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Related Experiment Video

Updated: Apr 20, 2026

Rapid Screening of HIV Reverse Transcriptase and Integrase Inhibitors

Rapid Screening of HIV Reverse Transcriptase and Integrase Inhibitors

Published on: April 9, 2014

Adding value to antiretroviral proficiency testing.

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.

|November 22, 2014

Summary

This summary is machine-generated.

Proficiency testing (PT) ensures accurate measurement of antiretroviral (ARV) drug levels in clinical trials. The Clinical Pharmacology Quality Assurance Program (CPQA) validated ARV method precision, specificity, and stability for reliable long-term storage.

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Area of Science:

Clinical Pharmacology
Laboratory Science
Drug Monitoring

Background:

Clinical trial specimens require adherence to regulatory bioanalytical guidance for antiretroviral (ARV) concentration testing.
Ensuring accuracy in ARV measurements is critical for patient safety and trial integrity.

Purpose of the Study:

To assess the precision, specificity, and stability of laboratory methods used for quantifying antiretroviral (ARV) drug concentrations.
To validate long-term storage conditions for ARV analytes in plasma specimens.

Main Methods:

The Clinical Pharmacology Quality Assurance Program (CPQA) conducted 8 rounds of proficiency testing (PT) over 4 years.
Ten laboratories participated, submitting blinded data on ARV assay performance.
Specificity, precision, and analyte stability were evaluated under defined conditions.

Main Results:

Proficiency testing data confirmed the continued acceptable precision of ARV measurement methods across participating laboratories.
Specificity testing revealed minimal bias for individual ARV assays.
Hemolyzed and lipemic samples showed minimal impact (≤ 10%) on results compared to controls.
Antiretrovirals (ARVs) demonstrated stability in plasma stored at -70°C for 2.5 to 3.6 years.

Conclusions:

Proficiency testing by CPQA confirmed the ongoing acceptability of laboratory assay performance for precision and specificity.
The study established the stability of ARVs during extended long-term storage, crucial for biobanking and retrospective analyses.
CPQA's PT program is vital for maintaining high-quality bioanalytical data in clinical trials involving antiretrovirals.