Adding value to antiretroviral proficiency testing
Related Experiment Video
Updated: Apr 20, 2026
Rapid Screening of HIV Reverse Transcriptase and Integrase Inhibitors
Published on: April 9, 2014
Robin DiFrancesco1, Charlene R Taylor, Susan L Rosenkranz
1HIV Clinical Pharmacology Research Program, Translational Pharmacology Research Core, New York State Center of Excellence in Bioinformatics & Life Sciences; School of Pharmacy & Pharmaceutical Sciences, University at Buffalo, Buffalo, NY USA.
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.
