Performance of 30 commercial SARS-CoV-2 serology assays in testing symptomatic COVID-19 patients

被引：12

作者：

Vauloup-Fellous, Christelle ^{[1
]}

Maylin, Sarah ^{[2
]}

Perillaud-Dubois, Claire ^{[1
]}

Brichler, Segolene ^{[3
,4
]}

Alloui, Chakib ^{[3
,4
]}

Gordien, Emmanuel ^{[3
,4
]}

Rameix-Welti, Marie-Anne ^{[5
,6
]}

Gault, Elyanne ^{[5
,6
]}

Moreau, Frederique ^{[5
,6
]}

Fourati, Slim ^{[7
]}

Challine, Dominique ^{[7
]}

Pawlotsky, Jean-Michel ^{[7
]}

Houhou-Fidouh, Nadhira ^{[8
]}

Damond, Florence ^{[8
]}

Mackiewicz, Vincent ^{[8
]}

Charpentier, Charlotte ^{[8
]}

Meritet, Jean-Francois ^{[9
]}

Rozenberg, Flore ^{[9
]}

Podglajen, Isabelle ^{[10
]}

Marot, Stephane ^{[11
]}

Petit, Heloise ^{[11
]}

Burrel, Sonia ^{[11
]}

Akhavan, Sepideh ^{[11
]}

Leruez-Ville, Marianne ^{[12
]}

Avettand-Fenoel, Veronique ^{[12
]}

Fourgeaud, Jacques ^{[12
]}

Guilleminot, Tiffany ^{[12
]}

Gardiennet, Elise ^{[12
]}

Bonacorsi, Stephane ^{[13
]}

Carol, Agnes ^{[13
]}

Carcelain, Guislaine ^{[14
]}

Villemonteix, Juliette ^{[14
]}

Boukli, Narjis ^{[15
]}

Gozlan, Joel ^{[15
]}

Morand-Joubert, Laurence ^{[15
]}

Legoff, Jerome ^{[2
]}

Delaugerre, Constance ^{[2
]}

Chaix, Marie-Laure ^{[2
]}

Roque-Afonso, Ana-Maria ^{[1
]}

Dortet, Laurent ^{[16
,17
]}

Naas, Thierry ^{[16
,17
]}

Ronat, Jean-Baptiste ^{[16
,17
]}

Lepape, Samuel ^{[1
]}

Marcelin, Anne-Genevieve ^{[11
]}

Descamps, Diane ^{[8
]}

机构：

[1] Univ Paris Saclay, Hop Paul Brousse, AP HP, Virol,Dept Virol,INSERM,U1193, F-94804 Villejuif, France

[2] Univ Paris, Hop St Louis, Dept Agents Infect, Serv Virol,INSERM,UMR 944, Paris, France

[3] Univ Paris Nord, Hop Avicenne, Lab Microbiol Clin, Ctr Natl Reference Hepatites B C & Delta, F-93009 Bobigny, France

[4] Unite INSERM U955, Creteil, France

[5] Univ Paris Saclay, Hop Ambroise Pare, AP HP, Lab Microbiol, Boulogne, France

[6] Univ Versailles St Quentin, Univ Paris Saclay, INSERM, UMR 1173 2I, Versailles, France

[7] Univ Paris Est, Dept Virol, Hop Henri Mondor, Viruses Hepatol Canc Res Unit,INSERM,U955, Creteil, France

[8] Univ Paris, Hop Bichat Claude Bernard, AP HP, Lab Virol,INSERM,UMR 1137,IAME, F-75018 Paris, France

[9] Univ Paris, Hop Cochin, APHP Ctr, Serv Virol, Paris, France

[10] Univ Paris, Hop Europeen Georges Pompidou, APHP Ctr, Serv Virol, Paris, France

[11] Sorbonne Univ, Hop Pitie Salpetriere, AP HP, IPLESP,Lab Virol,INSERM, Paris, France

[12] Univ Paris, Hop Necker, APHP,Inst Cochin, Lab Microbiol Clin,Fac Med,INSERM,U1016,CNRS,UMR, Paris, France

[13] Univ Paris, Hop Robert Debre, Serv Microbiol, Paris, France

[14] Univ Paris, Hop Robert Debre, Lab Immunol, Paris, France

[15] Univ Paris 06, Hop St Antoine, AP HP,Tenon,Trousseau, Dept Virol,Sorbonne Univ,INSERM,UPMC,UMR S 1136,I, Paris, France

[16] Univ Paris Saclay, Serv Bacteriol Hyg, Hop Bicetre, Inserm,U1184, Le Kremlin Bicetre, France

[17] Univ Paris Saclay, LabEx LERMIT, Le Kremlin Bicetre, France

来源：

EUROPEAN JOURNAL OF CLINICAL MICROBIOLOGY & INFECTIOUS DISEASES | 2021年 / 40卷 / 10期

关键词：

Serology; SARS-CoV-2; COVID-19; ANTIBODIES;

D O I：

10.1007/s10096-021-04232-3

中图分类号：

R51 [传染病];

学科分类号：

100401 ;

摘要：

We report evaluation of 30 assays' (17 rapid tests (RDTs) and 13 automated/manual ELISA/CLIA assay (IAs)) clinical performances with 2594 sera collected from symptomatic patients with positive SARS-CoV-2 rRT-PCR on a respiratory sample, and 1996 pre-epidemic serum samples expected to be negative. Only 4 RDT and 3 IAs fitted both specificity (> 98%) and sensitivity (> 90%) criteria according to French recommendations. Serology may offer valuable information during COVID-19 pandemic, but inconsistent performances observed among the 30 commercial assays evaluated, which underlines the importance of independent evaluation before clinical implementation.

引用

页码：2235 / 2241

页数：7

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