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Cross-Network PBMC Processing SOP

What is the Cross-Network PBMC Processing SOP?

The Cross-Network Peripheral Blood Mononuclear Cell (PBMC) Processing Standard Operating Procedure (SOP) provides instructions for processing PBMC at network (ACTG, HPTN, HVTN, IMPAACT, and MTN) site-affiliated laboratories, and is intended to simplify and clarify PBMC processing, especially at shared sites.

If you have trouble accessing any of the documents on this page, click Contact Us in the menu at the top of the page and send a message to the HANC Laboratory Project Manager.


What are the requirements for use of the SOP?

Use of the Cross-Network PBMC Processing SOP is required for the cryopreservation of all PBMC for ACTG, HPTN, HVTN, IMPAACT, and MTN studies.

English Version 

Currently, all labs should use Version 6.0 of the Cross-Network PBMC Processing SOP, as of April 26, 2018.
Version 6.0 differs from 5.2 by the following changes: 
  • Section 8.1.4: Additional requirements captured in October 7, 2016 memo for ACTG and IMPAACT labs​ only added. Additional cryovial-related requirements for all networks also added.
  • Section 18.2.1: Additional guidelines related to freezer set point temperatures added.
  • Appendix G: Added additional information to the Cryovial section related to use of the SARSTEDT Screw cap micro tube.
Please refer to Appendix H of the SOP for a complete history of changes.


Portuguese, Spanish, and Thai Versions

Version 6.0 of the Cross-Network PBMC Processing SOP is available in Spanish (South American), Portuguese (Brazilian), and Thai effective April 30, 2018


Not all sections of the Cross-Network PBMC Processing SOP are needed in my laboratory. May we modify it?

The Laboratory Director is responsible for the implementation of this HANC SOP or laboratory-specific SOP and for ensuring that all appropriate personnel are trained. A laboratory-specific SOP must:
  • Include, without procedural modification, the portions of the current version of the Cross-Network PBMC Processing SOP that are used within the network site-affiliated laboratory
  • Reference the current version of the Cross-Network PBMC Processing SOP
Note: For laboratories processing HVTN PBMCs, the laboratory must use the HANC PBMC SOP as written or the HVTN-specific version of the HANC SOP.
 
To develop a laboratory-specific SOP, click on the appropriate version and it will open as a new document. Save it with the desired name and make the necessary changes.
 
 

What are the requirements for reporting results?

The requirements for reporting results have changed with version 3.0. Use of a PBMC Processing Worksheet and the Laboratory Data Management System (LDMS) is now required for all networks to track the timing of processing, calculations and documentation of problems that arise during processing. Be sure to review section 5 Reporting Results for the new requirements for use of a PBMC Processing Worksheet and the LDMS.

HVTN

The use of the HVTN PBMC Processing Worksheet in its entirety is required. If a protocol-specific PBMC worksheet is not required in the “HVTN Protocol Specific Processing Instructions,” the generic worksheet below and in Appendix A of the SOP may be used.
 

ACTG, HPTN, IMPAACT, MTN

The laboratory may use the HVTN PBMC Processing Worksheet, or modify it as appropriate for networ​k policy and laboratory’s procedures. If the lab chooses to develop its own PBMC Processing Worksheet and supplementary tracking materials (such as the LDMS, or a separate worksheet or log) the laboratory will use the guidelines in section 5 Reporting Results of the SOP.
 

Several PBMC Processing Worksheet templates that meet the requirements are provided below. To develop a laboratory-specific worksheet, click on the appropriate version and it will open as a new document. Save it with the desired name and make the necessary changes.


Where's the Example Manual Counting SOP that is referenced?

Below is the Example PBMC Hemacytometer Counting SOP. Note that this is an example - not a required - SOP. It must be tailored to laboratory-specific and/or study-specific requirements before it can be used.

To develop a laboratory-specific PBMC Hemacytometer Counting SOP, save (don't open) the file to your computer. Open the document, save it as a new file, and make the necessary changes.


Quick Guides

Before using the SOP for the first time, thoroughly review all sections that apply to your network(s) for important notes and details. When you are familiar with the procedures, you may use the quick guides found in the appendices.
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