Iintlobo ezingama-28 zeHuman Papillomavirus (16/18/45Typing) Isixhobo sokuFumanisa iNucleic Acid (iFluorescence PCR)

Inkcazo emfutshane:

[ImvelisoIkhowudi] I-HWTS-CC024

[Ukusetyenziswa Okucetywayo]

Le khithi ifanelekile ekufumaneni i-in vitro qualitative specific types ezingama-28 ze-human papillomavirus (HPV 6, 11, 16, 18, 26, 31, 33, 35, 39, 40, 42, 43, 44, 45, 51, 52, 53, 54, 56, 58, 59, 61, 66, 68, 73, 81, 82, 83) nucleic acidsngaphakathizonyangoumchamoisampuli,isampuli yeswabhu yomlomo wesibeleko yabasetyhini kunye nesampuli yeswabhu yomlomo wesibeleko yabasetyhinikunye ne-HPV 16/18/45 ukufunyanwa kokuthayipha, ngelixaezinye iintlobo azinakuba ngokupheleleyoodumileyo, ukubonelelauncedo kwiukuxilongwa kunye nonyango losulelo lwe-HPV.


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Igama lemveliso

 Iintlobo ezingama-28 zeHuman Papillomavirus (16/18/45Typing) Isixhobo sokuFumanisa iNucleic Acid (iFluorescence PCR)

I-Epidemiology

I-Human Papillomavirus (HPV) ikwintsapho yePapillomaviridae yentsholongwane ye-DNA encinci, engagqunywanga, ejikelezayo enemicu emibini, enobude be-genome obumalunga ne-8000 base pairs (bp). I-HPV yosulela abantu ngokudibana ngqo okanye ngokungathanga ngqo nezinto ezingcolisiweyo okanye ukudluliselwa ngokwesondo. Le ntsholongwane ayijoliswanga nje kuphela kumninimzi, kodwa ikwajoliswa nakwizicubu ezithile, kwaye inokosulela kuphela ulusu lomntu kunye neeseli ze-epithelial ze-mucosal, nto leyo ebangela iintlobo ngeentlobo zee-papillomas okanye ii-warts eluswini lomntu kunye nomonakalo okhulayo kwi-epithelium yokuzala.

Umhlaza womlomo wesibeleko yenye yezona zifo zixhaphakileyo kwindlela yokuzala yabasetyhini. Izifundo zibonise ukuba usulelo oluqhubekayo lwe-HPV kunye nosulelo oluninzi zezinye zezona zizathu ziphambili zomhlaza womlomo wesibeleko. Okwangoku, unyango olusebenzayo oluqatshelweyo alusekho kumhlaza womlomo wesibeleko obangelwa yi-HPV, ngoko ke ukufunyanwa kwangoko kunye nokuthintela usulelo lomlomo wesibeleko olubangelwa yi-HPV yeyona nto iphambili ekuthinteleni umhlaza womlomo wesibeleko. Kubaluleke kakhulu ukumisela uvavanyo olulula, olucacileyo nolukhawulezayo lokuxilonga i-etiology yokuxilongwa kweklinikhi kunye nonyango lomhlaza womlomo wesibeleko.

Iiparameters zobugcisa

Indawo yokugcina izinto ≤ -18℃
Beka ubomi kwishelufa Iinyanga ezili-12
Uhlobo lweSibonelelo Uirayiniisampuli,Fisampuli ye-emale cervical swab, Fisampuli ye-emale vaginal swab
CV <5.0%
I-LoD Umda woKuchongwa (i-LoD): I-LoD yekhithi yi-300Cii-opioids/mL
Ukuchaneka Akukho mpendulo idibeneyokunye neentsholongwane ezifanayo.
Izixhobo Ezisebenzayo Inkqubo ye-PCR ye-Applied Biosystems 7500 Real-Time, Iinkqubo ze-PCR ze-Applied Biosystems 7500 Fast Real-Time, Iinkqubo ze-PCR ze-QuantStudio®5 Real-Time, Iinkqubo ze-PCR ze-SLAN-96P Real-Time (Hongshi Medical Technology Co., Ltd.), Iinkqubo ze-PCR ze-LightCycler®480 Real-Time, Iinkqubo ze-PCR ze-LineGene 9600 Plus Real-Time Detection (FQD-96A,IHangzhouItekhnoloji yeBioer), i-MA-6000 Real-Time Quantitative Thermal Cycler (Suzhou Molarray Co., Ltd.), iBioRad CFX96 Real-Time PCR System kunye neBioRad CFX Opus 96 Real-Time PCR System.

 

Itshaneli:

I-Reaction Buffer I-Fluorophore Umcimi-mlilo
I-PCR-Mix1/PCR-Mix2 I-FAM akukho nanye
I-VIC(I-HEX) akukho nanye
I-ROX akukho nanye
CY5 akukho nanye

Ukuhamba komsebenzi: Jonga iKit IFU ukuze ufumane iinkcukacha

Isisombululo 1 (Ukukhupha i-nucleic acid ngokuzenzekelayo)

2

Isisombululo sesi-2: (I-Macro kunye ne-Micro-Test Sample Release Reagent)

3

Ii-reagents zifuna kodwa azibonelelwanga:I-Macro & Micro-Test Sample Release Reagent (HWTS-3005-8), i-Macro & Micro-Test Viral DNA/RNA Kit (HWTS-3017) (engasetyenziswa kunye ne-Macro & Micro-Test Automatic Nucleic Acid Extractor (HWTS-EQ011)) yiJiangsu Macro & Micro-Test Med-Tech Co., Ltd., i-Macro & Micro-Test Viral DNA/RNA Column (HWTS-3020-50).

Izinto ezisetyenziswayo kufuneka kodwa azibonelelwanga: Akukho DNase/RNase eyi-1.5mLci-entrifugetii-ubes,DImpumlo/RIingcebiso ezingenayo iNase, iityhubhu zePCR eziyi-0.2mL, i-desktop centrifuge, umxube we-desktop oscillation.


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