Adding value to antiretroviral proficiency testing

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

doi:10.4155/bio.14.139

Adding value to antiretroviral proficiency testing

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

Pharmacy

SUNY Buffalo
Frontier Science & Technology Research Foundation
RTI International
New York State Department of Health

Research output: Contribution to journal › Article › peer-review

15 Scopus citations

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.

Original language	English
Pages (from-to)	2721-2732
Number of pages	12
Journal	Bioanalysis
Volume	6
Issue number	20
DOIs	https://doi.org/10.4155/bio.14.139
State	Published - Oct 1 2014

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10.4155/bio.14.139

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title = "Adding value to antiretroviral proficiency testing",

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.",

author = "Robin DiFrancesco and Taylor, \{Charlene R.\} and Rosenkranz, \{Susan L.\} and Tooley, \{Kelly M.\} and Pande, \{Poonam G.\} and Siminski, \{Suzanne M.\} and Jenny, \{Richard W.\} and Morse, \{Gene D.\}",

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doi = "10.4155/bio.14.139",

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volume = "6",

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T1 - Adding value to antiretroviral proficiency testing

AU - DiFrancesco, Robin

AU - Taylor, Charlene R.

AU - Rosenkranz, Susan L.

AU - Tooley, Kelly M.

AU - Pande, Poonam G.

AU - Siminski, Suzanne M.

AU - Jenny, Richard W.

AU - Morse, Gene D.

PY - 2014/10/1

Y1 - 2014/10/1

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AB - 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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JO - Bioanalysis

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Adding value to antiretroviral proficiency testing

Abstract

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