InRatio - status update?

[Protimenow]

I first reported, on this forum, about the recall of InRatio strips. The 'new style' strips apparently had some serious issues, resulting in a few reported deaths.
Before learning of the recall, I had personally decided NOT to use the InRatio because, for my own testing, it reported results that were sometimes MUCH higher than blood draws or my other meters.

I stopped looking on eBay for more information -- sales of meters, sales of strips - relating to InRatio because, frankly, I didn't care. I had a year's supply of strips that I let expire because I no longer trusted the meter.

It looks as if the strips are now in short supply. I've seen packages of 12 strips for more than $200. If any of you are still using an InRatio, I'd be interested in whether or not you're using the old style strips (which are probably close to expiring), or using the new ones (and, if so, how much are you paying for them?).

From your personal perspectives, what's the status of InRatio meters and supplies?

Thanks

 

[dick0236]

From your personal perspectives, what's the status of InRatio meters and supplies?

Thanks

I used up my remaining strips and "mothballed" my INRatio2. Have been using a CoaguchekXS, thru a self-testing monitoring company for about 2 months.....very satisfied. Cost is about $6/test and the meter seems to read my INR in a much tighter range than the INRatio2.

 

[newmitral]

I noted in this older thread here:

http://www.valvereplacement.org/foru...call-important

that I believe Alere had (and possibly still has) some serious quality control/assurance procedure issues mainly because they were unable to trace the defective test strips to specific manufacturing lots. As a result they had to recall all of the new design strips, and I'm sure the FDA came down hard on them. That's probably also why the distribution chain is limited for now, and will not likely loosen up till they have shown they have made improvements. The FDA has different labeling rules for items sold to end consumers versus medical professionals specifically to address such recall situations, and I suspect the Alere Inratio2 strips are not marked in accordance with FDA direct consumer sales regulations - hence their current policy to restrict sales to only medical professionals for the moment. I'm by no means an expert on this, and this is just my opinion after having done a small amount of research on the situation, so take this with a grain of salt.

Having anticipated the limited future availability of Inratio2 test strips, I ordered a batch of old design test strips early on, and did enough comparison tests with my specific batch of new-design test strips to prove to my satisfaction that my specific batch of new test strips was fine. In addition, I purchased a used Coaguchek-XS machine and test strips for that meter so I could ride out any test strip shortage problems without worry.

The Coaguchek-XS and Inratio2 meters both give essentially the same results whenever I have done side-by-side testing. Results for myself have always been with +/- 0.2 in INR, and usually within +/-0.1 which is excellent agreement. Another forum member, Aggie85, came by to use my meters to help investigate her INR test discrepancies, and the 2 meters agreed to within 0.1 in INR for her as well. This is to be expected since the two meters use essentially the same test technique.

From your personal perspectives, what's the status of InRatio meters and supplies?

I believe the availability of Inratio2 test strips will improve in time once they get past their current problem and likely FDA scrutiny. On the other hand, I foresee a long term problem of availability of home-test INR supplies from ALL manufacturers for an entirely different reason. With the drug manufacturing industry pushing doctors to switch their ACT patients to the new drugs that don't require INR testing, the market for the INR testing supplies will shrink accordingly. Thus, prices for the supplies will increase because they will become more of a "specialty" item. Some meter manufacturers may leave the market altogether if the number of home-testers (and clinic testers) drops below the number where it remains profitable to continue. Frankly, I see this as a bigger long-term availability issue which will effect all point-of-care/home INR testing in the long run.

 

[dick0236]

........ I foresee a long term problem of availability of home-test INR supplies from ALL manufacturers for an entirely different reason. With the drug manufacturing industry pushing doctors to switch their ACT patients to the new drugs that don't require INR testing, the market for the INR testing supplies will shrink accordingly. Thus, prices for the supplies will increase because they will become more of a "specialty" item. Some meter manufacturers may leave the market altogether if the number of home-testers (and clinic testers) drops below the number where it remains profitable to continue. Frankly, I see this as a bigger long-term availability issue which will effect all point-of-care/home INR testing in the long run.

I agree with this assessment since the vast majority of ACT patients requiring INR testing currently are non-valve patients and as that market shrinks, so will the manufacturers that supply the INR market.

 

[Protimenow]

I spoke to an executive at one of the meter manufacturers a few years ago, and he mentioned the research that was being done to find an anticoagulant that was reliable and that wouldn't require testing. He seemed to think that it was a few years down the road. He seemed to be just slightly concerned that the need for testing may be reduced once such a drug/drugs becomes available.

So far, no truly safe drug has been developed -- and none for mechanical valves. The current drugs are irreversible and expensive.

When/if such a drug becomes available for valvers, in addition to people with A-Fib, it will probably cost $2500 or more per year, if experience with some of the current medications are any indicator. The patent protection for these drugs will allow the drug manufacturers to charge many dollars per day. So, even a PERFECT drug will be extremely expensive when compared to warfarin, which costs a dime or so each day.

With decades of experience prescribing and managing anticoagulation using warfarin, and relatively inexpensive testing and tools for management, it may be somewhat difficult to make the case against warfarin.

It may be a long time, too, before mechanical valves or other implantables that can last for decades and not require anticoagulants can be developed, and may be 50 or more years until all of the current valvers, still relying on anticoagulation, will finally drop out of the population requiring anticoagulant therapy.

I suspect that the need for warfarin will continue for a LONG time -- and that there will probably be a large enough market for one or two manufacturers to do well selling supplies and meters.