Performance characteristics between TDx®FLx and TBA™-25FR for the therapeutic drug monitoring of methotrexateReportar como inadecuado

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Journal of Pharmaceutical Health Care and Sciences

, 2:7

First Online: 08 March 2016Received: 25 August 2015Accepted: 01 March 2016DOI: 10.1186-s40780-016-0042-y

Cite this article as: Kaneko, T., Fujioka, T., Suzuki, Y. et al. J Pharm Health Care Sci 2016 2: 7. doi:10.1186-s40780-016-0042-y


BackgroundHigh-dose methotrexate HDMTX is used in the treatment of certain malignancies, including leptomeningeal metastases, systemic non-Hodgkin lymphoma, acute lymphoblastic leukemia, and osteosarcoma. High circulating levels of methotrexate can cause severe myelosuppression. The present study aimed to examine the differences in plasma MTX concentrations measured by two immunoassay systems currently available in the Japanese market, a TDX-FLX analyzer and a TBA-25FR analyzer.

MethodsA total of 69 plasma samples from 16 patients were assayed by a fluorescence polarization immunoassay technique using a TDx-FLx analyzer Abbott Diagnostics, Chicago, Illinois, U.S.A. and a homogeneous enzyme immunoassay technique using a TBA-25FR analyzer Toshiba Medical Systems, Tokyo, Japan.

ResultsAssay results were very consistent between the two systems, with good correlation 24 h after the start of treatment TBA-25FR = 1.06・TDX-FLX, −1.31, r = 0.99, 48 h after the start of treatment TBA-25FR = 1.00・TDX-FLX, +0.027, r > 0.99, and 72 h after the start of treatment TBA-25FR = 1.09・TDX-FLX, +0.011, r > 0.99.

ConclusionsThe calibration curve spanned one order of magnitude with a linear working range from the lowest to the highest standard. The standard deviations show the excellent reproducibility of repeated measurements at each standard level for both immunoassay systems. However, when using the TBA-25FR, it is necessary to perform measurements in the low-concentration range with care.

KeywordsMethotrexate High-dose Methotrexate Therapeutic drug monitoring Automatic immunoassay systems  Download fulltext PDF

Autor: Tetsuya Kaneko - Takashi Fujioka - Yosuke Suzuki - Yuhki Sato - Hiroki Itoh


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