Detection of SARS-CoV-2 N-antigen in blood during acute COVID-19 provides a sensitive new marker and new testing alternatives.

Antigen Antigenemia Blood COVID-19 Diagnostic Plasma SARS-CoV-2 Serum

Journal

Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases
ISSN: 1469-0691
Titre abrégé: Clin Microbiol Infect
Pays: England
ID NLM: 9516420

Informations de publication

Date de publication:
08 12 2020
Historique:
received: 05 10 2020
revised: 23 11 2020
accepted: 24 11 2020
entrez: 11 12 2020
pubmed: 12 12 2020
medline: 12 12 2020
Statut: aheadofprint

Résumé

Molecular assays on nasopharyngeal swabs remain the cornerstone of COVID-19 diagnostic. The high technicalities of nasopharyngeal sampling and molecular assays, as well as scarce resources of reagents, limit our testing capabilities. Several strategies failed, to date, to fully alleviate this testing process (e.g. saliva sampling or antigen testing on nasopharyngeal samples). We assessed the clinical performances of SARS-CoV-2 nucleocapsid antigen (N-antigen) ELISA detection in serum or plasma using the COVID-19 Quantigene® (AAZ, France) assay. Performances were determined on 63 sera from 63 non-COVID patients and 227 serum samples (165 patients) from the French COVID and CoV-CONTACT cohorts with RT-PCR confirmed SARS-CoV-2 infection, including 142 serum (114 patients) obtained within 14 days after symptoms' onset. Specificity was 98.4% (95% confidence interval [CI], 95.3 to 100). Sensitivity was 79.3% overall (180/227, 95% CI, 74.0 to 84.6) and 93.0% (132/142, 95% CI, 88.7 to 97.2) within 14 days after symptoms onset. 91 included patients had a sera and nasopharyngeal swabs collected in the same 24 hours. Among those with high nasopharyngeal viral loads, i.e. Ct value below 30 and 33, only 1/50 and 4/67 tested negative for N-antigenemia, respectively. Among those with a negative nasopharyngeal RT-PCR, 8/12 presented positive N-antigenemia; the lower respiratory tract was explored for 6 of these 8 patients, showing positive RT-PCR in 5 cases. This is the first evaluation of a commercially available serum N-antigen detection assay. It presents a robust specificity and sensitivity within the first 14 days after symptoms onset. This approach provides a valuable new option for COVID-19 diagnosis, only requiring a blood draw and easily scalable in all clinical laboratories.

Identifiants

pubmed: 33307227
pii: S1198-743X(20)30721-7
doi: 10.1016/j.cmi.2020.11.025
pmc: PMC7724284
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Investigateurs

Christophe Choquet (C)
Jean-François Timsit (JF)
Jade Ghosn (J)
Charlotte Charpentier (C)
Diane Descamps (D)
Nadhira Houhou-Fidouh (N)
Alpha Diallo (A)
Soizic Le Mestre (S)
Noémie Mercier (N)
Christelle Paul (C)
Ventzislava Petrov-Sanchez (V)
Denis Malvy (D)
Catherine Chirouze (C)
Claire Andrejak (C)
François Dubos (F)
Patrick Rossignol (P)
Olivier Picone (O)
François Bompart (F)
Tristan Gigante (T)
Morgane Gilg (M)
Bénédicte Rossignol (B)
Claire Levy-Marchal (C)
Marine Beluze (M)
Jean Sébastien Hulot (JS)
Delphine Bachelet (D)
Krishna Bhavsar (K)
Lila Bouadma (L)
Anissa Chair (A)
Camille Couffignal (C)
Charlene Da Silveira (C)
Marie Pierre Debray (MP)
Diane Descamps (D)
Xavier Duval (X)
Philippine Eloy (P)
Marina Esposito-Farese (M)
Nadia Ettalhaoui (N)
Nathalie Gault (N)
Jade Ghosn (J)
Isabelle Gorenne (I)
Isabelle Hoffmann (I)
Ouifiya Kafif (O)
Sabrina Kali (S)
Antoine Khalil (A)
Cédric Laouénan (C)
Samira Laribi (S)
Minh Le (M)
Quentin Le Hingrat (Q)
François-Xavier Lescure (FX)
Jean Christophe Lucet (JC)
France Mentré (F)
Jimmy Mullaert (J)
Nathan Peiffer-Smadja (N)
Gilles Peytavin (G)
Carine Roy (C)
Marion Schneider (M)
Nassima Si Mohammed (NS)
Lysa Tagherset (L)
Coralie Tardivon (C)
Marie Capucine Tellier (MC)
Jean-François Timsit (JF)
Théo Trioux (T)
Sarah Tubiana (S)
Benoit Visseaux (B)
Noémie Vanel (N)
Romain Basmaci (R)
François Angoulvant (F)
Florentia Kaguelidou (F)
Justine Pages (J)
Christelle Tual (C)
Aurélie Veislinger (A)
Sandrine Couffin-Cardiergues (S)
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Salma Jaafoura (S)
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Marina Mambert (M)
Maude Bouscambert (M)
Alexandre Gaymard (A)
Bruno Lina (B)
Manuel Rosa-Calatrava (M)
Olivier Terrier (O)
Dehbia Benkerrou (D)
Céline Dorival (C)
Amina Meziane (A)
François Téoulé (F)
Jérémie Guedj (J)
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Guillaume Lingas (G)
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Laurent Abel (L)
Mathilde Desvallée (M)
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Commentaires et corrections

Type : ErratumIn

Informations de copyright

Copyright © 2020. Published by Elsevier Ltd.

