https://doi.org/10.4081/mm.2021.10315

Qualitative evaluation of the new rapid point-of-care antigen Afias Covid-19/Flu Ag Combo assay

Vol. 36 No. 3 (2021)
Published: 30 December 2021
Sars-CoV-2, Covid-19, POCT, diagnosis, screening, immuno-assay, rapid antigen test
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Authors

Mara Lorusso
maralorusso81@libero.it
https://orcid.org/0000-0002-1472-5171
Microbiology Unit, Di Venere Hospital, ASL Bari, Italy.
Edmondo Adorisio
Clinical Pathology and Microbiology Operative Unit, Di Venere Hospital, ASL Bari, Italy.
Giuseppe Gagliardi
Microbiology Unit, Di Venere Hospital, ASL Bari, Italy.
Achille Meneghini
Self-employed consultant, Italy.
Domenico Lagravinese
Prevention Department, ASL Bari, Italy.
Mario Antonio Lerario
Civil Protection Apulia Region, Italy.

Background: An interim guidance document by the WHO (World Health Organization) suggests the use of rapid diagnostic tests based on antigen detection as an alternative to the real-time PCR test for the diagnosis of SARS-CoV2 infection, when the molecular RT-PCR test is not available, or the turnaround time is excessive, precluding its clinical and/or public health usefulness. Rapid antigenic tests are recommended when a  minimum of  80% sensitivity and 97% specificity are ensured.

Methods: Here we employ a new assay for screening applications based on lateral-flow immunofluorescence assay, with microfluidic technology (Boditech AFIAS COVID-19/Flu Ag Combo) on a point-of-care analyzer AFIAS-6 (BoditechMed. Inc.) and compare it with a reference molecular method and an alternative screening immunochromatographic method (Boditech AFIAS COVID-19 Ag). Our study was carried out on stored UTM (at -20°C) samples of patients admitted to Di Venere Hospital of Bari that were already tested with molecular methods.

Results: The new AFIAS COVID-19 Flu/Ag Combo test reached a clinical sensitivity of 92% on positive samples with Ct< 30, and a clinical specificity of 97.9% on negative samples.  Sensitivity is higher than the reference immunochromatographic test AFIAS COVID-19/Ag (92.0% vs 88.0%) while specificity remains unchanged (97.9% vs 98.0%). In addition the new AFIAS Combo test confirm the same negative predictive value (NPV, 95.9%) of the rapid reference test (AFIAS COVID 19-Ag) and an agreement with the molecular test of 95.9% (Cohen's k = 0.908).

Conclusions: Considering its qualitative improvement, rapidity and ease of use we suggests AFIAS Combo test as a valid alternative to the reference lateral flow test (AFIAS COVID-19 Ag) and an adequate screening test.

Keywords: SARS-CoV2; COVID-19; POCT; diagnosis; screening; immunoassay; rapid antigen test

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How to Cite

Lorusso, M. ., Adorisio, E., Gagliardi, G., Meneghini, A., Lagravinese, D., & Lerario, M. A. (2021). Qualitative evaluation of the new rapid point-of-care antigen Afias Covid-19/Flu Ag Combo assay. Microbiologia Medica, 36(3). https://doi.org/10.4081/mm.2021.10315

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