In:
PLOS ONE, Public Library of Science (PLoS), Vol. 16, No. 4 ( 2021-4-8), p. e0249972-
Abstract:
We evaluated the diagnostic accuracy of two newly developed, point-of-care, rapid antigen tests (RATs) for detecting SARS-CoV-2, the AFIAS COVID-19 Ag and the ichroma TM COVID-19 Ag, and investigated antigen kinetics. A total of 200 serially collected nasopharyngeal (NP) specimens from 38 COVID-19 patients and 122 specimens from negative controls were analyzed. Diagnostic sensitivity and specificity were assessed in comparison to molecular test results and subdivided according to targeted genes ( E , RdRP , and N ) and days post-symptom onset (PSO). For the kinetics evaluation, cut-off-indices from serial NP specimens were used according to the number of days PSO. Both RATs showed sensitivity of 91.3‒100% for specimens with cycle threshold (Ct) 〈 25. The specificity of AFIAS was 98.7‒98.9% and that of ichroma TM was 100.0%. The kappa values of AFIAS and ichroma TM for the molecular testing of specimens with Ct 〈 25 ( RdRP ) were 0.97 and 1.00, respectively. The sensitivity of AFIAS and ichroma TM for all genes was lower for specimens collected at 8‒14 PSO than for those collected before 7-days PSO. The kinetics profiles showed that antigen levels gradually decreased from ≤ 7-days PSO to 〉 22-days PSO. Both RATs showed excellent specificity and acceptable sensitivity for NP specimens with higher viral loads and for specimens collected within 7-days PSO. Hence, they have the potential to become useful tools for the early detection of SARS-CoV-2. However, because of concerns about false negativity, RATs should be used in conjunction with molecular tests.
Type of Medium:
Online Resource
ISSN:
1932-6203
DOI:
10.1371/journal.pone.0249972
DOI:
10.1371/journal.pone.0249972.g001
DOI:
10.1371/journal.pone.0249972.g002
DOI:
10.1371/journal.pone.0249972.t001
DOI:
10.1371/journal.pone.0249972.t002
DOI:
10.1371/journal.pone.0249972.t003
Language:
English
Publisher:
Public Library of Science (PLoS)
Publication Date:
2021
detail.hit.zdb_id:
2267670-3
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