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

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

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

ACTG/IMPAACT Guidelines for Shipping & Receiving Biological Substance_Category B Specimens
Dec. 01, 2023, v4.0, LTC SOP 022

ACTG/IMPAACT Specimen Shipment Notice
Nov. 01, 2023

ACTG/IMPAACT Shipment Checklist
Nov. 01, 2023

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

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

Shipping Demonstration Video

Shipping Addresses and Instructions

Shipment Evaluation Procedure
May 12, 2022, v8.0

Appendix 1: Shipment Evaluation Form
May 12, 2022 v8.0, LTC SOP 073 Appendix 1 Form

BRI CDC Import Permit
Issued: Aug 24, 2020

NICHD Repository Shipping SOP
13Sep2024; v7.0

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

Cerebral Spinal Fluid
06Jan2025, v2.0, LTC SOP 067

Cold Chain Guidelines
Cross-Network Cold Chain Guidelines

Dried Blood Spot (DBS) Card Preparation Standard Operating Procedure
23May2023, v3.0, LTC SOP 055

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

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

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

Leukopak PBMC Processing Standard Operating Procedure
22Nov2022; v2.0; LTC SOP 61

• PBMC Processing Worksheet Example 1 (Leukopak PBMC Processing Standard Operating Procedure APPENDIX 1)
• PBMC Processing Worksheet Example 2 (Leukopak PBMC Processing Standard Operating Procedure APPENDIX 2)

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

Male Genital Secretion Collection and Processing
Aug 10, 2015, v2.0, LTC SOP 015

PAXgene® Blood RNA Tube Collection, Processing and Storage Policy
Mar 17, 2025, v1.0, LTC SOP 076

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

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

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

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

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

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