{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,8]],"date-time":"2026-09-08T22:51:32Z","timestamp":1788907892907,"version":"build-2803163510"},"reference-count":12,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2021,6,30]],"date-time":"2021-06-30T00:00:00Z","timestamp":1625011200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2021,6,30]],"date-time":"2021-06-30T00:00:00Z","timestamp":1625011200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Infect Dis"],"published-print":{"date-parts":[[2021,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Purpose<\/jats:title>\n                <jats:p>With over 50 SARS-CoV-2 gene amplification assays that have been EUA cleared with minimal experimental validation performed, it is likely that not all of these assays are comparable in their ability to detect SARS-CoV-2 in clinical specimens. Thermo Fisher Scientific is a relatively new company in the molecular diagnostics field and the purpose of this study was to compare the performance of the Thermo Fisher TaqPath\u2122 Combo Kit with an established test, the Cepheid Xpert\u00ae Xpress SARS-CoV-2 assay, for its ability to detect SARS-CoV-2 in nasopharyngeal specimens.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>A total of 300 randomly selected nasopharyngeal specimens were evaluated and tested by the TaqPath and GeneXpert assays. Discordant test specimens were arbitrated by performing an alternative PCR assay and Sanger sequencing.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>The TaqPath assay had a 96.7 and 99.6% positive and negative agreement respectively when compared to the Xpert Xpress test. However, after test arbitration, the three discordant specimens were arbitrated in favor of the TaqPath assay producing a positive and negative percent agreement of 100% for the TaqPath Combo Kit while the Xpress SARS-CoV-2 assay had a positive and negative percent agreement of 98.3 and 99.2% respectively.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>The TaqPath Combo Kit is a high complexity assay that compares favorably with the Xpert Xpress test and can be reliably used for the detection of SARS-CoV-2 in nasopharyngeal specimens.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s12879-021-06347-6","type":"journal-article","created":{"date-parts":[[2021,6,30]],"date-time":"2021-06-30T11:04:26Z","timestamp":1625051066000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Comparative evaluation of the Thermo fisher TaqPath\u2122 COVID-19 combo kit with the Cepheid Xpert\u00ae Xpress SARS-CoV-2 assay for detecting SARS-CoV-2 in nasopharyngeal specimens"],"prefix":"10.1186","volume":"21","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5068-1137","authenticated-orcid":false,"given":"Paul A.","family":"Granato","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simon R.","family":"Kimball","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brenda R.","family":"Alkins","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Deirdre C.","family":"Cross","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melissa M.","family":"Unz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2021,6,30]]},"reference":[{"key":"6347_CR1","volume-title":"Situation summary","author":"CDC","year":"2020","unstructured":"CDC (2020) Situation summary. https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/cases-updates\/summary.html."},{"issue":"10224","key":"6347_CR2","doi-asserted-by":"publisher","first-page":"565","DOI":"10.1016\/50140-6736(20)30251-8","volume":"395","author":"R Lu","year":"2020","unstructured":"Lu R, Zhao X, Li J, Niu P, Yang B, Wu H, et al. Genomic characterization and epidemiology of 2019 novel coronavirus: implications for virus origins and receptor binding. Lancet. 2020;395(10224):565\u201374. https:\/\/doi.org\/10.1016\/50140-6736(20)30251-8.","journal-title":"Lancet"},{"key":"6347_CR3","volume-title":"WHO Director-General\u2019s remarks at the media briefing on 2019-nCoV on 11 February 2020","author":"WHO","year":"2020","unstructured":"WHO (2020) WHO Director-General\u2019s remarks at the media briefing on 2019-nCoV on 11 February 2020. http:\/\/www.who.int\/publications-detail\/laboratory-testing-for-2109-novel-coronavirus-in-suspected-human-cases-20200117."},{"issue":"4","key":"6347_CR4","doi-asserted-by":"publisher","first-page":"536","DOI":"10.1038\/541564-020-0695-2","volume":"5","author":"Coronaviridae Study Group of the International Committee on Taxonomy of Viruses","year":"2020","unstructured":"Coronaviridae Study Group of the International Committee on Taxonomy of Viruses. The species severe acute respiratory syndrome-related coronavirus: classifying 2019-nCoV and naming it SAR-CoV-2. Nat Microbial. 