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Published in 2018 at "Journal of Medical Virology"
DOI: 10.1002/jmv.25189
Abstract: Commutability between human cytomegalovirus (CMV) viral load assays (VLA) is poor, despite the development of a WHO CMV International Standard (CMV IS). We evaluated a new CMV VLA, cobas® CMV, as compared to our current…
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Keywords:
viral load;
cmv;
laboratory developed;
cobas cmv ... See more keywords
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Published in 2020 at "Annals of diagnostic pathology"
DOI: 10.1016/j.anndiagpath.2020.151590
Abstract: PD-L1 expression in non-small cell lung cancer (NSCLC) is predictive of response to treatment with PD-1 and PD-L1 inhibitors. Different inhibitors have been developed with different PD-L1 assays, which use different PD-1 antibody clones on…
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Keywords:
agreement;
cell lung;
ventana;
non small ... See more keywords
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Published in 2020 at "Diagnostic Microbiology and Infectious Disease"
DOI: 10.1016/j.diagmicrobio.2020.115228
Abstract: In this study, 127 sputum/tracheal aspirate specimens were evaluated by a laboratory-developed real-time RT-PCR method and Fusion SARS-CoV-2 assay. These specimens were collected from the patients who have nasopharyngeal swab (NPS) samples being used for…
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Keywords:
cov detection;
sars cov;
tracheal aspirate;
sputum tracheal ... See more keywords
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Published in 2017 at "Experimental and molecular pathology"
DOI: 10.1016/j.yexmp.2017.02.002
Abstract: Targeted genomic profiling (TGP) using massively parallel DNA sequencing is becoming the standard methodology in clinical laboratories for detecting somatic variants in solid tumors. The variety of methodologies and sequencing platforms in the marketplace for…
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Keywords:
solid tumor;
targeted genomic;
genomic profiling;
laboratory ... See more keywords
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Published in 2018 at "American Journal of Clinical Pathology"
DOI: 10.1093/ajcp/aqy014
Abstract: Objectives We introduce regulatory terms, definitions, and the Quality System Regulation as proposed by the US Food and Drug Administration in the 2014 draft guidance entitled Framework for Regulatory Oversight of Laboratory Developed Tests and…
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Keywords:
developed tests;
prepared regulatory;
inevitable prepared;
facing inevitable ... See more keywords
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Published in 2020 at "Laboratory medicine"
DOI: 10.1093/labmed/lmaa086
Abstract: OBJECTIVE Regulations for clinical laboratories in the United States are complex. The goal of this review is to improve the clarity of laboratory-developed test (LDT) regulation to facilitate innovation. METHODS A literature and regulation review…
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Keywords:
regulations surrounding;
level overview;
high level;
overview regulations ... See more keywords
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Published in 2021 at "Journal of Clinical Pathology"
DOI: 10.1136/jclinpath-2020-207128
Abstract: Developing and deploying new diagnostic tests are difficult, but the need to do so in response to a rapidly emerging pandemic such as COVID-19 is crucially important. During a pandemic, laboratories play a key role…
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Keywords:
sars cov;
laboratory developed;
emergency use;
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Published in 2022 at "Journal of Clinical Pathology"
DOI: 10.1136/jclinpath-2022-208353
Abstract: Aims The first aim of this study is to compare and validate the performance of the programmed death receptor ligand 1 (PD-L1) IHC 22C3 pharmDx assay kit processed via Dako Omnis platform with the Dako…
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Keywords:
agreement;
laboratory developed;
pathology;
dako omnis ... See more keywords
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Published in 2020 at "Diagnostics"
DOI: 10.3390/diagnostics10050332
Abstract: A laboratory-developed test (LDT) is a type of in vitro diagnostic test that is designed, manufactured and used in the same laboratory (i.e., an in-house test). In this study, a metabolomics-based LDT was developed. This…
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Keywords:
test;
developed test;
laboratory;
test ldt ... See more keywords