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11-16
CELL-DYN
®
3200 System Operator’s Manual
9140181H—October 2001
Quality Control
Quality Control Guide
Section 11
Assay Verification
New lots of control material should be analyzed in parallel with current lots prior
to their expiration dates. Perform the following steps to accomplish the transition
to a new lot:
1. Set up a control file for the new lot.
2. Verify values for each new control lot by running each level of control in
triplicate along with either replicate QC specimens or the old control when it
is still in date.
3. Run the new controls twice a day for five days to establish a mean.
4. Use the mean of the ten runs to verify that the new lot yields the expected
results. The mean should fall within the range specified by the manufacturer
in the package insert.
5. If the calculated mean falls within the range specified by the manufacturer,
use it in place of the manufacturer's stated mean.
6. When results for any parameter(s) are flagged (outside of operator-defined
limits or reportable range), reconfirm calibration for that parameter using
specimens with known reference values. When calibration confirmation
results are acceptable, establish a new working mean and limits for each level
of the new lot of control.
A control file should be set up for the new lot number to easily establish the mean.
If desired, this sample control file can then be used to run the control for the
remainder of the dating period. It is not necessary to create another file.
The expected ranges published by manufacturers are generally too broad for
effective Quality Control
1
. Therefore, each laboratory should establish acceptable
ranges. These ranges may be determined by evaluating three to six months of data
(data from the Interlaboratory QC Program may be used) for a particular level of
control. The individual SD (standard deviation) values may be averaged as follows:
N = number of values in a group
SD = standard deviation of values in that group
i
= the last group of values
The resulting long-term instrument SD and the laboratory-established mean for
each lot number should be used to monitor instrument performance.
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