Skyla HB1 - Selecting an External Control; Using a Skyla TM Reagent Disc for the Quality; Control Test; Performing a Quality Control Test

3-19
 Perform a quality control
test if you have doubts
regarding analysis results.
Note:
1. Contact authorized
skyla
TM
technical support
personnel or agents to
inquire about commercially
available controls.
2. If you have any questions
about the selection of
reagent discs, please
contact authorized
skyla
TM
technical support personnel
or agents.
long-term supply and provide ade
quate traceability
information.
It is recommended that the quality control
test be
performed:
 At least every 30 days.
 Whenever
there is a significant change to the
laboratory environment.
 After the analyzer has been used for staff training.
 When test results are inconsistent with
patient
symptoms or diagnosis.
3.9.1 Selecting an External Control
Select a commercially available control
that covers all test
markers of the reagent discs selected for the control test
and the concentrations thereof.
3.9.2 Using a skyla
TM
Reagent Disc for the Quality
Control Test
Any skyla
TM
reagent disc can be used
to perform the
quality control test. Make sure that the
known
concentrations of the test markers in the control
cover
the test markers of the reagent disc.
3.9.3 Performing a Quality Control Test
Turn on the analyzer
by pressing the power button on the
front of the analyzer and wait for about 15
minutes for
the self-test and calibration of the analyzer to be
completed. Remove the reag
ent disc from the
refrigerator.

Follow the procedures as indicated in Section 3.2
‘Sample Preparation’ and 3.3 ‘Preparation Before
Testing’.

Follow the procedures as indicated in Section 3.4
‘Dispensing the Sample.’ Use a micro
pipette to
dispense 200μL of the control into the
reagent disc via
the sample port.