Clinical Mass Spectrometry—Achieving Prominence in Laboratory Medicine

Annesley, Thomas M.; Cooks, R. Graham; Herold, David A.; Hoofnagle, Andrew N.

doi:10.1373/clinchem.2015.251272

Cited by 29 publications

(9 citation statements)

References 20 publications

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“…Despite being the gold standard, LC-MS/MS is still quite demanding and the complexity of the entire system makes routine measurement a very substantial challenge and it is still limited to very few laboratories [16][17][18][19][20][21]. An immunoassay offers a simpler approach in contrast.…”

Section: Discussionmentioning

confidence: 99%

“…The introduction of LC-MS/MS allowed the use of isotope dilution mass spectrometry also in routine testing; however, the application of this technology is still very demanding and limited to very few laboratories at present [16][17][18][19][20] with The Reference Institute for Bioanalytics (RfB; Bonn, Germany) reporting only 2.7% (14/513) laboratories using LC-MS/MS in their last survey [21]. Consequently, immunoassays are still the mainstay of cortisol testing worldwide [22].…”

Section: Introductionmentioning

confidence: 99%

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Multicenter performance evaluation of a second generation cortisol assay

Vogeser¹,

Kratzsch

Bae

et al. 2017

Clinical Chemistry and Laboratory Medicine (CCLM)

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Background: Untreated disorders of the adrenocortical system, such as Cushing's or Addison's disease, can be fatal, and accurate quantification of a patient's cortisol levels is vital for diagnosis. The objective of this study was to assess the analytical performance of a new fullyautomated Elecsys ® Cortisol II assay (second generation) to measure cortisol levels in serum and saliva. Methods: Four European investigational sites assessed the intermediate precision and reproducibility of the Cortisol II assay (Roche Diagnostics) under routine conditions. Method comparisons of the Cortisol II assay vs. liquid chromatography-tandem mass spectrometry (LC-MS/MS), the gold standard for cortisol measurement, were performed. Cortisol reference ranges from three US sites were determined using samples from self-reported healthy individuals.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Multicenter performance evaluation of a second generation cortisol assay

Vogeser¹,

Kratzsch

Bae

et al. 2017

Clinical Chemistry and Laboratory Medicine (CCLM)

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“…As a result, non-comparable results are reported between laboratories, for example in the case of thyroglobulin [4,22]. MS-based technologies are the method of choice for tackling these issues and recently steps towards harmonized MS-based measurements have been reported [23][24][25]. This approach is also used by working groups and committees of the International Federation of Clinical Chemistry (IFCC) for standardization of protein measurands (www.ifcc.org/ifcc-scientific-division/).…”

Section: Clinical Chemistry Proteomics and Metrological Traceabilitymentioning

confidence: 99%

Proteoform Analysis to Fulfill Unmet Clinical Needs and Reach Global Standardization of Protein Measurands in Clinical Chemistry Proteomics

Burgt

Cobbaert

2018

Clinics in Laboratory Medicine

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In clinical testing of protein markers, structure variants of the measurand are often not taken into account. This heterogeneous character of protein measurands in immunoassays often renders test standardization impossible. Consequently, test results from different methods can lead to underdiagnosis or overdiagnosis and, thus, undertreatment or overtreatment of patients. The systematic structural analysis of protein isoforms has been coined proteoform profiling and is performed through mass spectrometry-based proteomics strategies. Knowledge on proteoforms allows refining existing uni-marker tests and moreover has great potential to contribute to the urgent need for new tests to predict prognosis and severity of diseases.

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“…Indeed, an entire issue of Clinical Chemistry was recently devoted to LC-MS and its role in laboratory medicine. Annesley et al introduce that special issue [14]. In HPLC, advances in column technology to offer a wider range of chemistries and smaller particle sizes coupled with instrumentation capable of operating at higher pressures (smaller particle size in columns causes increased back pressure) and greater retention time precision has allowed for greater resolution and separation of analytes and faster and more reproducible separations.…”

Section: Liquid Chromatography-mass Spectrometry (Lc-ms)mentioning

confidence: 99%

Can LC and LC-MS ever replace immunoassays?

Cross¹,

Hornshaw²

2016

J Appl Bioanal

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IntroductionThis review is not intended as a summary of research and development of immunoassays and liquid chromatography-mass spectrometry but rather as a brief summary of the pros and cons of each technology applied to the quantitative measurement of biomolecules primarily in biofluids. The ability to detect and quantitate biomolecules revolutionised science in the twentieth century and continues to this day. It allows scientists, for example, to conduct research to find and validate biomarkers, but has found its most prominent role in diagnostic applications where it is used to monitor the presence and levels of biomolecules in human samples for the diagnosis and monitoring of disease, in food and beverages to ensure food safety and authenticity and in the environment to monitor the presence and levels of contaminants of ground, waste and drinking water. The growth in personalised or precision medicine will be accompanied by an increased need to detect and quantify panels of biomolecules as biomarkers, as well as a range of drugs taken as treatment or as a measure to delay or prevent onset of disease, following the paradigm of the right drug for the right patient at the right time and importantly at the right dose. Increased health and safety regulations demand more testing of food and beverage and environmental samples. With increasing need for biomolecule detection and quantitation comes the demand for high-throughput, lower cost per sample analysis and more accurate results. Traditionally, immunoassays have been the technology of choice for the detection and quantitation of biomolecules. However, over the past two decades alternative technologies have been shown to offer a complementary role to immunoassays. Liquid chromatography-mass spectrometry (LC-MS) is one such technology and for some applications has been shown to offer a powerful alternative to immunoassays. With the increasing demands for routine biomolecule quantitation coming from a broad range of fields, are immunoassays the best solution to keep pace with the increased throughput needed, demand for lower cost per sample and improved accuracy Immunoassays have been the technology of choice for the analysis of biomolecules for many decades across a wide range of applications in research, diagnostics and infectious disease monitoring. There are good reasons for the wide adoption of immunoassays but even such a well established and characterised technique has limitations and as such investigators are looking at alternative technologies. One such alternative is liquid chromatography (LC) and, more specifically, liquid chromatography coupled with mass spectrometry (LC-MS). This article will review both immunoassay and LC and LC-MS technologies and methodologies and discuss the advantages and limitations of both approaches. In addition, the next developments that will need to occur before there is widespread adoption of LC and LC-MS technology preferentially over immunoassays will be examined.

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Clinical Mass Spectrometry—Achieving Prominence in Laboratory Medicine

Cited by 29 publications

References 20 publications

Multicenter performance evaluation of a second generation cortisol assay

Multicenter performance evaluation of a second generation cortisol assay

Proteoform Analysis to Fulfill Unmet Clinical Needs and Reach Global Standardization of Protein Measurands in Clinical Chemistry Proteomics

Can LC and LC-MS ever replace immunoassays?

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