Objective To compare the differences in results of valproic acid plasma concentration detected by fluorescence immunochromatographic assay (FICA) versus HPLC, and to evaluate the clinical applicability of FICA.

Methods The performance of FICA for detecting valproic acid plasma concentration was validated. The concentrations of valproic acid in the plasma of 50 patients were measured by FICA and HPLC, respectively. Statistical analyses including the Shapiro-Wilk test, Bland-Altman plot, and Passing-Bablok regression were employed for consistency evaluation.

Results The performance validation met the requirements. The Bland-Altman plot indicated poor agreement between the two methods. The Spearman correlation coefficient was 0.918 (P<0.01). The Passing-Bablok regression equation wasY=1.186X-11.311 (n=47), with an intercept of -11.311 (95% CI: -16.512 to -4.111) and a slope of 1.186 (95% CI: 1.055 to 1.314).

Conclusion The consistency between FICA and HPLC for determining valproic acid plasma concentration is suboptimal, and the two methods are not interchangeable. FICA can serve as a tool for emergency screening and as a contingency supplement to HPLC.

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