Adding value to antiretroviral proficiency testing
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2014 |
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| Erschienen: |
2014 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:6 |
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| Enthalten in: |
Bioanalysis - 6(2014), 20 vom: 12. Okt., Seite 2721-32 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
DiFrancesco, Robin [VerfasserIn] |
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| Links: |
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| Themen: |
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| Anmerkungen: |
Date Completed 06.07.2015 Date Revised 13.11.2018 published: Print Citation Status MEDLINE |
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| doi: |
10.4155/bio.14.139 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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NLM243696345 |
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| 520 | |a 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 | ||
| 520 | |a EXPERIMENTAL: The Clinical Pharmacology Quality Assurance Program (CPQA) designed 8 proficiency testing (PT) rounds over 4 years to assess precision, specificity and stability | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, N.I.H., Extramural | |
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| 700 | 1 | |a Rosenkranz, Susan L |e verfasserin |4 aut | |
| 700 | 1 | |a Tooley, Kelly M |e verfasserin |4 aut | |
| 700 | 1 | |a Pande, Poonam G |e verfasserin |4 aut | |
| 700 | 1 | |a Siminski, Suzanne M |e verfasserin |4 aut | |
| 700 | 1 | |a Jenny, Richard W |e verfasserin |4 aut | |
| 700 | 1 | |a Morse, Gene D |e verfasserin |4 aut | |
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