False tacrolimus concentrations measured by antibody-conjugated magnetic immunoassay in liver transplant patient: 2 case reports and literature review

Safe use of tacrolimus relies on regular whole-blood drug monitoring. Of the methods used to assess whole-blood tacrolimus concentration, antibody-conjugated magnetic immunoassay is mostly used for therapeutic drug monitoring because it requires only a minimal sample preparation and no pretreatment procedure. However, several cases recently have been reported in which abnormally false elevated tacrolimus concentrations were measured by antibody-conjugated magnetic immunoassay (>15 ng/mL), despite the absence of clinical symptoms. We present 2 cases of falsely detected tacrolimus concentrations that did not show abnormally high values within the therapeutic range. Whole-blood tacrolimus concentrations obtained by antibody-conjugated magnetic immunoassay showed well-controlled concentrations (approximately 2-8 ng/mL), whereas those obtained by another immunoassay and in washed erythrocytes were below the assay range (< 1.2 ng/mL). Thus, antibody-conjugated magnetic immunoassay can elicit falsely positive results of tacrolimus concentrations, even though they are within the therapeutic range.