[Litlbits]

There is a device called Filmarray that can detect and confirm Ebola in about an hour. Texas Health Presbyterian has had the device for 2 years as do many other hospitals in the US. FDA only allows its use for research, not diagnosing actual patients. Hospitals can request special permission to use it for Ebola testing but The FDA's review and decision on the request takes 20 days or so. There are different panels used in the device depending on what disease, virus you are looking for, the FDA has to approve first and again, only for research purposes.

Had Texas Health Presbyterian been able to use the device, Thomas Duncan, Nina Pham and Amy Vinson would have been diagnosed the same day they showed up with symptoms. Since they were not, testing was done by CDC which takes 2 days or more. In the meantime, many healthcare workers were exposed without knowing that is what they were dealing with.

This is appalling!!! We have the means to get a quick diagnosis and the government won't allow its use????? There are several articles on the web about this but it hasn't gotten a lot of attention. I can't link from IPad or I would link the sites here. BUT just type in Filmarray Ebola and you can read for yourself. Two sites: washingtontimes.com and dailymail uk.com.

 

[chickenista]

Not exactly.
The device 'could' detect it if they were calibrated to do so.
Since they haven't been, it can't be assumed to actually be correct in it's results.
The FDA and the company that makes it are working to get it up to speed so that it can be used.

Sure wouldn't want a lot of false negatives roaming around.

 

[Litlbits]

Bio fire, the company that makes the device states on their website that the machine is easy to use, takes 2 minutes and gives highly accurate results. They have numerous panel kits depending on what you are testing for such as respitory or gastrointestinal or bio threat. There is no mention of calibration.

The point of my original post was that the FDA is dragging their feet on giving approval for use in diagnosing patients with possible Ebola. This is unacceptable. The quicker we can diagnose these people the quicker they can be placed in isolation and treatment started and I think that is the key to saving lives. Healthcare workers would also benefit in knowing quickly as to how to handle the patient and properly protect themselves. Contact tracing would benefit because you are not waiting two days or more for results and then scramble to find everyone.

And even if the device needs to be calibrated why in the world would we not do that asap so that it is good to go and have the bio threat panels on hand as well. I have read that the device is already in use in West Africa by the medical teams there. So the FDA is creating the problem and it needs to be corrected now!

 

[DEKE01]

The FDA is responsible for the deaths of millions of people over the last few decades. But hey, they are from the gov't and they are here to help. :runforhills:

 

[Ozarks Tom]

The bureaucrats at the FDA have power. Exercising that power is nearly orgasmic to the type person who seeks out those jobs. For them, being in control is much more important than just saving lives.

 

[mekasmom]

Maybe they are afraid it would cause a panic because it has spread further than they are admitting??????

 

[happycat47111]

Maybe they are afraid it would cause a panic because it has spread further than they are admitting??????

I kind of doubt it. I think it's more along the lines of the powers that be at the FDA don't hold enough monetary interest in the device to let it be used. Every single thing the FDA does comes down to money. Everything. You grease the right palms, you can get anything past them until there's a large enough outcry that they can't ignore it. But that could be my cynicism talking.

 

[Litlbits]

The FDA gave emergency approval to use the devise to test a 5 year old boy in NY a couple of days ago. However, the health regulators in NY stopped it from being used because THEY wanted to make sure it gives accurate results. So the boy was tested by sending the blood to the CDC instead which then took 12 hours to give results.Thank goodness he tested negative.

Since time is of the essence in order to start treatment and give the patient the very best opportunity to survive, having results in 1 hour instead of 12 or more could make a major difference. They (CDC, WHO and NIH) are still trying to determine why some people survive and others don't but they have already concluded that the earlier treatment begins the better the odds of survival. Obviously there are other factors too but they are really focusing on beginning treatment immediately.