ORIGINAL RESEARCH

The importance of determining SARS-CoV-2 N-Ag serodiagnostics for the management of COVID-19 pneumonia in hospital settings

Lebedin YuS1, Lyang OV2, Galstyan AG, Panteleeva AV1, Belousov VV3, Rebrikov DV3
About authors

1 XEMA Co. Ltd., Moscow, Russia

2 Federal Center for Brain Research and Neurotechnologies of FMBA, Moscow, Russia

3 Center for Precision Genome Editing and Genetic Technologies for Biomedicine, Pirogov Russian National Research Medical University, Moscow, Russia

About paper

Funding: this work was partially supported by a grant № 075-15-2019-1789 from the Ministry of Science and Higher Education of the Russian Federation allocated to the Center for Precision Genome Editing and Genetic Technologies for Biomedicine.

Acknowledgement: we acknowledge Natalia Usman for helpful discussions

Author contribution: Lebedin YS designed the study, performed the sampling, conducted molecular studies and drafted the manuscript, Lyang OV and Galstyan AG performed the clinical examinations and sampling, conducted biochemical and molecular studies, Panteleeva AV conducted molecular studies and drafted the manuscript, Belousov VV and Rebrikov DV designed the study and drafted the manuscript. All authors read and approved the final version of the manuscript.

Compliance with ethical standards: the study protocol was reviewed and approved by the Local Ethics Committee at the Pirogov Russian State Medical University (Protocol № 2020/07 dated March 16, 2020,); the study was conducted in accordance with the Declaration of Helsinki.

Received: 2021-02-11 Accepted: 2021-02-24 Published online: 2021-02-28
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  1. Dioverti MV, Razonable RR. Cytomegalovirus. Microbiol Spectr. 2016; 4 (4). DOI: 10.1128/microbiolspec.DMIH2-0022-2015.
  2. Laing N, Tufton H, Ochola E, P'Kingston OG, Maini MK, Easom N. Hepatitis B assessment without hepatitis B virus DNA quantification: a prospective cohort study in Uganda. Trans R Soc Trop Med Hyg. 2019; 113 (1): 11–17. DOI: 10.1093/trstmh/try117.
  3. Thai KTD, Götz H, Slingerland BCGC, Klaasse J, Schutten M, GeurtsvanKessel CH. An analysis of the predictive value of the HIV Ag/Ab screening assay within the performance characteristics of the DiaSorin LIAISON XL for the detection of blood-borne viruses. J Clin Virol. 2018; 102: 95–100. DOI: 10.1016/j.jcv.2018.02.018.
  4. Loughlin L, Hellyer TP, White PL, et al. Pulmonary Aspergillosis in Patients with Suspected Ventilator-associated Pneumonia in UK Intensive Care Units [published online ahead of print, 2020 Jul 1]. Am J Respir Crit Care Med. 2020; 10.1164/rccm.2020020355OC. DOI: 10.1164/rccm.202002-0355OC.
  5. Edelstein PH, Jørgensen CS, Wolf LA. Performance of the ImmuView and BinaxNOW assays for the detection of urine and cerebrospinal fluid Streptococcus pneumoniae and Legionella pneumophila serogroup 1 antigen in patients with Legionnaires' disease or pneumococcal pneumonia and meningitis. PLoS One. 2020; 15 (8): e0238479. Published 2020 Aug 31. DOI: 10.1371/ journal.pone.0238479.
  6. Chiche L, Forel JM, Papazian L. The role of viruses in nosocomial pneumonia. Curr Opin Infect Dis. 2011; 24 (2): 152–56. DOI: 10.1097/QCO.0b013e328343b6e4.
  7. Che XY, Qiu LW, Pan YX, Wen K, Hao W, Zhang LY, et al. Sensitive and specific monoclonal antibody-based capture enzyme immunoassay for detection of nucleocapsid antigen in sera from patients with severe acute respiratory syndrome. J Clin Microbiol. 2004 Jun; 42 (6): 2629–35. DOI: 10.1128/JCM.42.6.2629-2635.2004.
  8. Xiao-yan Che, Biao Di, Guo-ping Zhao, Ya-di Wang, Li-wen Qiu, Wei Hao, et al. A Patient with Asymptomatic Severe Acute Respiratory Syndrome (SARS) and Antigenemia from the 2003– 2004 Community Outbreak of SARS in Guangzhou, China, Clinical Infectious Diseases. 2006; 43 (1): e1–e5. DOI: 10.1086/504943.
  9. Prikaz departamenta zdravoohranenija goroda Moskvy ot 22 marta 2020 g. # 230 «Ob utverzhdenii reglamentov (algoritmov) raboty medicinskih organizacij, podvedomstvennyh Departamentu zdravoohranenija goroda Moskvy v period s 23 po 30 marta 2020 g. po okazaniju medicinskoj pomoshhi pacientam, zabolevshim novoj koronavirusnoj infekciej (COVID-19), i kontaktnym s nimi licam». Available from: https://rg.ru/2020/03/24/moscowprikaz230-reg-dok.html. Russian.
  10. Prikaz Departamenta zdravoohranenija goroda Moskvy ot 06 aprelja 2020 g. # 351 «O porjadke vypiski iz medicinskih organizacij (stacionarov), podvedomstvennyh Departamentu zdravoohranenija goroda Moskvy, pacientov s vnebol'nichnoj pnevmoniej ili koronavirusnoj infekciej (COVID-19), dlja prodolzhenija lechenija v ambulatornyh uslovijah (na domu)». Available from: https://www.mos.ru/dzdrav/documents/ department-acts/view/239550220/. Russian.
  11. Huang X, Liu X, Chen J, et al. Evaluation of Blood-Based Antibody Rapid Testing for HIV Early Therapy: A Meta-Analysis of the Evidence. Front Immunol. 2018; 9: 1458. Published 2018 Jun 26. DOI: 10.3389/fimmu.2018.01458.
  12. Le Hingrat Q, Visseaux B, Laouenan C, Tubiana S, Bouadma L, Yazdanpanah Y, et al. Detection of SARS-CoV-2 N-antigen in blood during acute COVID-19 provides a sensitive new marker and new testing alternatives. Clinical Microbiology and Infection. December 2020. DOI: 10.1016/j.cmi.2020.11.025.
  13. Ogata AF, Maley AM, Wu C, Gilboa T, Norman M, Lazarovits R, et al. Ultra-Sensitive Serial Profiling of SARS-CoV-2 Antigens and Antibodies in Plasma to Understand Disease Progression in COVID-19 Patients with Severe Disease, Clinical Chemistry. 2020; 66 (12): 1562–72. DOI: 10.1093/clinchem/hvaa213.