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2020 ; 509
(ä): 79-82
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Evaluation of the EDI enzyme linked immunosorbent assays for the detection of
SARS-CoV-2 IgM and IgG antibodies in human plasma
#MMPMID32526218
Bundschuh C
; Egger M
; Wiesinger K
; Gabriel C
; Clodi M
; Mueller T
; Dieplinger B
Clin Chim Acta
2020[Oct]; 509
(ä): 79-82
PMID32526218
show ga
BACKGROUND: Besides SARS-CoV-2 RT-PCR testing, serological testing is emerging as
additional option in COVID-19 diagnostics. Aim of this study was to evaluate
novel immunoassays for detection of SARS-CoV-2 antibodies in human plasma.
METHODS: Using EDI(TM) Novel Coronavirus COVID-19 Enzyme Linked Immunosorbent
Assays (ELISAs), we measured SARS-CoV-2 IgM and IgG antibodies in 64 SARS-CoV-2
RT-PCR confirmed COVID-19 patients with serial blood samples (n = 104) collected
at different time points from symptom onset. Blood samples from 200 healthy blood
donors and 256 intensive care unit (ICU) patients collected before the COVID-19
outbreak were also used. RESULTS: The positivity rates in the COVID-19 patients
were 5.9% for IgM and 2.9% for IgG ? 5 days after symptom onset; Between day 5
and day 10 the positivity rates were 37.1% for IgM and 37.1% for IgG and rose to
76.4% for IgM and 82.4% for IgG after > 10-15 days. After 15-22 days the "true"
positivity rates were 94.4% for IgM and 100% for IgG. The "false" positivity
rates were 0.5% for IgM and 1.0% for IgG in the healthy blood donors, 1.6% for
IgM and 1.2% for IgG in ICU patients. CONCLUSIONS: This study shows high "true"
vs. low "false" positivity rates for the EDI(TM) SARS-CoV-2 IgM and IgG ELISAs.