College of American Pathologists\u27 Laboratory Standards for Next-Generation Sequencing Clinical Tests

Context.-The higher throughput and lower per-base cost of next-generation sequencing (NGS) as compared to Sanger sequencing has led to its rapid adoption in clinical testing. The number of laboratories offering NGS-based tests has also grown considerably in the past few years, despite the fact that specific Clinical Laboratory Improvement Amendments of 1988/College of American Pathologists (CAP) laboratory standards had not yet been developed to regulate this technology. Objective.-To develop a checklist for clinical testing using NGS technology that sets standards for the analytic wet bench process and for bioinformatics or \u27\u27 dry bench\u27\u27 analyses. As NGS-based clinical tests are new to diagnostic testing and are of much greater complexity than traditional Sanger sequencing-based tests, there is an urgent need to develop new regulatory standards for laboratories offering these tests. Design.-To develop the necessary regulatory framework for NGS and to facilitate appropriate adoption of this technology for clinical testing, CAP formed a committee in 2011, the NGS Work Group, to deliberate upon the contents to be included in the checklist. Results.-A total of 18 laboratory accreditation checklist requirements for the analytic wet bench process and bioinformatics analysis processes have been included within CAP\u27s molecular pathology checklist (MOL). Conclusions.-This report describes the important issues considered by the CAP committee during the development of the new checklist requirements, which address documentation, validation, quality assurance, confirmatory testing, exception logs, monitoring of upgrades, variant interpretation and reporting, incidental findings, data storage, version traceability, and data transfer confidentiality

Candida sp. infections in patients with Diabetes mellitus

Candidiasis has increased substantially worldwide over recent decades and is a significant cause of morbidity and mortality, especially among critically ill patients. Diabetes mellitus (DM) is a metabolic disorder that predisposes individuals to fungal infections, including those related to Candida sp., due to a immunosuppressive effect on the patient. This review aims to discuss the latest studies regarding the occurrence of candidiasis on DM patients and the pathophysiology and etiology associated with these co-morbidities. A comprehensive review of the literature was undertaken. PubMed, Scopus, Elseviers ScienceDirect, and Springers SpringerLink databases were searched using well-defined search terms. Predefined inclusion and exclusion criteria were applied to classify relevant manuscripts. Results of the review show that DM patients have an increased susceptibility to Candida sp. infections which aggravates in the cases of uncontrolled hyperglycemia. The conclusion is that, for these patients, the hospitalization periods have increased and are commonly associated with the prolonged use of indwelling medical devices, which also increase the costs associated with disease management.This study was supported by the Portuguese Foundation for Science and Technology (FCT) under the scope of: the strategic funding of UID/BIO/04469/2013 unit, COMPETE 2020 (POCI-01-0145-FEDER-006684) and BioTecNorte operation (NORTE-01-0145-FEDER-000004) funded by the European Regional Development Fund under the scope of Norte2020-Programa Operacional Regional do Norte, financially supported by project UID/EQU/00511/2019 - Laboratory for Process Engineering, Environment, Biotechnology and Energy – LEPABE funded by national funds through FCT/MCTES (PIDDAC), and by Célia F. Rodrigues’ [SFRH/BD/93078/2013] PhD grant and M. Elisa Rodrigues [SFRH/BPD/95401/2013] post-doc grant.info:eu-repo/semantics/publishedVersio

1955 -- Correspondence, Miscellaneous -- letter, 1955-08-26

Letter from Hoeltge, Fred C. to Sabin, Albert B. dated 1955-08-26.Sabin Collection Fair Use Policy</a

Economics and Antitrust Law

(Statement of Responsibility) by Christopher Hoeltge(Thesis) Thesis (B.A.) -- New College of Florida, 1991(Electronic Access) RESTRICTED TO NCF STUDENTS, STAFF, FACULTY, AND ON-CAMPUS USE(Bibliography) Includes bibliographical references.(Source of Description) This bibliographic record is available under the Creative Commons CC0 public domain dedication. The New College of Florida, as creator of this bibliographic record, has waived all rights to it worldwide under copyright law, including all related and neighboring rights, to the extent allowed by law.(Local) Faculty Sponsor: Coe, Richar