Great news for hypochondriacs: you no longer have to go to the ER or see a doctor to find out if you are having a heart attack– at least if you live in Europe. Now you can do it from the comfort of your own home. A Chinese company announced that its consumer test for MI had received CE certification in Europe. Here is a summary of the product from Medagadget:
The AMI diagnostic kit can be used by consumers for the early diagnosis of myocardial infarction. It requires the user to place a blood sample on a marker after which a plus or minus sign will appear, indicating whether the user should seek medical attention. It is based on an assay of heart-type fatty acid binding protein (hFABP), which peaks as early as one hour after myocardial damage occurs, much earlier than the clinically used markers troponin and CKMB. The kit has already been on the market in China since 2007.
The Mayo’s Allan Jaffe provided the following comment to CardioBrief:
The self testing kit for hFABP (heart fatty acid binding protein) probes a non cardiac specific marker that is elevated fairly early after AMI. It is hard to tell its sensitivity compared to the standard laboratory assay which is quite sensitive. In general so called point of care (POC) assays are less sensitive. It is particularly likely to be elevated in larger AMIs such as ST elevation AMI (STEMI) very early. However, we would prefer to have patients with symptoms respond immediately to an emergency room rather than delay for any testing. In addition, since this test is not specific for cardiac damage, unless used in patients likely to have an AMI, it is likely to cause a large number of unnecessary presentations of individuals who are worried and who have non cardiac problems.
Cardiobrief; March 26, 2010
Commentary
I will be very interested to see how this works out — how much people use the test, how many false visits to the emergency room, how many correct visits to the emergency room. Personally, I would like to have the option of taking a test immediately at home if I was not sure whether it was a heart attack or not… Once one has a had a heart attack, the fear is always there, with any kind of chest pain…
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{ 2 comments… read them below or add one }
I think this AMI test kit news is frightening. First of all, it’s made in China, home of melamine-laced baby formula and 45,000 toxic children’s toys. China has a confirmed reputation for adulterated drugs and low quality products, some of which have proven to be lethal. If they can’t get plastic toys right, why would we trust our hearts to their iffy quality control standards?
Outsourcing to China is also part of a disturbing Big Pharma trend. Any of us who take cardiac meds every day should be truly alarmed. Drug companies with massive Western operations are shutting them down and moving them to China to reduce costs. The question is: “How will government regulators monitor drug safety if all the factories are in China?”
As industry journal BNET warned last year, the FDA had only 12 inspectors in all of China, who were able to visit just 80 of 714 drug establishments in China over the previous two years. More on this at: “Do You Want To Take Medications Made in China?”
http://ethicalnag.org/2009/12/04/china/
But the real concern I have over this home-based, do-it-yourself heart attack checklist is that it completely bypasses the ONLY THING we should be doing if we suspect heart attack symptoms: CALL 911! No fussing over producing a blood sample, figuring out the correct procedure and assessing results in the middle of a heart attack!
Cheers,
Carolyn
Carolyn:
Thanks for the articulate and informative response.
Big Pharma obviously has enough problems in credibility without outsourcing medication manufacture to China. Didn’t know this was happening, though makes sense that it would given the focus on the bottom line.
I hope to find the research, but I suspect that more than 50% of folks who should be calling 911 with heart attack symptoms are waiting too long or not calling at all. I do know that women are more likely to ignore symptoms than men. If this test or a similar one (assuming quality manufacturing and reliability) increased the likelihood of calling 911, or calling 911 more quickly, then it might turn out to be a good thing.
(To repeat my story for other readers (www.heartak.com), it took me about 45 minutes to take action after experiencing the first symptoms — pain in my chest, which I thought was indigestion/heartburn. When I started having trouble breathing and was bending over in pain, I knew was seriously wrong. I had my wife drive me to the hospital, since the nearest ambulance was about seven – ten minutes away, and the hospital was a fifteen. This was a mistake, since they could have dealt with the symptoms, performed an EKG before getting to the hospital, and sped up the process of diagnosis and treatment. We also lost some time trying to get the dogs back in the house at -20 degrees.
Again, the message if you have anything like heart attack symptoms — don’t wait, don’t drive, call 911.
Steve