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10.3390/v13061043

http://scihub22266oqcxt.onion/10.3390/v13061043
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suck abstract from ncbi


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pmid34072890      Viruses 2021 ; 13 (6): ä
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  • Evaluation of Production Lots of a Rapid Point-of-Care Lateral Flow Serological Test Intended for Identification of IgM and IgG against the N-Terminal Part of the Spike Protein (S1) of SARS-CoV-2 #MMPMID34072890
  • Hoffman T; Kolstad L; Ronnberg B; Lundkvist A
  • Viruses 2021[May]; 13 (6): ä PMID34072890show ga
  • The potential of rapid point-of-care (POC) tests has been subject of doubt due to an eventual risk of production errors. The aim was therefore to evaluate the two separate production lots of a commercial POC lateral flow test, intended for the detection of IgM and IgG against the SARS-CoV-2 spike protein (S1). Control samples consisted of serum from individuals with confirmed SARS-CoV-2 infection and pre-COVID-19 negative sera gathered from a biobank. The presence of anti-S1 IgM/IgG in the sera was verified by an in-house Luminex-based serological assay (COVID-19 SIA). One hundred samples were verified as positive for anti-S1 IgG and 74 for anti-S1 IgM. Two hundred samples were verified as negative for anti-S1 IgM/IgG. For the two lots of the POC-test, the sensitivities were 93.2% and 87.8% for IgM and 93.0% and 100% for IgG. The specificities were 100% for IgM and 99.5% for IgG. The positive predictive value was 100% for IgM and 98.9% and 99.0% for IgG. The negative predictive value was 97.6% and 95.7% for IgM, and 96.6% and 100% for IgG. The evaluated POC-test is suitable to assess anti-SARS-CoV-2 S1 IgM and IgG, as a measure of previous virus exposure on an individual level. The external validation of separate lots of rapid POC-tests is encouraged to ensure high sensitivity before market introduction.
  • |*Point-of-Care Testing[MESH]
  • |Antibodies, Viral/*blood/immunology[MESH]
  • |COVID-19 Serological Testing/*methods[MESH]
  • |COVID-19/*diagnosis/immunology[MESH]
  • |Humans[MESH]
  • |Immunoglobulin G/blood/immunology[MESH]
  • |Immunoglobulin M/blood/immunology[MESH]
  • |Sensitivity and Specificity[MESH]


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