Antiphospholipid Antibody Syndrome (APS) - SAY NO to Home INR and Finger Stick Machines!!

Ran across this on Facebook today. Poor guy suffered a clot because his machine was off.

Maybe if he’d have known ahead of time, he could have avoided the inevitable wrong reading.

I utilized the machine Coagucheck and by an error of measurement I suffered a very serious clot. The machine gave me an INR of 4 and really was of 1.3. Now I control me puncturing me in vein.

That’s a HUGE difference. HUGE. 3.7 difference. 3.7 is some people’s therapeutic INR and there was that MUCH of a difference with this poor guy’s reading from his damn machine!!

And that clot he suffered from could have been a stroke or a PE and could have killed him.

Is it really worth the risk people?

Source: http://www.facebook.com/APSFA

A new forum popped into my reader today…and wouldn’t you know, there are a FEW threads about INR testing machines. Funny, I never found this forum before today.

The next 4 posts are my findings from this new source…link is in most of the posts.

 

Do they make you mad?

They should.

 

I don’t understand how people can still advise other people on how wonderful these machines are. They’re inaccurate. Plain and simple.

What gets me is no one ever blames the company…they blame the time, the environment, the moon cycle…everything but the company. The company that we’re focused on in the following posts allows 10-30% error and still calls that “accurate”.

Let me say that again. The company that makes these machines allows for 10-30% error and still calls that “accurate”.

Does that seem wrong to anyone else.

Do you want breaks on your car that may fail 10-30% of the time? Do you want to skydive with a parachute that is KNOWN to not open 10-30% of the time? Do you want to wash your hair with a shampoo that 10-30% of the time causes hair to fall out?

 

Probably not.

 

Yet, you’ll use a machine that could be wrong 10-30% of the time to test someone as important as YOUR BLOOD.

Repeat that. Does it even make SENSE?

People…the facts are in black and white. The truth is out there. Don’t be one of the 10-30% of people who’s machine fails them and results in a major bleed or clot.

         Because that clot or bleed may be your last.

Source: http://z10.invisionfree.com/Hughes_APS_Support/index.php?showtopic=8883

…even though there is usually between 0.1 and 0.5 difference between a venous reading and my monitor…
Read on people…read on.

the" trombosedienst" (the nurses who check my INR) want to put me on self-management. There is a little problem. The self-management machine has not given a proper value of my INR. last time they tried ,the blood from the artery punction was measured as 2.1 while the machine gave a value 6.8
now here is the question: what kind of machines are you using for self-management and how precise are they?

I use a Roche CoaguChek S monitor....I have successfully used a monitor since June 2003. I bought the new Coaguchek model last year and it has been even better than my old XS monitor.
I find my machine very reliable and put my trust in it....and my life it is usually between 0.1 and 0.5 difference between a venous reading and my monitor. This could be due to a difference in the time that both tests are run.
Hope that helps.

So, your machine is very reliable…and you put your trust and your LIFE in it…YET…it is usually OFF? and this is due to a difference in TIME?
Seriously? Are you seriously telling me that you put your trust and your LIFE in the “hands” of a machine that’s usually WRONG??
Oh, you’ve got to be kidding me.

Source: http://z10.invisionfree.com/Hughes_APS_Support/index.php?showtopic=8883

Source: http://z10.invisionfree.com/Hughes_APS_Support/index.php?showtopic=9725

Hmm…maybe THAT’s why the machine is giving false readings…hmmm

I have been getting odd results from my machine, and have typically lost my handbook
just found this from the roche website, it looks as if the way we have been told to clean it, is leading to incorrect results
click here http://www.poc.roche.com/en_US/pdf/09-112_...XS_UMDC_PST.pdf

Thanks …… i have been having the same problem...will give it a try

where do you get your alcohol from?

i just used water...but its still not correct...5.5 at home and 6.1 at the clinic !

So maybe if we all get our alcohol from the same store on the same day within the same timeframe then our machines will FINALLY give us a correct reading!!!
Hahahaha….WRONG WRONG WRONG people!! THE MACHINES DON’T WORK CORRECTLY FOR APS PATIENTS!!!!!!!!!!!!!!!!!!!!!!!!!!!

