Virusi ya Papilloma y'abantu (ubwoko 28) Isesengura ry'imiterere y'uturemangingo tw'umubiri

Virusi ya Papillomavirusi y'abantu (ubwoko 28) Ishusho y'imiterere y'ibinyabuzima

Ibisobanuro bigufi:

Kwemeza Ibicuruzwa

CE, Minisiteri y'Ubuzima ya Seribiya, TFDA, AMPS

Iyi mashini ikoreshwa mu gupima aside nucleic y’ubwoko 28 bwa virusi ya papilloma y’umuntu (HPV6, 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) mu nkari z’abagabo n’abagore n’uturemangingo tw’inkondo y’umura tw’abagore, itanga uburyo bw’inyongera bwo gusuzuma no kuvura ubwandu bwa HPV.

Ohereza imeri kuri twe

Ibisobanuro birambuye ku gicuruzwa

Ibirango by'ibicuruzwa

Izina ry'igicuruzwa

HWTS-CC013-Human Papillomavirus (Ubwoko 28) Igikoresho cyo Gupima Genotype (Fluorescence PCR)

HWTS-CC016A-Ifite Papillomavirusi y’umuntu yumye mu buryo bwa “Konjesha” (ubwoko 28) Ifite Agakoresho ko Gupima Genotype (Fluorescence PCR)

Ubumenyi bw'indwara

Kanseri y'inkondo y'umura ni kimwe mu bibyimba bibi bikunze kugaragara mu myanya myibarukiro y'abagore. Ubushakashatsi bwakozwe mbere bwagaragaje ko kwandura indwara zidakira no kwandura virusi nyinshi za papillomavirusi y'umuntu ari imwe mu mpamvu zikomeye zitera kanseri y'inkondo y'umura. Kuri ubu, haracyari ikibazo cyo kubura uburyo bwiza bwo kuvura HPV, bityo kumenya HPV y'inkondo y'umura hakiri kare no kuyirinda hakiri kare ni byo bintu byo gukumira kanseri. Gushyiraho uburyo bworoshye, bwihariye kandi bwihuse bwo gusuzuma indwara ni ingenzi cyane mu gusuzuma kanseri y'inkondo y'umura.

Umuyoboro

Ikimenyetso cy'ibiza	FAM	VIC/HEX	ROX	CY5
Uburyo bwo Gupima Indwara ya HPV mu Guhindura Ingirabuzimafatizo 1	16	18	/	Igenzura ry'imbere
Uburyo bwo Guhindura Ingirabuzimafatizo za HPV mu Gupima Ubwinshi bw'Ingirabuzimafatizo 2	56	/	31	Igenzura ry'imbere
Uburyo bwo Gupima Ingirabuzimafatizo za HPV mu Gupima Ingirabuzimafatizo 3	58	33	66	35
Uburyo bwo Gupima Ingirabuzimafatizo za HPV 4	53	51	52	45
Uburyo bwo Gupima Ingirabuzimafatizo za HPV 5	73	59	39	68
Uburyo bwo Gupima Indwara ya HPV 6	6	11	83	54
Uburyo bwo Gupima Ingirabuzimafatizo za HPV 7	26	44	61	81
Uburyo bwo Gupima Ingirabuzimafatizo za HPV 8	40	43	42	82

Ibipimo bya tekiniki

Ububiko	Amazi: ≤-18℃
Igihe cyo kumara	Amezi 12
Ubwoko bw'ingero	Igitambaro cyo mu nda, Igitambaro cyo mu gitsina, Inkari
Ct	≤28
CV	≤5.0%
LoD	Kopi 300/mL
umwihariko	Ibisubizo byose biba bibi iyo agakoresho gakoreshejwe mu gupima ingero zitari izihariye zifite ingaruka zijyanye na ko, harimo ureaplasma urealyticum, chlamydia trachomatis yo mu myanya ndangagitsina, candida albicans, neisseria gonorrhoeae, trichomonas vaginalis, mold, gardnerella n'izindi ndwara za HPV zitari muri ako gakoresho.
Ibikoresho Bikoreshwa	Sisitemu ya PCR ikoreshwa mu gihe nyacyo ya 7500 Sisitemu za PCR zikoreshwa mu buryo bwihuse 7500 QuantStudio^®Sisitemu 5 za PCR mu gihe nyacyo Sisitemu za PCR za SLAN-96P mu gihe nyacyo LightCycler^®Sisitemu 480 za PCR mu gihe nyacyo Sisitemu zo Gusuzuma za LineGene 9600 Plus mu gihe nyacyo MA-6000 Umuvuduko w'ubushyuhe mu gihe nyacyo Sisitemu ya BioRad CFX96 ya PCR mu gihe nyacyo Sisitemu ya BioRad CFX Opus 96 ya PCR mu gihe nyacyo

Urugendo rw'akazi

Reba Kit IFU kugira ngo umenye byinshi
Igisubizo cya 1 (Gukuramo aside nucleique mu buryo bwikora)

Reba Kit IFU kugirango umenye ibisobanuro birambuye Igisubizo cya 1

Igisubizo cya 2: (Icyitegererezo cyo gusohora icyitegererezo cya Macro na Micro-Test)

Reba Kit IFU kugirango umenye ibisobanuro birambuye Igisubizo cya 2

Reagents zikenewe ariko ntizitangwa

Ikizamini cya Macro & Micro-Test Release Reagent (HWTS-3005-8), Macro & Micro-Test Viral DNA/RNA Kit (HWTS-3017) (ishobora gukoreshwa hamwe na Macro & Micro-Test Automatic Nucleic Acid Extractor (HWTS-3006B, 3006C)) na Jiangsu Macro & Micro-Test Med-Tech Co., Ltd., Macro & Micro-Test Viral DNA/RNA Column (HWTS-3020-50).

Ibikoresho bikoreshwa bigomba ariko ntibitangwa

1.5mL y'imiyoboro ya centrifuge ya DNase/RNase-Free, DNase/RNase-Free tips, 0.2mL y'imiyoboro ya PCR, centrifuge ya desktop, na mixer ya desktop oscillation.

Ibanjirije iyi: Ubwoko 28 bwa Virusi ya Papilloma y'Umuntu (Type 16/18) ya aside nucleic

Ibikurikira: Ubwoko 15 bwa virusi ya papilloma y'abantu ifite ibyago byinshi byo kurwara kanseri y'uruhu E6/E7 Gene mRNA

Andika ubutumwa bwawe hano hanyuma ubwoherereze