ACTG/IMPAACT Laboratory Resources

ACTG/IMPAACT Laboratory Manual

The ACTG/IMPAACT Lab Technologist Committee develops and maintains a variety of laboratory SOPs intended for use by laboratories affiliated with the ACTG and IMPAACT networks.

View archived documents and SOPs

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

Mycobacteriology Laboratory Sourcebook for Harmonization and Support of Tuberculosis (TB) Clinical Trials
v1.0 March 07, 2018, v1.0

Mycobacteriology Laboratory Checklists
March 07, 2018, Checklists from the TB Sourcebook v1.0

Quality Indicator Report Form
March 07, 2018, Sample QI Monthly Report Form

Quality Assurance Guidelines
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
Feb 17, 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
Feb 27, 2017 version 2.0

Cat. B Shipping SOP
Jun 30, 2016, v3.0 LTC SOP 022

Cat. B Shipment Checklist
Jun 30, 2016 v3.0

Guidelines for Shipment and Receipt of Category A Infectious Specimens and Dangerous Goods
Mar 04, 2008, v1.0, LTC SOP 021

CDC Import Permit Resources

Instructions for Overnight Shipment
May 02, 2008, v2.0, LTC SOP 023

International Shipment Checklist
Sept 01, 2015 version 3

Microscope Slides and Paraffin Block Storage and Handling SOP
February 22, 2018, v1.0, LTC SOP 075

Shipping Demonstration Video

Shipping Addresses and Instructions

Shipping Notice (Ambient, Refrigerated, Frozen) Worksheet Only
April 08, 2015, v4.0 Worksheet Only

Shipping Notice (Ambient, Refrigerated, or Frozen)
April 08, 2015, v4.0

Shipment Evaluation SOP
Aug 31, 2015, v7.0, LTC SOP 073

Appendix A: Shipment Evaluation Form
Aug 31, 2015 v7.0, LTC SOP 073 Appendix A Form

Appendix B: Shipment Evaluation Reference Sheet
Aug 31, 2015 V7.0, LTC SOP 073 Appendix B

Appendix C: Shipment Evaluation Score Table
Aug 31, 2015 v7.0, LTC SOP 073 Appendix C

BRI CDC Import Permit
Issued: Aug 24, 2020

NICHD Repository Shipping SOP
June 19, 2020, v5.0

Specimen Processing

Adipose Tissue Biopsy SOP
Nov 13, 2015, v1.0, LTC SOP 072

Cerebral Spinal Fluid
April 08, 2013, v1.0, LTC SOP 067

Cold Chain Guidelines
Cross-Network Cold Chain Guidelines

Dried Blood Spots (DBS) Processing
Mar 19, 2012, v2.0, LTC SOP 055

Dried PBMC Pellet Processing (LDMS Specimen Code BLD/EDTA or ACD/PEL)
Nov 29, 2012, v.4.0, LTC SOP 059

Apr 21, 2014, v1.0, LTC SOP 069

Female Genital Secretion Collection and Processing
Aug 12, 2015, v2.0, LTC SOP 016

Male Genital Secretion Collection and Processing
Aug 10, 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
July 15, 2014, LTC SOP 071

Umbilical Cord Blood Collection
Jan 18, 2013, v1.0, LTC SOP 063

Peripheral Blood Mononuclear Cells (PBMC) Cryopreservation
Cross-Network PBMC Processing SOP

PBMC Thawing
Nov 26, 2012, v1.0, LTC SOP 065

PBMC Isolation from Leukapheresis
Jun 11, 2013, v1.0, LTC SOP 061

Preparation of PHA-Stimulated Uninfected Donor PBMCs
Oct 01, 2004, v1.0, LTC SOP 036

Serum Processing from Whole Blood
Feb 05, 2016, v1.0, LTC SOP 066

Appendix A: Leukapheresis Processing Worksheet Example
Jul 11, 2019, v2.0, LTC SOP 061 Appendix A.

Appendix B: Leukapheresis Processing Record Example
Jul 11, 2019, v2.0, LTC SOP 061 Appendix B.


3-Color Advanced Flow
Mar 26, 2002, v3.0, LTC SOP 024

Sample Analysis of Histogram (3-color)
Apr 26, 2002, v3.0, LTC SOP 025

CD38 Quantitation Assay
May 07, 2004, v2.0, LTC SOP 026

Dye Dilution (CFSE) Proliferation
Apr 12, 2004, v1.0, LTC SOP 030

Ki-67 Proliferation
Oct 19, 2001, v1.0, LTC SOP 031


Perkin-Elmer (NEN Life Sciences) HIV-1 p24 Antigen ELISA
May 21, 2004, v2.0, LTC SOP 045

Celera ViroSeq HIV-1 Genotyping
Jun 01, 2004, v2.0, LTC SOP 053

Bayer TruGene HIV-1 Genotyping
May 21, 2004, v2.0, LTC SOP 054

Roche Amplicor HIV-1 DNA Test, v1.0
Apr 28, 2004, v2.0, LTC SOP 047


Collection Storage Transport Expectorated Sputum SOP
July 01, 2014, v1.0, LTC SOP 070

