Establishing Syva Methotrexate Assay on Siemens Dimension RxL Analyzer: Experience in a Tertiary Cancer Care Laboratory

Chavan, Preeti; Bhat, Vivek; Karmore, Ashwadeep; Mohite, Rajani; Waykar, Swati; Kadu, Hemali

doi:10.4103/0974-2727.187923

Cited by 3 publications

(7 citation statements)

References 3 publications

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“…The values are significantly less than the manufacturers' and Bio-Rad unity worldwide report's provided values. Our precision was comparable to that of Chavan et al where levels 1 and 2 IQC were 0.60 and 2.8%, respectively [ 8 ]. It is, however, much lesser compared to the CV% range of 0.88-9.43 reported by Borgman et al [ 6 ] and 5.31-8.43 reported by Suh-Lailam et al [ 19 ].…”

Section: Discussionsupporting

confidence: 88%

“…The estimated LoD in all cases was lower than the manufacturers' claimed 0. [8,22,20]. Thus, our assay sensitivity was corroborated by previous studies.…”

Section: Shi Et Al Studied the Syva Emit Mtx Assay In Siemenssupporting

confidence: 89%

“…The manufacturer claims a lower linearity level of 0.3 mmol/L. However, our study estimated linearity from 0.07 to 1.99 mmol/L, which is more sensitive than that reported by Chavan et al (0.17-1.98 mmol/L) [8]. Lim et al reported a lower linearity limit of 0.6 mmol/L ranging up to 1.92 mmol/L with R 2 =0.955, similar to our study [20].…”

Section: Shi Et Al Studied the Syva Emit Mtx Assay In Siemenscontrasting

confidence: 83%

“…The estimated LoD in all cases was lower than the manufacturers' claimed 0.3 mmol/L. Our study estimated LoD of 0.07 mmo/L, while Wilson et al estimated 0.20 mmol/L, Chavan et al had 0.17 mmol/L, and Lim et al estimated 0.06 mmol/L [ 8 , 22 , 20 ]. Thus, our assay sensitivity was corroborated by previous studies.…”

Section: Discussioncontrasting

confidence: 62%

“…The analytical range for the Syva EMIT MTX assay is 0.3-2 mmol/L. However, in clinical practice, the levels of MTX are frequently maintained below this limit for leucovorin rescue and need to be measured [ 8 ]. Low-end precision performances are very important for laboratory methods, especially when their results have clinical significance at these levels [ 9 ].…”

Section: Introductionmentioning

confidence: 99%

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Processing Validation Metrics of Syva Enzyme-Multiplied Immunoassay Technique (EMIT) Methotrexate Assay for Beckman Coulter System

Nayak¹,

Patel²,

Nanda³

et al. 2023

Cureus

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Background: High-dose methotrexate (HDMTX), defined as a dose greater than 500 mg/m 2 , is used to treat a variety of cancers; and though safe, it can cause major toxicity. Syva enzyme-multiplied immunoassay technique (EMIT) methotrexate (MTX) assay (Gurgaon, India: Siemens Healthcare Diagnostics Ltd.) uses a homogeneous enzyme immunoassay method. Low-end precision performances are very important for laboratory methods, especially when their results have clinical significance at these levels.Methodology: A total of 25 replicates (five replicates per run, for five runs) were analyzed for profiling. Precision, accuracy, linearity, limit of blank, limit of detection, and limit of quantification were determined using existing guidelines. Imprecision profile and limit of quantitation (LoQ) at 10% were determined by fitting data with hyperbolic regression.Results: The coefficient of variation percentage (CV%) for low, mid, and high-level internal quality control (IQC) was 1.25%, 3.45%, and 1.55%, respectively. Similarly, estimated bias was -4.58%, -3.54%, -7.21% for each level. The assay linearity was maintained from a range of 0.041-1.993 mmol/L with an R 2 of 0.959. The limit of detection was estimated to be 0.07 mmol/L. Conclusion: Syva EMIT MTX assay can be precisely and accurately used to measure low levels of serum methotrexate at levels lower than claimed by the manufacturer, aiding in the monitoring of toxicity in patients.

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Section: Discussionsupporting

confidence: 88%

“…The estimated LoD in all cases was lower than the manufacturers' claimed 0. [8,22,20]. Thus, our assay sensitivity was corroborated by previous studies.…”

Section: Shi Et Al Studied the Syva Emit Mtx Assay In Siemenssupporting

confidence: 89%

Section: Shi Et Al Studied the Syva Emit Mtx Assay In Siemenscontrasting

confidence: 83%

Section: Discussioncontrasting

confidence: 62%

Section: Introductionmentioning

confidence: 99%

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Processing Validation Metrics of Syva Enzyme-Multiplied Immunoassay Technique (EMIT) Methotrexate Assay for Beckman Coulter System

Nayak¹,

Patel²,

Nanda³

et al. 2023

Cureus

View full text Add to dashboard Cite

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A successful compartmental approach for the treatment of breast cancer brain metastases

Nguyen

Angeli

Darrouzain

et al. 2019

Cancer Chemother Pharmacol

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High‐dose methotrexate pharmacokinetics and its impact on prognosis of paediatric acute lymphoblastic leukaemia patients: A population pharmacokinetic study

Chen,

Li,

et al. 2024

Br J Haematol

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SummaryThis study delivers a comprehensive evaluation of the efficacy and pharmacokinetics of high‐dose methotrexate (HDMTX) in a large cohort of Chinese paediatric acute lymphoblastic leukaemia patients. A total of 533 patients were included in the prognostic analysis. An association was observed between lower steady‐state MTX concentrations (<56 μmol/L) and poorer outcomes in intermediate‐/high‐risk (IR/HR) patients. Subgroup analysis further revealed that this relationship between concentrations and prognosis was even more pronounced in patients with MLL rearrangements. In contrast, such an association did not emerge within the low‐risk patient group. Additionally, utilizing population pharmacokinetic modelling (6051 concentrations from 815 patients), we identified the significant impact of physiological maturation, estimated glomerular filtration rate, sex and concurrent dasatinib administration on MTX pharmacokinetics. Simulation‐based recommendations include a reduced dosage regimen for those with renal insufficiency and a specific 200 mg/kg dosage for infants under 1 year. The findings underscore the critical role of HDMTX in treating IR/HR populations and call for a reassessment of its application in lower‐risk groups. An individualized pharmacokinetic dosage regimen could achieve the most optimal results, ensuring the largest proportion of steady‐state concentrations within the optimal range.

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Establishing Syva Methotrexate Assay on Siemens Dimension RxL Analyzer: Experience in a Tertiary Cancer Care Laboratory

Cited by 3 publications

References 3 publications

Processing Validation Metrics of Syva Enzyme-Multiplied Immunoassay Technique (EMIT) Methotrexate Assay for Beckman Coulter System

Processing Validation Metrics of Syva Enzyme-Multiplied Immunoassay Technique (EMIT) Methotrexate Assay for Beckman Coulter System

A successful compartmental approach for the treatment of breast cancer brain metastases

High‐dose methotrexate pharmacokinetics and its impact on prognosis of paediatric acute lymphoblastic leukaemia patients: A population pharmacokinetic study

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