Eun Hee Lee (Presenter)
Green Cross Laoboratories
Bio: I am a president of Green Cross Laboratories. I am a medical doctor majored laboratory medicine. I grauated school of medicine, Ewha womens university in South Korea on 1986.
Authorship: Eunhee Lee, Juhee Park, Jungsun Han, Songhyeon Yang, Euna Park, Seungman Park
Green Cross Laboratories, South Korea
| Short Abstract We developed liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for serum total testosterone. The accuracy, imprecision, limit of quantification (LOQ), and linearity of LC-MS/MS method were validated and compared with enzyme chemiluminescence immunoassay(ECLIA) and radioimmunoassay(RIA) methods. The accuracy, precision, LOQ, and linearity were excellent. Especially the accuracy for LC-MS/MS method was better than ECLIA and RIA methods. The LC-MS/MS method showed excellent performance compared with ECLIA and RIA. |
Long Abstract
Introduction: Radio-immunoassay is unsatisfactory for measuring serum total testosterone in women and children due to an inaccuracy in low concentration and potential possibility of cross reactivity. The LC-MS/MS method can be an alternative technology for measuring in the clinical laboratory. We developed and validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method.
Methods: The accuracy, imprecision, limit of quantification, and linearity of LC-MS/MS method were validated. We also compared that performance to ECLIA (Roche diagnostics, Germany) and RIA (Asbach Medical Products, Germany) using standard reference material (SRM).
Results: The recovery rate of LC-MS/MS method for National Institute of Standard and Technology (NIST) standard reference material (SRM) 971 were 100.1% for low concentration and 101.8% for high. The recovery rate of ECLIA and RIA for low concentration were 95.8% and 104.1%, and those for high concentration were 206.9% and 97.2%, respectively. The imprecision (CVs) of LC-MS/MS method were 3.2%, 2.3%, and 2% for low (0.159 ng/mL), mid (5.146 ng/mL), and high (8.130 ng/mL) concentration, respectively. The low limit of quantitation was 0.5 ng/mL. The calibration curve over concentration range from 0.05 ng/mL to 50 ng/mL was linear and reproducible (R2=0.9999).
Conclusions: We developed an accurate and sensitive LC-MS/MS assay for serum total testosterone. The LC-MS/MS method showed better performance than ECLIA and RIA.
References & Acknowledgements:
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