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Primerjava testa POCT Sofia SARS antigen FIA s testom PCR nazofaringealnega brisa pri bolnikih s sumom na okužbo s SARS-CoV-2 = Comparison of POCT Sofia SARS antigen FIA test with a PCR test of nasopharyngeal swab in patients with suspected SARS-CoV-2 infection : magistrski študijski program Laboratorijska biomedicinaČernila, MancaRazpoložljivost natančnih in hitrih diagnostičnih orodij za določanje prisotnosti SARS-CoV-2 je bistvenega pomena za spopadanje s trenutno pandemijo. Obratna transkripcija in verižna reakcija s ... polimerazo v realnem času (rRT-PCR) velja za zlati standard diagnostike virusa SARS-CoV-2. Pomanjkanje oskrbe z reagenti in časovna zamudnost testa, omejujeta število dnevno izvedenih testov, kar je spodbudilo razvoj hitrih diagnostičnih testov, ki slonijo na zaznavanju virusnih antigenov. Namen te magistrske naloge je primerjava Quidelovega hitrega testa Sofia SARS antigen FIA® (Sofia) s testom rRT-PCR. Za namen primerjave smo testirancem odvzeli dva brisa, prvega za testiranje s testom Sofia in drugega za testiranje s testom rRT-PCR. V celoti smo brise odvzeli 146 pacientom, pripeljanim in hospitaliziranim v sivi coni Klinike za infekcijske bolezni in vročinska stanja UKC Ljubljana in 672 pacientom pripeljanim na oddelek Internistične prve pomoči UKC, ki so bili testirani ne glede na to ali so izkazovali simptome covid-19. V skupini 1, skupini simptomatskih testirancev, je bila občutljivost antigenskega testa 90,0 % in specifičnost 97,5 %. V skupini 2, skupini tako simptomatskih kot asimptomatskih testirancev, pa je bila občutljivost antigenskega testa 81,4 % in specifičnost 98,9 %. Iz naših podatkov smo zaključili, da je test Sofia diagnostično primerljiv testu rRT-PCR v primeru testiranja simptomatskih pacientov in nekoliko manj zanesljiv v primeru testiranja asimptomatskih pacientov. To smo potrdili z McNemarjevim statističnim testom. Vrednost p je bila v primeru simptomatskih testirancev 0,625, v primeru tako simptomatskih kot asimptomatskih testirancev pa je bila vrednost p manjša od 0,001. Lažno negativni rezultati hitrih antigenskih testov so se poleg asimptomatskih pacientov pojavljali tudi pri testirancih z visokimi pražnimi vrednostmi (Ct >30). Kljub temu pa naši rezultati kažejo, da test Sofia ustreza kriterijem diagnostičnega testa po kriterijih Svetovne zdravstvene organizacije, saj izkazujejo visoko občutljivost in specifičnost ter morda najpomembneje, visoko negativno napovedno vrednost( > 95 %).Type of material - master's thesis ; adult, seriousPublication and manufacture - Ljubljana : [M. Černila], 2021Language - slovenianCOBISS.SI-ID - 91845635
Author
Černila, Manca
Other authors
Osredkar, Joško, 1955- |
Logar, Mateja, 1970-
Topics
COVID-19 |
SARS-CoV-2 |
Sofia SARS antigen FIA |
klinična veljavnost |
analitična veljavnost |
diagnostična orodja |
diagnostični testi
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Library/institution |
City | Acronym | For loan | Other holdings |
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Faculty of Pharmacy, Ljubljana | Ljubljana | FFALJ |
reading room 1 cop.
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DRS, in which the journal is indexed
Database name | Field | Year |
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Links to authors' personal bibliographies | Links to information on researchers in the SICRIS system |
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Černila, Manca | ![]() |
Osredkar, Joško, 1955- | 10691 |
Logar, Mateja, 1970- | 16183 |
Source: Personal bibliographies
and: SICRIS
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