Laboratory Guidance Documents

The Laboratory Manual was created by the ACTG/IMPAACT Laboratory Technologist Committee and collaborating investigators in June 2004. It was created for the purpose of having a consensus method to help standardize assay performance across all laboratories participating in a particular study.
Access the ACTG/IMPAACT Laboratory Manual on the HANC website

Additional Guidance Documents

• VQA HIV RNA Copy Control (200cp/mL) Implementation Plan - 17 Dec 2010
• Cross-Network PBMC Processing SOP
• Viral Load Platforms for HIV Clinical Trials - 6 Feb 2009
• IMPAACT Guidance: Template Protocol Language for Determination of HIV Status – 10 Nov 2021
• Definitions for HIV Transmission in Breastfed Infants - 11 Dec 2007
• Application for Import Permit for Biological Substances for UCT PK Samples
• Annotated Example of Application for Import Permit for Biological Substances
• Please note - as of November 2016, the South African Department of Health has requested that all import permit applications be accompanied by either an MTA or a letter from the country of origin, indicating their knowledge about the export. Please contact Sandra Castel (sandra.castel@uct.ac.za) with any questions.

IMPAACT Laboratory Center Communications to IMPAACT Laboratories

• Transition from the Xpert MTB/RIF to Xpert MTB/RIF Ultra - 19 July 2018
  • Appendix 1 - April 2018
• New Vendor for IMPAACT/ACTG Network-approved FBS: Nucleus Biologics - 19 July 2018
• Required use of the LDMS Preloads or Quick Add Templates - 11 May 2018
• IMPAACT/ACTG Memo: Mycobacteriology Laboratory Sourcebook for Harmonization and Support of Tuberculosis (TB) Clinical Trials - 24 April 2018
• Required Use of the LDMS Reagent Logging Module - 23 February 2018
  • Web LDMS Reagant Log QR Guide
  • Windows LDMS Reagant Log QR Guide
• Document Retention Policy - 23 February 2018