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Auteurs

Quentin LE Hingrat (QL)

Université de Paris, IAME, INSERM, Paris, France; Virology, Assistance Publique-Hôpitaux de Paris, Bichat-Claude Bernard University Hospital, Paris, France.

Benoit Visseaux (B)

Université de Paris, IAME, INSERM, Paris, France; Virology, Assistance Publique-Hôpitaux de Paris, Bichat-Claude Bernard University Hospital, Paris, France. Electronic address: benoit.visseaux@aphp.fr.

Cédric Laouenan (C)

Université de Paris, IAME, INSERM, Paris, France; Center for Clinical Investigation, Assistance Publique-Hôpitaux de Paris, Bichat-Claude Bernard University Hospital, Paris, France.

Sarah Tubiana (S)

Université de Paris, IAME, INSERM, Paris, France; Center for Clinical Investigation, Assistance Publique-Hôpitaux de Paris, Bichat-Claude Bernard University Hospital, Paris, France.

Lila Bouadma (L)

Université de Paris, IAME, INSERM, Paris, France; Medical and Infectious Diseases Intensive Care Unit, Assistance Publique-Hôpitaux de Paris, Bichat-Claude Bernard University Hospital, Paris, France.

Yazdan Yazdanpanah (Y)

Université de Paris, IAME, INSERM, Paris, France; Tropical and infectious diseases Department, Assistance Publique-Hôpitaux de Paris, Bichat-Claude Bernard University Hospital, Paris, France.

Xavier Duval (X)

Université de Paris, IAME, INSERM, Paris, France; Center for Clinical Investigation, Assistance Publique-Hôpitaux de Paris, Bichat-Claude Bernard University Hospital, Paris, France.

Charles Burdet (C)

Université de Paris, IAME, INSERM, Paris, France; Center for Clinical Investigation, Assistance Publique-Hôpitaux de Paris, Bichat-Claude Bernard University Hospital, Paris, France.

Houria Ichou (H)

Virology, Assistance Publique-Hôpitaux de Paris, Bichat-Claude Bernard University Hospital, Paris, France.

Florence Damond (F)

Université de Paris, IAME, INSERM, Paris, France; Virology, Assistance Publique-Hôpitaux de Paris, Bichat-Claude Bernard University Hospital, Paris, France.

Mélanie Bertine (M)

Université de Paris, IAME, INSERM, Paris, France; Virology, Assistance Publique-Hôpitaux de Paris, Bichat-Claude Bernard University Hospital, Paris, France.

Nabil Benmalek (N)

Virology, Assistance Publique-Hôpitaux de Paris, Bichat-Claude Bernard University Hospital, Paris, France.

Christophe Choquet (C)

Université de Paris, IAME, INSERM, Paris, France; Virology, Assistance Publique-Hôpitaux de Paris, Bichat-Claude Bernard University Hospital, Paris, France.
Virology, Assistance Publique-Hôpitaux de Paris, Bichat-Claude Bernard University Hospital, Paris, France.

Jean-François Timsit (JF)

Université de Paris, IAME, INSERM, Paris, France; Virology, Assistance Publique-Hôpitaux de Paris, Bichat-Claude Bernard University Hospital, Paris, France.
Université de Paris, IAME, INSERM, Paris, France; Medical and Infectious Diseases Intensive Care Unit, Assistance Publique-Hôpitaux de Paris, Bichat-Claude Bernard University Hospital, Paris, France.

Jade Ghosn (J)

Université de Paris, IAME, INSERM, Paris, France; Virology, Assistance Publique-Hôpitaux de Paris, Bichat-Claude Bernard University Hospital, Paris, France.
Université de Paris, IAME, INSERM, Paris, France; Tropical and infectious diseases Department, Assistance Publique-Hôpitaux de Paris, Bichat-Claude Bernard University Hospital, Paris, France.

Charlotte Charpentier (C)

Université de Paris, IAME, INSERM, Paris, France; Virology, Assistance Publique-Hôpitaux de Paris, Bichat-Claude Bernard University Hospital, Paris, France.
Université de Paris, IAME, INSERM, Paris, France; Virology, Assistance Publique-Hôpitaux de Paris, Bichat-Claude Bernard University Hospital, Paris, France. Electronic address: benoit.visseaux@aphp.fr.

Diane Descamps (D)

Université de Paris, IAME, INSERM, Paris, France; Virology, Assistance Publique-Hôpitaux de Paris, Bichat-Claude Bernard University Hospital, Paris, France.
Université de Paris, IAME, INSERM, Paris, France; Virology, Assistance Publique-Hôpitaux de Paris, Bichat-Claude Bernard University Hospital, Paris, France. Electronic address: benoit.visseaux@aphp.fr.

Nadhira Houhou-Fidouh (N)

Université de Paris, IAME, INSERM, Paris, France; Virology, Assistance Publique-Hôpitaux de Paris, Bichat-Claude Bernard University Hospital, Paris, France. Electronic address: benoit.visseaux@aphp.fr.

Classifications MeSH