Viris Grip A / Viris Grip B
Non pwodwi
HWTS-RT176-Twous Deteksyon Asid Nikleyik Viris Grip A/Viris Grip B ki seche nan frizè (PCR fliyoresans)
Apwobasyon pwodwi
IVDR
Epidemyoloji
Selon diferans antijenik ki genyen ant jèn NP ak M yo, viris grip lakapab divize an kat kalite: viris grip A (IFV A), viris grip B (IFV B),viris grip C (IFV C) ak viris grip D (IFV D) [1]. Pou viris grip A,Li gen anpil lame ak serotip konplèks epi li ka gaye nan mitan lame yo atravèrekombinasyon jenetik ak mitasyon adaptatif. Moun pa gen iminite dirab kontviris grip A a, kidonk moun tout laj jeneralman sansib. Viris grip Ase patojèn ki pi enpòtan ki lakòz pandemi grip [2]. Pou viris grip B a,Li gaye sitou nan ti zòn epi kounye a pa gen okenn soutip. Moun nanEnfeksyon yo sitou koze pa viris grip B/Yamagata oswa B/Victorialiyaj. Pami ka grip konfime chak mwa nan 15 peyi nan laNan rejyon Azi Pasifik la, pousantaj dyagnostik viris grip B a varye ant 0 ak 92%.[3]. Kontrèman ak viris grip A a, sèten gwoup moun, tankou timoun akgranmoun aje yo, yo sansib a viris grip B a, ki ka fasilman lakòz konplikasyon,poze plis fado pou sosyete a pase viris grip A a [4].Yon rezilta negatif pa eskli enfeksyon IFV A/B epi li pa ta dwe itilize kòm mezisèl baz pou dyagnostik, tretman, oswa lòt desizyon jesyon. Yon pozitifRezilta a pa elimine enfeksyon bakteri oswa lòt ko-enfeksyon viral deyò IFV aViris A/B.
Paramèt teknik
| Depo | 2-28 ℃ |
| Dire lavi etajè | 12 mwa |
| Kalite echantiyon | prelèvman orofarenjyen imen, prelèvman nazofarenjyen |
| Ct | ≤38 |
| CV | <5.0% |
| LoD | 200 Kopi/mL oubyen 0.05TCID50/mL |
| Espesifikite | Reyaktivite kwaze: Pa gen okenn reyaktivite kwaze ant twous la ak Bocavirus, Viris respiratwa senkityal tip B, Viris Herpes simplex tip 1, Enterovirus, Adenovirus (Tip 1), Adenovirus (Tip 3), Adenovirus (Tip 7), SARS-CoV, Adenovirus (Tip 1), Adenovirus (Tip 3), Adenovirus (Tip 7), SARS-CoV, Norovirus, Streptococcus pneumoniae, Legionella, Bordetella pertussis, Neisseria gonorrhoeae, Aspergillus fumigatus, Moraxella catarrhalis, Rhinovirus, Viris Parainfluenza (Tip 1), Viris Parainfluenza (Tip 3), Viris Parainfluenza (Tip 2), Viris Varicella-zostèr, Viris lawoujòl, Kowonaviris imen, MERS-CoV, Chlamydia pneumoniae, Klebsiella pneumoniae, Pneumocystis jirovecii, Staphylococcus aureus, Candida albicans. Cryptococcus neoformans, Lactobacillus, Cytomegalovirus, Viris Epstein-Barr, Viris oreyon, Metapneumovirus imen (A1), Metapneumovirus imen (B2), Nouvo kowonaviris 2019-nCoV, Rotavirus, Mycoplasma pneumoniae, Streptococcus pyogenes, Haemophilus influenzae, Mycobacterium tuberculosis, Candida glabrata, Streptococcus salivarius, Corynebacterium, Viris grip A, Viris grip B, ADN jenomik imen |
| Enstriman Aplikab yo | Kalite I: Sistèm PCR an tan reyèl Applied Biosystems 7500, SLAN-96PSistèm PCR an tan reyèl (Hongshi Medical Technology Co., Ltd.). Tès tip II: EudemonTM AIO800 (HWTS-EQ007) pa Jiangsu Macro & Mikwo-Test Med-Tech Co., Ltd. |
Yo bezwen reyaktif/enstriman men yo pa bay yo
1) Twous Ekstraksyon ARN: Twous Makro & Makro & Mikwo-Tès ADN/ARN Viral(HWTS-3017) (ki ka itilize avèk Makro & Mikwo-Tès Nikleik OtomatikEkstraktè Asid (HWTS-EQ011)) pa Jiangsu Macro & Micro-Test Med-Tech Co.,Ltd., Twous Makro & Mikwo-Tès ADN/ARN Viral (HWTS-3017-8) (itilize avèkEudemonTM AIO800 (HWTS-EQ007) pa Jiangsu Macro & Micro-Test Med-TechKonpayi, Ltd.
2) Solisyon pou Prezève Echantiyon: Twous pou Pran Echantiyonaj Viris (JXZZ20182400236) paYocon Biology (Beijing) Co., Ltd., UTM® Universal Transport Medium™(GXB20191277) pa Copan Italia SpA, Koleksyon Echantiyon Makro & Mikwo-Tès,Twous pou voye lapòs ak anbake (HWTS-3002) pa Jiangsu Macro & Micro-Test Med-TechKonpayi, Ltd.
Konsomab nesesè men yo pa bay:Konsèy san DNase/RNase, gan jetab,Tib EP san DNase/RNase.









