Rapid diagnostics for SARS-CoV-2 virus: point-of-care testing and lessons learned during the pandemic

BioanalysisVol. 13, No. 15 CommentaryFree AccessRapid diagnostics for SARS-CoV-2 virus: point-of-care testing and lessons learned during the pandemicTrieu Nguyen & Anders WolffTrieu *Author correspondence: E-mail Address: [email protected]://orcid.org/0000-0002-3862-7373Department of Biotechnology Biomedicine, Technical University Denmark, Ørsteds Plads, DK-2800 Kgs, Lyngby, DenmarkSearch more papers by this author Wolff https://orcid.org/0000-0001-9596-1215Department authorPublished Online:21 Jul 2021https://doi.org/10.4155/bio-2021-0100AboutSectionsPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInRedditEmail Keywords: coronavirusCOVID-19in vitro diagnostic regulationlessonsnucleic amplificationpandemicpoint-of-care testingrapid diagnosticsreverse-transcription polymerase chain reactionSARS-CoV-2The COVID-19 pandemic originated from an outbreak novel coronavirus in Wuhan City, Hubei Province China, late 2019. The virus was later named severe acute respiratory syndrome-related 2, or SARS-CoV-2, February 2020 [1]. More than a year into (at time we write article May 2021), world is still struggling with testing, isolating clusters, curfews lockdowns as there lack efficient antiviral distribution vaccines work progress. currently its third wave. This commentary focuses on early, onsite rapid detection, such (POC) SARS-CoV-2. POC serology tests, namely antibodies-related are not discussed viewpoint they applicable early detection due antibody's long-overdue presentation response (which can commence at 2 weeks later) majority cases after exhibiting symptoms.Test, test, test: PCR testing“Test, test. Test every suspected case,” Tedros Adhanom Ghebreyesus, World Health Organisation (WHO) Director-General, pressed news conference Geneva, Switzerland March 2020. Testing certainly essential isolate clusters prevent spread new variants. current standard method, real-time reverse-transcription reaction (RT-rPCR), incompetent widespread it endures prolonged turn-around times (>24 h deliver result [2]) primarily counts high biosafety-level laboratories skillful technicians. In RT-rPCR test certificate be issued within 24 h. On other hand, Denmark has also implemented antigen hour sample taken.POC tests have probability tremendously improve healthcare many ways, enabling only but mitigation spreading disease, especially remote areas. means performed near patient conducted untrained operator [3,4]. concept traced back 15th century when urine inspected patient's home [5]. useful screening places airports.When comes clinical disease diagnostics, besides factor, criteria sensitivity specificity analytical techniques. Both nucleic amplification >95% [6]. latter, however, owns higher [7,8] mainly concentration genetic materials amplification. However, preparation contributed longer compared testing.SARS-CoV-2 testing: state art lessonsThe achievement been incredible [6] results (with nasopharyngeal swab) delivered min taken. One example that EU, enforced mandatory Copenhagen (CPH) airport all passengers who arrive entry restriction January writing article. obtained quickly technician takes samples, free charge Denmark.The commercial is, costly. For example, April 2021, one cost approximately 200 euros Finland [9].The less sensitive (>80% sensitivity) acid (e.g., LAMP >90% [7,8].The commercialization isothermal amplification-based device so far come established companies (that company-based laboratory-based university) Abbott (ID NOW platform) Cuehealth (Cue Covid-19 test) [10].Until now article), university-based using reverse transcription loop-mediated amplification, yet successfully commercialized feed market's urgent need serve pandemic.There reasons may tumbled process; among them, following three considered most significant: (i)The test's samples hurdle even though overcome future;(ii)The cooperation between facilities actual limited short-handed workforce middle pandemic;(iii)Commercialization medical devices (IVDs) needs meet regulation ISO (14971:2019, 23640:2015 on), European Directive 98/79/EC (IVDD) Diagnostic Regulation (IVDR). These regulations taken account simultaneously laboratory research investigation, beginning, safety quality demands nationally internationally, emergency use authorization.Conclusion future perspectiveTesting central measures mitigate potential outbreaks viruses replicate, mutate. mutate, dominant variants will appear, which could emerge pose health economic problems our community. At manuscript, variant, B.1.617, emerged detected India [11]. surge 300,000 positive recorded daily – highest number up till country. best thing do these circumstances, general, eliminate circulating virus. that, tools implement testing. Further, authorization investigations first instance.Financial competing interests disclosureThe authors received funded Union's Horizon CORONADX 101003562. no relevant affiliations financial involvement any organization entity interest conflict subject matter manuscript apart those disclosed.No assistance utilized production manuscript.References1. T, Duong Bang D, A. 2019 (COVID-19): paving road diagnostics. Micromachines 11(3), 306 (2020).Crossref, Google Scholar2. Bissonnette L, Bergeron MG. Infectious management through personalized medicine molecular technologies. J. Pers. Med. 2(2), 50–70 (2012).Crossref, Medline, Scholar3. Andreasen SZ, A, DD. From lab chip point care devices: role open source microcontrollers. 9(8), 403 (2018).Crossref, Scholar4. Chidambara VA, SZ et al. Point-of-care pathogen detections: important factors realise towards commercialization. TrAC - Trends Anal. Chem. 131, 116004 CAS, Scholar5. Eijkel Chip-based capillary electrophoresis platforms: toward applications. Bioanalysis 7(11), 1385–1387 (2015).Link, Scholar6. Corman VM, Haage VC, Bleicker T Comparison seven tests: single-centre evaluation study. Lancet Microbe. 2(7), E311–E319 (2021).Crossref, Scholar7. CDC. Interim Guidance Antigen https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antigen-tests-guidelines.htmlGoogle Scholar8. Dinnes J, Deeks JJ, Berhane S Rapid, molecular-based diagnosis infection. Cochrane Database Syst. Rev. http://doi.wiley.com/10.1002/14651858.CD013705.pub2Google Scholar9. Terveystalo. Safe travel coronavirus. (2021). https://www.terveystalo.com/en/finnair/Google Scholar10. Rezaei M, Razavi Bazaz S, Zhand Point age COVID-19. Diagnostics 11(1), 9 Scholar11. Le Page M. India's covid-19 surge. New Sci. 250(3330), 7 ScholarFiguresReferencesRelatedDetailsCited ByWillingness UK public volunteer relation pandemic22 2022 | BMC Public Health, Vol. 22, 1A Smartphone-Based Detection Method Colloidal Gold Immunochromatographic Strip13 December 2021 Photonics, 8, 12Special Focus Issue COVID-19: bioanalytical considerations, contributions part 1Sankeetha Nadarajah18 August Bioanalysis, STAY CONNECTED Metrics History Received 14 Accepted July Published online 21 print Information© Newlands PressKeywordscoronavirusCOVID-19in reactionSARS-CoV-2Financial manuscript.PDF download