Evaluation of the Novel Methotrexate Architect Chemiluminescent Immunoassay: Clinical Impact on Pharmacokinetic Monitoring

Aumente, M.D.; López-Santamaría, Julia; Donoso-Rengifo, María Concepción; Reyes-Torres, I; Hervás, Pablo Montejano

doi:10.1097/ftd.0000000000000434

Cited by 9 publications

(5 citation statements)

References 22 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Meanwhile, it was very valuable to develop a selective, sensitive, rapid and simple method to determine the MTX concentration in children's plasma. There were several analytical methods for the determination of MTX plasma including fluorescence polarization immunoassay, 15,16 HPLC, 17 and LC-MS/MS. 18 To some extent, these previous methods were not going to deal with emergency situations (an abnormally high concentration of MTX plasma and large sample size measurement) the reason why these existed had their own drawbacks, including time-consuming requirement for plasma sample preparation, long-term chromatographic run, and low sensitivity.…”

Section: Introductionmentioning

confidence: 99%

<p>Development and Validation of UHPLC-MS/MS Assay for Therapeutic Drug Monitoring of High-dose Methotrexate in Children with Acute Lymphoblastic Leukemia</p>

Lian¹,

Lin

Cui³

et al. 2020

DDDT

View full text Add to dashboard Cite

Purpose Precise and timely detection of methotrexate (MTX) concentration played a key role in high-dose MTX individualization therapy in acute lymphoblastic leukemia (ALL) children to avoid serious adverse effects or nonresponse. This report described a sensibility and validation of ultra-high performance liquid chromatography tandem mass spectrometry (UHPLC-MS/MS) method for therapeutic drug monitoring (TDM) of methotrexate concentration in children’s plasma. Methods One-step protein precipitation of samples was accomplished by adding 200 μL of acetonitrile to 100 μL of plasma sample. The separation of plasma samples was carried out on a ZORBAX Eclipse Plus C18 Rapid Resolution HD column with gradient elution using a mobile phase constituted of acetonitrile and 1% formic acid. The detection was executed by electrospray ionization (ESI) of triple quadrupole tandem mass spectrometer (TQMS) in the multiple reaction monitoring (MRM) mode with the transitions m/z 455.2 → 307.9 for methotrexate and m/z 458.2 → 311.2 for IS, separately. Linear concentration range of the calibration curve was 44–11,000 nmol/L and 44 nmol/L was the lower limit of quantification. Results The methotrexate elution time was at 1.577 min, and the overall running time was only 3.3 min. The intra- and interday precision for all the analysis results was within 11.24%, and mean recoveries rate of methotrexate exceeded 87.98%. Conclusion The described and fully validated UHPLC-MS/MS method was successfully applied in clinical TDM after infusion of high-dose methotrexate 1–5 g/m 2 to 41 childpatients.

show abstract

Section: Introductionmentioning

confidence: 99%

<p>Development and Validation of UHPLC-MS/MS Assay for Therapeutic Drug Monitoring of High-dose Methotrexate in Children with Acute Lymphoblastic Leukemia</p>

Lian¹,

Lin

Cui³

et al. 2020

DDDT

View full text Add to dashboard Cite

show abstract

“…At present, many methods have been developed for monitoring the blood concentration of MTX, such as immunoassay, high-performance liquid chromatography (HPLC), and liquid chromatography–mass spectrometry (LC–MS). − However, these methods are costly, time-consuming, and complex. Thus, a rapid, simple, sensitive, specific, and low-cost method for monitoring the blood concentration of MTX is highly desirable.…”

mentioning

confidence: 99%

Selection of a Structure-Switching Aptamer for the Specific Methotrexate Detection

Wang

Zhang

et al. 2021

ACS Sens.