2020;5(4):536\u201344. https:\/\/doi.org\/10.1038\/541564-020-0695-2.","journal-title":"Nat Microbial"},{"key":"6347_CR5","unstructured":"WHO. 2020. WHO Director-General\u2019s remarks at the media briefing on 2019-nCoV on 11 March 2020. https:\/\/www.who.int\/dg\/speeches\/deatil\/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19%2D%2D-11-march-2020."},{"key":"6347_CR6","volume-title":"Coronavirus COVID-19 global cases by the Center for Systems Science and Engineering (CSSE) at Johns Hopkins University (JHU)","author":"John Hopkins University","year":"2020","unstructured":"John Hopkins University (2020) Coronavirus COVID-19 global cases by the Center for Systems Science and Engineering (CSSE) at Johns Hopkins University (JHU). https:\/\/coronavirus.jhu.edu\/map.html."},{"key":"6347_CR7","doi-asserted-by":"publisher","first-page":"e00796","DOI":"10.1128\/JCM.00796.20","volume":"58","author":"SL Mitchell","year":"2020","unstructured":"Mitchell SL, St. George K, Rhoads DD, Butler-Wu SM, Dharmarha V, McNult P, et al. Understanding, verifying, and implementing emergency use authorization molecular diagnostics for the detection of SARS-CoV-2 RNA. J Clin Microbiol. 2020;58:e00796\u201320. https:\/\/doi.org\/10.1128\/JCM.00796.20.","journal-title":"J Clin Microbiol"},{"key":"6347_CR8","unstructured":"Vandenberg O, Martiny D, Rochas O, vanBelkum A, Kozlakidis Z. Nat Rev Microbiol. 2020; http:\/\/www.nature.com\/articles\/s41579-020-00461-z."},{"key":"6347_CR9","volume-title":"Xpert Xpress SARS-CoV-2 Test (POC)","author":"Cepheid","year":"2020","unstructured":"Cepheid. 2020. Xpert Xpress SARS-CoV-2 Test (POC). https:\/\/www.fda.gov\/media\/136315\/download."},{"key":"6347_CR10","volume-title":"TaqPath\u2122 COVID-19 Combo Kit","author":"TF Scientific","year":"2020","unstructured":"Thermo Fisher Scientific (2020) TaqPath\u2122 COVID-19 Combo Kit. http:\/\/www.fda.gov\/media\/136112\/download."},{"key":"6347_CR11","volume-title":"QIAstat-Dx\u00ae Respiratory SARS-CoV-2 Panel Instructions for Use (Handbook)","author":"GH Qiagen","year":"2020","unstructured":"Qiagen GmbH (2020) QIAstat-Dx\u00ae Respiratory SARS-CoV-2 Panel Instructions for Use (Handbook). https:\/\/www.fda.gov\/media\/136571\/download."},{"issue":"3","key":"6347_CR12","doi-asserted-by":"publisher","first-page":"483","DOI":"10.1016\/j.rbmo.2020.06.001","volume":"41","author":"A LaMarca","year":"2020","unstructured":"LaMarca A, Capuzzo M, Paglia T, Roli L, Trenti T, Nelson SM. Testing for SARS-CoV-2 (COVID-19): a systemic review and clinical guide to molecular and serological in-vitro diagnostic tests. Reprod BioMed Online. 2020;41(3):483\u201399. https:\/\/doi.org\/10.1016\/j.rbmo.2020.06.001.","journal-title":"Reprod BioMed Online"}],"container-title":["BMC Infectious Diseases"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12879-021-06347-6.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s12879-021-06347-6\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12879-021-06347-6.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,6,30]],"date-time":"2021-06-30T11:05:41Z","timestamp":1625051141000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmcinfectdis.biomedcentral.com\/articles\/10.1186\/s12879-021-06347-6"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,6,30]]},"references-count":12,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2021,12]]}},"alternative-id":["6347"],"URL":"https:\/\/doi.org\/10.1186\/s12879-021-06347-6","relation":{},"ISSN":["1471-2334"],"issn-type":[{"value":"1471-2334","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,6,30]]},"assertion":[{"value":"16 April 2021","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"15 June 2021","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"30 June 2021","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The protocol was reviewed and approved by Advarra Institutional Review Board (Columbia, MD) and determined that informed consent was not required for this study (CR0025633). Methods were carried out in accordance with relevant guidelines and regulations.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"non appliable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors have no financial or competing interests to disclose.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"623"}}