Contraception · 2024
Comparison of etonogestrel bioanalytical assay results in plasma and serum within and across laboratories.
СтатьяСравнительное исследованиеПоддержка NIH: внешняя программаПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Sunagawa Shawnalyn W, Winchester Lee C, Wichman Christopher S, Avedissian Sean N, Erikson David W, Kernan Molly, Marzinke Mark A, Mykris Timothy M, Nandakumar Renu, Nolin Thomas D, Podany Anthony T, West Raymond E, Chen Beatrice A, Chappell Catherine A, Scarsi Kimberly K
Аннотация
OBJECTIVES: To compare performance characteristics of etonogestrel bioanalytical assays across laboratories.
STUDY DESIGN: We conducted a blinded, six laboratory study: five academic laboratories and one contracted commercial laboratory (reference). Etonogestrel was quantitated at each laboratory in both prepared serum and/or plasma samples of six known etonogestrel concentrations, and in 60 clinical samples from participants using etonogestrel-containing contraceptive methods. Per regulatory guidance, laboratory accuracy (percent bias) and precision (coefficient of variation; CV) were defined as ±15% of the nominal prepared concentration. We compared inter- and intra-laboratory agreement using a Kendall's Tau-B and Passing-Bablok regression.
RESULTS: For prepared samples, six laboratories analyzed serum and three laboratories analyzed plasma. All etonogestrel results were within ±15% for accuracy across all concentrations at four labs, including the reference laboratory. All labs demonstrated high precision, with only one occurrence of CV >15%. We found a positive association between prepared plasma and serum etonogestrel results (Kendall's Tau-B 0.80-0.88). For clinical samples, five laboratories analyzed serum and three laboratories analyzed plasma. Compared to the reference laboratory, inter-laboratory serum etonogestrel concentrations were positively correlated (Kendall's Tau-B 0.76-0.95). Proportional bias was observed, meaning individual lab etonogestrel results were consistently higher (slope estimates 0.78-0.95) or lower (slope estimates 1.05-1.10) than the reference laboratory. In clinical samples, intra-laboratory results were well associated between plasma and serum (Kendall's Tau-B 0.92-0.96).
CONCLUSIONS: There was good intra-laboratory agreement, irrespective of sample matrix; however, there was inter-laboratory variability in etonogestrel results. Differences between laboratory results should be considered when comparing etonogestrel pharmacokinetics across studies.
IMPLICATIONS: Etonogestrel concentrations were highly precise within each laboratory and were comparable between serum and plasma. Results varied between laboratories (5-28% higher to 5-9% lower compared to the Organon commercial laboratory). To minimize variability, we recommend utilizing a single laboratory that conducts routine proficiency testing for etonogestrel analysis within a study.
STUDY DESIGN: We conducted a blinded, six laboratory study: five academic laboratories and one contracted commercial laboratory (reference). Etonogestrel was quantitated at each laboratory in both prepared serum and/or plasma samples of six known etonogestrel concentrations, and in 60 clinical samples from participants using etonogestrel-containing contraceptive methods. Per regulatory guidance, laboratory accuracy (percent bias) and precision (coefficient of variation; CV) were defined as ±15% of the nominal prepared concentration. We compared inter- and intra-laboratory agreement using a Kendall's Tau-B and Passing-Bablok regression.
RESULTS: For prepared samples, six laboratories analyzed serum and three laboratories analyzed plasma. All etonogestrel results were within ±15% for accuracy across all concentrations at four labs, including the reference laboratory. All labs demonstrated high precision, with only one occurrence of CV >15%. We found a positive association between prepared plasma and serum etonogestrel results (Kendall's Tau-B 0.80-0.88). For clinical samples, five laboratories analyzed serum and three laboratories analyzed plasma. Compared to the reference laboratory, inter-laboratory serum etonogestrel concentrations were positively correlated (Kendall's Tau-B 0.76-0.95). Proportional bias was observed, meaning individual lab etonogestrel results were consistently higher (slope estimates 0.78-0.95) or lower (slope estimates 1.05-1.10) than the reference laboratory. In clinical samples, intra-laboratory results were well associated between plasma and serum (Kendall's Tau-B 0.92-0.96).
CONCLUSIONS: There was good intra-laboratory agreement, irrespective of sample matrix; however, there was inter-laboratory variability in etonogestrel results. Differences between laboratory results should be considered when comparing etonogestrel pharmacokinetics across studies.
IMPLICATIONS: Etonogestrel concentrations were highly precise within each laboratory and were comparable between serum and plasma. Results varied between laboratories (5-28% higher to 5-9% lower compared to the Organon commercial laboratory). To minimize variability, we recommend utilizing a single laboratory that conducts routine proficiency testing for etonogestrel analysis within a study.