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KMID : 1100820140040040187
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Laboratory Medicine Online
2014 Volume.4 No. 4 p.187 ~ p.190
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Performance Evaluation of the Syva EMIT Methotrexate Assay on the Toshiba 200FR NEO
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Lim Jin-Sook
Kim Ji-Myung
Sohn Yong-Hak
Koo Sun-Hoe
Kwon Kye-Chul
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Abstract
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Background: Methotrexate (MTX) is an antifolate antagonist that is widely used for treating various malignancies and non-malignant diseases. MTX levels should be monitored when used in high concentration to determine when to start leucovorin rescue. In this study, we evaluated the analytical performance of the EMIT Methotrexate Assay on a 200FR NEO Chemistry Analyzer (Toshiba Medical System Co., Japan) and compared it with Viva-E Drug Testing System (Siemens Healthcare, Germany).
Methods: According to the Clinical Laboratory and Standards Institute (CLSI) Evaluation Protocol (EP) 5-A2, three concentrations of the Liquichek Therapeutic Drug Monitoring Control (Bio-Rad Laboratories, USA) were analyzed twice a day for 20 days to monitor assay precision. The 200FR NEO and Viva-E instruments were compared using 40 patients' sera, according to CLSI EP9-A2. The linearity and carry-over rate were also evaluated.
Results: Between-run CVs for low-, medium-, and high-level controls were 4.9%, 0.9%, and 2.0%, respectively, whereas between-day CVs for low-, medium-, and high-level controls were 8.1%, 1.3%, and 3.5%, respectively. In the linearity test, the coefficient of determination (R2) was 0.98 (0.06-1.92 μmol/L). In the comparison study, R2 was 0.955, showing good correlation between the 200FR NEO and Viva-E instruments. The carry-over rate was 0.9%.
Conclusions: The EMIT assay showed good precision, linearity, and carry-over rate on the Toshiba 200FR. An excellent correlation was observed when comparing results obtained using the Toshiba and Viva-E instruments. In conclusion, the Syva EMIT MTX assay can be readily used for MTX monitoring on the Toshiba 200FR NEO.
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KEYWORD
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Methotrexate, EMIT, Therapeutic drug monitoring
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