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A systematic and meta-analysis review on the diagnostic accuracy of antibodies in the serological diagnosis of COVID-19.
Vengesai, Arthur; Midzi, Herald; Kasambala, Maritha; Mutandadzi, Hamlet; Mduluza-Jokonya, Tariro L; Rusakaniko, Simbarashe; Mutapi, Francisca; Naicker, Thajasvarie; Mduluza, Takafira.
  • Vengesai A; Department of Biochemistry, University of Zimbabwe, P.O. Box MP 167, Mt Pleasant, Harare, Zimbabwe. arthurvengesai@gmail.com.
  • Midzi H; Optics and Imaging, Doris Duke Medical Research Institute, College of Health Sciences, University of KwaZulu-Natal, Durban, KwaZulu-Natal, South Africa. arthurvengesai@gmail.com.
  • Kasambala M; Department of Biochemistry, University of Zimbabwe, P.O. Box MP 167, Mt Pleasant, Harare, Zimbabwe.
  • Mutandadzi H; Department of Biochemistry, University of Zimbabwe, P.O. Box MP 167, Mt Pleasant, Harare, Zimbabwe.
  • Mduluza-Jokonya TL; College of Health Sciences, University of Zimbabwe, Box A178 Mazowe Street Avondale, Harare, Zimbabwe.
  • Rusakaniko S; Department of Biochemistry, University of Zimbabwe, P.O. Box MP 167, Mt Pleasant, Harare, Zimbabwe.
  • Mutapi F; Optics and Imaging, Doris Duke Medical Research Institute, College of Health Sciences, University of KwaZulu-Natal, Durban, KwaZulu-Natal, South Africa.
  • Naicker T; College of Health Sciences, University of Zimbabwe, Box A178 Mazowe Street Avondale, Harare, Zimbabwe.
  • Mduluza T; Institute for Immunology and Infection Research and Centre for Immunity, Infection and Evolution, School of Biological Sciences, Ashworth Laboratories, University of Edinburgh, King's Buildings, Charlotte Auerbach Rd, Edinburgh, EH9 3JT, UK.
Syst Rev ; 10(1): 155, 2021 05 26.
Article in English | MEDLINE | ID: covidwho-1277973
ABSTRACT

BACKGROUND:

Serological testing based on different antibody types are an alternative method being used to diagnose SARS-CoV-2 and has the potential of having higher diagnostic accuracy compared to the current gold standard rRT-PCR. Therefore, the objective of this review was to evaluate the diagnostic accuracy of IgG and IgM based point-of-care (POC) lateral flow immunoassay (LFIA), chemiluminescence enzyme immunoassay (CLIA), fluorescence enzyme-linked immunoassay (FIA) and ELISA systems that detect SARS-CoV-2 antigens.

METHOD:

A systematic literature search was carried out in PubMed, Medline complete and MedRxiv. Studies evaluating the diagnostic accuracy of serological assays for SARS-CoV-2 were eligible. Study selection and data-extraction were performed by two authors independently. QUADAS-2 checklist tool was used to assess the quality of the studies. The bivariate model and the hierarchical summary receiver operating characteristic curve model were performed to evaluate the diagnostic accuracy of the serological tests. Subgroup meta-analysis was performed to explore the heterogeneity.

RESULTS:

The pooled sensitivity for IgG (n = 17), IgM (n = 16) and IgG-IgM (n = 24) based LFIA tests were 0.5856, 0.4637 and 0.6886, respectively compared to rRT-PCR method. The pooled sensitivity for IgG (n = 9) and IgM (n = 10) based CLIA tests were 0.9311 and 0.8516, respectively compared to rRT-PCR. The pooled sensitivity the IgG (n = 10), IgM (n = 11) and IgG-IgM (n = 5) based ELISA tests were 0.8292, 0.8388 and 0.8531 respectively compared to rRT-PCR. All tests displayed high specificities ranging from 0.9693 to 0.9991. Amongst the evaluated tests, IgG based CLIA expressed the highest sensitivity signifying its accurate detection of the largest proportion of infections identified by rRT-PCR. ELISA and CLIA tests performed better in terms of sensitivity compared to LFIA. IgG based tests performed better compared to IgM except for the ELISA.

CONCLUSIONS:

We report that IgG-IgM based ELISA tests have the best overall diagnostic test accuracy. Moreover, irrespective of the method, a combined IgG/IgM test seems to be a better choice in terms of sensitivity than measuring either antibody type independently. Given the poor performances of the current LFIA devices, there is a need for more research on the development of highly sensitivity and specific POC LFIA that are adequate for most individual patient applications and attractive for large sero-prevalence studies. SYSTEMATIC REVIEW REGISTRATION PROSPERO CRD42020179112.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Type of study: Diagnostic study / Experimental Studies / Observational study / Reviews / Systematic review/Meta Analysis Limits: Humans Language: English Journal: Syst Rev Year: 2021 Document Type: Article Affiliation country: S13643-021-01689-3

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Type of study: Diagnostic study / Experimental Studies / Observational study / Reviews / Systematic review/Meta Analysis Limits: Humans Language: English Journal: Syst Rev Year: 2021 Document Type: Article Affiliation country: S13643-021-01689-3