Assay Verification - Abbott CELL-DYN 3000 Operator's Manual

Quality Control

Assay Verification

7-14
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• Store the controls at recommended temperatures. Storage in a
central location in the refrigerator, away from the door if it is
opened frequently, is advisable.
• Carefully warm and resuspend the product according to the
directions given in the package insert. Proper mixing is essential
for accurate results.
• Check the open-vial stability dating and do not use products longer
than is recommended as results may be compromised.
• Wipe the threads on the vial and the inside of the cap.
• Never subject a vial to excessive heat or agitation.
New lots of control material should be analyzed in parallel with current
lots prior to their expiration dates. This may be accomplished by running
the new controls twice a day for five days. The mean of the ten runs is
used to confirm the assay value. A control file is set up for the new lot
number to easily establish the mean. If desired, this same control file can
then be used to run the control for the remainder of the dating period.
Creating another file is not required.
The expected ranges published by manufacturers are generally too broad
for effective quality control.
acceptable ranges. These ranges may be determined by evaluating three
to six months of data (data from the Interlaboratory Quality Control
Program may be used) for a particular level of control. The individual SD
values may be averaged as follows:
Average SD =
where:
N = number of values in a group
SD = Standard Deviation of the values
i = the last group of values
The resultant long-term instrument SD and the laboratory-established
mean for each lot number should be used to monitor instrument
performance.
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1
Therefore, each laboratory should establish
2
(N1 x SD1 )+(N2 x SD2
(N1 + N2 + ...Ni) - 1
CELL-DYN® 3000 System Operator's Manual
Chapter 7
2 2
)+...(Ni x SDi )
9140240E — May 1995