6. Quality
Control
54
Instructions for Use for SUNRISE No. 30086638 Rev No. 2.9
2021-07
6.3
Operational Qualification (OQ)
The following test can be performed to ensure that the instrument is working
correctly, and accurate results are being obtained.
The repeatability and accuracy of the instrument may vary with the type of
solution and microplate used.
To eliminate this effect, the instruments are tested in the factory with a calibration
plate, which removes the influence of the solution and any variation due to the
positioning of the microplate when it is being measured.
6.3.1
QC PAC 2
QC PAC 2 provides an automated check of reader performance including
accuracy, linearity, precision, and alignment with NIST traceable standards. It
also detects damaged or mislabeled filters. For more information, see QC PAC 2
Instructions for Use.
CAUTION
USE ONLY “QC PAC 2 FOR SUNRISE INSTRUMENTS”. THE FORMER
VERSION OF THE QC PAC 2 (FOR SPECTRA INSTRUMENTS) IS NOT
COMPATIBLE WITH THE INSTRUMENT.
6.3.2
Microplate Test
If the optical densities of the wells in the microplate are not consistent, the results
obtained with this type of microplate will be influenced.
This inconsistency can be checked by reading an empty microplate.
The OD values obtained from the measurement of the empty microplate should
be in a narrow range. For example: +/- 0.010 OD.
If the OD values are not within this range this type of microplate should not be
used.
By using dual wavelength measurements, the influence of the difference in OD
values of the microplate is removed or reduced to a level that is within acceptable
limits.
