18 Nooc oo ah Fayraska Papilloma-ga Aadanaha ee Khatarta Sare leh (Qoraalka 16/18) Qalabka Ogaanshaha Aashitada Nukliyeerka (Fluorescence PCR)

Sharaxaad Gaaban:

Koodhka Badeecada

HWTS-CC018B

Ansixinta Badeecada

CE, TFDA

Isticmaalka Loogu Talogalay

Qalabkani wuxuu ku habboon yahay ogaanshaha tayada ee in vitro ee 18 nooc oo fayrasyada papilloma-da aadanaha (HPV) (HPV16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73, 82) jajabyada gaarka ah ee aashitada nucleic ee muunadaha kaadida aadanaha, muunadaha suufka afka ilmo-galeenka dumarka, muunadaha suufka siilka dumarka iyo nooca HPV 16/18.


Faahfaahinta Badeecada

Calaamadaha Alaabta

Magaca alaabta

18 Nooc oo ah Fayraska Papilloma-ga Aadanaha ee Khatarta Sare leh (Qoraalka 16/18) Qalabka Ogaanshaha Aashitada Nukliyeerka (Fluorescence PCR)

Cudurrada Faafa

Fayraska Human Papillomavirus (HPV) wuxuu ka tirsan yahay qoyska Papillomaviridae ee molecule yar, aan la daboolin, oo wareegsan oo fayras DNA ah oo laba jibbaaran, oo dhererkiisu yahay hidde-side qiyaastii 8000 oo lammaane saldhig ah (bp). HPV wuxuu ku dhacaa aadanaha iyada oo loo marayo taabasho toos ah ama aan toos ahayn oo lala yeesho walxaha wasakhaysan ama gudbinta galmada. Fayrasku ma aha oo kaliya mid gaar u ah martida, laakiin sidoo kale waa mid gaar u ah unugyada, wuxuuna ku dhici karaa oo keliya maqaarka aadanaha iyo unugyada epithelial-ka xuubka, isagoo sababa noocyo kala duwan oo papillomas ama burooyinka maqaarka aadanaha iyo dhaawac faafa oo ku dhaca epithelium-ka habka taranka.

Kansarka ilmo-galeenka waa mid ka mid ah burooyinka ugu badan ee ku dhaca habka taranka dumarka. Daraasaduhu waxay muujiyeen in caabuqyada joogtada ah ee HPV iyo caabuqyada badan ay yihiin mid ka mid ah sababaha ugu waaweyn ee kansarka ilmo-galeenka. Waqtigan xaadirka ah, daawaynta waxtarka leh ee la aqoonsan yahay weli ma jiraan kansarka ilmo-galeenka ee uu keeno HPV, sidaa darteed helitaanka hore iyo ka hortagga caabuqa ilmo-galeenka ee uu sababo HPV waa furaha ka hortagga kansarka ilmo-galeenka. Waa muhiimad weyn in la sameeyo baaritaan fudud, gaar ah oo degdeg ah oo lagu ogaanayo cudurka kansarka ilmo-galeenka si loo ogaado cudurka iyo daaweynta kansarka ilmo-galeenka.

Kanaal

Kaydka Falcelinta Weriyaha Dab-damiye
Kaydka Falcelinta 18HPV FAM Midna ma jiro
VIC (HEX) Midna ma jiro
ROX Midna ma jiro
CY5 Midna ma jiro

Halbeegyada Farsamada

Kaydinta ≤ -18℃
Muddada khaanadaha 12 bilood
Nooca Muunada Kaadida, muunadda suufka afka ilmo-galeenka dumarka, muunadda suufka siilka dumarka
CV <5.0%
LoD Xadka Ogaanshaha (LoD): LoD ee xirmada waa 300 Nuqullo/mL
Gaar ahaanshaha Ma jiro wax falcelin isdhaafsi ah oo lala yeesho jeermisyada kale ee la xiriira taranka iyo DNA-da hidde-sidaha aadanaha.
Qalabka Khuseeya Nidaamyada PCR-ka ee Waqtiga-dhabta ah ee SLAN-96P (Hongshi Medical Technology Co., Ltd.), Nidaamyada PCR-ka ee Waqtiga-dhabta ah ee la Adeegsado ee Biosystems 7500, Nidaamyada PCR-ka ee Waqtiga-dhabta ah ee la Adeegsado ee Biosystems 7500, Nidaamyada PCR-ka ee Waqtiga-dhabta ah ee QuantStudio®5, Nidaamyada PCR-ka ee Waqtiga-dhabta ah ee LightCycler®480, Nidaamyada Ogaanshada PCR-ka ee LineGene 9600 Plus (FQD-96A, Tiknoolajiyadda Hangzhou Bioer) iyo MA-6000 Wareegga Kulaylka ee Waqtiga-dhabta ah ee MA (Suzhou Molarray Co., Ltd.), Nidaamka PCR-ka ee Waqtiga-dhabta ah ee BioRad CFX96, Nidaamka PCR-ka ee Waqtiga-dhabta ah ee BioRad CFX Opus 96.

Socodka Shaqada: Faahfaahin dheeraad ah ka eeg Qalabka IFU

Xalka 1 (Soo saarista aashitada nukliyeer-ka ee otomaatiga ah)

Socodka Shaqada Fiiri Qalabka IFU wixii faahfaahin ah Xalka 1aad

Xalka 2aad: (Macro & Micro-Test Reagent oo ah wakiilka sii deynta muunadda)

Socodka Shaqada Fiiri Qalabka IFU wixii faahfaahin ah Xalka 2

Reagent-yadu waxay u baahan yihiin laakiin lama bixin

Wakiilka Soo-saarista Muunadda ee Macro & Micro-Test (HWTS-3005-8), Qalabka DNA/RNA ee Macro & Micro-Test ee Viral (HWTS-3017) (kaas oo loo isticmaali karo Macro & Micro-Test Automatic Nucleic Acid Extractor (HWTS-EQ011)) oo ay samaysay Jiangsu Macro & Micro-Test Med-Tech Co., Ltd., Macro & Micro-Test Viral DNA/RNA Column (HWTS-3020-50).

Qalabka la isticmaalo waa loo baahan yahay laakiin lama bixin

1.5mL oo ah tuubooyinka centrifuge-ka ee aan lahayn DNase/RNase, talooyin aan lahayn DNase/RNase, 8-tuubo oo loogu talagalay PCR, centrifuge-ka desktop-ka, isku-darka vortex-ka desktop-ka.


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