View full text Add to dashboard Cite

Methotrexate (MTX), a folate antagonist drug, has been widely used for treating various cancers. Since high-dose MTX treatment can cause unwanted serious side effects, tracking the blood concentration of MTX is essential for safe medication. However, available methods are often complex, time-consuming, and expensive. In this study, a highly selective DNA aptamer was selected for recognizing MTX based on a capture–systematic evolution of ligands by an exponential enrichment (C-SELEX) approach. Taking advantage of our selected MTX aptamer, we further unveil a novel structure-switching fluorescent sensor for the specific and rapid monitoring of MTX with good analytical performances (i.e., a linear detection range of 0.1–2 μM with a low detection limit (LOD) of 0.03 μM in buffer and a linear detection range of 0.5–10 μM with an LOD of 0.18 μM in 50% serum). Compared with conventional methods, this assay has great potential for detecting the blood concentration of MTX in clinical use. By coupling with other sensory techniques, our presented aptamer will potentially inspire the development of various sensors toward the monitoring of MTX.

show abstract

“…18 poorer imprecisions than those obtained in previously published results with ARK on Cobas c502, that itself had poorer imprecisions than MTX-ARCHI. 17 Several authors compared assays for MTX determination vs TDX or mass spectrometry 10,16,17,[19][20][21] but no recent comparison was performed with HPLC method. The maximal and minimal systematic bias (-0.075 and 0.002 mM) were observed for MTX-TDX and MTX-ARCHI, respectively, below 0.1 mM in accord with bias criteria.…”

Section: Discussionmentioning

confidence: 99%

Comparison of four immunoassays to an HPLC method for the therapeutic drug monitoring of methotrexate: Influence of the hydroxylated metabolite levels and impact on clinical threshold

Descoeur

Dupuy

Bargnoux

et al. 2021

J Oncol Pharm Pract

View full text Add to dashboard Cite

Objectives Methotrexate requires therapeutic drug monitoring in oncology because of narrow therapeutic index, especially the metabolite 7-hydroxymethotrexate exhibits nephrotoxicity. The goal of this study was to evaluate different assays and their impact on clinical decisions. Methods Following routine measurement with Abbott TDxFLx® assay (MTX-TDX), 62 samples were analysed on Architect®i1000 (MTX-ARCHI), Xpand® (ARK/XPND), Indiko® (ARK/INDI), and HPLC (MTX-HPLC) as the reference method. The influence of 7-hydroxymethotrexate was explored on ARK reagent to document the cause of the observed bias. ROC curves were built to study the impact of the method on the discharge thresholds for the patients at three levels. Results Total imprecision was below 2.60% for the methotrexate-ARCHI and close to 10% for both ARK assays for plasma pools. The correlation coefficients were 0.93, 0.93, 0.89 and 0.95, the Bland–Altman difference plot revealed a bias of 0.075, 0.037, 0.049 and –0.002, and the number of results exceeding the TE criteria of 0.1 µM was 17 (27%), 13 (21%), 15 (24%) and 15 (24%) for MTX-TDX, ARK/INDI, ARK/XPND and MTX-ARCHI, respectively. Cross reactivity with 7-hydroxymethotrexate was between 1 and 9%. Overestimation of methotrexate concentration was between –4% and +32%. The most robust clinical level was found to be the highest level (0.2 µM) with ROC curves. Conclusions The authors found the best results for imprecision with chemiluminescent microparticle immunoassay method on methotrexate-ARCHI, with bias below to the RICOS recommendations and best correlation to the reference method. Impact on the threshold values for clinical decision need to be clearly exposed to clinicians.

show abstract

Evaluation of the Novel Methotrexate Architect Chemiluminescent Immunoassay: Clinical Impact on Pharmacokinetic Monitoring

Cited by 9 publications

References 22 publications

<p>Development and Validation of UHPLC-MS/MS Assay for Therapeutic Drug Monitoring of High-dose Methotrexate in Children with Acute Lymphoblastic Leukemia</p>

<p>Development and Validation of UHPLC-MS/MS Assay for Therapeutic Drug Monitoring of High-dose Methotrexate in Children with Acute Lymphoblastic Leukemia</p>

Selection of a Structure-Switching Aptamer for the Specific Methotrexate Detection

Comparison of four immunoassays to an HPLC method for the therapeutic drug monitoring of methotrexate: Influence of the hydroxylated metabolite levels and impact on clinical threshold

Contact Info

Product

Resources

About