Source: http://z10.invisionfree.com/Hughes_APS_Support/index.php?showtopic=9725

Source: http://z10.invisionfree.com/Hughes_APS_Support/index.php?showtopic=9796

This will blow your mind!! I don’t know if it’s ignorance, or what the heck is going on, but wait till you read this. I will put my comments at the end. This blows me away. The different colors are just to separate the posts from each other.

Can u hear me screaming !
Had inr Clinic this afternoon...my machine said 5.3...the clinic 7 !!!
so just rang Roche their trying to tell me because the clinic doesnt use their machine and its a differant make that my inr wont tally...well what good is that to me confused.gif
I told her my machine is pretty much spot on apart from these last few weeks....
I wouldnt have bought a machine i said if it wasnt to give me readings i mean for goodness sake do they tell u that unless the clinics meachine is their make then we wont get a correct inr grrr...shes speaking to her supervisor and calling me back....

(sorry) to hear that you are having trouble at your inr clinic.
I have much the same trouble when I go to the surgery to have my blood pressure checked. I get the impression that they do not like us doing things ourselves.

It is quite common to get different readings from different machines...
My hemos office uses the pt/inr/ratio one and it is different from the vienous draw at the hospital. I do have the LA so that may be why? Do you have the pos lupus anticoagulant? I would not blame it on Roche... it seems to be a common issue from what I know on other home testing machines as well.
But i do know how frustrating it is. I am waiting for the day that we wont have to test...hope its in my lifetime!

mines playing up at the moment, too ……, but i am wondering if i am having antibodies that i don't normally have?  cos thats when the readings can go wrong i think, is that right?
I am going to contact Roche tomorrow and see if they can help any. I have tried different test pots and that but havent cleaned it yet, as i am going to ask em where to get the alcohol from, did get the vodka but drank it hehehe! (no not really, never drunk vodka actually!, drank lots of other stuff though)
will let you know how i get on, hope they can help us both, is yours still under guarantee?

That's frustrating, (name-removed), but I think it would be good to get the machine checked against a number of blood samples. A one off doesn't really tell you much, and who's to say it's not a hospital error with your sample?
I self manage, so never know what a clinic test would say in comparison to my machine. Makes me think that maybe I should do the occasional comparison.
I do remember that Roche have always said that people with a +ana need to be aware that they may have inaccurate test readings... It's all rather an inexact science, isn't it?
Do let us know what they say.

well seems the girl was calling me from a call centre in Germany !
Spoke with …… who has given me a phone num which i have called and left a message.
The girl panicked me by saying oh how high it was etc etc and if i need to call an ambulance...than when i said it had been 10 she almost fell off her chair i feel sure i heard a thud
if she had spoken to someone who is not familiar with an high inr she would have scared them for sure.
don't get me wrong …… i am not blaming Roche just saying that i was given confusing information.
My machine as always been spot on when checked against the finger prick at the clinic.
…… anti bio do make a diiferance to our inr...
anyway hopefully going to have a venous test tomrrow so will let u know how it goes

I was also told that the hospital tests (vienous) are always slightly different to the finger prick tests....don't know why.I have found mine is usually the same...
I have found Roche are pretty good and the machines are usually quite accurate.
I hope todays test will go ok .....I know you havent been to well for a few weeks...maybe Ally could be right...some different antibodies that could be cocking up the result?
Let us know how you get on

could you send me the number to call cos i think he was probably German or certainly had an accent of foreign kinds! bet i have called the same number.  
my inr is just dropping so maybe it is the antibiotics, thanks honey, totally didnt think of it
its great this site eh, we keep each other going eh

thanks chick, but they have just called me
I am going to get 90 % isopropanol (sp) or 96 % ethenol to clean it first, then if its still giving way out readings, they are going to send me a new machine.
He was lovely (calling from Germany) and said if the range is 2.0 to 4.5 then they work on the thing that between 10 % to 30% difference is acceptable for the machine, but as mine is much more different, then that is unacceptable.
So sounds fair to me, will clean it and see what happens next smile.gif
and hope your venous samples ok chickie, i have mine done everytime like that at the hossie too

they have just called back again, to say they want me to use some strips that they are going to send me, at the hospital at the same time as the venous bloods taken. and to test at the same time with my old strips too.
then record the results and phone them with what they are.
so will see what happens next!?

