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10.1093/jalm/jfaa079

http://scihub22266oqcxt.onion/10.1093/jalm/jfaa079
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32428207!7313967!32428207
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suck abstract from ncbi


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pmid32428207      J+Appl+Lab+Med 2020 ; 5 (5): 908-920
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  • Longitudinal Monitoring of SARS-CoV-2 IgM and IgG Seropositivity to Detect COVID-19 #MMPMID32428207
  • Suhandynata RT; Hoffman MA; Kelner MJ; McLawhon RW; Reed SL; Fitzgerald RL
  • J Appl Lab Med 2020[Sep]; 5 (5): 908-920 PMID32428207show ga
  • BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is a novel beta-coronavirus that has recently emerged as the cause of the 2019 coronavirus pandemic (COVID-19). Polymerase chain reaction (PCR) based tests are optimal and recommended for the diagnosis of an acute SARS-CoV-2 infection. Serology tests for viral antibodies provide an important tool to diagnose previous exposure to the virus. Here we evaluate the analytical performance parameters of the Diazyme SARS-CoV-2 IgM/IgG serology assays and describe the kinetics of IgM and IgG seroconversion observed in patients with PCR-confirmed COVID-19 who were admitted to our hospital. METHODS: We validated the performance of the Diazyme assay in 235 presumed SARS-CoV-2 negative subjects to determine specificity. Subsequently, we evaluated the SARS-CoV-2 IgM and IgG seroconversion of 54 PCR-confirmed COVID-19 patients and determined sensitivity of the assay at three different timeframes. RESULT: Sensitivity and specificity for detecting seropositivity at >/=15 days following a positive SARS-CoV-2 PCR result, was 100.0% and 98.7% when assaying for the panel of IgM and IgG. The median time to seropositivity observed for a reactive IgM and IgG result from the date of a positive PCR was 5 days (IQR: 2.75-9 days) and 4 days (IQR: 2.75-6.75 days), respectively. CONCLUSIONS: Our data demonstrate that the Diazyme IgM/IgG assays are suited for the purpose of detecting SARS-CoV-2 IgG and IgM in patients with suspected SARS-CoV-2 infections. For the first time, we report longitudinal data showing the evolution of seroconversion for both IgG and IgM in a cohort of acutely ill patients in the United States. We also demonstrate a low false positive rate in patients who were presumed to be disease free.
  • |*Betacoronavirus/immunology/isolation & purification[MESH]
  • |*Coronavirus Infections/diagnosis/immunology/virology[MESH]
  • |*Immunoglobulin G/blood/isolation & purification[MESH]
  • |*Immunoglobulin M/blood/isolation & purification[MESH]
  • |*Pandemics[MESH]
  • |*Pneumonia, Viral/diagnosis/immunology/virology[MESH]
  • |*Seroconversion[MESH]
  • |Antibodies, Viral/blood/isolation & purification[MESH]
  • |COVID-19[MESH]
  • |COVID-19 Testing[MESH]
  • |Clinical Laboratory Techniques/methods[MESH]
  • |Female[MESH]
  • |Humans[MESH]
  • |Male[MESH]
  • |Middle Aged[MESH]
  • |Monitoring, Immunologic/methods[MESH]
  • |SARS-CoV-2[MESH]


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