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.
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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. Version 4.0 of the Cross-Network PBMC Processing SOP is available effective October 3, 2011. Laboratories where the staff speak English are required to use version 4.0 no later than October 13, 2011. Laboratories where the staff don't speak English may continue to use version 2.0 until new translations are available.
Note: There are just two changes from v3.0 to v4.0. The first is a typographical correction; the second is a change to shipping requirements for IMPAACT labs (see p. 28).
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, save (don't open) the Template (rtf)to your computer. Open the document, save it as a new file, 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. Laboratories with staff that don't speak English may continue to use version 2.0 of the worksheet until translations are available.
ACTG, HPTN, HPTN, MTN
The laboratory may use the HVTN PBMC Processing Worksheet, or modify it as appropriate for that 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, 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.