i have received the test strips today and my inr with the new ones is 3.8, test with the old one comes up at 3.4, 3.2 so am wondering if it could be my test strips?
the code i have at the mo is 267, wondering if yours is the same batch?
p.s.! i found another box of strips which are a different code and they are testing me at 3.7 so thats what makes me think its probably those strips which are cocked up!

wonderful news that you have gone to all that effort honey...sometimes it pays off to just do a few more comparison tests.
good news that Roche sent you out the other strips to try.......and had offered a new machine if the problem had still be there.
…… hope you manage to get the probs with your machine all sorted.....check the strips like …… mentioned

update...
new test strips and chip and its still out.
Hospital test from yesterday 4.1...mine 4.9
so just spoke to them and their sending me a brand new one !! should get it in 3-5 days also a jiffy bag for my old one wow...what service is that !!
my inr mon was 7 and 4.1 yesterday ...but i missed a dose mon ...it had to be done...
it was horrid yesterday...they took my blood then just let it come out to take some for my machine yuk made me all quesy !!
inr clinic later today

omg! really they did that! yuk!!!
glad they are sending you a new machine

hiya what number did you call please hunny?
they are saying that 1.0 is ok for the machine to be out, and that they are different readings to the hospital inr
apparantly its like comparing celcius to farenheit?
dead confused!

OK…did you make it through all of that mess? Sorry about the spelling and the language…I believe most of the members of this forum are from overseas and they talk well…you read that mess, right? Anyway…let us review.
So the machine is off…the person asks on this forum…is given a number of reasons why it could be off…antibodies are different, +ana, the machine is dirty? (that’s a new one…and I have more on this!), the strips are different…etc. BUT…they NEVER blame the company!
The company KNOWS these machines don’t work with APS patients. They have it in their literature. READ THE PAPERWORK, people!!! They say that ppl with a positive ANA may have false readings…but hey it is ok for you to use with your APS?!  And no comparison...so how do you even know it is accurate?!
Hell, how do you EVER know it’s accurate unless you do comparison draws every.time.???

Source: http://z10.invisionfree.com/Hughes_APS_Support/index.php?showtopic=9796

Source: http://z10.invisionfree.com/Hughes_APS_Support/index.php?showtopic=5477


This forum advertises for these machines. I mean, there’s an actual post on this forum with a link to the manufacturer and a phone number to call if you’re ready to “gain more independence”…yeah, that and risk your life on a daily basis by checking your INR with these INACCURATE machines! Can you believe they actually ADVERTISE for these? They tell you there are problems…they’re “usually” off by whatever margin…yet, they put their LIVES in the hands of these machines.

And they’re trying to sell them to you.

CLICK HERE TO VIEW THE ROCHE WEBSITE
Self-Monitoring
Choose independence
Has your doctor just told you that from now on you need to use oral anticoagulant drugs, and that the clotting times of your blood will have to be checked regularly?
Oral anticoagulation therapy is necessary if you have an artificial heart valve, or if you are affected by atrial fibrillation or thrombotic diseases. Taking an oral anticoagulant or "blood thinner" is very important for your health. It is important for the dosage to be exactly right. This requires regular monitoring, as people react differently to those drugs or as several factors may interfere with it e.g. food, other drugs, etc.
This monitoring, after being released from the hospital, usually takes place at your doctor's or in an anticoagulation clinic. It traditionally requires a blood sample being drawn from a vein at a doctor's office or at a private or hospital lab/anticoagulation clinic. It results in commonly long waiting times and potential time losses i.e different appointments, which reduce your independence.
However, recent developments are now allowing patients to monitor medication themselves. This is so called Coagulation Self-Monitoring. Self-Monitoring has many advantages: it is straightforward, it makes routine testing easier, it gives your independence back and it means you can be directly involved in your own health, collaborating with your Healthcare Professional. Even more important, experience has shown that more frequent testing reduces complications resulting from the underlying disease or from the anticoagulant itself.
With the CoaguChek XS or S system, we can help you to get back to a lifestyle as independent and as safe as possible, based on our more than ten years experience in helping patients monitoring their coagulation status - anywhere and anytime.
The information provided on this website will answer many of your questions. Be sure to ask your doctor or Healthcare Professional if you have others.
Go for more independence and safety! Choose Coagulation Self-Monitoring!

