Adding value to antiretroviral proficiency testing

Papers of special note have been highlighted as: • of interest; •• of considerable interest

References

• 1 US DHHS. Medicare, Medicaid and CLIA programs; regulations implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA)–HCFA. Final rule with comment period. Fed. Regist. 57(40), 7002–7186 (1992).
  MedlineGoogle Scholar
• 2 DiFrancesco R, Rosenkranz SL, Taylor CR et al. Clinical Pharmacology Quality Assurance (CPQA) Program: Longitudinal Analysis of Antiretroviral (ARV) Proficiency Testing for International Laboratories. Ther. Drug Monit. 35(5), 631–642 (2013).
  MedlineGoogle Scholar
• 3 Holland DT, DiFrancesco R, Stone J, Hamzeh F, Connor JD, Morse GD. Adult and Pediatric AIDS Clinical Trials Group Pharmacology Laboratory Committees, Pediatric AIDS Clinical Trials Group. Quality assurance program for clinical measurement of antiretrovirals: AIDS clinical trials group proficiency testing program for pediatric and adult pharmacology laboratories. Antimicrob. Agents Chemother. 48(3), 824–831 (2004).
  Medline CASGoogle Scholar
• 4 Holland DT, DiFrancesco R, Connor JD, Morse GD. Quality assurance program for pharmacokinetic assay of antiretrovirals: ACTG proficiency testing for pediatric and adult pharmacology support laboratories, 2003 to 2004: a requirement for therapeutic drug monitoring. Ther. Drug Monit. 28(3), 367–374 (2006).
  Medline CASGoogle Scholar
• 5 Aarnoutse RE, Verweij-van Wissen CP, van Ewijk-Beneken Kolmer EW et al. International interlaboratory quality control program for measurement of antiretroviral drugs in plasma. Antimicrob. Agents Chemother. 46(3), 884–886 (2002).
  Medline CASGoogle Scholar
• 6 Droste JA, Aarnoutse RE, Koopmans PP, Hekster YA, Burger DM. Evaluation of antiretroviral drug measurements by an interlaboratory quality control program. J Acquir. Immune Defic. Syndr. 32(3), 287–291 (2003).
  MedlineGoogle Scholar
• 7 Burger D, Teulen M, Eerland J, Harteveld A, Aarnoutse R, Touw D. The International Interlaboratory Quality Control Program for Measurement of Antiretroviral Drugs in Plasma: a global proficiency testing program. Ther. Drug Monit. 33(2), 239–243 (2011).
  Medline CASGoogle Scholar
• 8 EMA. Guideline on Bioanalytical Method Validation. EMA, Committee for Medicinal Products for Human Use, London, UK (2011).• Specificity in the presence of common abnormalities is required by the EMA guidelines. Hemolysis is one plasma abnormality that these guidelines specifically list.
  Google Scholar
• 9 US FDA. Guidance for Industry: Bioanalytical Method Validation. US Department of Health and Human Services, US FDA, Center for Drug Evaluation and Research. Rockville, MD, USA (2001).• The US FDA requires that the intra-assay and inter-assay precision of a validated bioanalytical method be ≤15% and that stability be proven for the intended storage conditions.
  Google Scholar
• 10 Savoie N, Garofolo F, van Amsterdam P et al. White Paper on Recent Issues in Regulated Bioanalysis & Global Harmonization of Bioanalytical Guidance. Bioanalysis 2(12), 1945–1960 (2010).
  CASGoogle Scholar
• 11 Berube E, Taillon M, Furtado M, Garofolo F. Impact of sample hemolysis on drug stability in regulated bioanalysis. Bioanalysis 3(18), 2097–2105 (2011).
  CASGoogle Scholar
• 12 Dimeski G. Interference Testing. Clin Biochem Rev 29(1), S43–S48 (2008).
  MedlineGoogle Scholar
• 13 Lindegardh N, Hanpithakpong W, Kamanikom B et al. Major pitfalls in the measurement of artemisinin derivatives in plasma in clinical studies. J Chromatogr. B Analyt. Technol. Biomed Life Sci. 876(1), 54–60 (2008).
  Medline CASGoogle Scholar
• 14 Chin C, Zhang ZP, Karnes HT. A study of matrix effects on an LC/MS/MS assay for olanzapine and desmethyl olanzapine. J Pharm Biomed Anal. 35(5), 1149–1167 (2004).
  Medline CASGoogle Scholar
• 15 Hughes N, Bajaj N, Fan J, Wong E. Assessing matrix effects of hemolyzed samples in bioanalysis. Bioanalysis 1(6), 1057–1066 (2009).
  CASGoogle Scholar
• 16 Cembrowski GS, Carey RN. Adding value to proficiency testing programs. Clin. Chem. 46(1), 7–8 (2000).
  Medline CASGoogle Scholar
• 17 DiFrancesco R, Tooley K, Rosenkranz SL et al. Clinical Pharmacology Quality Assurance for HIV and Related Infectious Diseases Research. Clin. Pharmacol. Ther. 93(6), 479–482 (2013).• The Clinical Pharmacology Quality Assurance and Quality Control program provides support to ensure the integrity of clinical trial pharmacology results. A proficiency testing program specifically ensures that participating laboratories are accurately quantitating antiretrovirals of current interest.
  Medline CASGoogle Scholar
• 18 Kazmierczak SC. Hemolysis, Lipemia, and High Bilirubin: Effect on Laboratory Tests. In: Accurate Results in the Clinical Laboratory: A Guide to Error Detection and Correction. Dasgupta A, Sepulveda JL (Eds). Elsevier Inc, Waltham MA, USA, 53–62 (2013).
  Google Scholar