Different Approaches for Quality Assurance Programs of Peripheral Blood Monononuclear Cell Cryoprese

1
Different Approaches for Quality Assurance
Programs of Peripheral Blood Monononuclear Cell
Cryopreservation

• Adriana Weinberg
• Dec 2006

2
Rationale for establishing PBMC cryopreservation
QA programs

• Increasing use of cryopreserved PBMC for
  immunological and other assays.
• Functional immunological assay results are
  unreliable when PBMC viability lt70
• Weinberg A et al. Clin Diag Lab Immunol
  20007714l
• Multiple challenges to achieve viability 70
  and to ensure recovery of an adequate number of
  cells.

3
What can a QA program contribute?

• Identify laboratories/sites that can adequately
  perform the procedure
• Determine the quality of the samples on an
  ongoing basis
• Offer technical advise to laboratories that are
  not performing well
• Provide SOPs
• Offer training to laboratories unfamiliar with
  the cryopreservation technique

4
Objective

• Compare different approaches to cryopreservation
  QA programs

5

• AACTG cryo QA
• Offered by the IQA in collaboration with the
  AACTG
• Participation 20 ? 43 domestic sites
• Sites sent 2 samples (HIV and HIV-) q 4 mo
• Samples were analyzed by the IQA and results were
  reported to the sites
• After a sequence of bad results (viabilitylt80
  and/or recoverylt80) sites were contacted to
  offer technical advise
• Initiated in 2000 ongoing

• International QA pilot
• Offered by the IQA in collaboration with the
  PACTG
• 4 ? 7 Brazilian sites
• Consensus SOP
• Send outs regular conference calls for
  discussion of the results and troubleshooting
• Wet lab training sessions at the IQA
• Initiated in 2003 ongoing

6

• A and C
• International QA
• Pilot
• B and D
• AACTG QA
• Arrows indicate wet lab workshops

7
International QA pilot AACTG QA
8
Shipment conditions and costs

• International samples were shipped with World
  Courier
• 2 to 3 days in transit
• Dry ice always in sufficient quantity at delivery
• 300/shipment

9
Conclusions

• Pro-active QA approach was associated with fast
  and steady improvement
• In contrast, there was no change in the overall
  quality of samples over time with a
  non-interventional approach
• The pro-active approach was more costly
• Cost benefit analyses will determine the optimal
  approach in individual circumstances

10
Acknowledments

• IQA
• Raul Louzao
• Tom Denny
• DAIDS
• Daniella Livnat

• NICHD/HPTN Brazil
• Jorge Pinto
• Marisa Mussi-Pinhata
• Maria Leticia Souza Cruz
• Andrea de Castro
• Maria de Fatima Huff
• Maria Cecilia Sucupira
• Celso Granato