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"justification": [
"Tyks Kliinisen mikrobiologian laboratoriossa on ollut k\u00e4yt\u00f6ss\u00e4 Genomican Clart HPV4 DNA-monistusmenetelm\u00e4\u00e4n perustuva m\u00e4\u00e4ritysmenetelm\u00e4 ja analyysilaitteisto kohdunkaulasy\u00f6v\u00e4n seulontojen ja limakalvojen HPV-infektioiden diagnostiikassa. Menetelm\u00e4 on verifioitu Tanskan HPV-seulontoja tekev\u00e4n referenssilaboratorion kanssa. Menetelm\u00e4 t\u00e4ytt\u00e4\u00e4 IARC:n ja WHO:n asettamat vaatimukset.",
"",
"Labema Oy:n tarjoama menetelm\u00e4 toteaa ja erottelee kaikki kliinisesti merkitt\u00e4v\u00e4t HPV-genotyypit (HPV 6, 11, 16, 18, 26, 31, 33, 35, 39, 40, 42, 43, 44, 45, 51, 52, 53, 54, 56, 58, 59, 61, 62, 66, 68 a ja b, 70, 71, 72, 73, 81, 82, 83, 84, 85 ja 86) yhdell\u00e4 reaktiolla. Genotyypitys tapahtuu PCR-monistusmenetelm\u00e4ll\u00e4 ja sit\u00e4 seuraavalla hybridisaatiolla mikrosiruformaatissa. Laitteisto analysoi genotyypit automaattisesti mikrosirulta, lis\u00e4ksi tulos voidaan todentaa visuaalisesti tarkastelemalla mikrosirua. Tuloksen luotettavuutta lis\u00e4\u00e4 triplikaattina tapahtuva jokaisen genotyypin, DNA:n (toimii n\u00e4ytteen laadun kontrollina), PCR- ja hybridisaatiokontrollien hybridisaatio. HPV-testaus voidaan suorittaa suoraan n\u00e4ytteest\u00e4 ilman DNA:n eristyst\u00e4.",
"",
"Suorahankinnan perusteena on markkinoiden ainoa toimittaja ja laitteisto, joka soveltuu yll\u00e4 mainittujen tutkimusten suorittamiseen niin analysaattorin, kuin tarvittavien nukleiinihappotestien osalta. Labema Oy:n tarjoamat nukleiinihappotestit ovat olleet aiemmin k\u00e4yt\u00f6ss\u00e4, ne on verifioitu HPV-seulontaan ja genotyypitykseen ja ovat Finasin akkreditoimat. Lis\u00e4ksi nukleiinihappotestit ovat ainoat kaupalliset HPV-tyypitykseen ja seulontaan tarkoitetut testit, joissa detektio tapahtuu mikrosirutekniikalla ja jotka toteavat erikseen kaikki merkitt\u00e4v\u00e4t kliiniset genotyypit analysoinnin tapahtuessa suoraan n\u00e4ytteest\u00e4 ilman nukleiinihappojen eristyst\u00e4. (Laki julkisista hankinnoista ja k\u00e4ytt\u00f6oikeussopimuksista 2016\/1397, 40 \u00a7 2mom).",
"",
"Hankittava laitteisto ja siihen liittyv\u00e4t nukleiinihappotestit hankitaan k\u00e4ytt\u00f6korvausperiaatteella, jolloin k\u00e4ytt\u00f6kustannukset perustuvat suoritettujen tutkimusten m\u00e4\u00e4r\u00e4\u00e4n. Laitteistolla suoritettava vuosittainen tutkimusm\u00e4\u00e4r\u00e4 on 10 080 n\u00e4ytett\u00e4 ja k\u00e4ytt\u00f6korvausperusteinen tutkimushinta on 25,50\u20ac\/n\u00e4yte.",
"",
"K\u00e4ytt\u00f6korvausperusteinen tutkimushinta perustuu nukleiinihappotestien hintaan ja kulutukseen 10 080 n\u00e4ytteen osalta. Tutkimushinta sis\u00e4lt\u00e4\u00e4 my\u00f6s analyysilaitteen ja analyysilaitteen huollot",
"",
"Vuosittaisen tutkimusm\u00e4\u00e4r\u00e4n mukainen vuosikustannus on 257 040 euroa. Hankinnan sopimuskausi on vuosi 2023 ja hankinta sis\u00e4lt\u00e4\u00e4 optiokaudet vuosista 2024 ja 2025. Hankinnan arvo optiokausien kanssa on 771 120 euroa",
""
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