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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Introduction

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

Quality Assurance Guidelines

Division of AIDS (DAIDS) Guidelines for Good Clinical Laboratory Practice (GCLP) Standards

GCLP Online Training
Link to DAIDS Learning Management System - search catalog for "GCLP"

DAIDS Laboratory Audit Process
DAIDS Presentation, 2012

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

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 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

GALT SOP
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

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

Tuberculosis

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

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

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

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

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

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 #:20H250
FBS Heat Inactivated US origin

As of March 3, 2022 a total of 138 (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
Email: research.teamserum@milliporesigma.com
Fax: 1-800-579-1850

Please have the following information ready when placing your order:

Quote #: 22794126
Material #: F4135-500ml
Batch #: 20H250
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 20H250

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
Email: DGXBaltimoreSpecialStudiesDepartment@questdiagnostics.com

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: DGXBaltimoreSpecialStudiesDepartment@questdiagnostics.com

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
USA

Phone: 301.881.7636
Fax: 301.770.9811
Email: brirepository@afbr-bri.com

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
Email: fbs.gbo@thermo.comryan.busa-babay@thermofisher.com

LDMS#: 243

Other Instructions

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