Self-Monitoring: Self-Monitoring at home
CoaguCheck S system for home monitoring
The CoaguChek S or its successor, the CoaguChek XS system, is a device which allows you to manage your own oral anticoagulation therapy at home. The method is known as Patient Self-Monitoring.
The CoaguChek XS or CoaguChek S is a portable, easy to use and battery-powered monitor that provides accurate readings quickly and easily. These systems are used successfully by doctors and health care professionals in anticoagulation clinics, and also by patients undertaking Coagulation Self-Monitoring (or even Self-Management), after a proper professional training.
Self-Monitoring has the benefit of being accurate and can be reproduced, as results are never affected by variations in test methodology or different laboratory environments. Each test result can be compared directly with previous tests. This means that you and your doctor are always fully aware of any changes and drug dosage can be adjusted appropriately.
Using the CoaguChek system for Self-Monitoring at home is simpler than travelling to an anticoagulation clinic, a lab or to your doctor's office. A busy schedule needn't be interrupted and there are no transportation or logistics problems for people having a difficult access to healthcare facilities. The system is accessible at any time and can be used whenever and wherever needed. Thereby the CoaguChek XS strips can be stored at room temperature for a long time.
You gain more independence!
Where to Buy
For more product or support information, or if you wish to proceed and purchase a CoaguChek XS system please call our CoaguChek Careline free on: 0808 100 7666

Join…see for yourself. http://z10.invisionfree.com/Hughes_APS_Support/index.php?showtopic=5477

The following is a conversation between members of a well known Yahoo group. (link at the bottom). This is kind of a long post, but it does show both sides.

I am post op and there's been some "difficult" communication between hematology and surgeon, so agreed to hematologist who monitors with no INR machine on site. It's an oncology center, the other hematologist sent me to Cardiac Center.  My surgeon, a GYN says the INR machines are not nearly as accurate as doing the full lab (from blood draw from vein).  Is that the consensus in medical community?  Oh, and before anyone suggests I see a rheumatologist, I am in a part of the country where I believe I can safely say the rheumatologists are ENTIRELY unaware of APS being the realm of Rheumatology, even when I bring in Dr. Hughes publications and tell them about the very first podcast in the Oxford JOurnal of Rheumatology (they send table of contents to mailbox free for creating a login, and then sometimes TOC links to something really good like the podcast a few months back.  I simply get blank stares and referred to hematologists who are primarily oncologists, even though they believe they are fully aware of APS, the hematologists I've met here (3) firmly (let me emphasize FIRMLY) believe that APS is asymptomatic, and if they aren't going to listen to their own colleagues in other parts of the world, why would they listen to a 'mere' patient like me?  It's very draining to try new doctors, hear them say they know all about APS, and yet no nothing of the discussion content here in this forum or in the International Community.  I guess few decades behind.

Right now I am having bleeding because my INR got to 3.9, and pain with it, which I am not sure is from the laparoscopic total hysterectoy (took ovaries too). 

So, dear group, what is your believes on INR accuracy and, when in geographic part of USA that hasn't a clue APS belongs in Rheumatology, where is the next best place to be monitored: a cardiac center with an INR machine or an oncology center that doesn't own a single INR machine.

She asks a question about machine accuracy…because her surgeon brought up that they are “not nearly as accurate” as a vein draw. Good question! However, you need to ask that question somewhere where people are going to give you an answer that is FACT and backed up with PROOF. Not personal experiences.
Here’s the answers she got:

I am now on my second Coagucheck machine and as far as I am concerned, their use has not only been of immense convenience but has probably saved my bacon on a number of occasions.

I had a bit of a fight to get my first Coaguchek X but when I arrived at the surgery after rehearsing my arguments, the doctor said she had changed her mind as her father had started using one. It was agreed that I would have periodic checks through the surgery/lab tests, to see how they compared with my own home testing. There has never been more than 0.2 difference, more often less. The makers of the equipment say that a small difference is not unexpected.

The NHS pay for my strips, I bought both machines. I went on to the XS updated version because it was smaller, and the strips do not have to be kept in a fridge. Also with arthritis in my hands it is easier to use.