Sputum Processing for Storage
Oct 16, 2015, v1.0 LTC SOP 074

Study31/A5349 TB Harmonized Key Elements
July 02, 2015, v1.9

Anemometer Memo
March 09, 2018, TBLDWG memo

Site Tuberculosis Infection Control SOP
March 17, 2017, v1.0, ACTG SOP 160

TB Sourcebook
Mycobacteriology Laboratory Sourcebook for Harmonization and Support of Tuberculosis (TB) Clinical Trials

QFT Plus SOP v1.0
Requirements for collection, processing and storage of specimens for use with the QIAGEN QFT-Plus IGRA

QFT-Plus Blood Collection and Processing Timepoint Collection Form
August 13, 2019

QFT Incubation Time Calculator

FBS Ordering Procedure

Note: This information applies to ACTG and IMPAACT laboratories only.

Heat-inactivated fetal bovine serum (FBS) is being held on reserve at Sigma Aldrich. Please note that the VQA and IQA validation testing of these lots for use in culture experiments and for Peripheral Blood Mononuclear Cell (PBMC) cryopreservation have been completed. A certificate of analysis of each company's lot is available upon request.

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Recommended for U.S. and non-U.S. sites

Sigma Aldrich
Batch #:20E043
FBS Heat Inactivated US origin

As of April 19, 2021 a total of 400 (500 mL) of the current batch of heat inactivated FBS remain on reserve with Sigma Aldrich. The price per bottle of $389.00 will be extended through April 30, 2022. This price includes shipping and handling and dry ice fees for a minimum order of 6 bottles (shipping charges will be added for orders less than 6 bottles).

Placing Orders:

Call: 1-800-220-0195
Fax: 1-800-579-1850

Please have the following information ready when placing your order:

Quote #: 22794126
Material #: F4135-500ml
Batch #: 20E043
Serum Expiration: May, 2025

View the list of ordering contacts for non-U.S. sites

If you have any specific questions relating to this lot of FBS, please contact Sheila Kohlman at Sigma Aldrich at +1-314 -289-6007 / +1-314-873-9935.

FBS Certificate of Analysis LOT 20E043

If you would like a copy of a Certificate of Analysis from a previous lot, please contact Tyler Brown.

Recommended for South Africa sites

Gamma-irradiated Gemini Gamma-irradiated Gemini GemCellTM Bio Products
Lot # A88E82G
FBS Gamma Irradiated Heat-Inactivated US Origin

***Filtration would be recommended after thawing and before aliquoting out.

To order the FBS product, e-mail BARC procurement department:

Attention: Lionel Baeta and May Meyile
Cc: Peter Meewes
Product name and code: BARC Gem cell Bovine Serum, lot number A88E82G
Price per 500/ml bottle: R12455.00

The South African Department of Agriculture now requires that Fetal Bovine Serum (FBS) of foreign origin be gamma irradiated prior to import and use.

The ACTG in collaboration with BARC South Africa identified a lot of gamma-irradiated FBS. The Immunology Quality Assessment Center (IQA) assessed the suitability of the FBS lot for use. The results were acceptable and the ACTG approved the use of this lot of FBS for processing ACTG specimens.

Lot Information:
Catalogue Number: 100-500
Lot Number: A88E82G
Expiration Date: March 2020
FBS Certificate of Analysis

Shipping Information

Please verify the Shipping Contact Information and Instructions as indicated on the Protocol LPC and/or lab information on the FSTRF Portal.

View our shipping demonstration video

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Specimen Type: HIV RNA - Adults

Shipping Address
Quest Diagnostics Incorporated
Attn: Special Studies
1715 Twin Springs Road
Baltimore, MD 21227

Phone: 410.314.1551
Fax: 443.833.3862

LDMS#: 33

Other Instructions

Sites must register with Quest prior to shipping.
To register, site should contact: Larry Hirsch, 410.314.1547

Ship overnight Monday through Wednesday preferred; Thursday OK.
Mark Thursday shipments as “OK to deliver on Saturday”.

Include appropriate Quest Requisition and LDMS manifest.
Email electronic LDMS manifest to:

Specimen Type: NIAID Repository Specimens

Shipping Address
Biomedical Research Institute
c/o John C. Ward, Jr.
9410 Key West Avenue, First Floor
Rockville, MD 20850

Phone: 301.881.7636
Fax: 301.770.9811

LDMS#: 999

Other Instructions

Instructions for shipping ACTG specimens to BRI (ACTG password required)
Instructions for shipping IMPAACT specimens to BRI (IMPAACT password required) 

Specimen Type: NICHD Repository Specimens

Shipping Address
Fisher Bioservices - NICHD Repository
ATTN: Ryan Patrick Babay
625 Lofstrand Lane
Rockville, MD 20850 USA

Phone: 301.354.0325
Fax: 301.838.9753

LDMS#: 243

Other Instructions

For shipping instructions to Fisher BioServices, use the most recent NICHD Repository Shipping SOP found under Shipping Guidelines.