A comparison of 7 commercial anti-SARS-CoV-2 antibody immunoassays
Introduction Serological testing in SARS-CoV-2 infection is gaining both patients’ and clinicians’ attention. Antibody assessment has potential multidirectional utility, hampered by the scarcity of clinical validation studies of the tests available on the market. Therefore, this study aimed to provi...
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| Format: | Article |
| Language: | English |
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Termedia Publishing House
2020-08-01
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| Series: | Archives of Medical Science |
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| Online Access: | https://www.archivesofmedicalscience.com/A-comparison-of-7-commercial-anti-SARS-CoV-2-antibody-immunoassays,126022,0,2.html |
| _version_ | 1797435447303995392 |
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| author | Jakub Swadźba Maciej Bednarczyk Tomasz Anyszek Emilia Martin |
| author_facet | Jakub Swadźba Maciej Bednarczyk Tomasz Anyszek Emilia Martin |
| author_sort | Jakub Swadźba |
| collection | DOAJ |
| description | Introduction
Serological testing in SARS-CoV-2 infection is gaining both patients’ and clinicians’ attention. Antibody assessment has potential multidirectional utility, hampered by the scarcity of clinical validation studies of the tests available on the market. Therefore, this study aimed to provide some evidence on the clinical utility of anti-SARS-CoV-2 commercial assays, based on the comparison of the results obtained with different methods.
Material and methods
The study included 52 samples from patients and healthy volunteers. The control samples (n = 20) were obtained during the SARS-CoV-2 pandemic. The case cohort consisted of 32 consecutive patients referred to the Diagnostyka medical laboratory for anti-SARS-CoV-2 antibody testing. For the purpose of this study, the MAGLUMI chemiluminescent immunoassay (CLIA) was chosen as a comparative method. All samples were tested with this method, as well as with the Euroimmun enzyme-linked immunosorbent assay (ELISA) and five different lateral flow immunoassays (LFIAs).
Results
The results obtained in this study provide evidence for high overall concordance between the comparative CLIA method and both ELISA and different LFIAs. The agreement between CLIA and LFIAs was 92.3–98.0% for IgG and 90.0–96.1% for IgM, depending on the kit. The concordance between CLIA and ELISA was 92.3% for IgG and 75.0% for IgA (compared to the MAGLUMI CLIA IgM).
Conclusions
The results obtained in this study provide evidence for high overall concordance between the comparative CLIA method and different LFIAs. This could justify the use of LFIAs in some settings, where automated assays are not available, provided that some limitations are considered. |
| first_indexed | 2024-03-09T10:48:14Z |
| format | Article |
| id | doaj.art-3e01413e84624873b2dbba40d57dc320 |
| institution | Directory Open Access Journal |
| issn | 1734-1922 1896-9151 |
| language | English |
| last_indexed | 2024-03-09T10:48:14Z |
| publishDate | 2020-08-01 |
| publisher | Termedia Publishing House |
| record_format | Article |
| series | Archives of Medical Science |
| spelling | doaj.art-3e01413e84624873b2dbba40d57dc3202023-12-01T09:49:08ZengTermedia Publishing HouseArchives of Medical Science1734-19221896-91512020-08-011951281128810.5114/aoms.2020.98361126022A comparison of 7 commercial anti-SARS-CoV-2 antibody immunoassaysJakub Swadźba0Maciej Bednarczyk1Tomasz Anyszek2Emilia Martin3Department of Laboratory Medicine, Andrzej Frycz Modrzewski Krakow University, Medical Faculty, Krakow, PolandMedical Laboratory Diagnostyka, Krakow, PolandDepartment of Laboratory Medicine, Andrzej Frycz Modrzewski Krakow University, Medical Faculty, Krakow, PolandMedical Laboratory Diagnostyka, Krakow, PolandIntroduction Serological testing in SARS-CoV-2 infection is gaining both patients’ and clinicians’ attention. Antibody assessment has potential multidirectional utility, hampered by the scarcity of clinical validation studies of the tests available on the market. Therefore, this study aimed to provide some evidence on the clinical utility of anti-SARS-CoV-2 commercial assays, based on the comparison of the results obtained with different methods. Material and methods The study included 52 samples from patients and healthy volunteers. The control samples (n = 20) were obtained during the SARS-CoV-2 pandemic. The case cohort consisted of 32 consecutive patients referred to the Diagnostyka medical laboratory for anti-SARS-CoV-2 antibody testing. For the purpose of this study, the MAGLUMI chemiluminescent immunoassay (CLIA) was chosen as a comparative method. All samples were tested with this method, as well as with the Euroimmun enzyme-linked immunosorbent assay (ELISA) and five different lateral flow immunoassays (LFIAs). Results The results obtained in this study provide evidence for high overall concordance between the comparative CLIA method and both ELISA and different LFIAs. The agreement between CLIA and LFIAs was 92.3–98.0% for IgG and 90.0–96.1% for IgM, depending on the kit. The concordance between CLIA and ELISA was 92.3% for IgG and 75.0% for IgA (compared to the MAGLUMI CLIA IgM). Conclusions The results obtained in this study provide evidence for high overall concordance between the comparative CLIA method and different LFIAs. This could justify the use of LFIAs in some settings, where automated assays are not available, provided that some limitations are considered.https://www.archivesofmedicalscience.com/A-comparison-of-7-commercial-anti-SARS-CoV-2-antibody-immunoassays,126022,0,2.htmllateral flow immunoassaychemiluminescent immunoassayenzyme-linked immunosorbent assaycovid-19 |
| spellingShingle | Jakub Swadźba Maciej Bednarczyk Tomasz Anyszek Emilia Martin A comparison of 7 commercial anti-SARS-CoV-2 antibody immunoassays Archives of Medical Science lateral flow immunoassay chemiluminescent immunoassay enzyme-linked immunosorbent assay covid-19 |
| title | A comparison of 7 commercial anti-SARS-CoV-2 antibody immunoassays |
| title_full | A comparison of 7 commercial anti-SARS-CoV-2 antibody immunoassays |
| title_fullStr | A comparison of 7 commercial anti-SARS-CoV-2 antibody immunoassays |
| title_full_unstemmed | A comparison of 7 commercial anti-SARS-CoV-2 antibody immunoassays |
| title_short | A comparison of 7 commercial anti-SARS-CoV-2 antibody immunoassays |
| title_sort | comparison of 7 commercial anti sars cov 2 antibody immunoassays |
| topic | lateral flow immunoassay chemiluminescent immunoassay enzyme-linked immunosorbent assay covid-19 |
| url | https://www.archivesofmedicalscience.com/A-comparison-of-7-commercial-anti-SARS-CoV-2-antibody-immunoassays,126022,0,2.html |
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