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10.1097/QCO.0000000000000659 http://scihub22266oqcxt.onion/10.1097/QCO.0000000000000659 32657967!ä!32657967 Deprecated: Implicit conversion from float 209.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 209.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 209.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 209.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534       Curr+Opin+Infect+Dis 2020 ; 33 (4): 304-311 Nephropedia Template TP {{tp|p=32657967|t=2020. Laboratory-developed test regulation and the immunocompromised patient: uncertainty ahead |pdf=|usr=}}{{32657967}} gab.com Text Laboratory-developed test regulation and the immunocompromised patient: uncertainty ahead JO: Curr Opin Infect Dis http://www.kidney.de/pget.php?&tw=1&pmid=32657967 #FOAvip PURPOSE OF THE REVIEW: Laboratory-developed tests (LDTs) are essential for the clinical care of immunocompromised individuals. These patients often require specialized testing not available from commercial manufacturers and are therefore dependent on the laboratory to create, validate, and perform these assays. Recent paradigm-shifting legislation could alter the way that LDTs are operationalized and regulated. RECENT FINDINGS: On March 5th, 2020 the Verifying Accurate and Leading-Edge In-Vitro Clinical Tests Development Act (VALID) was introduced in the US Congress. This statute would overhaul existing regulatory framework by unifying the oversight of LDTs and commercial in-vitro diagnostic tests (IVDs) through the FDA. If enacted, LDTs would be subject to regulatory requirements like those found in commercial submissions for market review. Stakeholders continue to discuss the details and scope of the proposed legislation in the setting of the Severe Acute Respiratory Syndrome Coronavirus 2 pandemic, where LDTs are integral to the national COVID-19 response. SUMMARY: Congressional lawmakers have introduced legislation to alter the regulatory framework governing LDTs. Moving forward, a balance must be struck to ensure the availability of safe and accurate testing without delays or overregulation that could be harmful to patients. The downstream implications of how VALID and other legislation will impact laboratories, clinicians, and patients warrant close examination. Twit Text FOAVip Laboratory-developed test regulation and the immunocompromised patient: uncertainty ahead ????Curr Opin Infect Dis http://www.kidney.de/pget.php?&tw=1&pmid=32657967 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=32657967 #FOAvip English Wikipedia <ref>{{Cite pmid|32657967}}</ref> Laboratory-developed test regulation and the immunocompromised patient: uncertainty ahead #MMPMID32657967 Clark AE; Levy J; Lee FM Curr Opin Infect Dis 2020[Aug]; 33 (4): 304-311 PMID32657967show ga PURPOSE OF THE REVIEW: Laboratory-developed tests (LDTs) are essential for the clinical care of immunocompromised individuals. These patients often require specialized testing not available from commercial manufacturers and are therefore dependent on the laboratory to create, validate, and perform these assays. Recent paradigm-shifting legislation could alter the way that LDTs are operationalized and regulated. RECENT FINDINGS: On March 5th, 2020 the Verifying Accurate and Leading-Edge In-Vitro Clinical Tests Development Act (VALID) was introduced in the US Congress. This statute would overhaul existing regulatory framework by unifying the oversight of LDTs and commercial in-vitro diagnostic tests (IVDs) through the FDA. If enacted, LDTs would be subject to regulatory requirements like those found in commercial submissions for market review. Stakeholders continue to discuss the details and scope of the proposed legislation in the setting of the Severe Acute Respiratory Syndrome Coronavirus 2 pandemic, where LDTs are integral to the national COVID-19 response. SUMMARY: Congressional lawmakers have introduced legislation to alter the regulatory framework governing LDTs. Moving forward, a balance must be struck to ensure the availability of safe and accurate testing without delays or overregulation that could be harmful to patients. The downstream implications of how VALID and other legislation will impact laboratories, clinicians, and patients warrant close examination. |*Clinical Laboratory Techniques[MESH] |*Immunocompromised Host[MESH] |*Uncertainty[MESH] |Betacoronavirus/pathogenicity[MESH] |COVID-19[MESH] |COVID-19 Testing[MESH] |Clinical Laboratory Services/*legislation & jurisprudence[MESH] |Congresses as Topic[MESH] |Coronavirus Infections/*diagnosis[MESH] |Health Services Research/legislation & jurisprudence[MESH] |Humans[MESH] |Laboratories, Hospital/*legislation & jurisprudence[MESH] |Pandemics[MESH] |Pneumonia, Viral/*diagnosis[MESH] |Quality Assurance, Health Care[MESH] |SARS-CoV-2[MESH] |United States[MESH]Laboratory-developed test regulation and the immunocompromised patient(epmc).pdf DeepDyve Pubget Overpricing