I recently had to have some teeth extracted and I needed to have my INR not much above 3.0 They didn't want to rely on my results and brought out their own machine - an older Coagucheck X! Their result mirrored mine exactly.

I know of some surgeries that use the Coagucheck machines for routine INR tests so the word is spreading slowly.

Roche do indeed say that in some cases the machine may not be suitable for APS patients. Because of this Roche let me try one for several months to make sure I was suitable and would get consistent results. I did.

When I saw Prof Hughes privately recently, he was very pleased that I was using the coagucheck machine and encouraged me to check my blood every two days or so. That would be impossible without home testing if I wanted a life- and a real pain for my surgery. Following my closure of PFO procedure my coagulation has been monitored even more closely in the first instance - I am sure all at my surgery were very pleased to be able to know how my INR was behaving just by ringing me. Fotr me, having a result in minutes is far preferable to waiting for up to a week (by which time it can be too late) It has been proven accurate and allows me to get on with life.

I am aware that the accuracy is not the only issue, there are politics involved and issues to do with letting patients have some control. At the moment I am perfectly competent at taking the test and working out what dose of warfarin to have. Not all are so fortunate. Encouraging more to self-test would have an effect on lab budgets!

On the subject of self testing vs lab testing, one important factor is what happens with the results. Many surgeries use a computer program called INRstar. To my mind it is potentially the most dangerous aspect of INR testing. If you are self testing then I suggest that you either get out of the INRStar system and work out your own doses, or if you cannnot, then you make sure that your surgery feeds in the right data every time (this can be tedious for them). Assuming, incorrectly, that you have taken the dose that the INRstar program suggests can lead to inappropriate suggestions for future doses. They say garbage in garbage out but nothing in can also mean garbage out.

Finally, on the question of Heamatologist vs Rheumatologist, I guess it depends on the individual doctor. I've stopped seeing the haemotologist, we had different ideas on what was expected from the relationship- he considerd his role was just to monitor my INR. He had not accepted my argument for an INR above 2.6 even after being given Dr Khamasta's paper that advised people with my history should be above 3.0. Whe the stroke consultant upped it (after three TIAs) he used the same study to justify the raise. The Lupus unit at St Thom's (where Prof Hughes was) seems to be made up of Rheumatologists  from what I can see - that tells you something.

I know Clair that my experience is of the UK but hopefully it may be of help. I have spent about £750 buying my two machines (and got back £100 selling the first on EBay)and I get the strips, (which are about £2 odd a time), free but, if push came to shove, I would finance the whole thing myself if I had to. With my medical history, my life depends on self-testing as far as I am concerned.

It does seem to me that doctors who know much about APS support the self-testing for those who can manage it.

“My life depends on self-testing”? Really? You’re not giving your life much of a chance. Why would you play Russian Roulette with your life and these machines that just are NOT accurate for APS patients. Wait though…the great Dr. Graham Hughes was pleased! woo hoo! Well there’s a reason to risk your life since your machine has never been more than 0.2 off…most often less. Whoop de doo. Do you do vein comparisons EVERY TIME you use your machine? Wait…no, you don’t? WELL HOW DO YOU KNOW THEN???? UGH!
and:

I can only speak from my own experience but I've had way more accurate readings when a vein was tapped and the blood sent to the lab than trying the handheld INR machine. I assume that's the machine you're referring to? I tried the handheld INR machines and got wildly inaccurate readings when I tested along with the blood draw in the lab (i.e. INR Machine said 6.1 and the vein draw said 2.6, huge difference).
Where do you live? I'm in Washington DC and am seen/treated by the heads of hematology at two hospitals here. Is there anything I can do?

Thank you,….you ARE correct!!
Another sensible answer:

I just started warfarin a few months ago and have yet to have a match between INR machine and vein stick. They've been off as much as .5. So I tell the dr I want to continue with vein sticks. I explained that the Coagcheck machine says IN THE DIRECTIONS that it is not accurate for APS patients. The reagent used on the test strips interacts with APS antibodies and produces inaccurate results. I doubt seriously that I'll ever home test, unless the manufacturers of the machines figure out how to make them accurate. I have three kids to raise, I'm not taking any chances with my health.

