I’m impressed

August 26, 2016

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In my last blog entry, I noted that the problem with patent based QC is that publications talked about its benefits using simulations, but no one was actually using patient based QC. Well, the article that was upcoming has come out and these authors are using patient based QC and provide an example where a shift in sodium values was detected. So I’m impressed.

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The problem with patient based QC

August 18, 2016

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In an editorial (actually more of a mini review) in Clinical Chemistry, the various patient based QC methods are reviewed. The editorial is provided because of a companion article that has yet to appear.

One problem with patient based QC is that it is always compared to traditional QC, perhaps with the goal that it could replace traditional QC. But why not do both.

And perhaps a bigger problem is that people study patient based QC by performing simulations and/or providing examples showing that retrospective analysis of a (known) problem (perhaps a clinician complaint) would have been detected by patient based QC.

But I am not aware of anyone routinely using patient based QC (with or without traditional based QC), for all assays.


Theranos Board now populated with past AACC presidents

August 10, 2016

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Theranos has been criticized for its board, which has two former secretaries of state (Henry Kissinger and George Schultz), two former senators and several former high ranking military officers and not much in the way of scientific expertise. Now, their scientific and medical advisory board includes four former AACC presidents: Susan Evans, Ann Gronowski, Larry Kricka, and Jack Ladenson. Note that although clinical chemists have been added, the fact that past presidents have been chosen conforms to Theranos’s strategy of favoring “official” types.

So here’s a question – if you were a well-known clinical chemist, would you accept a position to serve on Theranos’s board?


More AACC 2016 Philadelphia Notes

August 4, 2016

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As for the AACC 2016 app, it deconstructs the three program books into something pretty useless. With the physical books, one can page through them rather quickly. But with the app, most of the titles are cut off, so it takes forever to find things.

The posters were so far away, they seemed to be in a different zip code.

Several posters were interesting and I was impressed by a poster presented by Linda AC De Grande about the use of patient medians. Maybe one day QC using patients will be mainstream.

Although I’m no longer part of CLSI, I have attended CLSI meetings at the AACC national meeting since the 80s. But these meetings are not held any more at the national AACC meeting. This makes CLSI less inclusive since people can no longer simply drop in on the meetings.

Anyone who stayed at the Marriott (like me) was very happy since the convention center was a block away.

At a Siemens presentation about IQCP, it was implied that conducting IQCP might allow one to run QC less than once a month as long as there was no conflict with manufacturer’s IFU. Not sure if the presenter was correct but a scary thought nevertheless.


Theranos – Part 2

August 3, 2016

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I was among the multitudes who attended Elizabeth Homes’s presentation about Theranos at AACC in Philadelphia. Overall, I was impressed and here are some details. First, she said she wasn’t going to address past malfeasances (not the way she put it) but focus on Theranos’s new instrument.

As an aside, she had an identical accent to that of Mira Sorvino in “Romy and Michelle’s high school reunion”). For those who haven’t seen the movie, I would call this “adult valley girl”.

Her presentation included a lot of data analysis. Terms like ANOVA, Passing-Bablok regression, weighted Deming regression, CLSI guidelines EP05-A3 and EP09-A3, ATE (allowable total error) and others were pronounced and used correctly. (The ATE corresponded to CLIA limits). Having worked most of my career for manufacturers, there is a simple rule manufacturers never show bad data. Hence, until these data are reproduced by others….

The instrumentation was impressive from the standpoint that so many different assay types could fit in one relatively small box, but the technologies with which I am familiar were standard – nothing’s new. I don’t recall her mentioning any specific reagents. When you think about assays, reagents are the ballgame – the instrument is not that special. Something that did seem new was that the software for the instrument (the minilab) is in a central server. The advantages of this remain to be demonstrated.