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Comparison of a rapid immunochromatographic test with a chemiluminescence immunoassay for detection of anti-SARS-CoV-2 IgM and IgG.
Gambino, Caterina Maria; Lo Sasso, Bruna; Colomba, Claudia; Giglio, Rosaria Vincenza; Agnello, Luisa; Bivona, Giulia; Ciaccio, Marcello.
  • Gambino CM; Department of Biomedicine, Neurosciences and Advanced Diagnostics, Institute of Clinical Biochemistry, Clinical Molecular Medicine and Laboratory Medicine, University of Palermo, Palermo, Italy.
  • Lo Sasso B; Department of Biomedicine, Neurosciences and Advanced Diagnostics, Institute of Clinical Biochemistry, Clinical Molecular Medicine and Laboratory Medicine, University of Palermo, Palermo, Italy.
  • Colomba C; Department of Laboratory Medicine, University Hospital "P. Giaccone", Palermo, Italy.
  • Giglio RV; Department of Promoting Health, Maternal-Infant. Excellence and Internal and Specialized Medicine (ProMISE) G. D'Alessandro, University of Palermo, Palermo, Italy.
  • Agnello L; Department of Biomedicine, Neurosciences and Advanced Diagnostics, Institute of Clinical Biochemistry, Clinical Molecular Medicine and Laboratory Medicine, University of Palermo, Palermo, Italy.
  • Bivona G; Department of Biomedicine, Neurosciences and Advanced Diagnostics, Institute of Clinical Biochemistry, Clinical Molecular Medicine and Laboratory Medicine, University of Palermo, Palermo, Italy.
  • Ciaccio M; Department of Biomedicine, Neurosciences and Advanced Diagnostics, Institute of Clinical Biochemistry, Clinical Molecular Medicine and Laboratory Medicine, University of Palermo, Palermo, Italy.
Biochem Med (Zagreb) ; 30(3): 030901, 2020 Oct 15.
Article in English | MEDLINE | ID: covidwho-874947
Semantic information from SemMedBD (by NLM)
1. anti-IgM|CD40LG PART_OF 2019 novel coronavirus
Subject
anti-IgM|CD40LG
Predicate
PART_OF
Object
2019 novel coronavirus
2. Immunochromatographic test USES Chemiluminescence assay
Subject
Immunochromatographic test
Predicate
USES
Object
Chemiluminescence assay
3. Chemiluminescence assay METHOD_OF Detection
Subject
Chemiluminescence assay
Predicate
METHOD_OF
Object
Detection
4. Coronavirus antibody PART_OF 2019 novel coronavirus
Subject
Coronavirus antibody
Predicate
PART_OF
Object
2019 novel coronavirus
5. Infected PROCESS_OF Patients
Subject
Infected
Predicate
PROCESS_OF
Object
Patients
6. Serologic tests DIAGNOSES 2019 novel coronavirus
Subject
Serologic tests
Predicate
DIAGNOSES
Object
2019 novel coronavirus
7. Coronavirus antibody PART_OF Patients
Subject
Coronavirus antibody
Predicate
PART_OF
Object
Patients
8. CD40LG wt Allele|CD40LG PART_OF 2019 novel coronavirus
Subject
CD40LG wt Allele|CD40LG
Predicate
PART_OF
Object
2019 novel coronavirus
9. Antibodies PART_OF 2019 novel coronavirus
Subject
Antibodies
Predicate
PART_OF
Object
2019 novel coronavirus
10. Patients LOCATION_OF Specimen Type - Serum
Subject
Patients
Predicate
LOCATION_OF
Object
Specimen Type - Serum
11. Specimen Type - Serum LOCATION_OF Antibodies
Subject
Specimen Type - Serum
Predicate
LOCATION_OF
Object
Antibodies
12. IgG antibody PART_OF 2019 novel coronavirus
Subject
IgG antibody
Predicate
PART_OF
Object
2019 novel coronavirus
13. IgM immunoglobulin comple PART_OF C5203676
Subject
IgM immunoglobulin comple
Predicate
PART_OF
Object
C5203676
14. anti-IgM|CD40LG PART_OF 2019 novel coronavirus
Subject
anti-IgM|CD40LG
Predicate
PART_OF
Object
2019 novel coronavirus
15. Immunochromatographic test USES Chemiluminescence assay
Subject
Immunochromatographic test
Predicate
USES
Object
Chemiluminescence assay
16. Chemiluminescence assay METHOD_OF Detection
Subject
Chemiluminescence assay
Predicate
METHOD_OF
Object
Detection
17. Coronavirus antibody PART_OF 2019 novel coronavirus
Subject
Coronavirus antibody
Predicate
PART_OF
Object
2019 novel coronavirus
18. Infected PROCESS_OF Patients
Subject
Infected
Predicate
PROCESS_OF
Object
Patients
19. Serologic tests DIAGNOSES 2019 novel coronavirus
Subject
Serologic tests
Predicate
DIAGNOSES
Object
2019 novel coronavirus
20. Coronavirus antibody PART_OF Patients
Subject
Coronavirus antibody
Predicate
PART_OF
Object
Patients
21. CD40LG wt Allele|CD40LG PART_OF 2019 novel coronavirus
Subject
CD40LG wt Allele|CD40LG
Predicate
PART_OF
Object
2019 novel coronavirus
22. Antibodies PART_OF 2019 novel coronavirus
Subject
Antibodies
Predicate
PART_OF
Object
2019 novel coronavirus
23. Patients LOCATION_OF Specimen Type - Serum
Subject
Patients
Predicate
LOCATION_OF
Object
Specimen Type - Serum
24. Specimen Type - Serum LOCATION_OF Antibodies
Subject
Specimen Type - Serum
Predicate
LOCATION_OF
Object
Antibodies
25. IgG antibody PART_OF 2019 novel coronavirus
Subject
IgG antibody
Predicate
PART_OF
Object
2019 novel coronavirus
26. IgM immunoglobulin complex, circulating PART_OF 2019 novel coronavirus
Subject
IgM immunoglobulin complex, circulating
Predicate
PART_OF
Object
2019 novel coronavirus
ABSTRACT

