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Pregled bibliografske jedinice broj: 1115106

Comparison of diagnostic accuracy for eight SARS-CoV-2 serological assays


Tešija Kuna, Andrea; Hanžek, Milena; Vukasović, Ines; Nikolac Gabaj, Nora; Vidranski, Valentina; Ćelap, Ivana; Miler, Marijana; Stančin, Nevenka; Šimac, Brankica; Živković, Marcela et al.
Comparison of diagnostic accuracy for eight SARS-CoV-2 serological assays // Biochemia medica, 31 (2021), 1; 121-133 doi:10.11613/bm.2021.010708 (međunarodna recenzija, članak, znanstveni)


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Naslov
Comparison of diagnostic accuracy for eight SARS-CoV-2 serological assays

Autori
Tešija Kuna, Andrea ; Hanžek, Milena ; Vukasović, Ines ; Nikolac Gabaj, Nora ; Vidranski, Valentina ; Ćelap, Ivana ; Miler, Marijana ; Stančin, Nevenka ; Šimac, Brankica ; Živković, Marcela ; Žarak, Marko ; Kmet, Marta ; Jovanović, Marijana ; Tadinac, Sanja ; Šupraha Goreta, Sandra ; Periša, Josipa ; Šamija, Ivan ; Štefanović, Mario

Izvornik
Biochemia medica (1330-0962) 31 (2021), 1; 121-133

Vrsta, podvrsta i kategorija rada
Radovi u časopisima, članak, znanstveni

Ključne riječi
sensitivity ; specificity ; SARS-CoV-2 ; serological test

Sažetak
Introduction Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serological tests have been suggested as an additional diagnostic tool in highly suspected cases with a negative molecular test and determination of seroprevalence in population. We compared the diagnostic performance of eight commercial serological assays for IgA, IgM, and IgG antibodies to the SARS-CoV-2 virus. Materials and methods The comparison study was performed on a total of 76 serum samples: 30 SARS- CoV-2 polymerase chain reaction (PCR)-negative and 46 SARS-CoV-2 PCR- positive patients with asymptomatic to severe disease and symptoms duration from 3-30 days. The study included: three rapid lateral flow immunochromatographic assays (LFIC), two enzyme- linked immunosorbent assays (ELISA), and three chemiluminescence immunoassays (CLIA). Results Agreement between IgM assays were minimal to moderate (kappa 0.26 to 0.63) and for IgG moderate to excellent (kappa 0.72 to 0.92). Sensitivities improved with > 10 days of symptoms and were: 30% to 89% for IgM ; 89% to 100% for IgG ; 96% for IgA ; 100% for IgA/IgM combination ; 96% for total antibodies. Overall specificities were: 90% to 100% for IgM ; 85% to 100% for IgG ; 90% for IgA ; 70% for IgA/IgM combination ; 100% for total antibodies. Diagnostic accuracy for IgG ELISA and CIA assays were excellent (AUC ≥ 0.90), without significant difference. IgA showed significantly better diagnostic accuracy than IgM (P < 0.001). Conclusion There is high variability between IgM assays independently of the assay format, while IgG assays showed moderate to perfect agreement. The appropriate time for testing is crucial for the proper immunity investigation.

Izvorni jezik
Engleski

Znanstvena područja
Biotehnologija u biomedicini (prirodno područje, biomedicina i zdravstvo, biotehničko područje)



POVEZANOST RADA


Ustanove:
Farmaceutsko-biokemijski fakultet, Zagreb,
KBC "Sestre Milosrdnice",
Klinička bolnica "Dubrava"

Poveznice na cjeloviti tekst rada:

doi www.biochemia-medica.com

Citiraj ovu publikaciju:

Tešija Kuna, Andrea; Hanžek, Milena; Vukasović, Ines; Nikolac Gabaj, Nora; Vidranski, Valentina; Ćelap, Ivana; Miler, Marijana; Stančin, Nevenka; Šimac, Brankica; Živković, Marcela et al.
Comparison of diagnostic accuracy for eight SARS-CoV-2 serological assays // Biochemia medica, 31 (2021), 1; 121-133 doi:10.11613/bm.2021.010708 (međunarodna recenzija, članak, znanstveni)
Tešija Kuna, A., Hanžek, M., Vukasović, I., Nikolac Gabaj, N., Vidranski, V., Ćelap, I., Miler, M., Stančin, N., Šimac, B. & Živković, M. (2021) Comparison of diagnostic accuracy for eight SARS-CoV-2 serological assays. Biochemia medica, 31 (1), 121-133 doi:10.11613/bm.2021.010708.
@article{article, author = {Te\v{s}ija Kuna, Andrea and Han\v{z}ek, Milena and Vukasovi\'{c}, Ines and Nikolac Gabaj, Nora and Vidranski, Valentina and \'{C}elap, Ivana and Miler, Marijana and Stan\v{c}in, Nevenka and \v{S}imac, Brankica and \v{Z}ivkovi\'{c}, Marcela and \v{Z}arak, Marko and Kmet, Marta and Jovanovi\'{c}, Marijana and Tadinac, Sanja and \v{S}upraha Goreta, Sandra and Peri\v{s}a, Josipa and \v{S}amija, Ivan and \v{S}tefanovi\'{c}, Mario}, year = {2021}, pages = {121-133}, DOI = {10.11613/bm.2021.010708}, keywords = {sensitivity, specificity, SARS-CoV-2, serological test}, journal = {Biochemia medica}, doi = {10.11613/bm.2021.010708}, volume = {31}, number = {1}, issn = {1330-0962}, title = {Comparison of diagnostic accuracy for eight SARS-CoV-2 serological assays}, keyword = {sensitivity, specificity, SARS-CoV-2, serological test} }
@article{article, author = {Te\v{s}ija Kuna, Andrea and Han\v{z}ek, Milena and Vukasovi\'{c}, Ines and Nikolac Gabaj, Nora and Vidranski, Valentina and \'{C}elap, Ivana and Miler, Marijana and Stan\v{c}in, Nevenka and \v{S}imac, Brankica and \v{Z}ivkovi\'{c}, Marcela and \v{Z}arak, Marko and Kmet, Marta and Jovanovi\'{c}, Marijana and Tadinac, Sanja and \v{S}upraha Goreta, Sandra and Peri\v{s}a, Josipa and \v{S}amija, Ivan and \v{S}tefanovi\'{c}, Mario}, year = {2021}, pages = {121-133}, DOI = {10.11613/bm.2021.010708}, keywords = {sensitivity, specificity, SARS-CoV-2, serological test}, journal = {Biochemia medica}, doi = {10.11613/bm.2021.010708}, volume = {31}, number = {1}, issn = {1330-0962}, title = {Comparison of diagnostic accuracy for eight SARS-CoV-2 serological assays}, keyword = {sensitivity, specificity, SARS-CoV-2, serological test} }

Časopis indeksira:


  • Current Contents Connect (CCC)
  • Web of Science Core Collection (WoSCC)
    • Science Citation Index Expanded (SCI-EXP)
    • SCI-EXP, SSCI i/ili A&HCI
  • Scopus
  • MEDLINE


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