Re: [Appropriate number of events]

From: Maciej Simm (simmmmer@yahoo.com)
Date: Fri Oct 26 2001 - 16:47:50 EST


I had trouble sending this email the first time so sorry about any
duplicates:

Michelle -

Howard Shapiro wrote this email about a year ago and it was so good
of a tutorial that I kept it and attached it in this email.
maciej

--- Howard Shapiro <hms@shapirolab.com> wrote:

> Jim Houston wrote-
>
> >Those of us doing CD34 enumeration are routinely asked to give
> results
> >sometimes as low as .1%.  In fact normal adults have a measurable
> percentage
> >as low as .02%.  When I first started CD34 enumeration 5 years ago
> I was
> >told you had to have at least 50 of these positive events to be
> significant.
> >Needless to say we acquire alot of data to get these numbers.
> >
> >20 years ago I believed the error  by flow to be around 2-5%.  If
> you run
> >the same tube 10 times you will get some variance in the
> percentage you are
> >looking for, particularly in the levels of .1%.  The problem
> occurring is
> >the significance of an increase from a measured .2% to a .4%
> level.  Is this
> >increase real or is it a factor of the instrument.  When this
> number is used
> >to calculate Absolute numbers in a leukopheresis product then it
> can be
> >significant.
> >
> >Now I have been requested to give numbers lower than .01%.  How to
> make this
> >accurate?  Good question.  I assume that most populations have
> some inherent
> >properties to them.  They scatter light in discrete patterns and
> have some
> >sort of phenotype unique to them.  The more parameters I use the
> better the
> >confidence level.  If I set all analysis markers by isotype
> controls then
> >that could make my decision easier, but these give erroneous
> results if you
> >look at the data carefully.  If you collect 500,000 cells and then
> see a
> >population of 16 are these real????
> >
> >In practice the low %'s <1% are at best sometimes subjective to
> the
> >operator's experience.
> >
> >A good question is not only the ability by flow to give these low
> %'s but
> >how reproducible is it.  Some labs are running their samples in
> doublets or
> >triplets then averaging.  This will drive the cost up a bit.
> >
> >Are there any statisticians out there who can answer some of these
> >questions?
>
> As I pointed out in an earlier posting on rare event analysis, it
> is
> possible, under the right circumstances, to detect one cell in 10
> million.
>
> The question Jim has asked, though, refers to the accuracy and
> precision of
> estimating counts of rare events, in this case, the number and/or
> percentage of CD34+ cells.
>
> When anything is being counted, Poisson statistics come into play;
> if you
> count n of anything, the standard deviation will be the square root
> of
> n.  The coefficient of variation (CV), in per cent, will be 100
> divided by
> the square root of n.  This assumes that the counting process
> itself is
> perfect; the point is that if you count 25 objects, you'll get a
> standard
> deviation of five objects, and a CV of 100/5, or 20 per cent; if
> you count
> 100 objects, the standard deviation will be 10, and the CV will be
> 10 per
> cent, and it is easy to see that getting precision to 1 per cent
> requires
> that you count 10,000 objects.  If these objects are rare cell
> types
> present at a frequency of one per million cells in the sample, you
> have to
> analyze 10 billion cells to find the 10,000 cells you're interested
> in.
>
> The same statistics apply to counting everything from photons and
> photoelectrons (peaks from dimly fluorescent cells have bigger CV's
> than
> peaks from brightly fluorescent cells because fewer photons are
> collected
> from the dim cells) to votes (if 3,000,000 votes are counted, one
> expects a
> standard deviation of 1,732 votes, or roughly 6 parts in 10,000,
> meaning
> that if the process is supposedly only 99.9% reliable, or accurate
> (10
> parts in 10,000), as it was widely stated to be, neither Bush nor
> Gore has
> a strong claim to having won the Florida Presidential vote).
>
> We have a little more control over cell counting than over vote
> counting.  If you count enough cells, you can accurately
> discriminate
> between, say, .01% and .02%.  If you only count 10,000 cells total,
> you'd
> expect to find one cell (and a CV of 100%) in the sample with .01%
> and 2
> cells (CV of 70.7%) in the sample with .02%; so 10,000 cells total
> is too
> small a sample to let you discriminate.  If you count 1,000,000
> cells
> total, you end up with 100 cells in the .01% sample (CV 10%) and
> 200 cells
> (7.1% CV) in the .02% sample, and this difference will be
> statistically
> significant.
>
> The best way to do counts - although almost nobody does them this
> way - is
> to always count the same number of cells of interest, which gives
> you equal
> precision no matter what the value is.  Normally, we do absolute
> counts by
> analyzing a fixed volume of blood (or other sample) and percentage
> counts
> by analyzing a fixed number of cells.  The alternative is to decide
> on the
> level of precision you want - suppose it is 5%.  Then you have to
> count 400
> cells (the square root of 400 is 20, and 100/20 = 5).  What you do
> is
> measure the volume of sample (in the case of absolute counts), or
> the total
> number of cells (in the case of percentage counts), which has to be
> analyzed to yield 400 of the cells of interest.  If the cells of
> interest
> are at .01%,, you'll have to count 4,000,000 cells total to find
> your 400
> cells of interest; if they are at 1%, you'll only have to count
> 40,000
> cells, but, instead of the .01% value being much less precise than
> the 1%
> value, both will have the same 5% precision.  The down side of this
> is that
> it requires some reprogramming of the apparatus, and possibly uses
> more
> reagent, but, if you want good numbers, there is simply no
> alternative.
>
> -Howard
>
>

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