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American journal of clinical pathology, ISSN 0002-9173, 06/2019, Volume 152, Issue 2, pp. 122 - 131
To provide a clinical laboratory perspective on the Verifying Accurate Leading-edge IVCT Development Act (VALID) discussion draft. This potential legislative... 
Journal Article
AMERICAN JOURNAL OF CLINICAL PATHOLOGY, ISSN 0002-9173, 08/2019, Volume 152, Issue 2, pp. 122 - 131
Objectives: To provide a clinical laboratory perspective on the Verifying Accurate Leading-edge IVCT Development Act (VALID) discussion draft. This potential... 
Regulations | Laboratory-developed test | PATHOLOGY | In vitro diagnostics | In vitro clinical test | Review | Editor's Choice
Journal Article
American Journal of Clinical Pathology, ISSN 0002-9173, 04/2018, Volume 149, Issue 6, pp. 484 - 498
Objectives: We introduce regulatory terms, definitions, and the Quality System Regulation as proposed by the US Food and Drug Administration in the 2014 draft... 
Laboratory developed tests | Quality management system | Design control | Quality system regulation | PATHOLOGY | Laboratories | Polls & surveys | Quality management
Journal Article
Technology and Health Care, ISSN 0928-7329, 2016, Volume 24, Issue 6, pp. 949 - 956
Journal Article
American Journal of Clinical Pathology, ISSN 0002-9173, 07/2012, Volume 138, Issue 1, pp. 20 - 26
Journal Article
DIAGNOSTICS, ISSN 2075-4418, 02/2019, Volume 9, Issue 1, p. 20
Sepsis, a dysregulated host response to infection, is a major health burden in terms of both mortality and cost. The difficulties clinicians face in diagnosing... 
MORTALITY | CRITERIA | MANAGEMENT | laboratory developed test | machine learning | biomarker | WARNING SCORE MEWS | PREDICTION | DEFINITIONS | MEDICINE, GENERAL & INTERNAL | medical informatics | clinical decision support | SEPTIC SHOCK | INTERNATIONAL GUIDELINES | electronic health record | sepsis | CAMPAIGN
Journal Article
Lab Medicine, ISSN 0007-5027, 2019, Volume 50, Issue 2, pp. 194 - 201
Objectives To determine whether different laboratory developed test (LDT) risk stratification proposals would assign differing levels of risk to selected LDTs... 
Measurement | Validity | Laboratory developed test | Reliability | Risk assessment | Classification | risk assessment | reliability | laboratory developed test | validity | MEDICAL LABORATORY TECHNOLOGY | classification | measurement
Journal Article
Cancer Journal (United States), ISSN 1528-9117, 2014, Volume 20, Issue 1, pp. 85 - 90
Journal Article
CLINICS IN LABORATORY MEDICINE, ISSN 0272-2712, 09/2016, Volume 36, Issue 3, pp. 575 - 575
The scope of FDA's jurisdiction over laboratory-developed tests (LDTs), and whether FDA has such jurisdiction at all, has been a heavily debated issue over the... 
FDA | taboratory tests | Laboratory-developed test | IVD | MEDICAL LABORATORY TECHNOLOGY | LDT | CLIA
Journal Article
Journal of Mass Spectrometry, ISSN 1076-5174, 11/2018, Volume 53, Issue 11, pp. 1143 - 1154
Journal Article
Journal of Virological Methods, ISSN 0166-0934, 03/2019, Volume 265, pp. 42 - 48
Commercial multiplex assays, built on different chemistries and platforms are widely available for simultaneous detection of pathogens that cause respiratory... 
Commercial multiplex assays | Validation | Respiratory pathogens | Laboratory-developed tests | Real-time PCR | COMMUNITY-ACQUIRED PNEUMONIA | BIOCHEMICAL RESEARCH METHODS | INFLUENZA | DIAGNOSTIC-TESTS | TRACT INFECTIONS | HOSPITALIZATION | ACCURACY | IMPACT | VIROLOGY | BIOTECHNOLOGY & APPLIED MICROBIOLOGY | GENERATION | RAPID DIAGNOSIS | VIRUSES
Journal Article
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