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10.1093/ajcp/aqab041 http://scihub22266oqcxt.onion/10.1093/ajcp/aqab041 33822853!8083587!33822853     free     free     free Deprecated: Implicit conversion from float 229.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 229.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534       Am+J+Clin+Pathol 2021 ; 155 (6): 815-822 Nephropedia Template TP {{tp|p=33822853|t=2021. Digital Droplet PCR for SARS-CoV-2 Resolves Borderline Cases |pdf=|usr=}}{{33822853}} gab.com Text Digital Droplet PCR for SARS-CoV-2 Resolves Borderline Cases JO: Am J Clin Pathol http://www.kidney.de/pget.php?&tw=1&pmid=33822853 #FOAvip OBJECTIVES: The Bio-Rad SARS-CoV-2 ddPCR Kit (Bio-Rad Laboratories) was the first droplet digital polymerase chain reaction (ddPCR) assay to receive Food and Drug Administration (FDA) Emergency Use Authorization approval, but it has not been evaluated clinically. We describe the performance of ddPCR-in particular, its ability to confirm weak-positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) results. METHODS: We clinically validated the Bio-Rad Triplex Probe ddPCR Assay. The limit of detection was determined by using serial dilutions of SARS-CoV-2 RNA in an artificial viral envelope. The ddPCR assay was performed according to the manufacturer's specifications on specimens confirmed to be positive (n = 48) or negative (n = 30) by an FDA-validated reverse transcription-polymerase chain reaction assay on the m2000 RealTime system (Abbott). Ten borderline positive cases were also evaluated. RESULTS: The limit of detection was 50 copies/mL (19 of 20 positive). Forty-seven specimens spanning a range of quantification cycles (2.9-25.9 cycle numbers) were positive by this assay (47 of 48; 97.9% positive precent agreement), and 30 negative samples were confirmed as negative (30 of 30; 100% negative percent agreement). Nine of 10 borderline cases were positive when tested in triplicate. CONCLUSIONS: The ddPCR of SARS-CoV-2 is an accurate method, with superior sensitivity for viral RNA detection. It could provide definitive evaluation of borderline positive cases or suspected false-negative cases. Twit Text FOAVip Digital Droplet PCR for SARS-CoV-2 Resolves Borderline Cases ????Am J Clin Pathol http://www.kidney.de/pget.php?&tw=1&pmid=33822853 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=33822853 #FOAvip English Wikipedia <ref>{{Cite pmid|33822853}}</ref> Digital Droplet PCR for SARS-CoV-2 Resolves Borderline Cases #MMPMID33822853 Xu J; Kirtek T; Xu Y; Zheng H; Yao H; Ostman E; Oliver D; Malter JS; Gagan JR; SoRelle JA Am J Clin Pathol 2021[May]; 155 (6): 815-822 PMID33822853show ga OBJECTIVES: The Bio-Rad SARS-CoV-2 ddPCR Kit (Bio-Rad Laboratories) was the first droplet digital polymerase chain reaction (ddPCR) assay to receive Food and Drug Administration (FDA) Emergency Use Authorization approval, but it has not been evaluated clinically. We describe the performance of ddPCR-in particular, its ability to confirm weak-positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) results. METHODS: We clinically validated the Bio-Rad Triplex Probe ddPCR Assay. The limit of detection was determined by using serial dilutions of SARS-CoV-2 RNA in an artificial viral envelope. The ddPCR assay was performed according to the manufacturer's specifications on specimens confirmed to be positive (n = 48) or negative (n = 30) by an FDA-validated reverse transcription-polymerase chain reaction assay on the m2000 RealTime system (Abbott). Ten borderline positive cases were also evaluated. RESULTS: The limit of detection was 50 copies/mL (19 of 20 positive). Forty-seven specimens spanning a range of quantification cycles (2.9-25.9 cycle numbers) were positive by this assay (47 of 48; 97.9% positive precent agreement), and 30 negative samples were confirmed as negative (30 of 30; 100% negative percent agreement). Nine of 10 borderline cases were positive when tested in triplicate. CONCLUSIONS: The ddPCR of SARS-CoV-2 is an accurate method, with superior sensitivity for viral RNA detection. It could provide definitive evaluation of borderline positive cases or suspected false-negative cases. |*Real-Time Polymerase Chain Reaction/methods[MESH] |*Sensitivity and Specificity[MESH] |COVID-19/*diagnosis[MESH] |Humans[MESH] |Limit of Detection[MESH] |RNA, Viral/analysis/genetics[MESH] |SARS-CoV-2/*genetics/pathogenicity[MESH]Digital Droplet PCR for SARS-CoV-2 Resolves Borderline Cases (epmc).pdf DeepDyve Pubget Overpricing