Article
Virology
J. R. Caldera, Hannah K. Gray, Omai B. Garner, Shangxin Yang
Summary: The 2022 monkeypox outbreak posed a challenge for clinical laboratories, but our institution was able to quickly implement in-house testing to meet the diagnostic needs. However, the FDA restricted the testing of rectal swabs despite evidence of its clinical utility. Our experience showed the importance of separate authorization for testing non-lesion samples, despite using the same platform. This article provides a review of LDT validations and highlights the challenges posed by FDA regulations.
JOURNAL OF CLINICAL VIROLOGY
(2023)
Review
Biochemistry & Molecular Biology
Steven Lichtenberg, Oxana P. Trifonova, Dmitry L. Maslov, Elena E. Balashova, Petr G. Lokhov
Summary: Laboratory-developed tests (LDTs) are a subset of in vitro diagnostic devices that are manufactured and used within a single laboratory. This review analyzes the current state and development prospects of LDTs based on metabolomics, comparing them with scientific metabolomics study. Legal aspects of LDT regulation in various regions are discussed, along with recommendations for further introducing metabolomic LDTs into practice.
Editorial Material
Medicine, General & Internal
Udit Singhal, Caroline Horrow, Aaron S. Kesselheim, Todd M. Morgan
Summary: Advances in precision medicine have led to changes in the availability of laboratory-developed tests. Stricter regulatory oversight may be necessary, and a proposed FDA rule could be an important initiative.
NEW ENGLAND JOURNAL OF MEDICINE
(2023)
Editorial Material
Cell Biology
Ali Motazedian, Mark A. Dawson
Summary: Chromosomal instability (CIN) is a crucial factor in cancer progression, and a new study has identified the MSL chromatin complex as a potential vulnerability for targeting CIN in cancer cells, providing a promising direction for further research and potential therapeutic development.
NATURE CELL BIOLOGY
(2021)
Editorial Material
Oncology
Kenneth Offit, Catherine M. Sharkey, Dina Green, Xiaohan Wu, Magan Trottier, Jada G. Hamilton, Michael F. Walsh, Sita Dandiker, Sami Belhadj, Steven M. Lipkin, Thelma Alessandra Sugranes, Michele Caggana, Zsofia K. Stadler
Summary: Cancer predictive or diagnostic assays, known as Laboratory-Developed Tests (LDTs), lack proper regulatory oversight in the US. They enter the market without review, potentially jeopardizing patient safety. The proposed Verifying Accurate Leading-edge IVCT Development Act aims to harmonize regulations and address concerns over the quality, utility, and safety of LDTs for cancer genomics.
JOURNAL OF CLINICAL ONCOLOGY
(2023)
Article
Environmental Sciences
Zhou Yongchao, Tang Lei, Zhang Wenming, Zhang Yiping, Fang Lei, Zhang Tuqiao
Summary: This study investigated the effects of iron-carbon (Fe-C) particles on the inhibition of sulfide in the liquid phase and hydrogen sulfide (H2S) and methyl mercaptan (MeSH) in the headspace in a laboratory-scale reactor simulating a gravity-flow sewer system. The results demonstrated that Fe-C particles significantly reduced sulfide in the liquid phase and inhibited the flux of H2S and MeSH in the headspace. Additionally, the study analyzed the microbial community structures in the sediment surface and water, showing that Fe-C particles inhibited sulfate-reducing bacteria (SRB) while promoting sulfur-oxidizing bacteria (SOB).
ENVIRONMENTAL RESEARCH
(2023)
Article
Hematology
Chris Gardiner, Marion Echenagucia, Robert C. Gosselin
Summary: Laboratory-developed tests (LDTs) are widely used in clinical hemostasis laboratories, but their regulation varies globally. Proposed changes to regulations have raised concerns about the future of LDTs in clinical laboratories. LDTs are still necessary in specialist clinical laboratories to fulfill unmet clinical needs, especially in lower middle-income countries.
SEMINARS IN THROMBOSIS AND HEMOSTASIS
(2023)
Article
Pathology
Jenna Rychert, Robert L. Schmidt, Jonathan R. Genzen
Summary: This study retrospectively analyzed test order data from an academic medical center system in 2021, and found that 3.9% of the tests were laboratory-developed tests (LDTs), which were more commonly ordered in outpatient settings and represented a higher proportion in cancer center tests.
AMERICAN JOURNAL OF CLINICAL PATHOLOGY
(2023)
Article
Pathology
Jaco J. Verweij
Summary: This paper discusses setting tailor-made performance characteristics for the validation of laboratory developed tests (LDTs) for the molecular diagnosis of intestinal parasitic infections in compliance with ISO 15189 guidelines, emphasizing the importance of maintaining these tests through daily monitoring and reassessment of the test set-up. It highlights the necessity of modifying or adding additional characteristics based on personal insights to achieve continuous quality improvement in diagnostic laboratory practice.
EXPERT REVIEW OF MOLECULAR DIAGNOSTICS
(2022)
Article
Chemistry, Multidisciplinary
Weihai Zhang, Heng Liu, Xingnan Qi, Yinye Yu, Yecheng Zhou, Yu Xia, Jieshun Cui, Yueqing Shi, Rui Chen, Hsing-Lin Wang
Summary: Highly efficient and stable all-inorganic CsPb0.7Sn0.3IBr2 perovskite solar cells (PSCs) were fabricated by introducing an appropriate amount of multifunctional zinc oxalate (ZnOX), resulting in perovskite films with low defect density, high crystallinity, and superior electronic properties.
Editorial Material
Medicine, General & Internal
Eli Y. Adashi, I. Glenn Cohen
Summary: This viewpoint examines the regulatory oversight of laboratory-developed tests, discusses recent policy changes, and explores potential future considerations.
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
(2022)
Article
Acoustics
A. L. Padilla-Ortiz, Felipe Orduna-Bustamante
Summary: Binaural speech intelligibility tests were conducted to compare results between remote and laboratory tests. The study found that remote test scores were consistent with laboratory results, with little dependence on headphone price and test conditions.
Article
Virology
Mary Nehring, Sierra Pugh, Tina Dihle, Emily Gallichotte, Terry Nett, Eric Weber, Christie Mayo, Lori Lynn, Greg Ebel, Bailey K. Fosdick, Sue VandeWoude
Summary: During the early stages of the SARS-CoV-2 epidemic, research laboratories focused on developing diagnostic testing for public health surveillance while commercial and public diagnostic laboratories validated large scale testing methods. This study compared laboratory-based and commercially available assays using serum samples from skilled nursing facilities, finding that laboratory-based assays had comparable or superior sensitivity and specificity. The study also emphasized the importance of research laboratory tests as adjuncts to commercial testing facilities in early disease outbreaks.
Article
Medical Laboratory Technology
Kevin C. Graden, Shannon A. Bennett, Sarah R. Delaney, Hillary E. Gill, Maria A. Willrich
Summary: Regulations for clinical laboratories in the United States are complex and require review and discussion to facilitate innovation. Increased regulation is important for maintaining high-quality care, but could result in additional costs and hinder innovation.
LABORATORY MEDICINE
(2021)
Article
Endocrinology & Metabolism
Carole Ann Spencer
Summary: This review highlights the development of laboratory thyroid tests over the past seven decades, from manual isotopically labeled iodine procedures to automated nonisotopic tests. The introduction of radioimmunoassay techniques and monoclonal antibody technology has played a crucial role in the evolution of thyroid testing. Despite improvements, current tests still face limitations in terms of numerical differences and interferences from reagents and autoantibodies.
