SORT APPLICATION-Medh FLOW CYTOMETRY FACILITY

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Version 2015-03-05

SORT APPLICATION-MedH FLOW CYTOMETRY FACILITY

THIS SECTION WILL BE FILLED BY THE FACILITY
Sort ID:
Summaryrisk assessment for sorting:
Choice of security level for sorting (Biosafety level 1 (BSL1), Biosafety level (BSL2), Biosafety level 2 with containment in microbiological safety cabinet class 1 or II (BSL2:MSC) or Biosafety level 2 respirator (BSL2:Resp):

Investigator’s details

Name:
GroupLeader:
Tel (Mob):
E-mail:
KI Ref: ZZ

Sort details

Sorter:
Operator:
Date:
Estimated start time:
Estimated sample size and number of samples:
Sort modes (bulk, single-cell, other) and collection (tube, 96-plate, slide):
Viability dye (no/yes, specify)
Sort antibody panel:
Please write a brief description of the purpose of the sort including the populations to be sorted, including the number of cells required by each sorting mode:
Please show calculations to justify both the number of target cells and the sample size:
e.g. Target population frequency = 0.1%’
Number of target cells required = 1000
Sample size = 3 x 106
Theoretical yield incl. 50% sort yield = 1500
Staining protocol including controls (negative, comp tubes, FMO etc…) attached
Has the staining panel been used before? If so, please include profiles:
Sample temp: Collection temp: Collection medium:
Other special requests:

Risk assessment and choice of safety levels during cell sorting

Please answer ALL individual questions below. Use “NA”. when Not Applicable

If the material to be sorted is identical to previously risk assessed material, reference (sort Id and date) can be given to that sort application, instead of filling it in again below.
Are cells fixed or alive?
Species of cell to be sorted:
What is the origin of the cell (eg. from ATCC, sample from healthy donor…)
Primary cell (yes/no):
Cell line:
Risk assessment by ATCC or similar:
If human primary cells, have donor/patient been tested and found negative for HBV, HCV and HIV, or other for the patient or individual relevant pathogens?
Could there be any unknown infectious agents in the material to be sorted?
Has the cell been genetically altered (GMM)?
Method for genetic alteration
Time point of the genetic alteration/ number of passages (was it done less than a week ago?)
What kind of vector was used? (retro/lenti or other)
Nameof expression vector:
Packaging method (generation of retroviral system, transient transfection or stable producer line)
Envelope used (Ecotropic, amphotropic, VSVg or other)
Nature ofinsert:
Is the insert associated with or suspected to be involved in cellular transformation or associated with any other biological risk?
Who made the viral transduction (in the research group or by someone else)?
How has presence of free viral particles been eliminated (time after transduction, number of washes, other method)?
Overall risk assessment for sorting:

Date:

Sort Id:

Signature group leader:

Signature investigator:

Signature responsible for sort facility: