Neutralizing activity to SARS-CoV-2 of convalescent and control plasma used in a randomized controlled trial.


Journal

Transfusion
ISSN: 1537-2995
Titre abrégé: Transfusion
Pays: United States
ID NLM: 0417360

Informations de publication

Date de publication:
05 2021
Historique:
revised: 28 12 2020
received: 24 11 2020
accepted: 28 12 2020
pubmed: 16 1 2021
medline: 18 5 2021
entrez: 15 1 2021
Statut: ppublish

Résumé

There are limited data on the neutralizing activity of convalescent plasma (CP) administered in randomized controlled trials (RCT) of COVID-19 infection. As part of an RCT, CP was collected per FDA guidelines from individuals recovered from COVID-19 infection. CP donors had to have ≥145 optical density (OD) units (ideal target ≥300) using a semiquantitative, immunochromatographic test for IgG antibody to the nucleocapsid protein (NP) of SARS-CoV-2 (typical range 0-500 OD units). A random subset of samples [14 control plasma, 12 CP "medium-anti-NP" (145-299 OD units), and 13 CP "high" anti-NP (≥300 OD units)] were tested for neutralizing antibodies using an established viral luciferase antibody inhibition assay to detect the infection of SARS-CoV-2 pseudovirus that encoded spike protein (SARS2-S The uptake of SARS-CoV-2 pseudovirus by 293T Plasma from donors screened using an immunochromatographic test for IgG antibody to SARS-CoV-2 NP exhibited neutralizing activity meeting FDA's minimum standard in all randomly selected COVID-19 CP units.

Sections du résumé

BACKGROUND
There are limited data on the neutralizing activity of convalescent plasma (CP) administered in randomized controlled trials (RCT) of COVID-19 infection.
STUDY DESIGN AND METHODS
As part of an RCT, CP was collected per FDA guidelines from individuals recovered from COVID-19 infection. CP donors had to have ≥145 optical density (OD) units (ideal target ≥300) using a semiquantitative, immunochromatographic test for IgG antibody to the nucleocapsid protein (NP) of SARS-CoV-2 (typical range 0-500 OD units). A random subset of samples [14 control plasma, 12 CP "medium-anti-NP" (145-299 OD units), and 13 CP "high" anti-NP (≥300 OD units)] were tested for neutralizing antibodies using an established viral luciferase antibody inhibition assay to detect the infection of SARS-CoV-2 pseudovirus that encoded spike protein (SARS2-S
RESULTS
The uptake of SARS-CoV-2 pseudovirus by 293T
DISCUSSION
Plasma from donors screened using an immunochromatographic test for IgG antibody to SARS-CoV-2 NP exhibited neutralizing activity meeting FDA's minimum standard in all randomly selected COVID-19 CP units.

Identifiants

pubmed: 33448402
doi: 10.1111/trf.16283
pmc: PMC8014203
doi:

Substances chimiques

Antibodies, Neutralizing 0
Antibodies, Viral 0

Types de publication

Journal Article Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

IM

Pagination

1363-1369

Informations de copyright

© 2021 AABB.

Références

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Auteurs

Alex T Freedenberg (AT)

Department of Anesthesiology, Stony Brook University Medical Center, Stony Brook, New York, USA.

Chun-Hao Pan (CH)

Department of Pathology, Stony Brook University Medical Center, Stony Brook, New York, USA.

William E Diehl (WE)

Department of Pathology, Stony Brook University Medical Center, Stony Brook, New York, USA.

Jamie L Romeiser (JL)

Department of Anesthesiology, Stony Brook University Medical Center, Stony Brook, New York, USA.

Ga-Ram Hwang (GR)

Department of Pathology, Stony Brook University Medical Center, Stony Brook, New York, USA.

Cindy V Leiton (CV)

Department of Pathology, Stony Brook University Medical Center, Stony Brook, New York, USA.

Frauke Muecksch (F)

Laboratory of Retrovirology, The Rockefeller University, New York, New York, USA.

Kenneth R Shroyer (KR)

Department of Pathology, Stony Brook University Medical Center, Stony Brook, New York, USA.

Elliott Bennett-Guerrero (E)

Department of Anesthesiology, Stony Brook University Medical Center, Stony Brook, New York, USA.

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Classifications MeSH