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Humoral immunological kinetics of severe acute respiratory syndrome coronavirus 2 infection and diagnostic performance of serological assays for coronavirus disease 2019: an analysis of global reports.

  • Emeribe, Anthony Uchenna1
  • Abdullahi, Idris Nasir2
  • Shuwa, Halima Ali3
  • Uzairue, Leonard4
  • Musa, Sanusi2
  • Anka, Abubakar Umar2
  • Adekola, Hafeez Aderinsayo5
  • Bello, Zakariyya Muhammad2
  • Rogo, Lawal Dahiru6
  • Aliyu, Dorcas1
  • Haruna, Shamsuddeen2
  • Usman, Yahaya2
  • Muhammad, Habiba Yahaya6
  • Gwarzo, Abubakar Muhammad7
  • Nwofe, Justin Onyebuchi8
  • Chiwar, Hassan Musa9
  • Okwume, Chukwudi Crescent10
  • Animasaun, Olawale Sunday11
  • Fasogbon, Samuel Ayobami12
  • Olayemi, Lawal13
  • And 5 more
  • 1 Department of Medical Laboratory Science, Faculty of Allied Medical Sciences, University of Calabar, P.M.B 1115, Calabar, Cross River State, Nigeria. , (Niger)
  • 2 Department of Medical Laboratory Science, Faculty of Allied Health Sciences, College of Medical Sciences, Ahmadu Bello University, Zaria, Nigeria. , (Niger)
  • 3 University Health Services, College of Health and Medical Sciences, Federal University, Dutse, Nigeria. , (Niger)
  • 4 Department of Microbiology, Federal University of Agriculture Abeokuta, Nigeria. , (Niger)
  • 5 Department of Microbiology, Olabisi Onabanjo University, Ago-Iwoye, Nigeria. , (Niger)
  • 6 Department of Medical Laboratory Science, Faculty of Allied Health Sciences, Bayero University, Kano Nigeria. , (Niger)
  • 7 Department of Medical Microbiology and Parasitology, Federal University, Dutse, Nigeria. , (Niger)
  • 8 Department of Medical Laboratory Science, University of Nigeria, Enugu, Nigeria. , (Niger)
  • 9 Department of Medical Laboratory Science, University of Maiduguri Maiduguri, Nigeria. , (Niger)
  • 10 Department of Medical Laboratory Services, University of Nigeria Teaching Hospital, Enugu, Nigeria. , (Niger)
  • 11 Nigeria Field Epidemiology and Laboratory Training Programme, African Field Epidemiology Network, Abuja, Nigeria. , (Niger)
  • 12 Public Health In-vitro Diagnostic Control Laboratory, Medical Laboratory Science Council of Nigeria, Lagos, Nigeria. , (Niger)
  • 13 School of Medicine, Faculty of Health Sciences, National University of Samoa, Apia, Samoa. , (Samoa)
  • 14 Department of Family Medicine, University of Calabar Teaching Hospital, PMB 1278 Calabar, Cross River, Nigeria. , (Niger)
  • 15 WHO National Polio Reference Laboratory, University of Maiduguri Teaching Hospital, Maiduguri, Nigeria. , (Niger)
  • 16 Institute of Biomedicine, and MediCity Research Laboratories, University of Turku, 20014 Turku, Finland. , (Finland)
  • 17 Immunology Unit, Department of Medicine, Ahmadu Bello University, Zaria, Nigeria. , (Niger)
Published Article
International health
Publication Date
Jan 19, 2022
DOI: 10.1093/inthealth/ihab005
PMID: 33620427


As the coronavirus disease 2019 (COVID-19) pandemic continues to rise and second waves are reported in some countries, serological test kits and strips are being considered to scale up an adequate laboratory response. This study provides an update on the kinetics of humoral immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and performance characteristics of serological protocols (lateral flow assay [LFA], chemiluminescence immunoassay [CLIA] and ELISA) used for evaluations of recent and past SARS-CoV-2 infection. A thorough and comprehensive review of suitable and eligible full-text articles was performed on PubMed, Scopus, Web of Science, Wordometer and medRxiv from 10 January to 16 July 2020. These articles were searched using the Medical Subject Headings terms 'COVID-19', 'Serological assay', 'Laboratory Diagnosis', 'Performance characteristics', 'POCT', 'LFA', 'CLIA', 'ELISA' and 'SARS-CoV-2'. Data from original research articles on SARS-CoV-2 antibody detection ≥second day postinfection were included in this study. In total, there were 7938 published articles on humoral immune response and laboratory diagnosis of COVID-19. Of these, 74 were included in this study. The detection, peak and decline period of blood anti-SARS-CoV-2 IgM, IgG and total antibodies for point-of-care testing (POCT), ELISA and CLIA vary widely. The most promising of these assays for POCT detected anti-SARS-CoV-2 at day 3 postinfection and peaked on the 15th day; ELISA products detected anti-SARS-CoV-2 IgM and IgG at days 2 and 6 then peaked on the eighth day; and the most promising CLIA product detected anti-SARS-CoV-2 at day 1 and peaked on the 30th day. The most promising LFA, ELISA and CLIA that had the best performance characteristics were those targeting total SARS-CoV-2 antibodies followed by those targeting anti-SARS-CoV-2 IgG then IgM. Essentially, the CLIA-based SARS-CoV-2 tests had the best performance characteristics, followed by ELISA then POCT. Given the varied performance characteristics of all the serological assays, there is a need to continuously improve their detection thresholds, as well as to monitor and re-evaluate their performances to assure their significance and applicability for COVID-19 clinical and epidemiological purposes. © The Author(s) 2021. Published by Oxford University Press on behalf of Royal Society of Tropical Medicine and Hygiene.

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