Getting blood from someone's finger will lead to incorrect results in many tests because other things diffuse into the blood. The things can lead to very inaccurate results. This is a BIG problem for Theranos.
Theranos Has Struggled with Blood Tests
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Re: Theranos Has Struggled with Blood Tests
#82https://twitter.com/MadMoneyOnCNBC/status/654674975798919168
Re: Theranos Has Struggled with Blood Tests
#83You can resell a test so long as you follow the rules of the contract of the manufacturer and applicable CLIA and other FDA regulations. These are subject to audit etc... You should not report clinical results from tests not run in a CLIA or FDA approved way. So if a test is run on Siemens for reporting clinical results then the audit goes on that pathway. Diluting the pinprick blood to run on a test that requires larger volumes probably won't work either unless they've shown it does and that of course depends on the CLIA and/or FDA regulations around the test to prove equivalence. It seems like it won't work since the tests have specific input requirements (e.g. 100mL plasma vs 1mL). You might be able to go the other way.. but you miss the cellular and interstitial components that may add noise (e.g. potassium which cells bioaccumulate etc)..
Which other rules apply probably depends on interpretation of whether these are lab developed tests or FDA regulated and this area may require clarification etc... which will depend test to test etc...
Otherwise it sounds like they may have calibration issues which are normal. Outliers happen all the time. If the technology doesn't have some fundamental limit of detection based on the sample volume then they just need to keep iterating. Or the components of blood from the pin prick differ significantly from blood taken from the vein. The data may just be noisy. What that noise level is matters in terms of the detection limits. It is probably too early to tell. Internally they will be tracking this and trying to figure it out.
So this article seems like click bait, but what do I know.
Re: Theranos Has Struggled with Blood Tests
#84>>Theranos claims that the usual delay of testing in centralized laboratories is approximately 3 days and that they will generate and deliver their data much faster (e.g., within 4 h). The 3-day delay claim is not accurate. The bulk of laboratory testing in centralized laboratories is completed within an hour or two (calculated from time of sample collection to time of results posting for physician review). For examp…
The more I read about this company, Theranos, the more I get this feeling that one day I'll be reading an article in the WSJ or NYT titled "The Greatest Diagnostics Company That Never Was", or something along that line.
Re: Theranos Has Struggled with Blood Tests
#85Sounds like the accuracy testing should be blind but isn't. Why not? It seems like disclosing that a sample is a test is more likely to negatively affect the accuracy of the test than improve it. The need for double blind trials is normally well understood. This is not an experiment, but as a test it seems like it would benefit from at least single blind: lab is unaware - accuracy tests are mixed randomly into the ge…
Re: Theranos Has Struggled with Blood Tests
#86Side note: Did anyone else find the writing for this article absolutely horrendous? “They were never able to produce them,” she says. Ms. King says the company did show detailed testing-accuracy data to the nurse. I would have flunked freshman-english if I wrote papers like this. There was zero effort to link thoughts together all-throughout the piece. I thought the point of a pay-wall was to promote and support good…
I found it to be consistent with most similar pieces. Also, the author has won a Pulitzer for investigative journalism.
Re: Theranos Has Struggled with Blood Tests
#87Earlier quoted context omitted.
Anecdata: I'm a physician, and get tests done for myself and my family at the Theranos place in Palo Alto, for around $5/test (vs $50 for other labs), and I have no concern about the accuracy of the tests. This abstract discusses some of the possible reasons for variation in test results: http://www.ncbi.nlm.nih.gov/pubmed/10887452 Of course, none of this proves that the tests are reliable (consistent) and accurate,…
Do you know if anyone can get their blood tested or do you need an doctor's order? Their prices seem quick cheap and it would be nice to get some periodic readings for my chronic health problems.
If you are anywhere near Palo Alto and want to get some tests done, just message me, we'll sort something out :)
Re: Theranos Has Struggled with Blood Tests
#88Getting blood from someone's finger will lead to incorrect results in many tests because other things diffuse into the blood. The things can lead to very inaccurate results. This is a BIG problem for Theranos.
It is conceivable that they could use software to correct for this. Is there is something they can measure that indicates the amount of dilution with interstitial fluid,there might be a way to take account of it. Similarly you'd want to correct for hemolysis
Re: Theranos Has Struggled with Blood Tests
#89Earlier quoted context omitted.
Is he able to properly evaluate the accuracy of those results?
This is what the results look like: http://padlet.com/dpetersen/khmmi11wy8hz http://padlet.com/dpetersen/r6dg1vbxmz92 I don't know how an individual could evaluate the accuracy of these results, but the same goes for a non-Theranos blood test as well.
First link shows Vitamin D is very low and should be affecting your friends energy levels at the very least. Second link shows a 1500%(!) increase in AST in under a year and its way over limit.
One way to evaluate the accuracy is the sniff test, e.g. is the lab result congruent with how the person feels? Information on the internet around understanding your medical tests is pretty crappy unfortunately, but you can usually get to understand whether symptoms match. And if you have a doctor that gives you the time of day and helps you understand it, even more so. Your friend's AST result raises a question of whether there is an accuracy issue and should be investigated.
From WebMD [0] --
> High levels of AST may be caused by:
> * Liver damage from conditions such as hepatitis or cirrhosis.
> * A heart attack or heart failure.
> * Many medicines, such as statins, antibiotics, chemotherapy, aspirin, narcotics, and barbiturates.
> * High doses of vitamin A.
> * Kidney or lung damage.
> * Mononucleosis.
> * Some types of cancer.
> Many different conditions can raise AST blood levels, so other testing is usually needed to interpret an abnormal AST result.
[0] http://www.webmd.com/digestive-disorders/aspartate-aminotran...
Re: Theranos Has Struggled with Blood Tests
#90Side note: Did anyone else find the writing for this article absolutely horrendous? “They were never able to produce them,” she says. Ms. King says the company did show detailed testing-accuracy data to the nurse. I would have flunked freshman-english if I wrote papers like this. There was zero effort to link thoughts together all-throughout the piece. I thought the point of a pay-wall was to promote and support good…
I'm missing something. What's hard to follow here? I mean, it's not Hemingway, but the previous paragraphs describe the difficulty of the situation, in which Theranos -- according to the WSJ -- asked its employees to recant their statements to the WSJ (pre-publication). In the part that you excerpt, the WSJ reports the nurse saying that the company failed to produce data that would prove the accuracy of the test. The…
The excerpt I quoted was isolated like a paragraph, but I don't remember a paragraph being 2 poorly written sentences.
How would I have worded it? For one I would have presented one side of the entire story, and then an opposing view-point (i.e. the view point of Theranos execs), instead of "person a said x. person y said x'".
I guess I'm sorry I'd prefer writing hidden behind a pay wall to be a little more elegant than what an 8 year old could write.