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10.1039/d0an01988g http://scihub22266oqcxt.onion/10.1039/d0an01988g 33899053!8139840!33899053     free     free     free 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       Analyst 2021 ; 146 (8): 2449-2462 Nephropedia Template TP {{tp|p=33899053|t=2021. Current state of commercial point-of-care nucleic acid tests for infectious diseases |pdf=|usr=}}{{33899053}} gab.com Text Current state of commercial point-of-care nucleic acid tests for infectious diseases JO: Analyst http://www.kidney.de/pget.php?&tw=1&pmid=33899053 #FOAvip The COVID-19 pandemic has put the spotlight on the urgent need for integrated nucleic acid tests (NATs) for infectious diseases, especially those that can be used near patient ("point-of-care", POC), with rapid results and low cost, but without sacrificing sensitivity or specificity of gold standard PCR tests. In the US, the Clinical Laboratory Improvement Amendments Certificate of Waiver (CLIA-waiver) is mandated by the Food and Drug Administration (FDA) and designated to any laboratory testing with high simplicity and low risk for error, suitable for application in the POC. Since the first issuance of CLIA-waiver to Abbot's ID NOW Influenza A&B in 2015, many more NAT systems have been developed, received the CLIA-waiver in the US or World Health Organization (WHO)'s pre-qualification, and deployed to the front line of infectious disease detection. This review highlights the regulatory process for FDA and WHO in evaluating these NATs and the technology innovation of existing CLIA-waived systems. Understanding the technical advancement and challenges, unmet needs, and the trends of commercialization facilitated through the regulatory processes will help pave the foundation for future development and technology transfer from research to the market place. Twit Text FOAVip Current state of commercial point-of-care nucleic acid tests for infectious diseases ????Analyst http://www.kidney.de/pget.php?&tw=1&pmid=33899053 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=33899053 #FOAvip English Wikipedia <ref>{{Cite pmid|33899053}}</ref> Current state of commercial point-of-care nucleic acid tests for infectious diseases #MMPMID33899053 Zhang JY; Bender AT; Boyle DS; Drain PK; Posner JD Analyst 2021[Apr]; 146 (8): 2449-2462 PMID33899053show ga The COVID-19 pandemic has put the spotlight on the urgent need for integrated nucleic acid tests (NATs) for infectious diseases, especially those that can be used near patient ("point-of-care", POC), with rapid results and low cost, but without sacrificing sensitivity or specificity of gold standard PCR tests. In the US, the Clinical Laboratory Improvement Amendments Certificate of Waiver (CLIA-waiver) is mandated by the Food and Drug Administration (FDA) and designated to any laboratory testing with high simplicity and low risk for error, suitable for application in the POC. Since the first issuance of CLIA-waiver to Abbot's ID NOW Influenza A&B in 2015, many more NAT systems have been developed, received the CLIA-waiver in the US or World Health Organization (WHO)'s pre-qualification, and deployed to the front line of infectious disease detection. This review highlights the regulatory process for FDA and WHO in evaluating these NATs and the technology innovation of existing CLIA-waived systems. Understanding the technical advancement and challenges, unmet needs, and the trends of commercialization facilitated through the regulatory processes will help pave the foundation for future development and technology transfer from research to the market place. |*COVID-19[MESH] |*Communicable Diseases/diagnosis[MESH] |*Nucleic Acids/genetics[MESH] |Humans[MESH] |Pandemics[MESH] |Point-of-Care Systems[MESH] |Point-of-Care Testing[MESH]Current state of commercial point-of-care nucleic acid tests for infec(epmc).pdf DeepDyve Pubget Overpricing