Bio-Rad ProteinChip Qualification and Calibration Kits - Manual (Page 5)

Completion of each maintenance procedure and test is tracked using the ProteinChip SELDI OQ
form, a Microsoft Excel spreadsheet supplied on the CD. Test data are exported to the
ProteinChip SELDI OQ form, which then calculates whether the test passed or failed.
Upon completion of the OQ procedure, save, print, sign, date, and place copies of the following
documentation into a notebook or folder for audit review:
• Protocol acceptance page (Appendix B)
• ProteinChip SELDI OQ form summary
Table 1. Summary of procedures and tests.
R Reecco om mm meen nd deed d C Co on nssu um maab bllee E Essttiim maatteed d T Tiim mee
T Tiittllee FFrreeq qu ueen nccyy U Usseed d R Reeq qu uiirreed d D Deessccrriip pttiio on n
File and protocol
IIn niittiiaall S Seettu up p setup 20 min Complete this procedure the
first time you use the
ProteinChip OQ kit. This
procedure creates the
file structure necessary for
storing the protocols and creates
the routines for high voltage
conditioning and mass calibration.
M Maaiin ntteen naan nccee High voltage Weekly N/A 1–2 hr HV conditioning helps to
P Prro occeed du urree 1 1 (HV) depending on decontaminate the surfaces
conditioning instrument in the instrument.
M Maaiin ntteen naan nccee Detector Weekly ProteinChip 45 min to 4 hr This procedure uses the
P Prro occeed du urree 2 2 calibration detector depending on ProteinChip detector
calibration instrument calibration array to adjust
array the detector voltage. These
adjustments are based on a
rolling average that stabilizes
the gain, improving spectral
reproducibility over the lifetime
of the detector.
T Teesstt 1 1 Detector Biweekly ProteinChip 30 min to 1 hr This test uses the ProteinChip
sensitivity detector detector calibration array to
qualification measure the signal-to-noise
array ratio (S/N) of immunoglobubulin
(IgG) at two different
concentrations (10 fmol and
140 fmol). Measurements are
compared to a specification, and
a pass/fail disposition is
obtained.
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