Bio-rad ProteinChip Qualification and Calibration Kits Uživatelský manuál stáhnout pdf (Strana 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.

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TTiittllee FFrreeqquueennccyy UUsseedd RReeqquuiirreedd DDeessccrriippttiioonn

File and protocol

IInniittiiaall SSeettuupp

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.

MMaaiinntteennaannccee

High voltage Weekly N/A 1–2 hr HV conditioning helps to

PPrroocceedduurree 11

(HV) depending on decontaminate the surfaces

conditioning instrument in the instrument.

MMaaiinntteennaannccee

Detector Weekly ProteinChip 45 min to 4 hr This procedure uses the

PPrroocceedduurree 22

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.

TTeesstt 11

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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