Sedat Abusoglu,Duygu Eryavuz Onmaz,Gulsum Abusoglu et al.
Sedat Abusoglu et al.
Objectives: Recent studies have shown that derangements in kynurenine pathway metabolite levels are associated with various pathologies such as neurodegenerative diseases, schizophrenia, depression, bipolar disorder, rheu...
Evaluating the performance of the Roche FEN2 fentanyl immunoassay and its clinical implementation: The role of LDT-based mass spectrometry testing [0.03%]
罗氏芬诺香啡太尼免疫分析的性能评估及其临床应用:基于实验室检验的质谱检测的作用
Marlen Menlyadiev,Raymond T Suhandynata,Kyle Lund et al.
Marlen Menlyadiev et al.
Introduction: While laboratory-developed tests (LDTs) using liquid chromatography tandem mass spectrometry (LC-MS/MS) are widely employed to support the development of FDA-cleared drug immunoassays, their significance in ...
Comparison of two highly sensitive benzodiazepine immunoassay lab developed tests for urine drug testing in clinical specimens [0.03%]
两种高灵敏度苯二氮卓类药物免疫分析法在临床标本中的对比研究
Kyle Lund,Marlen Menlyadiev,Kyunghoon Lee et al.
Kyle Lund et al.
Background: The VALID Act is a legislative effort that, if enacted, would alter the regulatory requirements of laboratory developed tests (LDTs) used for clinical testing in the United States. Benzodiazepines, which are p...
Quantitative tandem mass spectrometry in the clinical laboratory: Regulation and opportunity for validation of laboratory developed tests [0.03%]
定量串联质谱在临床实验室中的监管和验证实验室开发检测的机会
Judith A Stone,J Grace van der Gugten
Judith A Stone
Tandem mass spectrometry is an important analytical tool for clinical laboratories, but tests developed and validated in-house (laboratory developed tests, or LDTs) require special consideration. In late 2022, the forecast for United States...
Mass spectrometry quantitation of immunosuppressive drugs in clinical specimens using online solid-phase extraction and accurate-mass full scan-single ion monitoring [0.03%]
在线固相萃取结合高精度全扫描-单离子监测免疫抑制药物的临床样本定量分析方法:基于质量测定法
Priscilla S-W Yeung,Paige Miller,Tran Bao Lai-Nyugen et al.
Priscilla S-W Yeung et al.
Introduction: Therapeutic drug monitoring (TDM) of immunosuppressants is essential for optimal care of transplant patients. Immunoassays and liquid chromatography-mass spectrometry (LC-MS) are the most commonly used metho...
A case series evaluation of comprehensive drug testing in the pediatric acute care setting [0.03%]
儿科急诊综合药物检测案例系列评估
Kara L Lynch
Kara L Lynch
Introduction: Drug testing typically follows a one-size-fits-all approach that is inadequate in some clinical scenarios, such as child maltreatment, neglect, and unintentional drug exposure. Results from immunoassay-based...
Brian N Kelly
Brian N Kelly
The regulatory landscape of laboratory developed tests: Past, present, and a perspective on the future [0.03%]
实验室检测试剂监管现状、现况及未来展望
Melissa M Budelier,Jacqueline A Hubbard
Melissa M Budelier
Pre-analytical sample handling standardization for reliable measurement of metabolites and lipids in LC-MS-based clinical research [0.03%]
基于LC-MS的临床研究中可靠测量代谢物和脂质的前分析样本处理标准化
A Sens,S Rischke,L Hahnefeld et al.
A Sens et al.
The emerging disciplines of lipidomics and metabolomics show great potential for the discovery of diagnostic biomarkers, but appropriate pre-analytical sample-handling procedures are critical because several analytes are prone to ex vivo di...