Do any of the USA members have any information on if or when self testing will be approved in the USA?
With parallel testing (at least at first) and education, I believe we can be healthier if we can self test and regulate.
I know there is much controversy over this, but my old coumadin clinic uses a finger prick machine. Since moving I go to a lab now and have it drawn from my vein now. The clinic is confident the results were accurate.
What are your thoughts and comments about this?
One other question I have is... articles about self testing state the APS antibodies are believed to cause the inaccuracy of the machines. Plaquenil usually removes these antibodies. So question is, why wouldn't the plaquenil make it a more accurate reading.
Many of our members self test safely and have a great partnership with their local hospital and GP doing this. However I can't speak for USA as we are a UK charity and forum, best wishes to you. MaryF
I'm finding out it's not approved or at least not recommended here in the USA.
Some of what I'm reading states the antibodies are the reason the machines give bad results. I'm on plaquenil, which is said to remove the antibodies, so as you can see why I'm a bit confused. I do have positive test results for the lupus anti-coagulant which I'm reading especially causes bad results.
So frustrating...
Yvonne
Hello Yvonne
I agree with what my colleague, Mary, has advised you.
Yes it is frustrating. When I was on Warfarin, now on Fragmin, I used to self test and self manage and only had problems with inaccurate readings for three months post heart surgery, which no one, not even the meter manufacturers, could explain; clearly whatever the do you one's blood - in the mechanical pump used when they stop your heart - in the OR must affect it is some way.
Just a small point of 'housekeeping' protocol. Could I ask you to please change your avatar to something that does not represent an organisation.
Very best wishes.
Dave
I've posed the question to one of my doctors, but they only say that it's not approved, but don't actually answer the questions. I supposed it isn't ethical for them to do so. I just want to be fully informed of all that I can about my disease, treatment, etc. Even if they are not approved. If it's something I as an APS sufferer should fight for if it's the right thing to do.
I live in N.H. USA-
I was going to a coumadin clinic and they used the finger prick machine .
I can't use it because i am L.A. positive and even the manufacturers won't stand behind their machines because of the L.A. status.
I have tested positive for the LA antibodies too. I get vein draws since moving to a new town and have to go to hospital lab. My old coumadin clinic used a prick machine. When I questioned the accuracy for APS patients, I was told it was accurate. To me that begs the question, how the clinic can use it to regulate, but I cannot? it's all confusing and frustrating.
You are so right. I have never thought of that. Here they always now take vein draws. Of course they were not accurate.
Did you notice if you got lower INR with the vein draws? It differ from 0.7 up to 1.0 in INR for me.
Kerstin
I can tell you that I have all the antibodies for APS and in high titres also. Have that since 2002.
I have been tested twice a year for The Cardiolipin antibodies and also for Beta2 Glycoprotein1. After I had started warfarin in 2011 they do not test me for Lupus Anticoagulant as it can be a misnormer.
I selftest but there is a discrepant between the labtest value (in vein always) and my machine. It has been the same difference all the time. It takes at least 2 hours after my machine test till I can test at the hospital in the vein.
They say Lupus Anticoagulant fluctuate over time. I know they are afraid of the discrepant with LA. We have tested very often in the beginning (the difference between the two) but now I only test every 3 month. It is about the same difference every time. If the INR is very high the difference is bigger and that can go up to around 1.0. If the INR is low it may be 0.7 or even less.
We are all individuals. I do not know if you have got LA. If not, it must be easier for you to have a machine. They are very reliable. I have Coagu Chek XS.
Hope I have helped you a little. I guess I have no alternative. I stick to my machine and with success also.
Kerstin in Stockholm
When you say LA and mean lupus anticoagulant, I do have positive tests for that particular particular antibody as well as the other two they look for in APS. I'm hearing LA in particular will throw off the machine. In the US you can get the machine, but health insurance won't cover it. I could probably get it my self out of my own pocket, but I'd need a prescription form the test scripts and not likely to get that from my docs.
