Liquid Chromatography–Tandem Mass Spectrometry or Automated Immunoassays: What Are the Future Trends in Therapeutic Drug Monitoring?

Brandhorst, Gunnar; Oellerich, Michael; Maine, Gregory T.; Taylor, Paul J.; Veen, Gerhard; Wallemacq, Pierre

doi:10.1373/clinchem.2011.167189

Cited by 54 publications

(37 citation statements)

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“…Therapeutic drug monitoring is integral to the standard of care for a growing number of clinical disciplines, including solid organ transplantation (1), oncology (2, 3), infectious disease management (4 – 6), and psychiatry (7). Although these tests provide valuable information that improves patient care by facilitating the maximization of the therapeutic effect and minimization of untoward side effects, the laboratory costs involved in performing these tests— either by MS or immunoassay—are not trivial (8, 9). …”

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confidence: 99%

Alternative Calibration Strategies for the Clinical Laboratory: Application to Nortriptyline Therapeutic Drug Monitoring

et al. 2013

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BACKGROUND The addition of a calibration curve with every run is both time-consuming and expensive for clinical mass spectrometry assays. We present alternative calibration strategies that eliminate the need for a calibration curve except as required by laboratory regulations. METHODS We measured serum nortriptyline concentrations prospectively in 68 patients on 16 days over a 2-month period using a method employing calibration schemes that relied on the measurement of the response ratio (RR) corrected by the response factor (RF), i.e., a measurement of the RR for an equimolar mixture of the analyte and internal standard. Measurements were taken with contemporaneous RF (cRF) measurements as well as sporadic RF (sRF) measurements. The measurements with these alternative calibration schemes were compared against the clinical results obtained by interpolation on a calibration curve, and those differences were evaluated for analytical and clinical significance. RESULTS The differences between the values measured by cRF and sRF calibration and interpolation on a calibration curve were not significant (P = 0.088 and P = 0.091, respectively). Both the cRF-and sRF-based calibration results demonstrated a low mean bias against the calibration curve interpolations of 3.69% (95% CI, −15.8% to 23.2%) and 3.11% (95% CI, −16.4% to 22.6%), respectively. When these results were classified as subtherapeutic, therapeutic, or supratherapeutic, there was categorical agreement in 95.6% of the cRF calibration results and 94.1% of the sRF results. CONCLUSIONS cRF and sRF calibration in a clinically validated liquid chromatography–tandem mass spectrometry assay yields results that are analytically and clinically commensurate to those produced by interpolation with a calibration curve.

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Alternative Calibration Strategies for the Clinical Laboratory: Application to Nortriptyline Therapeutic Drug Monitoring

et al. 2013

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“…More specifically, to make LC-MS/MS technology as convenient as possible for lab technicians, ideally a sort of "black box" LC-MS/MS unit should be integrated in existing chemistry analyzers. One suggestion that has been made in this regard is the development of an analyzing module with hybrid technology combining the characteristics of immunoassays and tandem MS 124 , potentially omitting the need for LC.…”

Section: Automationmentioning

confidence: 99%

Opening the toolbox of alternative sampling strategies in clinical routine: A key-role for (LC-)MS/MS

Velghe

Capiau

Stove

2016

TrAC Trends in Analytical Chemistry

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Alternative sampling strategies such as dried blood sampling, liquid microsampling and the sampling of oral fluid, hair, meconium, interstitial fluid, sweat, exhaled breath condensate and sputum offer interesting opportunities for many applications in clinical routine. Here, we provide an overview of different applications, with special attention to the pivotal role of LC-MS/MS in facilitating analysis of the collected matrices. Covered clinical fields include newborn screening, endocrinology, therapeutic drug monitoring, phenotyping, toxicology, proteomics and metabolomics. Furthermore, specific advantages, challenges and limitations of each alternative sampling strategy are discussed, along with recent advances and future trends that may contribute to routine implementation of these sampling strategies. Given the development of many recent potentially valuable clinical applications, the possibility of home sampling and the opportunity to obtain information that is hard to procure using traditional sampling, a well-balanced role for alternative sampling strategies can be envisaged in patient healthcare in the (near) future.

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“…High-performance liquid chromatography (HPLC) (Taylor, 2005), capillary electrophoresis (EC) (Kataoka et al, 1998; Pucci and Raggi, 2005), liquid or gas chromatography (LC or GC) coupled with UV spectroscopy (Serralheiro et al, 2013), or mass spectrometry (MS or eventually tandem MS, MS/MS) (Maurer and Peters, 2005) have been extensively applied to different varieties of pharmaceutical and abuse drugs with excellent performances (Brandhorst et al, 2012), with optimized protocols for the simultaneous separation and analysis of multiple drugs at a time, such as in the case of co-medication therapy, or simply, when analysis of a drug and its metabolite(s) is necessary.…”

Section: Traditional Tdm Pipelinementioning

confidence: 99%

On the Slow Diffusion of Point-of-Care Systems in Therapeutic Drug Monitoring

Sanavio

Krol

2015

Front. Bioeng. Biotechnol.

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Recent advancements in point-of-care (PoC) technologies show great transformative promises for personalized preventative and predictive medicine. However, fields like therapeutic drug monitoring (TDM), that first allowed for personalized treatment of patients’ disease, still lag behind in the widespread application of PoC devices for monitoring of patients. Surprisingly, very few applications in commonly monitored drugs, such as anti-epileptics, are paving the way for a PoC approach to patient therapy monitoring compared to other fields like intensive care cardiac markers monitoring, glycemic controls in diabetes, or bench-top hematological parameters analysis at the local drug store. Such delay in the development of portable fast clinically effective drug monitoring devices is in our opinion due more to an inertial drag on the pervasiveness of these new devices into the clinical field than a lack of technical capability. At the same time, some very promising technologies failed in the clinical practice for inadequate understanding of the outcome parameters necessary for a relevant technological breakthrough that has superior clinical performance. We hope, by over-viewing both TDM practice and its yet unmet needs and latest advancement in micro- and nanotechnology applications to PoC clinical devices, to help bridging the two communities, the one exploiting analytical technologies and the one mastering the most advanced techniques, into translating existing and forthcoming technologies in effective devices.

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Liquid Chromatography–Tandem Mass Spectrometry or Automated Immunoassays: What Are the Future Trends in Therapeutic Drug Monitoring?

Cited by 54 publications

References 0 publications

Alternative Calibration Strategies for the Clinical Laboratory: Application to Nortriptyline Therapeutic Drug Monitoring

Alternative Calibration Strategies for the Clinical Laboratory: Application to Nortriptyline Therapeutic Drug Monitoring

Opening the toolbox of alternative sampling strategies in clinical routine: A key-role for (LC-)MS/MS

On the Slow Diffusion of Point-of-Care Systems in Therapeutic Drug Monitoring

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