QC Testing
A patient injected with endotoxins could show these types of physical responses.
What is fever, septic shock, low white blood cell count, and/or death?
These track invalid test results in Agile.
What are NOEs?
After preparation the TLC Strips should be stored here.
What is the desiccator?
This is the volume of diluted sample that is used when testing.
What is 25 uL?
The expected dimensions of the TLC Strips.
What is 2 x 10 cm?
Clear, colorless, and free of particulate matter describes the acceptance criteria for this QC Test.
What is the appearance test?
The volume of kryptofix standard and FDG that should be used when performing the krytopfix spot test.
What is 4 uL?
What is the name of the software you use to remotely operate the Bioscan?
EZ Chrom (Open lab to EZ chrom)
This is the temperature range the PTS LAL Cartridges must be stored at.
What is 2-25 degrees Celsius?
The type of stationary phase media that is used for FDG TLC testing.
What is Silica Gel?
A steady stream of bubbles indicates this for the MFIT test.
What is the test is complete?
This dilution factor is used when performing the BET test on FDG with PTS Method.
What is 1:40?
This volume of standard and final product should be spotted on TLC test strip.
What is 0.5 uL?
The calibration has to be performed on the PTS Reader ____________.
What is annually?
The TLC SST has to be performed ____________.
What is daily?
This person is authorized to release a final product.
Who is a trained and qualified operator (pharmacist)?
This is the minimum time requirement between readings on the F18 Radionuclidic Identity test.
What is 10 minutes?
An OOS or DEV occurs, your first actions will be to __________and _________.
What are call RQCS and open report in Agile?
This step should be taken upon receipt of a new lot of PTS LAL Cartridges on-site?
What are check-in (per D0007808) and qualify the lot per D0008420?
These three tests make up the TLC SST.
What are normalization, resolution and positional linearity?
Rf stands for ____________ as it pertains to the TLC QC test.
What is retention factor?
Rf=distance traveled from origin/distance traveled by solvent front
The three F-18 components that can be seen on a TLC chromatogram when performing QC on an FDG sample.
What are free F18, F18 FDG, and unhydrolyzed FDG?
After spotting the TLC standard, it must dry for this amount of time.
What is 10min?
These determine Validity of the BET Test.
What are Rxn Spike and Sample CV% <25%, sample detected, and Spike Recovery 50-200%?
These are the two types of collimators for use with the TLC.
What is the high efficiency and high resolution?