Microbiologia Medica (Dec 2021)
Qualitative evaluation of the new rapid point-of-care antigen Afias Covid-19/Flu Ag Combo assay
Abstract
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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