I'm in Memphis TN. I haven't had too much of a problem finding good doctors who understand APS. But my first hemotologist refused to try anticoag treatment for symptoms outside of pregnancy. So I went to another one, who I just love. She's terrific. She's also a cancer doctor. I don't think there are any hemotologists here that aren't cancer doctors. My symptoms are primarily neurological, so I don't need a rhuematologist. I may eventually end up seeing a neurologist, but so far, I've been stable. I found out about my APS after three miscarriages. I got treatment and had identical twin girls in April.

I hope you get it figured out and find a good doctor. It makes a huge difference haven't doctors who understand the illness.

*eyeroll* on this next one…OFF is OFF people. How do you know what percentage it’s off…this isn’t a CONSTANT…it VARIES!!!

I have the Coaguchek XS (Roche) INR machine which I bought in 2008. For several weeks I had the chance to compare results from lab and the machine, with blood collected for both tests with no more than one hour difference.

What I can tell is that in my case, and this can be different from person to person, machine and test strips calibration, results were pretty accurate when INR ranged between 1 and 4, with less than 5% error. If INR was above 4, error was of the order of 10%, but still gave a direction that things were not right and needed adjustment. I haven't been requested to take any lab test since late March this year and am relying on my machine results only and on a balanced diet to keep the same dosage. Doctors in San Antonio, Texas, seem to rely on results from these machines too.

Another response. I don’t understand how if it is inaccurate at all how anyone can trust what the machine says! Are you doing comparisons 100% of the time? That’s the ONLY way to know if your machine is accurate…BECAUSE THEY AREN’T for patients who have APS!!!!

Hi, there is a real problem with both laboratory, clinical level machines and the home test machines. The problem is that all machines currently in use use the Prothrombin Time Test (PT) or the activated PT (aPTT), which can produce a false high reading on 20% of the patients who have active Lupus Anticoagulant test results. When these 20% have lower antibody activity levels the machines will read perfectly normally, however it is difficult to know if it is a high INR or a false high reading as the LA test is virtually never done at the same time and with the same blood draw, so the proof is very difficult to know whether the result is accurate or if the INR is high.

Laboratory tests will also rely on the PT or aPTT and will also give the same false high under the same circumstances. Patients with 'known' LA activity have to have their anticoagulation tested by a totally different method and the laboratory will have to be told that the patient has active LA for them to break away from their normal test procedure. If the laboratory is told the patient has APS, it is not enough information for them to carry out different tests, they have to be told exactly that the patient has high LA. Remember the laboratory staff are not doctors and have full training in the machines and test procedures but rely on the doctors asking for the right test, or else they just stick to the tests corresponding to the colour of the top on the blood test vial.

I do have active LA at times of a flare in my APS, and that has caused false high INR readings from my Roche Diagnostics CoaguChek machine, which agrees with every lab test I have ever had done (to within 0.04 of a variance as the home machine will round up or down to one decimal place). In these cases I am usually quite ill, so I assume the result to be high and carry out retests for a few days until I can be sure the INR is high  (and not false high) before changing my Warfarin doses. This has happened twice this year and the first time the INR corrected itself after three days and the second time (last Sunday) I had to change my dose by about 25% for a couple of days before the INR returned to normal.

I hope this helps a little in understanding how my machine can be accurate 50 times this year (out of 52 tests) and was 100% accurate for the last nine years compared to three times a year correlation laboratory tests.

And for the last one…let’s not blame the machine, let’s blame the antibodies. *smacks head* When will people learn?

I'm so sorry for everything that you are going through. I completely understand what you are saying it seems as if you can add Tennessee to your list of doctors who won't go the extra mile.

As for the the INR machines - well I had a machine some time in 2002 and it kept giving me error messages because of my antibody levels.  This past year at the Army base I was getting my blood checked there with a machine (and lab for the 1st couple of times) and it was pretty much on point.  They might have worked out most of the kinks with the new models.  My doctors keep my INR between 3 and 4 so if a tech doesn't know that they might think it to be an error.  Personally I have really small, hard to find veins so the machine was a relief for me.

All quotes taken from APLSUK & APS-SYNDROME…both yahoo groups. Happy reading!