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10.1002/jmv.26696

http://scihub22266oqcxt.onion/10.1002/jmv.26696
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33231312!7753814!33231312
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suck abstract from ncbi


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pmid33231312      J+Med+Virol 2021 ; 93 (5): 2838-2847
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  • Development, performance evaluation, and clinical application of a Rapid SARS-CoV-2 IgM and IgG Test Kit based on automated fluorescence immunoassay #MMPMID33231312
  • Kang K; Huang L; Ouyang C; Du J; Yang B; Chi Y; He S; Ying L; Chen G; Wang J
  • J Med Virol 2021[May]; 93 (5): 2838-2847 PMID33231312show ga
  • The ongoing coronavirus disease 2019 (COVID-19) epidemic has made a huge impact on health, economies, and societies all over the world. Although reverse transcription-polymerase chain reaction (RT-PCR)-based nucleic acid detection has been primarily used in the diagnosis of COVID-19, it is time-consuming with limited application scenarios and must be operated by qualified personnel. Antibody test, particularly point-of-care antibody testing, is a suitable complement to nucleic acid test as it provides rapid, portable, and cost-effective detection of infections. In this study, a Rapid Antibody Test Kit was developed based on fluorescence immunochromatography for the sensitive, accurate, and automated detection of immunoglobulin M (IgM) and IgG antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in human serum, plasma, and whole blood samples within 10 min. The sensitivity, specificity, precision, and stability of the test kit were of good performance. No cross-activity and no interference was observed. In the multiple-center parallel study, 223 samples from hospitalized patients were used to evaluate the clinical specificity of the test. Both SARS-CoV-2 IgM and IgG achieved a clinical specificity of 98.21%. The clinical sensitivities of SARS-CoV-2 IgM and IgG were 79.54% and 87.45%, respectively, among 733 reverse transcription-polymerase chain reaction (RT-PCR) confirmed SARS-CoV-2 samples. For the combined IgM and IgG assays, the sensitivity and specificity were 89.22% and 96.86%, respectively. Our results demonstrate that the combined use of IgM and IgG could serve as a more suitable alternative detection method for patients with COVID-19, and the developed kit is of great public health significance for the prevention and control of the COVID-19 pandemic.
  • |*Reagent Kits, Diagnostic[MESH]
  • |Adolescent[MESH]
  • |Adult[MESH]
  • |Aged[MESH]
  • |Aged, 80 and over[MESH]
  • |Animals[MESH]
  • |Antibodies, Viral/*blood[MESH]
  • |COVID-19 Testing/*methods[MESH]
  • |COVID-19/*diagnosis/immunology[MESH]
  • |Child[MESH]
  • |Child, Preschool[MESH]
  • |Female[MESH]
  • |Fluorescence[MESH]
  • |Fluorescent Antibody Technique/*methods[MESH]
  • |Humans[MESH]
  • |Immunoassay/*methods[MESH]
  • |Immunoglobulin G/*blood[MESH]
  • |Immunoglobulin M/*blood[MESH]
  • |Male[MESH]
  • |Mice[MESH]
  • |Middle Aged[MESH]
  • |Point-of-Care Testing[MESH]
  • |Recombinant Proteins[MESH]
  • |SARS-CoV-2/immunology/isolation & purification[MESH]
  • |Sensitivity and Specificity[MESH]
  • |Spike Glycoprotein, Coronavirus/genetics/immunology[MESH]


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