Hi Kerstin: I haven't been on here for awhile. I have APS and after my stroke in 2014 was told I have the Lupus factor?anticoagulant, however, my rheumatologist who tests me every 4 months since the I would no longer have the lupus anticoagulant/factor show up anymore since I'm on coumadin. Have you experienced that. Thanks.
Hi Loretta!
How nice to hear from you! I was diagnosed APS with 3 positive antibodies (included Lupus Anticoagulant, LA) with very high titres, in 2002. Ever since that date I have tested positive for all three antibodies.But ......
when I started Warfarin in 2011 they did the LA-test probably for the last time. I have heard that the LA testing is unreliable when on Warfarin. My Hematologist has also told me so. As they have not done the tests which are said to be unreliable I do not know how the result should be if they tested me. The other two still positive in high titres like before. I selftest with good result and always the same difference between the lab vein test and the machine finger prick test. Just a slight difference of the INR (0,2 - 0,2 which is quite ok according to my Hematologist and Roche.
Could that be the answer you asked for? Hope so.
Hope you are well!
Kerstin
Definitely. I think that's why she's not testing me for lupus anymore because of the warfarin. She is rather relying on the fact that I have 2 out of 3 indicators of lupus--arthritis and APS, and says that any other organ involvement would be a positive Lupus diagnosis. I have a regurgitive aortic valve but somehow she doesn't count that. I'm doing well and hope you are also. Good to hear from you too.
Suddenly it strikes me; could it be the "Lupus" (the illness SLE) they mean and not LA which is an antibody?
Do you selftest nowadays?
Kerstin
At the time of me and the Coumadin Clinic i was scheduled for my first surgery on hip for AVN. The woman at the clinic told me { everything ok . i treat ALL kinds of APS patients **&^^(*^^%$%**% YA RIGHT } she knew nothing and when i proved it to her she said {{ O I KNEW THAT } GRRRRRR
anyways the spread on the INR #"S were so far off and we couldn't have that as i needed to be 1.0 and then start bridging process pre- op and post .
My INR"S are and have always been a roller coaster since 2009.
I battle it every 3 days - warfarin has the 3 day half life BUT i go so far out of range high and low that they have to keep monitoring me because of these extreme's
We two understand eachother dont we?!
We both have 3 or 4 antibodies and also in high titres but I do not have Diabetes (my eldest daughter has type 1 Diabetes). We are in fact very rare. I guess your doctors know it now.
I know you will never give up on yourself. You have helped me with so much info about APS.
Kerstin
BIG HUGS---You are the only other i have ever met that has what we have .like i said if you don't hear from me after appt. at wound center today --you kick my BUTT and have me get back to you with what i find out with this foot
Casey sends his love with a tail wag and me BIG HUGS : -)
My INR has been in between 1.1 and 4.5 since being diagnosed with APS and on warfarin, with vein draws since November 2014. The last two test are in target range. I'm hoping I am finally on my "normal" dose or blood thinner. I have not had the same result more than twice in a row in my target range. I'm still learning not only about the disease, but how to live with it.
Diet -exercise- even stress -all can play a major roll i can go from a 2.4 on Monday to a 9.1 on Thursday. Then plummet to a 1.3 buy the following Monday again . my diet is set my exercise routine can differ with foot trouble and even a bad day with migraines and muscle spasms. but being hyperactive and stress with all my problems health wise is my concerns relating to the INR bounce and as i have said this has been going on since 2009 and 2 major operations as well as dental work also .i have 29 dia. medical problems to deal with . so it can get quite intense at times to say the least if they all start acting up at once or even just half of them . but we have to keep on getting on ..
you are on a site that is just fantastic , ask questions , read the material and many here can help you from there -- i don't know where i would be with out them here {six feet under most likely }..----- best of luck to you C & J
Hi I'm in New York City and have been on Warfarin a little over a year. I looked into self-testing and it appears that we would have to pay for it ourselves--not covered by insurance. Fortunately, I live near a great hospital 1 mile away and can actually walk there where I get my testing done and I have a great doctor that follows my numbers carefully and monitors my meds.
