SOP-SS-006

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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

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1. PURPOSE

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. STR4.1.1. Post-engraftment analysis service:

HTUhttp://www.uwhealth.org/servlet/Satellite?cid=1133175612017&aid=1126649145068&pa

gename=B_EXTRANET_UWH_CLIN_LAB_HANDBOOK%2FFlexMemberHandbook

%2FShow_ClinLabTest_UWHealth_R2&c=PageUTH

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. WiCell SOP-SS-001

4.4. WiCell SOP-QU-011

4.5. Wicell Form F-POL-LAB-005

4.6. 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-SS-

001. The DNA sample is stored in a 2.0ml screw top tube, labeled as described in SOP-

SS-001, and stored at 4 C̊ 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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7. PROCEDURE

7.1. Fill out required forms

7.1.1. On the designated computer in the cytogenetics laboratory, open up Microsoft OfficeAccess, 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 DescriptionEffective

Date

A Document Initiation. 06/26/07

BCombined HLA and STR SOP’s into one. Changed responsibility to Distribution

Lab, updated appropriate forms to correspond with current procedure.See SPDC

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9. APPROVALS

10/8/2009

X JJM

JJM

Quality Assurance Manager

10/8/2009

X TEL

TEL

Sr. Scientist/Director – Media Opt. & Dist.

SOP-SS-006

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