Development of rapid antigen test prototype for detection of SARS-CoV-2 in saliva samples

dc.contributor.authorKivrane, Agnija
dc.contributor.authorIgumnova, Viktorija
dc.contributor.authorLiepina, Elza Elizabete
dc.contributor.authorSkrastina, Dace
dc.contributor.authorLeonciks, Ainars
dc.contributor.authorRudevica, Zanna
dc.contributor.authorKistkins, Svjatoslavs
dc.contributor.authorReinis, Aigars
dc.contributor.authorZilde, Anna
dc.contributor.authorKazaks, Andris
dc.contributor.authorRanka, Renate
dc.contributor.institutionRīga Stradiņš University
dc.date.accessioned2022-08-16T21:03:50Z
dc.date.available2022-08-16T21:03:50Z
dc.date.issued2022-02-25
dc.descriptionFunding Information: This study was supported by VPP Program, Republic of Latvia Ministry of Education and Science, project No. VPP-COVID-2020/1-0025. Publisher Copyright: © 2022 Taylor and Francis Ltd. All rights reserved.
dc.description.abstractBackground: The development of easy-to-perform diagnostic methods is highly important for detecting current coronavirus disease (COVID-19). This pilot study aimed at developing a lateral flow assay (LFA)- based test prototype to detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus in saliva samples. Methods: Mice were immunized using the recombinant receptor-binding domain (rRBD) of SARS-CoV-2 virus spike protein. The combinations of the obtained mouse anti-receptor-binding domain (RBD) polyclonal antibodies (PAbs) and several commercial antibodies directed against the SARS-CoV-2 spike protein were used for enzyme-linked immunosorbent assay (ELISA) to select antibody pairs for LFA. The antibody pairs were tested in a LFA format using saliva samples from individuals with early SARS-CoV-2 infection (n = 9). The diagnostic performance of the developed LFA was evaluated using saliva samples from hospitalized COVID-19 patients (n = 111); the median time from the onset of symptoms to sample collection was 10 days (0-24 days, interquartile range (IQR): 7-13). The reverse transcription-polymerase chain reaction (rRT-PCR) was used as a reference method. Results: Based on ELISA and preliminary LFA results, a combination of mouse anti-RBD PAbs (capture antibody) and rabbit anti-spike PAbs (detection antibody) was chosen for clinical analysis of sample. When compared with rRT-PCR results, LFA exhibited 26.5% sensitivity, 58.1% specificity, 50.0% positive prediction value (PPV), 33.3% negative prediction value (NPV), and 38.7% diagnostic accuracy. However, there was a reasonable improvement in assay specificity (85.7%) and PPV (91.7%) when samples were stratified based on the sampling time. Conclusion: The developed LFA assay demonstrated a potential of SARS-CoV-2 detection in saliva samples. Further technical assay improvements should be made to enhance diagnostic performance followed by a validation study in a larger cohort of both asymptomatic and symptomatic patients in the early stage of infection.en
dc.description.statusPeer reviewed
dc.format.extent9
dc.format.extent593932
dc.identifier.citationKivrane, A, Igumnova, V, Liepina, E E, Skrastina, D, Leonciks, A, Rudevica, Z, Kistkins, S, Reinis, A, Zilde, A, Kazaks, A & Ranka, R 2022, 'Development of rapid antigen test prototype for detection of SARS-CoV-2 in saliva samples', Upsala Journal of Medical Sciences, vol. 127, no. 1, e8207. https://doi.org/10.48101/ujms.v127.8207
dc.identifier.doi10.48101/ujms.v127.8207
dc.identifier.issn0300-9734
dc.identifier.urihttps://dspace.rsu.lv/jspui/handle/123456789/9450
dc.identifier.urlhttp://www.scopus.com/inward/record.url?scp=85126399330&partnerID=8YFLogxK
dc.language.isoeng
dc.relation.ispartofUpsala Journal of Medical Sciences
dc.rightsinfo:eu-repo/semantics/openAccess
dc.subjectantigen test
dc.subjectCOVID-19
dc.subjectELISA
dc.subjectLateral flow assay
dc.subjectpoint-of-care testing
dc.subjectpolyclonal antibodies
dc.subject3.1 Basic medicine
dc.subject3.2 Clinical medicine
dc.subject1.1. Scientific article indexed in Web of Science and/or Scopus database
dc.subjectGeneral Medicine
dc.titleDevelopment of rapid antigen test prototype for detection of SARS-CoV-2 in saliva samplesen
dc.type/dk/atira/pure/researchoutput/researchoutputtypes/contributiontojournal/article

Files

Original bundle
Now showing 1 - 1 of 1
No Thumbnail Available
Name:
Development_of_rapid_antigen_test_prototype.pdf
Size:
580.01 KB
Format:
Adobe Portable Document Format