Transitioning cytomegalovirus viral load testing from a laboratory developed test to the cobas® CMV quantitative nucleic acid assay
Sign Up to like & getrecommendations! 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… read more here.
Keywords: viral load; cmv; laboratory developed; cobas cmv ... See more keywords
Comparability of laboratory-developed and commercial PD-L1 assays in non-small cell lung carcinoma.
Sign Up to like & getrecommendations! 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… read more here.
Keywords: agreement; cell lung; ventana; non small ... See more keywords
Analysis of sputum/tracheal aspirate and nasopharyngeal samples for SARS-CoV-2 detection by laboratory-developed test and Panther Fusion system
Sign Up to like & getrecommendations! 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… read more here.
Keywords: cov detection; sars cov; tracheal aspirate; sputum tracheal ... See more keywords
Variant call concordance between two laboratory-developed, solid tumor targeted genomic profiling assays using distinct workflows and sequencing instruments.
Sign Up to like & getrecommendations! 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… read more here.
Keywords: solid tumor; targeted genomic; genomic profiling; laboratory ... See more keywords
Laboratory-developed tests and in vitro diagnostics: A regulatory overview for anatomic pathology
Sign Up to like & getrecommendations! Published in 2025 at "American Journal of Clinical Pathology"
DOI: 10.1093/ajcp/aqae181
Abstract: Abstract Objectives The US Food and Drug Administration’s Final Rule on laboratory-developed tests was published on May 6, 2024. The objective of this article is to explain the Final Rule and existing in vitro diagnostic… read more here.
Keywords: anatomic pathology; final rule; pathology; developed tests ... See more keywords
Facing the Inevitable: Being Prepared for Regulatory Requirements for Laboratory Developed Tests
Sign Up to like & getrecommendations! 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… read more here.
Keywords: developed tests; prepared regulatory; inevitable prepared; facing inevitable ... See more keywords
A High-Level Overview of the Regulations Surrounding a Clinical Laboratory and Upcoming Regulatory Challenges for Laboratory Developed Tests.
Sign Up to like & getrecommendations! 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… read more here.
Keywords: regulations surrounding; level overview; high level; overview regulations ... See more keywords
International Council for Standardization in Haematology (ICSH) Guidance on the Validation of Laboratory Developed Tests in Haemostasis
Sign Up to like & getrecommendations! Published in 2025 at "International Journal of Laboratory Hematology"
DOI: 10.1111/ijlh.14502
Abstract: Laboratory developed tests (LDTs) are widely used in clinical hemostasis laboratories. An LDT may be defined as an in vitro diagnostic (IVD) test that is designed, manufactured, and used within a single laboratory. As with… read more here.
Keywords: international council; council standardization; laboratory; validation ... See more keywords
Development of a qualitative real-time RT-PCR assay for the detection of SARS-CoV-2: a guide and case study in setting up an emergency-use, laboratory-developed molecular microbiological assay
Sign Up to like & getrecommendations! 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… read more here.
Keywords: sars cov; laboratory developed; emergency use;
Verification and validation of the anti-PD-L1 antibody, Clone 22C3 on a laboratory-developed test
Sign Up to like & getrecommendations! 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… read more here.
Keywords: agreement; laboratory developed; pathology; dako omnis ... See more keywords
Diagnosis of Parkinson’s Disease by A Metabolomics-Based Laboratory-Developed Test (LDT)
Sign Up to like & getrecommendations! 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… read more here.
Keywords: test; developed test; laboratory; test ldt ... See more keywords