Izifo Eziyisithupha Zokuphefumula Eziyomisiwe Ngokuqandisa I-Nucleic Acid
Igama lomkhiqizo
Ikhithi Yokuthola Amagciwane Okuphefumula Ayisithupha Eyomisiwe Nge-HWTS-RT177 (i-Fluorescence PCR)
Ukuvunyelwa Komkhiqizo
I-IVDR
I-Epidemiology
Ukutheleleka komgudu wokuphefumula uhlobo oluvame kakhulu lwesifo kubantu, olungavela kunoma yisiphiubulili, ubudala kanye nesifunda, futhi ingenye yezimbangela ezibaluleke kakhulu zokugula nokufa emhlabeni [1]. Izifo zokuphefumula ezivame kakhulu emitholampilo zifaka phakathi igciwane lokuphefumula elihambisanayo, i-adenovirus, i-human metapneumovirus, i-rhinovirus, igciwane le-parainfluenza (I/II/III) kanye ne-mycoplasma pneumoniae, njll. [2,3]. Izimpawu zomtholampilo nezimpawu ezibangelwa ukutheleleka kwendlela yokuphefumula ziyafana, kodwa ukutheleleka okubangelwa yizifo ezahlukene kunezindlela zokwelapha ezahlukene, imiphumela yokwelapha kanye nendlela yesifo esiqhubeka ngayo [4,5]. Njengamanje, izindlela eziyinhloko zokuthola izifo zokuphefumula elabhorethri zifaka phakathi ukuhlukaniswa kwegciwane, ukutholwa kwe-antigen kanye nokutholwa kwe-nucleic acid, njll. Le khithi ithola futhi ihlonze ama-virtual nucleic acid athile kubantu abanezimpawu nezimpawu zokutheleleka kokuphefumula, kanye neminye imiphumela yezokwelapha neyelabhorethri ukusiza ekuxilongweni kokutheleleka kokuphefumula. Imiphumela yalolu vivinyo akufanele isetshenziswe njengesisekelo sodwa sokuxilongwa, ukwelashwa, noma ezinye izinqumo zokuphathwa kwesiguli.
Amapharamitha Obuchwepheshe
| Isitoreji | 2-28℃ |
| Isikhathi sokuphelelwa yisikhathi | Izinyanga ezingu-12 |
| Uhlobo Lwesifanekiso | i-swab ye-oropharyngeal yomuntu, i-nasopharyngeal swab |
| Ct | ≤38 |
| CV | <5.0% |
| I-LoD | Amakhophi angu-200/mL |
| Ukucaciswa | Ukusabela okuxubile: Akukho ukusabela okuxubile phakathi kwekhithi negciwane le-Human boca, i-Cytomegalovirus, igciwane le-Herpes simplex uhlobo 1, igciwane le-Varicella zoster, igciwane le-Epstein-barr, i-Bacillus pertussis, i-Chlamydia pneumoniae, i-Corynebacterium, i-Escherichia coli, i-Haemophilus influenzae, i-Lactobacillus, i-Legionella pneumophila, i-Moraxella catarrhalis, izinhlobo ezincishisiwe zesifo sofuba se-mycobacterium, i-Neisseria meningitidis, i-Neisseria spp. (Neisseria gonorrhoeae), i-Pseudomonas aeruginosa, i-Staphylococcus aureus, i-Staphylococcus epidermidis, i-Streptococcus pneumoniae, i-IFV A, i-IFV B, i-Parainfluenza IV, i-SARS-CoV-2, i-Coronavirus (HKU1), i-Coronavirus (OC43), i-Coronavirus (NL63). |
| Izinsimbi Ezisebenzayo | Uhlobo I: Izinhlelo ze-Biosystems ezisetshenzisiwe 7500 Real-Time PCR, SLAN-96P Izinhlelo ze-PCR Zesikhathi Sangempela (i-Hongshi Medical Technology Co., Ltd.). Ukuhlolwa kohlobo lwesibili: i-EudemonTM AIO800 (HWTS-EQ007) yi-Jiangsu Macro kanye I-Micro-Test Med-Tech Co., Ltd. |
Ukugeleza Komsebenzi
Uhlobo I: Kuhlelo lwe-PCR olujwayelekile
Uhlobo II: Ku-EudemonTMI-AIO800
Kudingeka ama-reagent/izinsimbi kodwa azinikezwanga
I-Macro & Micro-Test Viral DNA/RNA Kit (HWTS-3017) (engasetshenziswa ne-Macro & MicroTest Automatic Nucleic Acid Extractor (HWTS-EQ011)) yi-Jiangsu Macro & Micro-Test MedTech Co., Ltd. kanye ne-Macro & Micro-Test Viral DNA/RNA Kit (HWTS-3017-8) (esetshenziswa ne-I-EudemonTM AIO800) yi-Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.Isixazululo sokulondolozwa kwesampula: Isixazululo se-sodium chloride esingu-0.9%, Ikhithi Yokusampula Yegciwane (MT0301-1) ngeInkampani ye-Yocon Biology Technology (Beijing), i-UTM® Universal Transport Medium™ (GXB No.: 20191277) yi-Copan Italia SpA, Ikhithi Yokuqoqa Amasampula, Ukuthumela Iposi Nokuthumela (HWTS-3002) yi-Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Izinto ezisetshenziswayo zidinga kodwa azinikezwa:Amathiphu angenazo i-DNase/RNase, Amagilavu alahlwayo, ishubhu le-EP elingenayo i-DNase/RNase, i-Magnetic bead extractor noma i-magnetic rack.
