PN 177196BB
4-16
QUALITY ASSURANCE
REPRODUCIBILITY AND CARRYOVER CHECKS
c. Three tubes of the same normal, fresh whole-blood specimen, each cycled at least
seven times, are needed to meet the 20 sample requirement.
4. When using the software to do a reproducibility check, the instrument calculates the
mean and CV for each parameter.
a. CV or Coefficient of Variation is a percentage of deviation from the mean
b. Results that exceed the limits appear against a red background.
5. The instrument’s performance specifications for reproducibility are listed under
Heading 3.2, PERFORMANCE SPECIFICATIONS, in the Online Help System or the Instructions
for Use manual.
Carryover Check
1. Carryover is the interaction of the previous sample with the current sample.
2. A high to low carryover check verifies the high results of one sample do not affect the
low results of the next sample.
a. This instrument does not have an automated procedure for checking carryover.
b. The carryover check is done by analyzing a whole-blood specimen with high values
followed by a whole-blood specimen with low values; each specimen is run
consecutively in triplicate
c. Carryover is calculated as follows:
3. The instrument’s performance specifications for carryover are listed under
Heading 3.7
PERFORMANCE SPECIFICATIONS
, in the Online Help System or the Instructions for Use
manual.
CV%
SD
Mean
--------------
100×=
Carryover
Low 1 Low 3–
High 3 Low 3–
-----------------------------------------
100×=
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