machines have been sent back to the lab to be correlated with the lab's machine (don't know what THEY use), and checked with results of other patients tested the days I was. I'm the only one with crazy out of line results and it's still consistent (POC way higher than vein draw.) I tried again last week since I've had some major medication changes. POC read 6.1 and lab vein draw 20 min prior gave INR of 3.7.

I've spoken with owner/sales rep (???? Not sure his position but guy in authority there, LOL) at CoaguSense company and they have given me contact info for a local ACT clinic that uses the CS machines. I'm waiting on them to call me back to see if they'll let me do a trial test or two on the CS machine at their clinic. The guy at the company was great and said to tell the clinic he'd even reimburse them the strips used on me. The clinic was supposed to call me today, office manager said she had to check with the actual Dr in charge. I didn't hear from them, so I'll call again tomorrow to follow up.

The CoaguSense guy explained how their machine reads development of actual clot via a light passing through it. I'm probably messing up the method. But essentially totally different method than how CoaguCheck does, so maybe whatever my reading problem could be solved by their machine. I'll see if I can get the clinic to cooperate.

My current clinic pharmacist is very enthusiastic about having me try a different machine type. She'd like me home-monitoring if at all possible. I'm not sure how it work insurance wise, because the clinic does set up with Alere using either CoaguCheck or INRatio machines (I'm not sure what determines who gets which). I'm not sure what would happen if CoaguSense is only one that works. But, I'll jump off that bridge if I find it actually works! We can afford to buy my own if need be and will if it works and that is only choice. I want to have some ability to monitor on my own. My upcoming trip to Mexico, see other thread if interested, would be MUCH less worrisome if I could monitor on my own.

Trying to get folks to understand the problem is the biggest challenge. Everyone keeps thinking my INRs are bouncing back and forth. Not that tests via one method (POC) show different results than another method (vein draw) done at same hospital on same day.

Thanks for checking up with me. Did you have another idea on what to look for that might be causing it?
Linda

 

[Protimenow]

There are blood issues that could interfere with getting a correct result on the CoaguChek XS. If I recall, a problem with hematocrit level might be one of the issues. Perhaps there is something about your blood chemistry that throws it off. (I'm not an MD, but I wonder if you may have an issue with your platelets - if you have more than you should in your blood, perhaps this would mess up the electrical processes used by the XS -- have you had a CBC lately?).

At one time, I thought that I may have had a problem with MY blood and the CoaguChek XS and InRatio meters because the results were always high, but my CBC was fine.

The Coag-Sense (the company stopped calling it Coagusense for, apparently, some legal reasons) is an interesting device. The strips have a small wheel that starts turning when you add your blood. The blood mixes with the thrombin on the strip, and the blood starts to clot. An optical sensor determines when the clot has formed. There is supposed to be at least one clinic that uses the Coag-Sense as a second test if the other POCs report an INR above 4.0. This may be one of your best options, if the CoaguChek XS and something specifically about your blood chemistry produce erroneous results.

One other thing -- and I mentioned it earlier: the ProTime and ProTime 3 meters, built by ITC, are somewhat older technology but also use clot detection. The company makes a meter that is used at some clinics and even in Operating Rooms for quick, accurate blood component results. I have both types of meter -- unfortunately, I'll probably have to replace the batteries, but they can still be run off the charger. The strips that I have are probably expired.

These machines aren't quite as easy to use as the newer machines, and they require more blood. They also don't take the first drop, so you have to wipe off the first drop of blood. I've bought a few of these over the years, and sent a couple to people who wanted to test but didn't have the funds to buy one. If you're willing to get some cuvettes for one (ITC calls these cuvettes, instead of strips), I can send you one to try out and compare to the labs. If it works for you, we can explore our options.

So -- a CBC and a bit of a search for something in your blood that is throwing the XS off (and perhaps testing with an InRatio, if you can find someone with one) may be the first way to go. You might try to find a Coag-Sense somewhere (I have two), or a ProTime meter.