PMID- 36346813 OWN - NLM STAT- MEDLINE DCOM- 20221110 LR - 20221116 IS - 1932-6203 (Electronic) IS - 1932-6203 (Linking) VI - 17 IP - 11 DP - 2022 TI - Evaluation of a fluorescence in situ hybridization (FISH)-based method for detection of SARS-CoV-2 in saliva. PG - e0277367 LID - 10.1371/journal.pone.0277367 [doi] LID - e0277367 AB - The use of a non-invasive fluorescence in situ hybridization (FISH)-based method on saliva for the detection of SARS-CoV-2 is evaluated in a proof-of-concept study and thereafter utilized in an outpatient setting with the Biotrack-MED(R) analyzer. For a proof-of-concept study, saliva samples were obtained from 28 persons with mild or moderate COVID-19-related symptoms who were tested RT-PCR positive or negative for SARS-CoV-2. In an outpatient setting, 972 individual saliva samples were utilized. All saliva samples were FISHed with a Cy3-labeled SARS-CoV-2-specific DNA probe and were analyzed manually by fluorescence microscopy (proof-of-concept) or with the SARS-CoV-2 application of the Biotrack-MED(R) analyzer, a semi-autonomous multi-sample filter cytometer. The proof-of-concept study showed a sensitivity of 96.0% and a specificity of 98.5% and is therefore comparable to the RT-PCR analysis of nasopharyngeal swabs. The outpatient setting showed a sensitivity of 90.9% and a specificity of 94.5% and seems therefore a valid assay for the detection of SARS-CoV-2 in individuals that are healthy, mild or moderate symptomatic. In conclusion, the method evaluated in this study, the FISH-based SARS-CoV-2 application of the Biotrack-MED(R) analyzer, is a sensitive and reliable assay for the detection of SARS-CoV-2 in the general population. CI - Copyright: (c) 2022 Tamminga et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. FAU - Tamminga, Gerrit G AU - Tamminga GG AD - Biotrack, Leeuwarden, The Netherlands. FAU - Jansen, Gijsbert J AU - Jansen GJ AD - Biotrack, Leeuwarden, The Netherlands. FAU - Wiersma, Marit AU - Wiersma M AUID- ORCID: 0000-0002-6669-1110 AD - Biotrack, Leeuwarden, The Netherlands. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20221108 PL - United States TA - PLoS One JT - PloS one JID - 101285081 RN - 0 (RNA, Viral) SB - IM MH - Humans MH - *SARS-CoV-2/genetics MH - Saliva/chemistry MH - *COVID-19/diagnosis MH - In Situ Hybridization, Fluorescence MH - RNA, Viral/genetics/analysis MH - Nasopharynx MH - Specimen Handling/methods PMC - PMC9642907 COIS- GGT, GJJ and MW have read the journal's policy and these authors of this manuscript have the following competing interests: employed by the commercial company Biotrack and patents issued (WO 2010/040371 A1, EP 08874964.3) This does not alter our adherence to PLOS ONE policies on sharing data and materials. EDAT- 2022/11/09 06:00 MHDA- 2022/11/11 06:00 PMCR- 2022/11/08 CRDT- 2022/11/08 13:43 PHST- 2022/02/21 00:00 [received] PHST- 2022/10/25 00:00 [accepted] PHST- 2022/11/08 13:43 [entrez] PHST- 2022/11/09 06:00 [pubmed] PHST- 2022/11/11 06:00 [medline] PHST- 2022/11/08 00:00 [pmc-release] AID - PONE-D-22-05244 [pii] AID - 10.1371/journal.pone.0277367 [doi] PST - epublish SO - PLoS One. 2022 Nov 8;17(11):e0277367. doi: 10.1371/journal.pone.0277367. eCollection 2022.