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Evaluation of five immunoassays and one lateral flow immunochromatography for anti-SARS-CoV-2 antibodies detection.
Montolio Breva, Silvia; Molina Clavero, Carmen; Gómez Bertomeu, Frederic; Picó-Plana, Ester; Serrat Orús, Núria; Palau Sánchez, Inmaculada; Mestre-Prad, Maria Teresa; Sans-Mateu, Maria Teresa.
  • Montolio Breva S; Laboratori Clínic ICS Camp de Tarragona - Terres de l'Ebre - Hospital Universitari Joan XXIII, Tarragona, Spain. Electronic address: smontoliob.hj23.ics@gencat.cat.
  • Molina Clavero C; Laboratori Clínic ICS Camp de Tarragona - Terres de l'Ebre - Hospital Universitari Joan XXIII, Tarragona, Spain.
  • Gómez Bertomeu F; Laboratori Clínic ICS Camp de Tarragona - Terres de l'Ebre - Hospital Universitari Joan XXIII, Tarragona, Spain.
  • Picó-Plana E; Laboratori Clínic ICS Camp de Tarragona - Terres de l'Ebre - Hospital Universitari Joan XXIII, Tarragona, Spain.
  • Serrat Orús N; Laboratori Clínic ICS Camp de Tarragona - Terres de l'Ebre - Hospital Universitari Joan XXIII, Tarragona, Spain.
  • Palau Sánchez I; Laboratori Clínic ICS Camp de Tarragona - Terres de l'Ebre - Hospital Universitari Joan XXIII, Tarragona, Spain.
  • Mestre-Prad MT; Unitat Bàsica de Prevenció - Hospital Universitari Joan XXIII, Tarragona, Spain.
  • Sans-Mateu MT; Direcció Clínica Laboratoris ICS Camp de Tarragona-Terres de l'Ebre, Tarragona, Spain.
Enferm Infecc Microbiol Clin (Engl Ed) ; 40(9): 489-494, 2022 11.
Article in English | MEDLINE | ID: covidwho-2130666
ABSTRACT

INTRODUCTION:

In order to deal with the current pandemic caused by the novel SARS-CoV-2 coronavirus several serological immunoassays have been recently developed with the objective of being used as a complementary diagnostic tool and to support the RT-PCR technique currently considered the "gold-standard" method. However, these new assays need to be evaluated and validated. The purpose of this study was to assess the performance of five immunoassays (two ELISA and three CLIA assays) and one rapid immunochromatographic test for the detection of anti-SARS-CoV-2 antibodies.

METHODS:

Five semiquantitative immunoassays (MENARINI®, PALEX®, VIRCLIA®, ROCHE® and SIEMENS®) and one lateral flow rapid test (WONDFO®) were performed. A total of 124 samples were studied. Case serum samples (n=78) were obtained from COVID-19 patients confirmed by real-time RT-PCR/epidemiological-clinical-radiological criteria, and control non-SARS-CoV-2 samples (n=46) belonged to healthy healthcare workers involved in a seroprevalence study.

RESULTS:

Overall, the tests showed sensitivities around 70-90% and specificities greater than 95%, including the immunochromatographic test. In addition, we observed very good agreements among them, being better for the detection of IgG than for IgM antibodies (Cohen's kappa index of 0.95 for VIRCLIA® IgG with ROCHE®), as well as good diagnostic power of the tests as determined by the ROC curves.

CONCLUSIONS:

This study demonstrates the proper performance of the different immunoassays in order to be applied in the clinical practice as support in the diagnostic approach and in the development of vaccines and seroepidemiological studies of COVID-19.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Diagnostic study / Experimental Studies / Observational study / Prognostic study Topics: Vaccines Limits: Humans Language: English Journal: Enferm Infecc Microbiol Clin (Engl Ed) Year: 2022 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Diagnostic study / Experimental Studies / Observational study / Prognostic study Topics: Vaccines Limits: Humans Language: English Journal: Enferm Infecc Microbiol Clin (Engl Ed) Year: 2022 Document Type: Article