ACTG/IMPAACT Laboratory Manual

Procedures and SOPs Links

The ACTG/IMPAACT Laboratory Manual is developed and maintained by the ACTG/IMPAACT Lab Tech Committee (LTC).

Please note that archived documents are no longer in standardized use by ACTG/IMPAACT, nor are they updated by the LTC. They are posted here as resources, and are for informational purposes only.

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
PBMC Lab Readiness Guide and Resources
12 Aug 2011, v2.0, LTC 058
Biosafety Orientation
See Section I: Introduction of Biosafety in Microbiological and Biomedical Laboratories (BMBL), 5th Edition
Biosafety Checklist
23 Apr 2004, v1.0, LTC SOP 007
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

Specimen Processing

Dried Blood Spots (DBS) Card Collection, Processing and Storage Procedures
11 Mar 2009, v1.1, LTC SOP 055
Male Genital Secretion Collection and Processing
20 Apr 2004, v1.0, LTC SOP 015
Female Genital Secretion Collection and Processing
26 Apr 2004, v1.0, LTC SOP 016
Pediatric Stool Processing for Ova and Parasites
25 Mar 2004, v1.0, LTC SOP 017
Excisional Lymph Node Biopsy
28 Aug 2000, v1.0, LTC SOP 14
Peripheral Blood Mononuclear Cells (PBMC) Cryopreservation
Cross-Network PBMC Processing SOP
Dried PBMC Pellet Processing
20 Apr 2009, v3.0, LTC SOP 059

Specimen Shipping

Guidelines for Shipment and Receipt of Category A Infectious Specimens and Dangerous Goods
04 Mar 2008, v1.0, LTC SOP 021
Guidelines for Shipment and Receipt of Category B Biological Substance Shipment
02 May 2008, v2.0, LTC SOP 022
Instructions for Overnight Shipment
02 May 2008, v2.0, LTC SOP 023
Ambient Specimen Shipment Notice
04 Jun 2007, v2.0, LTC SOP 056
Frozen Specimen Shipment Notice
04 Jun 2007, v2.0, LTC SOP 057
Shipping Demonstration
Shipping Addresses and Instructions
ACTG/IMPAACT Laboratory Holiday Closures
How to Apply for a Centers for Disease Control and Prevention (CDC) Import Permit

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
Apoptosis - Propidium Iodide (PI) Method
10 May 2004, v2.0, LTC SOP 027
Apoptosis- PACTG TUNEL Method
15 Mar 1999, v2.0, LTC SOP 028
Dye Dilution (CFSE) Proliferation
12 Apr 2004, v1.0, LTC SOP 030
Ki-67 Proliferation
19 Oct 2001, v1.0, LTC SOP 031

Virology

Preparation of PHA-Stimulated Uninfected Donor PBMCs
01 Oct 2004, v1.0, LTC SOP 036
HIV Qualitative PBMC Micrococulture Assay
01 Jun 2004, v2.0, LTC SOP 038
HIV Qualitative PBMC Macrococulture Assay
01 May 2004, v2.0, LTC SOP 039
HIV Qualitative Cerebrospinal Fluid (CSF)/PBMC Microculture Assay
22 Apr 2004, v1.0, LTC SOP 040
Perkin-Elmer (NEN Life Sciences) HIV-1 p24 Antigen ELISA
21 May 2004, v2.0, LTC SOP 045
Roche Amplicor HIV-1 DNA Test, v1.0
28 Apr 2004, v2.0, LTC SOP 047
Standard Roche Monitor Test, v1.5, Microwell Plate
18 May 2004, v2.0, LTC SOP 048
Standard Roche Monitor Test, Boom Extraction
29 Apr 2004, v1.0, LTC SOP 049
UltraSensitive Roche Monitor Test, v1.5, Microwell Plate
18 May 2004, v2.0, LTC SOP 050
UltraSensitive Roche Monitor Test, Boom Extraction
26 Apr 2004, v1.0, LTC SOP 051
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

Immunology Archives

Cytotoxic T-Lymphocyte Method 1
23 Sept 1996, v2.0, LTC SOP 032
Cytotoxic T-Lymphocyte Method 2
23 Sept 1996, v2.0, LTC SOP 033
Inducible Cytokine Whole Blood Method
25 Mar 2004, v2.0, LTC SOP 034
Lymphocyte Proliferation Assay
01 Feb 2000, v1.0, LTC SOP 029

Virology Archives

HIV Quantitative PBMC Micrococulture
01 Mat 2004, v2.0, LTC SOP 037
HIV Syncytium-Inducing (MT-2) Assay
29 April 2004, v2.0, LTC SOP 041
Ghost Cell Assay
10 May 2004, v2.0, LTC SOP 042
50% Tissue Culture Infectious Dose (TCID50) Determination Quantitation of Viable HIV-1 Virions in Culture Supernatants
25 May 2004, v1.0, LTC SOP 043
Beckman-Coulter HIV-1 p24 Antigen ELISA
21 May 2004, v2.0, 044
Zeptometrix RETRO-TEK HIV-1 p24 Antigen ELISA
21 May 2004, v2.0, LTC SOP 046
Biomerieux NucliSens HIV-1 QT System
29 Apr 2004, v.1.0, LTC SOP 052

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