STANDARD OPERATING PROCEDURE Title: Submission Procedures and Requirements for Short Tandem Repeat (STR)

and/or Human Leukocyte Antigen (HLA) Testing

SOP Number: SOP-SS-006

1. PURPOSE

Version: B

1.1. This Standard Operating Procedure (SOP) will detail the process of sending genomic DNA isolated from human stem cells for short tandem repeat (STR) and/or human leukocyte antigen (HLA) testing. Testing is performed by the Molecular Diagnostic Lab at the University of Wisconsin Hospital and Clinics in Madison, WI. 2. SCOPE 2.1. This procedure applies to all WiCell laboratory personnel responsible for sending DNA for STR and HLA testing. 3. RESPONSIBILITIES 3.1. The Distribution Laboratory Manager is responsible for ensuring that all required personnel are properly trained and understands this SOP. 4. REFERENCES 4.1. STR 4.1.1. Post-engraftment analysis service: http://www.uwhealth.org/servlet/Satellite?cid=1133175612017&aid=1126649145068&pa gename=B_EXTRANET_UWH_CLIN_LAB_HANDBOOK%2FFlexMemberHandbook %2FShow_ClinLabTest_UWHealth_R2&c=Page
HTU UTH

4.1.2. Promega PowerPlex 1.2 kit: http://www.promega.com/applications/hmnid/productprofiles/pp12/default.htm 4.2. HLA 4.2.1. Abbot Molecular Test Kits: http://www.abbottmolecular.com/OrderingInfo_3469.asp 4.2.2. HLA Testing Service Resource: http://www.uwhealth.org/servlet/Satellite?cid=1133175612017&aid=1126649116867&page name=B_EXTRANET_UWH_CLIN_LAB_HANDBOOK%2FFlexMemberHandbook%2F Show_ClinLabTest_UWHealth_R2&c=Page 4.3. 4.4. 4.5. 4.6. WiCell SOP-SS-001 WiCell SOP-QU-011 Wicell Form F-POL-LAB-005 WiCell Form SOP-SS-006.01

5. DEFINITIONS (NOT APPLICAPLE) 6. EQUIPMENT AND MATERIALS 6.1. Required DNA samples 6.1.1. Test DNA sample that conforms to the required specifications described within SOP-SS001. The DNA sample is stored in a 2.0ml screw top tube, labeled as described in SOPSS-001, and stored at 4C in a box labeled, DNA to be sent. 6.2. Required forms 6.2.1. UW Sample Submission Form, F-POL-LAB-005. 6.2.2. Stem Cell Line Samples submitted for STR and/or HLA, SOP-SS-006.01.

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STANDARD OPERATING PROCEDURE Title: Submission Procedures and Requirements for Short Tandem Repeat (STR)
and/or Human Leukocyte Antigen (HLA) Testing

SOP Number: SOP-SS-006

Version: B

7. PROCEDURE 7.1. Fill out required forms 7.1.1. On the designated computer in the cytogenetics laboratory, open up Microsoft Office Access, G:/DNA Database, Forms: DNA Extraction Log. Search for each DNA sample to find the concentration and 260/280 ratio for each specimen. Write this information on the Stem Cell Lines form SOP-SS-006.01. 7.1.1.1. Provide a photocopy of SOP-SS-006.01 to WiCell QA. 7.1.1.2. The original form SOP-CC-006.01 is given to the UW Hospital and Clinic along with the specimens. 7.1.2. Deliver the UW sample Submission form F-POL-LAB-005 to the WiCell Administrative Services Manager. 7.2. Deliver the DNA sample and corresponding paperwork 7.2.1. A DNA sample, meeting the required specifications, is delivered directly to the Molecular Diagnostics Laboratory located in room D4/231 at the main University of Wisconsin Hospital complex along with form SOP-SS-006.01. 7.3. Testing methods Used at UW Hospital 7.3.1. STR 7.3.1.1. The UW hospital uses the PowerPlex 1.2 system from Promega to perform the short tandem repeat testing. 7.3.2. HLA 7.3.2.1. The UW Hospital performs HLA testing with the following kits available from Abbott Molecular. 7.3.2.1.1. 09K59-01 AlleleSEQR HLA-A SBT Pack 7.3.2.1.2. 09K60-01 AlleleSEQR HLA-B SBT Pack 7.3.2.1.3. 09K61-01 AlleleSEQR HLA-C SBT Pack 7.3.2.1.4. 09K62-01 AlleleSEQR HLA-DRB1 SBT Pack 7.3.2.1.5. 09K62-02 AlleleSEQR HLA-DRB1 SBT Pack 7.4. Data Review and Reporting 7.4.1. A results report will be sent from the hospital to WiCell QA and saved in the appropriate QC Lot File located on the R: drive. The data report may be in Word or PDF formats. 7.4.2. QA will review the data, and post it on the website once the lot is released. 8. REVISION HISTORY
Version Change Description Effective Date

A B

Document Initiation. Combined HLA and STR SOPs into one. Changed responsibility to Distribution Lab, updated appropriate forms to correspond with current procedure.

06/26/07 See SPDC

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STANDARD OPERATING PROCEDURE Title: Submission Procedures and Requirements for Short Tandem Repeat (STR)
and/or Human Leukocyte Antigen (HLA) Testing

SOP Number: SOP-SS-006

9. APPROVALS
10/8/2009
10/8/2009

Version: B

X JJM
JJM Quality Assurance Manager

X TEL
TEL Sr. Scientist/Director Media Opt. & Dist.

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