I was considering paying for it myself if I am confident it will give me fairly accurate results. I do test positive for the LA antibody, which will throw off the machine. Can you get the test strips without Rx? I just found out my Coumadin clinic does not accept APS patients anymore. They have them test through hospital or other labs, then call them on the phone.
By any chance is it Hospital for special surgery! I'm a Long Island New Yorker? I went to Dr. DORUK ERKAN a Rheumotologist and APS Specialist PLUS HAS WHOLE TEAM OF APS DOCS! Very knowledgeable and nice too also does lots of research for APS!
When I said they don't accept APS patients, it's because they only test for INR via finger prick machine and it usually give results higher than a lab would, especially if you are LA positive. I get tested at a small local hospital near me associated with my coumadin clinic and my results are phoned to me. I wish I had access to APS specialists. My docs are knowledgeable enough to treat me, but I have a rarer form of it, that it's only in my brain. Sometimes I have specific questions and or want to have discussions and can't. The doc I see regularly is a stroke and seizure neurologist along with my rheumatologist.
Hi I am being treated at Presbyterian Hospital. They're good but HSS I understand has the best APS knowledge and doctors. We should share numbers My home number is 212-. I'm in Manhattan but my daughter lives in LI.
****Edited by Admin****
Please do not post personal information for your own safety
Wow, I think that they no longer accept APS patients because it's so rare and needs specialized attention which is wise. I hope you have a good university hospital near you and please search for good doctors familiar with APS. It's hard but can be done. My previous doctor didn't have a clue about anything APS. Good luck to you.
They are still monitoring APS patients. Just not doing the blood tests in their office. They send us to a lab or hospital for vein draws and call us with the results and dose change if necessary.
There were some articles years ago about one brand of the machines being inaccurate, especially if you are positive for the lupus anticoagulant. The manufacturer states that the problem is resolved. If you want to see if the machine works for you, you can try using it and getting draws on the same day to see if they match. The manufacturers do say that the machines may sometimes need to be calibrated for aps and a representative will help you with this. Its always possible to get a draw and compare it with your machine, and see if it is still accurate.
The machines are approved in US, but you have 2 hurdles. The first is finding a dr who will let you have it. Drs are very reluctant to do this, I think they are bothered by the loss of control, and many US drs do not like patients who want to be involved in managing their own disease. Also they may think about it as a liability issue. But there are drs out there, if yours is opposed you can find a new one. I would start by telling your dr about all of your friends on this website who are using them. Many people in UK are successfully using them.
Your second hurdle is getting insurance companies to pay for it. A dr who is willing to let you have it will hopefully know how to manipulate the paperwork so that the insurance will pay. If you can put down that you travel, or that you live far away from the lab, this might help. Also the manufacturers will help you with getting the machine approved by the insurance. If the insurance wont pay the machines are expensive. I looked into this around 4 years ago and found that the cost was around $2500. They were much cheaper in the UK at that time, and maybe still are.
I'm on lovenox now so I never did get a machine. But I did find that you can do it in the US, with some effort. Good luck.
The Roche brand machine is on Amazon for apex $800. But I think that is the one that states not accurate with the LA antibody. I have docs that would probably help me, but would have to "fudge" the Dx code for the insurance to pay and I wouldn't ask them to do that. What is the brand you are referring to?
its great to know the prices have come down, but your insurance should pay anyway. I didn't mean that your dr should lie for you, but as you know the insurance people are always looking for ways to deny your claim, and your doctor's staff know how to carefully word a request that would prevent you from being rejected.
So here is what I did 4 years ago- I accessed 3 websites: coagucheckpatientservices.com, coagusense.com, and ptinr.com. These are 3 companies that sell the machines. On these websites you will find a customer service phone number. If you choose to purchase from them, they will help your dr's staff with the paperwork, they will calibrate it for you, and they will send someone to train you on how to use the machine. One of these people, I don't remember which, told me that the lupus anticoagulant issue was resolved, and is now just a matter of calibrating the machine. Of course you should still ask them about this, I was wondering if it has to be recalibrated if your level of LA changes. I did not purchase a machine, I use lovenox now. But I felt like all of these people were helpful and professional and eager to make it work for me.
Thanks for the info. Even if I have to pay for this machine myself it would be worth it for a couple of reasons. It would allow for long term travel and if accurate enough, it would allow me to be better regulated. My neurologist says, my INR not being high enough and/or regulated is the likely cause of the lesions on my brain.
That was unusual said by a Neurologist. They usually do not "get" that we have too thick blood.
Yes, first of all try to have your INR high enough and stable. It will be much easier with your ówn machine and then do it at least twice a week. Then you will learn.
My neurologist is the one who first suspected I had APS and had tests run to confirm. She usually only treats MS patients, but since I have "APS of the Brain" and it's attacking my central nervous system, she agreed to keep me as a patient.
I'm still very much in the learning process of all this. It's very slow going, especially since I'm being told that the way it's affecting me is rarer than APS itself.
I am so glad I found this forum. It's members are much more active and helpful than the others I've been on.
Good that she understands APS obviously!!.
We have one top-neurologist here in Stockholm who also understands APS. In 2002 he suspected I had MS but then he say all my positive antibodies in high titres and he said that I was very "rare" on this. At present I have an Reumatologist and a Hematologist and a Cardiologist (the last one when necessary).
The other Neurologists did not understand this "sticky blood".
It is good if we are able to help others who are "new" so they must not get a lot of unnecessary clots or dvt or tias.
I also have Pulmonary Hypertension and leaking heartvalves and that is of course serious but it is steady now since I keep my warfarin on a steady level. My high bloodpressure is now also ok with bloodpressuredrugs and warfarin.
Hope you have read "Sticky Blood Explained" by Kay Thackray.
Best to you from Kerstin
Good morning to all,
I was following this session and realized that you are in the US
I too am in the US, Oregon and I have a self test machine
It took a year and some months to obtain one, yet I am four months now with the machine and absolutely am an advocate for the use of it for home monitoring.
OHSU in Oregon issued me the monitor and my insurance is Aetna and they covered it. I pay 13.00 monthly for the machine and paid 170.00 for the first initial start up of the machine. The machine is through Alere management. The system set up and support is quiet efficient and it has been such a blessing as I test every four days and have been very consistent with my INR level which keeps me gauged in better health. I know how to eat to keep my blood levels where they need to be. I level consistently now between 3.5 and 4 INR.
Hope this helps.
Becca
Do you test positive for the LA antibodies (I have)? They are known to throw off the machines. Did you parallel test to insure the machine was consistent? I would very much like to self test in order to keep more consistency with my INR. My current range is 3 - 3.5. I would also like to get to a point where I don't have to lab test but every 6 weeks to 2 months so that we can travel for long periods of time.
Thanks so much form the info. I may come back to you for more info as to how you were able to obtain it and have your insurance pay for it. I'm told the code for APS Dx isn't the one so that the insurance would pay. I can afford to pay for the machine out right, but do you need an Rx for the test strips? I just need confidence the machine will be accurate with having the LA antibodies.
I have Lupus Non specific with the APLS
The machine is consistent by what I know of, we had a wonderful wonderful RN that now only travels to set up this machine, I believe I am one of 5 people in the NW area that has one. I'm not sure why you are only getting tested every six weeks to two months? I am not a medical provider yet I have had personal experience that this is too long of a time in between INR checks as the INR level is key absolutely KEY for remaining consistent in the ranges where you feel best.
My provider here where I live did not and still does not know much at all of the disease and they used to insist that I stay at a 2.3 level and I spent two years feeling horrible, constantly. Now that my INR level remains in the 3.5 to 4.0 level consistently I have found a much better health ride, so to speak.
Diet and FLUID are KEY KEY KEY. Please do not even hesitate to hydrate constantly it is vital for my feeling better on a daily basis as well as mobility.
Hope and pray you are finding answers. This forum has helped my life Significantly as many in the US do not understand or treat us with this disease correctly. They care, yet they simply do not have understanding and navigating through this disease is a life saver if you are wearing the right "life jacket" 
Testing via lab every 6 weeks or so is my goal after hoping acquiring the machine. I am currently testing every week or other week depending on the consistency of the results.