INTRODUCTION:

The 2019 Coronavirus disease (COVID-19) has been characterized as a pandemic, representing a serious global public health emergency. Serological tests have been proposed as reliable tools for detecting Coronavirus SARS-CoV-2 antibodies in infected patients, especially for surveillance or epidemiological purposes. The aim of this study is to evaluate the agreement between the IgM/IgG rapid assays, based on lateral flow immunochromatographic assay, and the fully automated 2019-nCoV IgM and IgG, based on chemiluminescence immunoassay. MATERIALS AND

METHODS:

SARS-CoV-2 antibodies were measured with the BIOSYNEX COVID-19 BSS IgM/IgG test (BIOSYNEX, Illkirch-Graffenstaden, France) and the MAGLUMI CLIA (IgM and IgG) (SNIBE - Shenzhen New Industries Biomedical Engineering, Shenzhen, China) in 70 serum samples from patients with PCR-confirmed diagnosis. The strength of the agreement of the two methods was calculated by using the Cohen Kappa index.

RESULTS:

The results showed a good grade of concordance between the two immunoassays with a Cohen's kappa coefficient of 0.71 (95%CI 0.54-0.87) for IgG SARS-CoV-2 antibodies and 0.70 (95%CI 0.53-0.87) for IgM SARS-CoV-2 antibodies. In addition, the rapid assays BIOSYNEX COVID-19 BSS for detecting SARS-CoV-2 antibodies showed a positive likelihood ratio (LR) of 10.63 (95%CI 2.79-40.57) for IgG and a LR of 6.79 (95%CI 2.93-15.69) for IgM.

CONCLUSION:

Our results suggest that the immunochromatographic rapid IgM/IgG test and the chemiluminescence IgM and IgG immunoassay have a good degree of concordance, suggesting that both could be considered as useful tools for epidemiologic surveillance.
Subject(s)
Keywords

Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Immunoglobulin G / Immunoglobulin M / Coronavirus Infections / Clinical Laboratory Techniques / Pandemics / Betacoronavirus / Antibodies, Viral Type of study: Diagnostic study / Screening study Limits: Aged / Female / Humans / Male / Middle aged Language: English Journal: Biochem Med (Zagreb) Year: 2020 Document Type: Article Affiliation country: Bm.2020.030901

Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Immunoglobulin G / Immunoglobulin M / Coronavirus Infections / Clinical Laboratory Techniques / Pandemics / Betacoronavirus / Antibodies, Viral Type of study: Diagnostic study / Screening study Limits: Aged / Female / Humans / Male / Middle aged Language: English Journal: Biochem Med (Zagreb) Year: 2020 Document Type: Article Affiliation country: Bm.2020.030901