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. 2014 Oct;6(20):2721-32.
doi: 10.4155/bio.14.139.

Adding value to antiretroviral proficiency testing

Robin DiFrancesco  1 , Charlene R Taylor, Susan L Rosenkranz, Kelly M Tooley, Poonam G Pande, Suzanne M Siminski, Richard W Jenny, Gene D Morse
Affiliations

Adding value to antiretroviral proficiency testing

Robin DiFrancesco et al. Bioanalysis. 2014 Oct.

Abstract

Background: Clinical trial specimens tested for antiretroviral (ARV) concentrations often require compliance with Clinical Laboratory Improvement Act and/or the Food and Drug Administration bioanalytical guidance.

Experimental: The Clinical Pharmacology Quality Assurance Program (CPQA) designed 8 proficiency testing (PT) rounds over 4 years to assess precision, specificity and stability.

Results: Ten laboratories provided blinded proficiency data to support continued acceptable precision of ARV methods. Specificity samples identified little bias for individual methods; hemolyzed (87%) and lipemic (86%) results were ≤ 10% of their control results. Stability was established for ARVs in plasma at -70°C for 2.5-3.6 years.

Conclusion: PT provided by the CPQA assured continued acceptability of individual laboratory assay performances for precision and specificity, and obtained ARV stability during long term storage.

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Figure 1
Adding more value to proficiency testing rounds.
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