Direct Detect® Spectrometer User Guide
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14.3 Operation Qualification Protocol (OQ)
1. Click on the instrument validation icon to open the instrument validation dialog box.
Figure 43.
Instrument validation dialog
2
1
2. Click on the
Operational Qualification (OQ) Run Test
button (2). This starts a system
check that takes several minutes to complete. Run this test regardless of the test
expiration date. A report displaying the OQ test results will be generated and stored in
C:\DirectDetect\Validation\Reports. The report can be viewed and printed by clicking on
the
button. Document results on the IQ/OQ/PQ Report Summary.
14.4 Performance Qualification Protocol (PQ)
1. After the OQ test has been successfully completed, run the PQ test by clicking on the
Performance Qualification (PQ) Run Test
button (1). Run this test regardless of the
test expiration date. A report displaying the PQ results will be generated and stored in
C:\DirectDetect\Validation\Reports. The report can be viewed and printed by clicking on
the
button. Document results on the IQ/OQ/PQ Report Summary.
14.5 Protein Measurement Verification
1. After successful completion of the OQ and PQ tests, the system is ready to verify that a
protein spotted on the card is equivalent to a standard.
2. Open a new vial of BSA standard.
3. Place the Assay-free card(s) on the spotting tray or other clean surface. Select an
appropriate buffer blank, preferably the same solution in which the BSA standard has
been prepared. The majority of commercially available BSA standards use NaCl (with
NaN
3
) as a buffer; check manufacturer specifications. Pipette exactly 2 µL of the buffer
solution to the default blank position on the card (position 1).
