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Performance of the Abbott SARS-CoV-2 IgG serological assay in South African 2 patients.
Jugwanth, Sarika; Gededzha, Maemu P; Mampeule, Nakampe; Zwane, Nontobeko; David, Anura; Burgers, Wendy A; Blackburn, Jonathan M; Grove, Jurette S; George, Jaya A; Sanne, Ian; Scott, Lesley; Stevens, Wendy; Mayne, Elizabeth S.
  • Jugwanth S; Department of Immunology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
  • Gededzha MP; National Health Laboratory Services, Johannesburg, South Africa.
  • Mampeule N; Department of Immunology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
  • Zwane N; National Health Laboratory Services, Johannesburg, South Africa.
  • David A; Department of Immunology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
  • Burgers WA; National Health Laboratory Services, Johannesburg, South Africa.
  • Blackburn JM; Department of Immunology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
  • Grove JS; Department of Molecular Medicine and Haematology, School of Pathology, Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa.
  • George JA; Division of Medical Virology, Department of Pathology, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.
  • Sanne I; Wellcome Centre for Infectious Diseases Research in Africa, Cape Town, South Africa.
  • Scott L; Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
  • Stevens W; Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
  • Mayne ES; Divisions of Chemical and System Biology, Department of Integrative Biomedical Sciences, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.
PLoS One ; 17(2): e0262442, 2022.
Article in English | MEDLINE | ID: covidwho-1854992
ABSTRACT
In late December 2019, pneumonia cases of unknown origin were reported in Wuhan, China. This virus was named SARS-CoV2 and the clinical syndrome was named coronavirus disease 19 (COVID-19). South Africa, despite strict and early lockdown has the highest infection rate in Africa. A key component of South Africa's response to SARSCoV2 was the rapid scale-up of diagnostic testing. The Abbott SARS-CoV2 assay detects IgG antibodies against the Nucleocapsid (N) protein of the SARS-CoV2 virus. This study undertook to validate and evaluate performance criteria of the Abbott assay and to establish whether this assay would show clinical utility in our population. Positive patients (n = 391) and negative controls (n = 139) were included. The Architect-i and Alinity-i systems were analyzers that were used to perform the SARS-CoV-2 IgG assay. In-house ELISA was incorporated into the study as a confirmatory serology test. A total of number of 530 participants was tested, 87% were symptomatic with infection and 13% were asymptomatic. When compared to RT-qPCR, the sensitivity of Architect and Alinity SARS-CoV2 assays was 69.5% and 64.8%, respectively. Specificity for Architect and Alinity assays was 95% and 90.3%, respectively. The Abbott assay was also compared to in house ELISA assay, with sensitivity for the Architect and Alinity assays of 94.7% and 92.5%, respectively. Specificity for Abbott Alinity assays was 91.7% higher than Abbott Architect 88.1%. Based on the current findings testing of IgG after 14 days is recommended in South Africa and supports other studies performed around the world.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunoglobulin G / COVID-19 Serological Testing / SARS-CoV-2 / COVID-19 / Antibodies, Viral Type of study: Cohort study / Diagnostic study / Experimental Studies / Observational study / Prognostic study Topics: Long Covid Limits: Adult / Aged / Female / Humans / Male / Middle aged / Young adult Country/Region as subject: Africa Language: English Journal: PLoS One Journal subject: Science / Medicine Year: 2022 Document Type: Article Affiliation country: Journal.pone.0262442

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunoglobulin G / COVID-19 Serological Testing / SARS-CoV-2 / COVID-19 / Antibodies, Viral Type of study: Cohort study / Diagnostic study / Experimental Studies / Observational study / Prognostic study Topics: Long Covid Limits: Adult / Aged / Female / Humans / Male / Middle aged / Young adult Country/Region as subject: Africa Language: English Journal: PLoS One Journal subject: Science / Medicine Year: 2022 Document Type: Article Affiliation country: Journal.pone.0262442