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Ann Clin Lab Sci ; 50(6): 852-854, 2020 Nov.
Article in English | MEDLINE | ID: covidwho-984501

ABSTRACT

Due to the COVID-19 pandemic, the Food and Drug Administration issued an Emergency Use Authorization to permit developers of certain serological tests to market their product prior to a comprehensive review. Nonetheless, the reliability of these assays is of great importance in order to be useful as a tool in estimating the relative proportions of different populations that have been exposed to SARS-CoV-2. We provide a sampling of 145 individuals from an ambulatory setting simultaneously tested with a qualitative point of care rapid finger prick Lateral Wave® IgM and IgG assay and a sample for the Mayo Clinic enzyme linked immunosorbent assay (ELISA) IgM/IgG antibody assay. Significant discrepancies did exist between the purported antibody responses as demonstrated by each assay.


Subject(s)
Antibodies, Viral/blood , COVID-19/diagnosis , Enzyme-Linked Immunosorbent Assay/methods , Immunoglobulin G/blood , Immunoglobulin M/blood , Point-of-Care Systems/standards , SARS-CoV-2/isolation & purification , Biological Assay , COVID-19/blood , COVID-19/virology , Humans , Serologic Tests/methods
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