This forum has many more active members who help out a lot. The other forum I'm on goes weeks and weeks if they even answer my questions. And then only "New" posts when a new person joins.
What is the brand name of the machine?
Have you tested for the lupus anticoagulant antibody? I don't have lupus, but do have the lupus anticoagulant antibody. I have primary APS.
the machine is through Alere Home Monitoring, your doctor has to prescribe it. I worked and worked to get the prescription. The prescription MUST read home monitor INR machine, they had to redo the specifics on the prescription 5 times. It was months until it was even approved through Alere before they issued it and there was a waiting time before they could send the RN that specializes in the operation of the sensitive machine along with the teaching of how I need to monitor, nutrition etc. It was a 4 hour session one on one with my family supports also learning how to monitor me and the machine. The machine itself is called CoaguCheck that is how it is spelled. I have to call in or log into the computer for my INR levels and if the INR's are at a not so good rate or if I miss the time to self test they call me immediately and counsel me over the phone and Alere themselves report to OHSU in Portland with my specialist there. I will double check with the lupus anticoagulant antibody, I get confused about the lupus involvement, as I do NOT have Lupus, I have the non specific title...it may be the same as what you described, I simply do not remember. I have been a pin cushion for so long and have had two surgeries this year so it's been quite a ride and so many tests...
Thanks for the info. I've already contacted Alere to get started. I'll ask them about the LA antibody and how they would recommend I go forward and if there is a facility near me. I know this will be a long road, but willing to travel to get more control and be healthier with this disease.
When I read what others go through with it , I feel blessed as I feel I don't have it so bad. Most of my symptoms are neurological and it has cost me my employment and being home all the time has been and still is quite an adjustment. Your mental affects are a lot like mine.
Do you take plaquenil ?
I do not take Plaguenil, I requested it and got a prescription at OHSU and now they wont let me have the prescription due to my eye health. I have lost sight temporarily on two occasions and am on my third new eye glass prescription in the last few years. Plaquenil can cause damage to the eyes is my understanding.
The RN had to travel a distance to come to me, this is partly why it took so long to get the machine once it was prescribed.
Plaquenil can build up a toxicity in your body that can cause eye problems. I had to get the OK to take it from my eye doc. Studies show that at a low enough dose it shouldn't negatively affect my eyes and the benefits out way the risks. Are you parallel testing with the machine? and how do the results compare?
I only go to the clinic about once or twice a year now unless I need immediate care for the lung support when I catch virus. However I have found that the machine is quite accurate. I'm satisfied with the level's from when I first started to now, I do trust it pertaining to my personal INR.
I also agree that Warfarin is the best drug, it's been around for many, many years and has been tested for many, many years. If you are stable in your eating and fluid and health Warfarin is a life saver, literally. I trust the history that is has, some of the newer thinners simply are not recommended for those of us with APS. It hinders not helps. I only wish I could find something beside plaquenil for the joint support, as the joints seize up constantly no matter what I do or where I sit with INR. The higher the INR though, the better my joints are, yet it never goes away.
I would love to know how or why it is that you are able to get accurate results with your machine. There is so much out there on both sides of the self testing issue. Most I come across is strongly against it. Mostly die to the lupus anticoagulant antibody, but also the APS antibody as well. Plaquenil removes antibodies from your system but not enough to make the machine accurate. Even the manufacturers claim their machines don't work well with APS patients. My goal is to be able to self test, even if I have to purchase the machine myself. However I do not want to waste the money or put my health in danger with inaccuracy.
Thanks Becca,
I'm so glad to have found y'all on this forum.
Hi Becca, I have followed your conversation just now with mylafont with intererest.
I have NOT lupus but Lupus Anticoagulant which is an antibody tested when you have APS as I have.
If you have Lupus Anticoagulant there can be a discrepence between the tested vein draw at the lab and with your own CoaguChek XS machine (this is the machine I use).
I have had that "discrepence" tested over 2 years now.
We have from the beginning tested every week my value with the machine and the vein value via the lab. The Hospital knows the two values all the time. I must say that I have had a fantastic support from the persons involved in my APS.
