Ukutheleleka okutheleleki nge-HIV HCV HCG kanye ne-Syphilish Rapid COMBO AYVER
Imininingwane yokukhiqiza
| Inombolo yemodeli | I-HBSAG / TP ne-HIV / HCV | Ukufaka ndawonye | Izivivinyo ezingama-20 / kit, 30Kits / CTN |
| Ibizo | I-HBSAG / TP ne-HIV / HCV Rapid Combo Test | Ukuhlukaniswa Kwensimbi | Iklasi III |
| Izici | Ukuzwela okuphezulu, ukuvakasha okulula | Isitifiketi | Ce / iso13485 |
| Ukuqonda nqo | > 97% | Impilo yeshelufu | Iminyaka emibili |
| Ukuhlahlela | Igolide le-colloidal | Isevisi ye-OEM / ODM | Kuyabonakala |
Ukuhamba phambili
Isikhathi Sokuhlola: 15-20mins
Isitoreji: 2-30 ℃ / 36-86 ℉
Indlela: Igolide leColloidal
Isici:
• Ubucayi obukhulu
• umphumela wokufunda ngemizuzu engu-15-20
• Ukusebenza okulula
• ukunemba okuphezulu
Ukusetshenziswa okuhlosiwe
Le khithi ilungele ukunqunywa kwe-vitro okufanelekile kwe-hepatitis B virus, i-syphilis Spirochete, i-hepatitis c virus e-sount serum / plas-Amasampula egazi aphelele wokuxilongwa okusizayo kwegciwane le-hepatitis B, i-Syphilis Spirochete, i-Hepatitis C Virus Effors. Imiphumela etholakele kufanelezihlaziywe ngokubambisana neminye imininingwane yomtholampilo. Yenzelwe ukusetshenziswa ngochwepheshe bezokwelapha kuphela.
Inqubo yokuhlola
| 1 | Funda umyalo wokusebenzisa futhi ngokuhambisana ngokuqinile nemiyalo yokusebenzisa umsebenzi odingekayo ukugwema ukunemba kwemiphumela yokuhlolwa |
| 2 | Ngaphambi kokuhlolwa, ikhithi kanye nesampula kuthathwe esimweni se-TheStorage futhi kulinganiselwe ekushiseni kwegumbi bese kuphawula. |
| 3 | Ukudwengula ukufakwa kwe-aluminium foil pauch, khipha idivaysi yokuhlola bese umaka, bese uyibeka ngokuqondile etafuleni lokuhlola. |
| 4 | Amasampula we-serum / ama-plasma ane-dropper elahlekile futhi angeze amaconsi ama-2 e-Wells ngayinye ye-S1 ne-S2; Faka amaconsi ama-3 e-Wells e-S1 ngayinye nama-S2 amasampula egazi wonke ngaphambi kokungeza amaconsi ayi-1 ~ 2 wesisombululo sokuhlanza i-Wells S1 ne-S2 bese kuqalwa isikhathi |
| 5 | Imiphumela yokuhlola kufanele ihunyushwe kungakapheli imizuzu eyi-15 ~ 20, uma imiphumela engaphezu kwama-20 min min ehunyushwa ayilungile. |
| 6 | Ukuhumusha okubukwayo kungasetshenziswa ngokuchazwa kwemiphumela. |
Qaphela: Isampula ngayinye izoba ngepayipi nge-pipette ehlanzekile yokulahla ukuze igweme ukungcoliswa kwesiphambano.
Ukusebenza kwemitholampilo
| Imiphumela ye-Wiz yeI-HBSAG
| Umphumela wokuhlola we-reagent reference | Isilinganiso esifanele sokuhlangana: 99.06% (95% CI 96.64% ~ 99.74%) Izinga elingezinhle zokuhlangana: 98.69% (95% CI96.68% ~ 99.49%) Inani eliphelele lokuhlangana: 98.84% (95% CI97.50% ~ 99.47% | ||
| -Qinisile | -Phikisayo | -Nke | ||
| Positve | 211 | 4 | 215 | |
| -Phikisayo | 2 | 301 | 305 | |
| -Nke | 213 | 305 | 518 | |
| Imiphumela ye-Wiz yeTP
| Umphumela wokuhlola we-reagent reference | Isilinganiso esihle sokuhlangana: 96.18% (95% CI 91.38% ~ 98.36%) Izinga Elingezinhle Zokuhlangana: 97.67% (95% CI95.64% ~ 98.77%) Inani eliphelele lokuhlangana: 97.30% (95% CI95.51% ~ 98.38%) | ||
| -Qinisile | -Phikisayo | -Nke | ||
| Positve | I-126 | 9 | 135 | |
| -Phikisayo | Okuthengwa edolo | 378 | 383 | |
| -Nke | 131 | I-387 | 518 | |
| Imiphumela ye-Wiz yeI-HCV
| Umphumela wokuhlola we-reagent reference | Inani elifanele lokuhlangana: 93.44% (95% CI 84.32% ~ 97.42%) Izinga elingezinhle zokuhlangana: 99.56% (95% CI98.42% ~ 99.88%) Inani eliphelele lokuhlangana: 98.84% (95% CI97.50% ~ 99.47%) | ||
| -Qinisile | -Phikisayo | -Nke | ||
| Positve | I-57 | 2 | 59 | |
| -Phikisayo | 4 | 455 | 459 | |
| -Nke | 61 | I-457 | 518 | |
| Imiphumela ye-Wiz yeIchusheni
| Umphumela wokuhlola we-reagent reference | Isilinganiso esihle sokuhlangana: 96.81% (95% CI 91.03% ~ 98.91%) Izinga elingezinhle zokuhlangana: 99.76% (95% CI98.68% ~ 99.96%) Inani eliphelele lokuhlangana: 99.23% (95% CI98.03% ~ 99.70%) | ||
| -Qinisile | -Phikisayo | -Nke | ||
| Positve | 91 | 1 | 92 | |
| -Phikisayo | + | 423 | 446 | |
| -Nke | 94 | 424 | 518 | |
