I-HIV HCV HBSAG Ethathelwanayo KANYE NOkuhlolwa kwe-Syphilish Rapid Combo
ULWAZI LOKHIQIZA
| Inombolo Yemodeli | I-HBsAg/TP&HIV/HCV | Ukupakisha | Izivivinyo ezingama-20/ikhithi, 30kits/CTN |
| Igama | HBsAg/TP&HIV/HCV Rapid Combo Test | Ukuhlukaniswa kwezinsimbi | Ikilasi III |
| Izici | Ukuzwela okuphezulu, ukusebenza okulula | Isitifiketi | CE/ ISO13485 |
| Ukunemba | > 97% | Impilo yeshelufu | Iminyaka Emibili |
| Indlela yokwenza | Igolide le-Colloidal | Isevisi ye-OEM/ODM | Iyatholakala |
Ukuphakama
Isikhathi sokuhlola: 15-20mins
Isitoreji:2-30℃/36-86℉
Indlela yokwenza: Igolide le-Colloidal
Isici:
• Ukuzwela okuphezulu
• umphumela wokufundwa emizuzwini eyi-15-20
• Ukusebenza okulula
• Ukunemba okuphezulu
UKUSETSHENZISWA OKUHLOSIWE
Le kit ilungele ukunqunywa kwekhwalithi ye-in vitro yegciwane le-hepatitis B, i-syphilis spirochete, i-human immunodeficiency virus, kanye negciwane le-hepatitis C ku-serum/plas-ma/lonke amasampula egazi okuxilongwa okuyisizayo kwegciwane le-hepatitis B, i-syphilis spirochete, i-human immunodeficiency virus, kanye nezifo zegciwane le-hepatitis C. Imiphumela etholiwe kufanelezihlaziywe ngokuhambisana nolunye ulwazi lomtholampilo. Ihloselwe ukusetshenziswa ochwepheshe bezokwelapha kuphela.
Inqubo yokuhlola
| 1 | Funda imiyalelo yokusetshenziswa futhi ngokuhambisana ngokuqinile nemiyalelo yokusetshenziswa okudingekayo ukuze ugweme ukuthikameza ukunemba kwemiphumela yokuhlolwa. |
| 2 | Ngaphambi kokuhlolwa, ikhithi nesampula kukhishwa esimweni sokugcina bese kulinganisa izinga lokushisa legumbi bese limaka. |
| 3 | Iklebhula iphakethe lesikhwama se-aluminium foil, khipha idivayisi yokuhlola bese uyimaka, bese uyibeka ivundlile etafuleni lokuhlola. |
| 4 | Amasampula e-aspirate serum/plasma ane-dropper elahlayo futhi engeza amaconsi angu-2 kumthombo ngamunye s1 no-s2; engeza amathonsi ama-3 emthonjeni ngamunye s1 kanye no-s2 ukuze uthole amasampula egazi lonke ngaphambi kokwengeza amathonsi angu-1~2 esixazululo sokugeza emthonjeni ngamunye s1 no-s2 futhi Isikhathi siyaqalwa. |
| 5 | Imiphumela yokuhlolwa kufanele ihunyushwe phakathi kwemizuzu eyi-15 ~ 20, uma imiphumela etolikiwe engaphezu kwemizuzu engama-20 ingavumelekile. |
| 6 | Ukuhumusha okubonakalayo kungasetshenziswa ekuchazeni umphumela. |
Qaphela: isampula ngayinye izofakwa ngepayipi ngepayipi elahlwayo elihlanzekile ukuze kugwenywe ukungcoliswa okuphambanayo.
UKUSEBENZA KOMTHOLAMPILO
| Imiphumela ye-WIZ yeHBsag
| Umphumela wokuhlola we-Reference reagent | Izinga lokuqondana okuhle:99.06% (95%CI 96.64%~99.74%) Izinga lokuqondana okubi:98.69% (95%CI96.68%~99.49%) Isamba sezinga lokuqondana:98.84% (95%CI97.50%~99.47% | ||
| Okuhle | Okubi | Ingqikithi | ||
| Positve | 211 | 4 | 215 | |
| Okubi | 2 | 301 | 303 | |
| Ingqikithi | 213 | 305 | 518 | |
| Imiphumela ye-WIZ yeTP
| Umphumela wokuhlola we-Reference reagent | Izinga lokuqondana okuhle:96.18% (95%CI 91.38%~98.36%) Izinga lokuqondana okubi:97.67% (95%CI95.64%~98.77%) Isamba sezinga lokuqondana:97.30% (95%CI95.51%~98.38%) | ||
| Okuhle | Okubi | Ingqikithi | ||
| Positve | 126 | 9 | 135 | |
| Okubi | 5 | 378 | 383 | |
| Ingqikithi | 131 | 387 | 518 | |
| Imiphumela ye-WIZ yeI-HCV
| Umphumela wokuhlola we-Reference reagent | Izinga lokuqondana okuhle:93.44% (95%CI 84.32%~97.42%) Izinga lokuqondana elibi:99.56% (95%CI98.42%~99.88%) Isamba sezinga lokuqondana:98.84% (95%CI97.50%~99.47%) | ||
| Okuhle | Okubi | Ingqikithi | ||
| Positve | 57 | 2 | 59 | |
| Okubi | 4 | 455 | 459 | |
| Ingqikithi | 61 | 457 | 518 | |
| Imiphumela ye-WIZ yeI-HIV
| Umphumela wokuhlola we-Reference reagent | Izinga lokuqondana okuhle:96.81% (95%CI 91.03%~98.91%) Izinga lokuqondana elibi:99.76% (95%CI98.68%~99.96%) Isamba sezinga lokuqondana:99.23% (95%CI98.03%~99.70%) | ||
| Okuhle | Okubi | Ingqikithi | ||
| Positve | 91 | 1 | 92 | |
| Okubi | 3 | 423 | 446 | |
| Ingqikithi | 94 | 424 | 518 | |
