ReviewJournal of mass spectrometry and advances in the clinical lab2023
Quantitative tandem mass spectrometry in the clinical laboratory: Regulation and opportunity for validation of laboratory developed tests.
Review in Journal of mass spectrometry and advances in the clinical lab, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
8 citing papers in PubMed, 13 citations in OpenAlex.
- A rime-like Au-Pt nanostructured film and polyaniline-MIP based electrochemical sensor for olanzapine detection.Mikrochimica acta · 2026Article
- Quantification of eight clinically relevant serum adrenal steroids in infants by UHPLC-APCI-MS/MS.Journal of mass spectrometry and advances in the clinical lab · 2025Article
- Comparative analysis of three thyroglobulin immunoassays: analytical performance and clinical implications.Thyroid research · 2025Article
- Current Analytical Methods and Challenges for the Clinical Diagnosis of Invasive Pulmonary Aspergillosis Infection.Journal of fungi (Basel, Switzerland) · 2024Review
- An end-to-end deep learning method for mass spectrometry data analysis to reveal disease-specific metabolic profiles.Nature communications · 2024Article
- Patient safety and healthcare quality of U.S. laboratory developed tests (LDTs) in the AI/ML era of precision medicine.Frontiers in molecular biosciences · 2024Article
- Article
- Advances in the Clinical Application of High-throughput Proteomics.Exploratory research and hypothesis in medicineArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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 (U.S.) federal regulation of LDTs changed unexpectedly when the VALID Act was not passed by the U.S. Congress. This Act would have modified the Food and Drug Administration's (FDA's) role to increase regulatory oversight for LDT providers. In this revised context, we review optimization of quantitative mass spectrometry LDT validation and suggest avenues other than an additional FDA mandate to achieve uniform best practice. Common challenges, logistical barriers, and recommendations for easing the burden of best-quality quantitative mass spectrometry LDT method validation are discussed.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.