ACTG/IMPAACT Laboratory Manual

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ACTG/IMPAACT Laboratory Manual

The ACTG/IMPAACT Laboratory Manual is developed and maintained by the ACTG/IMPAACT Lab Tech Committee (LTC). Latest version of the Internet Explorer browser is highly recommended to ensure proper functionality of the HANC website and documents.

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Introduction

Letter of Introduction
09 Jan 2009, v1.0, LTC SOP 002

Quality Assurance Guidelines

Division of AIDS (DAIDS) Guidelines for Good Clinical Laboratory Practice (GCLP) Standards
Translations of GCLP Standards
English, Chinese, Khmer, Spanish, Portuguese, Thai, French
DAIDS Laboratory Audit Process
DAIDS Presentation, 2012
GCLP Online Refresher Course
Link to DAIDS Learning Management System - search catalog for "GCLP"
IMPAACT International Laboratory Quality Assurance Program
IMPAACT document: LAB 6008 V02_426
PBMC Lab Readiness Guide and Resources
12 Aug 2011, v2.0, LTC 058
Certification Requirements for Laboratories Participating in ACTG Studies
01 Jun 2004, v1.0, LTC SOP 010
How to Apply for a CLIA Certificate
Centers for Medicare & Medicaid Services informational website

Quality Assurance Providers

Clinical Pharmacology Quality Assurance (CPQA)
Quality assurance provider for clinical pharmacology
Immunology Quality Assurance (IQA)
Quality assurance provider for flow cytometry and PBMC cryopreservation
Patient Safety in International Laboratories (pSMILE)
Quality assurance provider for patient safety testing
United Kingdom National External Quality Assessment Service (UK NEQAS)
Provider of stabilized samples for flow cytometry proficiency testing at non-US labs
Virology Quality Assurance (VQA)
Quality assurance provider for virology

Safety Resources

Biosafety Orientation
See Section I: Introduction of Biosafety in Microbiological and Biomedical Laboratories (BMBL), 5th Edition
Biosafety Checklist
17 Feb 2012, v2.0, LTC SOP 007
pSMILE Safety Resources
There are many useful and up-to-date resources for general safety and biosafety on the pSMILE site.
Safety Inspection Checklist for BSL-3 Laboratories
Microbiology laboratory safety checklist developed by the CDC and posted on pSMILE site.
MERIFLUOR® Cryptosporidium/Giardia Assay
Link to SOP on Meridian Bioscience website

Specimen Shipping

BRI PassThrough Shipment Instructions
03 June 2016 version 1.1
Cat. B Shipping SOP
30 Jun 2016, v3.0 LTC SOP 022
Cat. B Shipment Checklist
30 Jun 2016 v3.0
Guidelines for Shipment and Receipt of Category A Infectious Specimens and Dangerous Goods
04 Mar 2008, v1.0, LTC SOP 021
Instructions for Overnight Shipment
02 May 2008, v2.0, LTC SOP 023
International Shipment Checklist
01 Sept 2015 version 3
Shipping Demonstration
Shipping Addresses and Instructions
Shipping Notice (Ambient, Refrigerated, Frozen) Worksheet Only
08 April 2015, v4.0 Worksheet Only
Shipping Notice (Ambient, Refrigerated, or Frozen)
08 April 2015, v4.0
How to Apply for a Centers for Disease Control and Prevention (CDC) Import Permit
Shipment Evaluation SOP
31 Aug 2015, v7.0, LTC SOP 073
Appendix A: Shipment Evaluation Form
31 Aug 2015 v7.0, LTC SOP 073 Appendix A Form
Appendix B: Shipment Evaluation Reference Sheet
31 Aug 2015 V7.0, LTC SOP 073 Appendix B
Apperndix C: Shipement Evaluation Score Table
31 Aug 2015 v7.0, LTC SOP 073 Appendix C

Specimen Processing

Peripheral Blood Mononuclear Cells (PBMC) Cryopreservation
Cross-Network PBMC Processing SOP
Adipose Tissue Biopsy SOP
13 Nov 2015, v1.0, LTC SOP 072
Cerebral Spinal Fluid
08 April 2013, v1.0, LTC SOP 067
Dried Blood Spots (DBS) Processing
19 Mar 2012, v2.0, LTC SOP 055
Dried PBMC Pellet Processing (LDMS Specimen Code BLD/EDTA or ACD/PEL)
29 Nov 2012, v.4.0, LTC SOP 059
GALT SOP
21 Apr 2014, v1.0, LTC SOP 069
Female Genital Secretion Collection and Processing
12 Aug 2015, v2.0, LTC SOP 016
Male Genital Secretion Collection and Processing
10 Aug 2015, v2.0, LTC SOP 015
Lumbar Puncture with Sprotte Needle
A video on lumbar puncture using a Sprotte needle, by David B. Clifford, MD.
Lymph Node Biopsy SOP
15 July 2014, LTC SOP 071
Umbilical Cord Blood Collection
18 Jan 2013, v1.0, LTC SOP 063
PBMC Thawing
26 Nov 2012, v1.0, LTC SOP 065
PBMC Isolation from Leukapheresis
11 Jun 2013, v1.0, LTC SOP 061
Appendix B: Leukapheresis Processing Record
11 Jun 2013, v1.0 LTC SOP 061 Appendix B
Appendix C: Leukapheresis Processing Worksheet v1.4
11 Jun 2013, v1.0, LTC SOP 061 Appendix C. Link to IQA site. New Version
Preparation of PHA-Stimulated Uninfected Donor PBMCs
01 Oct 2004, v1.0, LTC SOP 036
Serum Processing from Whole Blood
05 Feb 2016, v1.0, LTC SOP 066

Immunology

3-Color Advanced Flow
26 Mar 2002, v3.0, LTC SOP 024
Sample Analysis of Histogram (3-color)
26 Apr 2002, v3.0, LTC SOP 025
CD38 Quantitation Assay
07 May 2004, v2.0, LTC SOP 026
Dye Dilution (CFSE) Proliferation
12 Apr 2004, v1.0, LTC SOP 030
Ki-67 Proliferation
19 Oct 2001, v1.0, LTC SOP 031

Virology

HIV Qualitative PBMC Macrococulture Assay
01 May 2004, v2.0, LTC SOP 039
Perkin-Elmer (NEN Life Sciences) HIV-1 p24 Antigen ELISA
21 May 2004, v2.0, LTC SOP 045
Celera ViroSeq HIV-1 Genotyping
01 Jun 2004, v2.0 LTC SOP 053
Bayer TruGene HIV-1 Genotyping
21 May 2004, v2.0, LTC SOP 054
Roche Amplicor HIV-1 DNA Test, v1.0
28 Apr 2004, v2.0, LTC SOP 047

Tuberculosis

Collection Storage Transport Expectorated Sputum SOP
01 July 2014, v1.0, LTC SOP 070
Sputum Processing for Storage
16 Oct 2015, v1.0 LTC SOP 074
Study31/A5349 TB Harmonized Key Elements
02 July 2015, v1.9

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