{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,21]],"date-time":"2026-01-21T18:34:01Z","timestamp":1769020441454,"version":"3.49.0"},"reference-count":25,"publisher":"MDPI AG","issue":"17","license":[{"start":{"date-parts":[[2021,8,25]],"date-time":"2021-08-25T00:00:00Z","timestamp":1629849600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Sensors"],"abstract":"<jats:p>Background: The standard test that identifies the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) is based on reverse transcriptase-polymerase chain reaction (RT-PCR) from nasopharyngeal (NP) swab specimens. We compared the accuracy of a rapid antigen detection test using exhaled breath condensate by a modified Inflammacheck\u00ae device with the standard RT-PCR to diagnose SARS-CoV-2 infection. Methods: We performed a manufacturer-independent, cross-sectional, diagnostic accuracy study involving two Italian hospitals. Sensitivity, specificity, positive (PLR) and negative likelihood ratio (NLR), positive (PPV) and negative predictive value (NPV) and diagnostic accuracy with 95% confidence intervals (95% CI) of Inflammacheck\u00ae were calculated using the RT-PCR results as the standard. Further RT-PCR tests were conducted on NP specimens from test positive subjects to obtain the Ct (cycle threshold) values as indicative evidence of the viral load. Results: A total of 105 individuals (41 females, 39.0%; 64 males, 61.0%; mean age: 58.4 years) were included in the final analysis, with the RT-PCR being positive in 13 (12.4%) and negative in 92 (87.6%). The agreement between the two methods was 98.1%, with a Cohen\u2019s \u03ba score of 0.91 (95% CI: 0.79\u20131.00). The overall sensitivity and specificity of the Inflammacheck\u00ae were 92.3% (95% CI: 64.0%\u201399.8%) and 98.9% (95% CI: 94.1%\u2013100%), respectively, with a PLR of 84.9 (95% CI: 12.0\u2013600.3) and a NLR of 0.08 (95% CI: 0.01\u20130.51). Considering a 12.4% disease prevalence in the study cohort, the PPV was 92.3% (95% CI: 62.9%\u201398.8%) and the NPV was 98.9% (95% CI: 93.3%\u201399.8%), with an overall accuracy of 98.1% (95% CI: 93.3%\u201399.8%). The Fagan\u2019s nomogram substantially confirmed the clinical applicability of the test in a realistic scenario with a pre-test probability set at 4%. Ct values obtained for the positive test subjects by means of the RT-PCR were normally distributed between 26 and 38 cycles, corresponding to viral loads from light (38 cycles) to high (26 cycles). The single false negative record had a Ct value of 33, which was close to the mean of the cohort (32.5 cycles). Conclusions: The modified Inflammacheck\u00ae device may be a rapid, non-demanding and cost-effective method for SARS-CoV-2 detection. This device may be used for routine practice in different healthcare settings (community, hospital, rehabilitation).<\/jats:p>","DOI":"10.3390\/s21175710","type":"journal-article","created":{"date-parts":[[2021,8,25]],"date-time":"2021-08-25T04:24:27Z","timestamp":1629865467000},"page":"5710","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":17,"title":["A Rapid Antigen Detection Test to Diagnose SARS-CoV-2 Infection Using Exhaled Breath Condensate by A Modified Inflammacheck\u00ae Device"],"prefix":"10.3390","volume":"21","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6751-9921","authenticated-orcid":false,"given":"Mauro","family":"Maniscalco","sequence":"first","affiliation":[{"name":"Istituti Clinici Scientifici Maugeri IRCCS, 27100 Pavia, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9398-0428","authenticated-orcid":false,"given":"Pasquale","family":"Ambrosino","sequence":"additional","affiliation":[{"name":"Istituti Clinici Scientifici Maugeri IRCCS, 27100 Pavia, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anna","family":"Ciullo","sequence":"additional","affiliation":[{"name":"Istituti Clinici Scientifici Maugeri IRCCS, 27100 Pavia, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Salvatore","family":"Fuschillo","sequence":"additional","affiliation":[{"name":"Istituti Clinici Scientifici Maugeri IRCCS, 27100 Pavia, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Valerio","family":"Valente","sequence":"additional","affiliation":[{"name":"Istituti Clinici Scientifici Maugeri IRCCS, 27100 Pavia, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carlo","family":"Gaudiosi","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, Boscotrecase Covid Hospital, 80042 Boscotrecase, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Debora","family":"Paris","sequence":"additional","affiliation":[{"name":"Institute of Biomolecular Chemistry, National Research Council, ICB-CNR, 80078 Pozzuoli, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Raffaele","family":"Cobuccio","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, Boscotrecase Covid Hospital, 80042 Boscotrecase, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Francesco","family":"Stefanelli","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, Boscotrecase Covid Hospital, 80042 Boscotrecase, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8643-658X","authenticated-orcid":false,"given":"Andrea","family":"Motta","sequence":"additional","affiliation":[{"name":"Institute of Biomolecular Chemistry, National Research Council, ICB-CNR, 80078 Pozzuoli, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2021,8,25]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"6","DOI":"10.1186\/s41256-020-00135-6","article-title":"The novel coronavirus outbreak in Wuhan, China","volume":"5","author":"Zhu","year":"2020","journal-title":"Glob. 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