I now know that the difference between the values are "around" an INR of 0,7. If I have a higer value at home the difference (discrepence) is bigger. Ex.: 4.1 (home) - 3.4 (lab), 5.5 (home) - 4.2(lab), 4.4 (home) - 3.6 (lab), 4.8 (home) - 3.7(lab). These values are taken from my notes. The real difference is then around an INR of 0,3 where you are uncertain how your INR actually is.
I can live with that. Without this machine I could not be on warfarin which I think is the best drug for us today if we manage to keep it in the right level! Soon I think they will have better drugs for us that need an INR over 3.5. It is said that I am primary APS and perhaps I am but during time more symptoms may develope. It is a strange illness.
This has to do with me and we are all different.
I am so glad that you feel alright with your CoaguChek machine! I trust mine also.
Kerstin
Is that .8 low or higher?
I have Lupus Anticoagulant.
My machine INR-value lies around 0,8 higher than with the vein-test at the lab. Always higher.
Kerstin
I live in the US , New Jersey, and have been self-testing since Nov. 2014--I am unaware of any regulations for this. Your doctor just has to approve and clear it with your insurance company--I test once a week via finger prick, call in the results to the company who supplied the machine, they in turn fax my doctor, and some time during the day a nurse practitioner in his office calls me to go over it with me and see if I need a change in diet or warfarin. It works well. Speak to your doctor about doing this. When I got the machine, the company sent someone to my house to train me how to use it.
Mozelle
I'm still researching it. Are you lupus anticoagulant positive? Research is showing that antibody is known to throw off the results of the machine. I'd plan to parallel test to see if the differences are consistent.
Hi mylafont
No, I'm not lupus anticoagulant positive. I have Factor V Leiden and also APS. Diagnosed beginning of 2014--but lifetime symptoms without knowing why. Also had DVT in leg several times through the last few years. I was travelling 30 miles round trip weekly to the doctor to test my INR for 9 months, then asked him if I could self test.
He approved--filled out the paperwork, submitted to my insurance company, they okayed it and now I'm doing it myself. It is so much easier--please look into it. You get a better handle on managing--with my doctor, if I am in range--they don't call me. Only when out of range do they call and discuss it with me. But if I see my number is a little high, I enjoy plenty of greens for the week--if on the low (but within range) side, I skip most greens until my next test.
That's my goal. I feel if i can get to that point id be better off. I think it's going to be a hurdle to get it approved to test against lab test until we are comfortable with the ranges between lab and machine are consistent enough. Thanks for your reply.
Lupus Anticoagulant is one of the 3 main antibodies tested for APS, it is not the other autoimmun illness called Lupus.
If you are Lupus Anticoagulant you may have a too high INR when doing the finger prick test. Did you do the LA-test before you started warfarin because after warfarin it can be a misnormer. They do not test Lupus Anticoagulant anymore on me after I have started warfarin. (I have all the antibodies for APS.)
I say this so it will not be a misunderstanding. It is very important. Hope you understand my Swedish point of view.
Kerstin in Stockholm
All antibody tests were done before warfarin. I'm not due those tests again until August. Thanks so much for the info. I have learned so much from you and other members since joining this forum.
The last post was meant for Mozelle as I thought that perhaps she had mixed the LA with Lupus.
I know you know that difference. But i am not sure everone with LA have a difference or such a big difference. I think I have talked with a man here who was LA and there were no difference between the vein test INR-number and the machine INR-number. It is not very common to have APS and be LA and selftest. So there are not so many people to ask about it.
You are always welcome. Good luck and take care.
Kerstin
Maybe with me have a different version of this disease, I may be one of those that can self test. I'm going to pursue this as far as I can take it.
Self testing for your inr level is allowed in the USA. My insurance company paid for my son's monitor. He had to be on warfarin for 3 months and then the doctor recommended self testing for him.
That's good to hear. I have a feeling I may have issues with my insurance co. They've already told me that the diagnosis code for APS doesn't approve the machine. I will work with my docs once I'm confident the numbers between machine and lab are consistent
Self testing
INR Self testing for triple + patients
