The Roche Total Mycophenolic Acid® assay: An application protocol for the ABX Pentra 400 analyzer and comparison with LC–MS in children with idiopathic nephrotic syndrome

Abstract

Background

For TDM of mycophenolate acid (MPA), the Roche Total Mycophenolic Acid® assay based on the inhibition of recombinant inosine monophosphate dehydrogenase (IMPDH) has been shown to be a simple and reliable alternative to chromatographic methods. We have adapted this assay on the ABX Pentra 400 analyzer (HORIBA).

Objective

To investigate the analytical performances of the Roche Total Mycophenolic Acid® assay on the ABX Pentra 400 and to compare it to an LC-MS method using samples from children with nephrotic syndrome treated with mycophenolate mofetil (MMF).

Material and methods

Configuration of the open-channel on the ABX Pentra 400 was based on the Roche MPA assay package insert. Precision was determined as described in the CLSI protocol EP5-A2. Comparison with the LC-MS method was performed using 356 plasma samples from 42 children with nephrotic syndrome (8 h pharmacokinetic profiles).

Results

The enzymatic assay demonstrated high precision. The %CV for Within Run Imprecision ranged from 5.5% at 1.2 mg/L to 1.5% at 14.1 mg/L and Total Imprecision ranged from 9.3% to 2.5%. The method comparison with plasma samples from children yielded overall a good correlation and a good agreement between both methods. The Passing Bablok regression analysis showed the following results: [Roche MPA assay]=1.058 [MPA LC-MS] −0.06; rho=0.996.

Conclusion

The Roche Total Mycophenolic Acid® assay is adaptable to the ABX Pentra 400 analyzer, and demonstrates accurate and precise measurement of MPA in plasma obtained from children with nephrotic syndrome.

Highlights

• •

  Adaptation of the Roche Total Mycophenolic Acid® assay to the Pentra 400 analyzer.

• •

  Comparison with LC-MS in children with idiopathic nephrotic syndrome.

• •

  Therapeutic drug monitoring of mycophenolate mofetil.