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La Rivista Italiana della Medicina di Laboratorio 2020 Sep 06

DOI: 10.23736/S1825-859X.20.00070-5


language: Italian

Total aripiprazole dosage: setting up the method on the Cobas 8000 analyzer

Gianni PARIGI 1, 2, Lucia TERZUOLI 1, 2 , Arianna GORACCI 3, Serena PICCIONE 3, Costanza TADDEUCCI 3, Marina SALVI 1, Carlo SCAPELLATO 1, Brunetta PORCELLI 1, 2

1 UOC Laboratorio Patologia Clinica, Azienda Ospedaliera Universitaria Senese, Siena, Italia; 2 Dipartimento di Biotecnologie Mediche, Università di Siena, Siena, Italia; 3 Dipartimento di Medicina Molecolare e dello Sviluppo, Università di Siena, Siena, Italia


BACKGROUND: Aripiprazole is a novel antipsychotic drug combining partial agonist activity at dopamine- 2, dopamine-3, and serotonin-1A receptors with antagonist activity at serotonin-2A and D2 receptors. It has been observed beneficial effects in patients with schizophrenia, mood disorders, acute mania. Its determination in serum allows the clinician to evaluate the patient’s resistance/adherence to treatment. We have adapted a assay for quantitative measurement of total aripiprazole (aripiprazole+dehydroaripiprazole) for automation on clinical biochemical analyzer in order to provide faster results.
METHODS: Aripiprazole dosage has been performed using the MyCare Psychiatry Total Aripiprazole Assay kit on the Cobas 8000 analyzer, module C702. The six-point calibration curve (0-1000 ng / mL) was verified by three controls (50-200-700 ng / mL). For the evaluation of the analytical precision of the method we analyzed four samples obtained from a pool of serum samples from healthy subjects, with the addition of a known quantity of aripiprazole, with final concentrations equal to 200-100-40-20 ng/mL. For each sample, five measurements were carried out within the same day and for five consecutive days. To assess drug stability, aliquots of the same serum samples were stored for 7 and 15 days at +4 °C and -20 °C. The determination of the drug was performed on serum samples of 10 control subjects (without aripiprazole treatment) and 10 patients admitted under treatment of oral aripiprazole (5mg/day).
RESULTS: The method applied to the Cobas 8000 analyzer was linear in a range between 45 and 1000 ng/mL, as declared by the manufacturing company. Test resulted to be repeatable, both within the same day and in different days, with CV<10% for concentrations between 40-200 ng/mL. The test resulted also specific, in fact, in control subjects, aripiprazole values are <20 ng/mL. The drug was stable for 15 days when serum samples were maintained at both +4 °C and -20 °C.
CONCLUSIONS: The kit evaluated can be easily adapted to the Cobas 8000 analyzer. The monitoring of aripiprazole therapy can be execute quickly, it is fundamental for clinician to establish its efficacy and tolerability e to recognize the patient’s resistance/adherence to treatment.

KEY WORDS: Aripripazole; Antipsycotic drugs; Schizophrenia; Automated analyzer

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