PROPRIETARY INFORMATION
CONFIDENTIAL MATERIAL
Not for Customer Distribution
Assays/Reagents
AEROSET
®
System Troubleshooting Guide
77
94816-107—November 2004
Establishing Quality Control Limits
Use the following instructions to establish quality control
limits for Abbott Clinical Chemistry assays.
Temporary Quality Control Limits
1. Enter the assay parameters for the appropriate new assay.
2. Calibrate and run three replicates each of a multi-level
control in a single run. Record the results on the
Temporary Control Limits Worksheet at the end of this
section. Do not discard any result unless it was generated
by operator error or instrument malfunction, or results
can be rejected as a statistical outlier.
3. Repeat the calibration and controls two more times for a
total of three calibration and control runs (nine values for
each control). Add fresh calibrators and controls to each
analyzer cup for each new run.
4. Calculate the mean for each control level and record it on
the worksheet. Multiply each mean by 0.20 and record the
result (20% of the mean) on the worksheet.
5. Determine the temporary control limits for each control
level (± 20% of each mean control concentration). For
example, if the mean control concentration of
Theophylline is 10 µg/mL, the control limits are
8 µg/mL (– 20%) and 12 µg/mL (+ 20%).
6. Use these temporary control limits when running patient
samples. Test at least two levels of control every 24 hours,
or more often as specified by the laboratory’s quality
control program.
7. Use the following rules to determine if the run can be
accepted.
a. If controls are within the temporary control limits,
accept the run.
b. If any control is not within its control limits, rerun
the control. If the control is within the control limits,
accept the run.
c. If the control is still not within its control limits,
reject the run. Recalibrate the assay. After
recalibration, if the controls are within their control
limits, test patient samples.
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